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{\f229\fswiss\fcharset0\fprq2{\*\panose 020b0606030402020204}Franklin Gothic Medium Cond;}{\f230\fscript\fcharset0\fprq2{\*\panose 03020402040607040605}French Script MT;}{\f231\froman\fcharset0\fprq2{\*\panose 0204060206030a020304}Footlight MT Light;} {\f232\froman\fcharset0\fprq2{\*\panose 02030808020601010101}Gloucester MT Extra Condensed;}{\f233\fswiss\fcharset0\fprq2{\*\panose 020b0802020104020203}Gill Sans MT Ext Condensed Bold;} {\f234\froman\fcharset0\fprq2{\*\panose 02020502050305020303}Goudy Old Style;}{\f235\froman\fcharset0\fprq2{\*\panose 0202090407030b020401}Goudy Stout;}{\f236\fscript\fcharset0\fprq2{\*\panose 03080302020302020206}Gradl;} {\f237\fdecor\fcharset0\fprq2{\*\panose 04040505050a02020702}Harrington;}{\f238\fnil\fcharset2\fprq2{\*\panose 05010101010101010101}Holidays MT;}{\f239\fdecor\fcharset0\fprq2{\*\panose 04020605060303030202}Imprint MT Shadow;} {\f240\fdecor\fcharset0\fprq2{\*\panose 04040403040a02020202}Juice ITC;}{\f241\fnil\fcharset2\fprq2{\*\panose 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04040403030d02020704}Matisse ITC;} {\f255\fscript\fcharset0\fprq2{\*\panose 03020802060602070202}Matura MT Script Capitals;}{\f256\fnil\fcharset0\fprq2{\*\panose 00000000000000000000}Mead Bold;}{\f257\fnil\fcharset0\fprq2{\*\panose 01010101010101010101}Mercurius Script MT Bold;} {\f258\fscript\fcharset0\fprq2{\*\panose 03090702030407020403}Mistral;}{\f259\froman\fcharset0\fprq2{\*\panose 02070704070505020303}Modern No. 20;}{\f260\fnil\fcharset2\fprq2{\*\panose 01010601010101010101}Monotype Sorts;} {\f261\fswiss\fcharset0\fprq2{\*\panose 020b0504020203020204}News Gothic MT;}{\f262\fmodern\fcharset0\fprq2{\*\panose 02010509020102010303}OCR A Extended;}{\f263\fdecor\fcharset0\fprq2{\*\panose 04050602080702020203}Onyx;} {\f264\fnil\fcharset2\fprq2{\*\panose 05000000000000000000}MS Outlook;}{\f265\fnil\fcharset2\fprq2{\*\panose 05010101010101010101}Parties MT;}{\f266\froman\fcharset0\fprq2{\*\panose 02020502060401020303}Perpetua;} {\f267\froman\fcharset0\fprq2{\*\panose 02020502060505020804}Perpetua Titling MT;}{\f268\fswiss\fcharset0\fprq2{\*\panose 020b0606030402050204}Placard Condensed;}{\f269\fdecor\fcharset0\fprq2{\*\panose 040506030a0602020202}Playbill;} {\f270\fdecor\fcharset0\fprq2{\*\panose 040c0101020201010102}Ransom;}{\f271\froman\fcharset0\fprq2{\*\panose 02060603050405020104}Rockwell Condensed;}{\f272\froman\fcharset0\fprq2{\*\panose 02060603020205020403}Rockwell;} {\f273\froman\fcharset0\fprq2{\*\panose 02060903040505020403}Rockwell Extra Bold;}{\f274\fnil\fcharset2\fprq2{\*\panose 05010101010101010101}Signs MT;}{\f275\fdecor\fcharset0\fprq2{\*\panose 04040a07060a02020202}Snap ITC;} {\f276\fnil\fcharset2\fprq2{\*\panose 05010101010101010101}Sports Two MT;}{\f277\fnil\fcharset2\fprq2{\*\panose 05010101010101010101}Sports Three MT;}{\f278\fdecor\fcharset0\fprq2{\*\panose 040409050d0802020404}Stencil;} {\f279\fdecor\fcharset0\fprq2{\*\panose 04020404030d07020202}Tempus Sans ITC;}{\f280\fnil\fcharset2\fprq2{\*\panose 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{\f440\fmodern\fcharset0\fprq1 MS Gothic Western{\*\falt \'82\'6c\'82\'72 \'83\'53\'83\'56\'83\'62\'83\'4e};}{\f438\fmodern\fcharset238\fprq1 MS Gothic CE{\*\falt \'82\'6c\'82\'72 \'83\'53\'83\'56\'83\'62\'83\'4e};} {\f439\fmodern\fcharset204\fprq1 MS Gothic Cyr{\*\falt \'82\'6c\'82\'72 \'83\'53\'83\'56\'83\'62\'83\'4e};}{\f441\fmodern\fcharset161\fprq1 MS Gothic Greek{\*\falt \'82\'6c\'82\'72 \'83\'53\'83\'56\'83\'62\'83\'4e};} {\f442\fmodern\fcharset162\fprq1 MS Gothic Tur{\*\falt \'82\'6c\'82\'72 \'83\'53\'83\'56\'83\'62\'83\'4e};}{\f445\fmodern\fcharset186\fprq1 MS Gothic Baltic{\*\falt \'82\'6c\'82\'72 \'83\'53\'83\'56\'83\'62\'83\'4e};} {\f450\fswiss\fcharset0\fprq2 Dotum Western{\*\falt \'b5\'b8\'bf\'f2};}{\f448\fswiss\fcharset238\fprq2 Dotum CE{\*\falt \'b5\'b8\'bf\'f2};}{\f449\fswiss\fcharset204\fprq2 Dotum Cyr{\*\falt \'b5\'b8\'bf\'f2};} {\f451\fswiss\fcharset161\fprq2 Dotum Greek{\*\falt \'b5\'b8\'bf\'f2};}{\f452\fswiss\fcharset162\fprq2 Dotum Tur{\*\falt \'b5\'b8\'bf\'f2};}{\f455\fswiss\fcharset186\fprq2 Dotum Baltic{\*\falt \'b5\'b8\'bf\'f2};} {\f470\fmodern\fcharset0\fprq1 MingLiU Western{\*\falt \'b2\'d3\'a9\'fa\'c5\'e9};}{\f490\fswiss\fcharset0\fprq2 Gulim Western{\*\falt \'b1\'bc\'b8\'b2};}{\f488\fswiss\fcharset238\fprq2 Gulim CE{\*\falt \'b1\'bc\'b8\'b2};} {\f489\fswiss\fcharset204\fprq2 Gulim Cyr{\*\falt \'b1\'bc\'b8\'b2};}{\f491\fswiss\fcharset161\fprq2 Gulim Greek{\*\falt \'b1\'bc\'b8\'b2};}{\f492\fswiss\fcharset162\fprq2 Gulim Tur{\*\falt \'b1\'bc\'b8\'b2};} {\f495\fswiss\fcharset186\fprq2 Gulim Baltic{\*\falt \'b1\'bc\'b8\'b2};}{\f517\froman\fcharset222\fprq2 Angsana New (Thai);}{\f527\fswiss\fcharset222\fprq2 Cordia New (Thai);}{\f548\froman\fcharset238\fprq2 Sylfaen CE;} {\f549\froman\fcharset204\fprq2 Sylfaen Cyr;}{\f551\froman\fcharset161\fprq2 Sylfaen Greek;}{\f552\froman\fcharset162\fprq2 Sylfaen Tur;}{\f555\froman\fcharset186\fprq2 Sylfaen Baltic;}{\f638\fswiss\fcharset238\fprq2 Tahoma CE;} {\f639\fswiss\fcharset204\fprq2 Tahoma Cyr;}{\f641\fswiss\fcharset161\fprq2 Tahoma Greek;}{\f642\fswiss\fcharset162\fprq2 Tahoma Tur;}{\f643\fswiss\fcharset177\fprq2 Tahoma (Hebrew);}{\f644\fswiss\fcharset178\fprq2 Tahoma (Arabic);} {\f645\fswiss\fcharset186\fprq2 Tahoma Baltic;}{\f646\fswiss\fcharset163\fprq2 Tahoma (Vietnamese);}{\f647\fswiss\fcharset222\fprq2 Tahoma (Thai);}{\f730\fscript\fcharset0\fprq2 Coronet;}{\f758\fmodern\fcharset238\fprq1 Lucida Console CE;} {\f759\fmodern\fcharset204\fprq1 Lucida Console Cyr;}{\f761\fmodern\fcharset161\fprq1 Lucida Console Greek;}{\f762\fmodern\fcharset162\fprq1 Lucida Console Tur;}{\f768\fswiss\fcharset238\fprq2 Lucida Sans Unicode CE;} {\f769\fswiss\fcharset204\fprq2 Lucida Sans Unicode Cyr;}{\f771\fswiss\fcharset161\fprq2 Lucida Sans Unicode Greek;}{\f772\fswiss\fcharset162\fprq2 Lucida Sans Unicode Tur;}{\f773\fswiss\fcharset177\fprq2 Lucida Sans Unicode (Hebrew);} {\f778\fswiss\fcharset238\fprq2 Verdana 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Tur;}{\f1062\fswiss\fcharset162\fprq2 Futura Lt BT Tur;}{\f1072\fdecor\fcharset162\fprq2 GoudyHandtooled BT Tur;} {\f1082\froman\fcharset162\fprq2 GoudyOlSt BT Tur;}{\f1092\fswiss\fcharset162\fprq2 Humanst521 BT Tur;}{\f1098\fswiss\fcharset238\fprq2 Kabel Bk BT CE;}{\f1101\fswiss\fcharset161\fprq2 Kabel Bk BT Greek;}{\f1102\fswiss\fcharset162\fprq2 Kabel Bk BT Tur;} {\f1108\fswiss\fcharset238\fprq2 Kabel Ult BT CE;}{\f1111\fswiss\fcharset161\fprq2 Kabel Ult BT Greek;}{\f1112\fswiss\fcharset162\fprq2 Kabel Ult BT Tur;}{\f1152\fscript\fcharset162\fprq2 OzHandicraft BT Tur;} {\f1158\froman\fcharset238\fprq2 PosterBodoni BT CE;}{\f1161\froman\fcharset161\fprq2 PosterBodoni BT Greek;}{\f1162\froman\fcharset162\fprq2 PosterBodoni BT Tur;}{\f1172\froman\fcharset162\fprq2 Serifa BT Tur;} {\f1182\froman\fcharset162\fprq2 Serifa Th BT Tur;}{\f1188\froman\fcharset238\fprq2 Souvenir Lt BT CE;}{\f1191\froman\fcharset161\fprq2 Souvenir Lt BT Greek;}{\f1192\froman\fcharset162\fprq2 Souvenir Lt BT 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\s24\qc \li0\ri0\sl300\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \b\scaps\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs40\insrsid10274 \par \par \par \par Making Sense of Commercial Speech: \par }\pard \s24\qc \li0\ri0\sl300\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\fs40\insrsid10274 A Theoretical Framework and A Case Study in Food and Drug Law \par }\pard\plain \ql \fi5790\li684\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin684\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\b\scaps\insrsid10274 \par \par \par \par \par \par \par }\pard \ql \fi720\li5040\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin5040\itap0 {\insrsid10274 \par \par \par \par }\pard \ql \fi540\li5040\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin5040\itap0 {\insrsid10274 Neel Sukhatme}{\super\insrsid10274 \par }{\insrsid10274 Harvard Law School \par Class of 2005 \par Third Year Written Work Requirement \par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\insrsid10274 \par }\pard \ql \fi540\li5040\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin5040\itap0 {\insrsid10274 April 22, 2005\sect }\sectd \marglsxn1800\margrsxn1800\linex0\endnhere\sectlinegrid360\sectdefaultcl\sftnbj \pard\plain \s6\qc \li0\ri0\sb480\sa120\keepn\widctlpar\aspalpha\aspnum\faauto\outlinelevel5\adjustright\rin0\lin0\itap0 \fs24\ul\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\scaps\ulnone\insrsid10274 Abstract \par }\pard\plain \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid10274 \par }\pard\plain \s17\ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid10274 This Note creates a theoretical fr amework for understanding commercial speech as a form of hybrid expression. It describes how commercial speech shares some features with expressive conduct and other characteristics with fully regulable \'93speech\'94 such as exterior product designs. It also discusses how courts have been increasingly treating commercial speech like core First Amendment expression, and how many food and drug regulations have been invalidated in recent years on commercial speech grounds. The Note explores the consequences of this doctrinal shift, and suggests strategies that food and drug regulators can use to immunize themselves from the commercial speech doctrine.}{\super\insrsid10274 \sect }\sectd \marglsxn1800\margrsxn1800\linex0\endnhere\sectlinegrid360\sectdefaultcl\sftnbj \pard\plain \s1\qc \li0\ri0\sb480\sa120\sl480\slmult1\keepn\widctlpar\noline\tx0\tx317\tx619\hyphpar0\aspalpha\aspnum\faauto\outlinelevel0\adjustright\rin0\lin0\itap0 \scaps\f287\fs22\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\insrsid10274 Introduction \par }\pard\plain \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid10274 Under}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 First}{ \expnd2\expndtw10\insrsid10274 }{\insrsid10274 Amendment}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 doctrine,}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 many}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 types}{ \expnd2\expndtw10\insrsid10274 }{\insrsid10274 of}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 speech}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 receive}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 the}{\expnd2\expndtw10\insrsid10274 }{ \insrsid10274 most}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 stringent}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 levels}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 of}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 constitutional}{ \expnd2\expndtw10\insrsid10274 }{\insrsid10274 protection,}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 whereas}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 other}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 types}{ \expnd2\expndtw10\insrsid10274 }{\insrsid10274 receive}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 no}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 protection}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 at}{\expnd2\expndtw10\insrsid10274 }{ \insrsid10274 all.}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 For}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 example,}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 some}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 categories}{ \expnd2\expndtw10\insrsid10274 }{\insrsid10274 of}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 speech,}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 such}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 as}{\expnd2\expndtw10\insrsid10274 }{ \insrsid10274 political}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 or}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 religious}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 speech,}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 are}{ \expnd2\expndtw10\insrsid10274 }{\insrsid10274 viewed}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 as}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 being}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 at}{\expnd2\expndtw10\insrsid10274 }{ \insrsid10274 the}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 core}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 of}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 the}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 First}{ \expnd2\expndtw10\insrsid10274 }{\insrsid10274 Amendment.}{\cs15\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\fs24\super\insrsid10274 *}{\insrsid10274 Neel Sukhatme is a John M. 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intermediate}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 scrutiny. \par }\pard\plain \s17\ql \fi684\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid10274 Having situated commercial speech within a hybrid speech framework, the Note then applies the doctrinal ideas discussed in the previous Parts in the particular context of food and drug law. Part VI begins this case study by exploring the history of regulation of speech in the food and drug law context. This Part notes how the amount and variety of speech regulation for foods and drugs has grown ove r the past century. \par }\pard \s17\ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\insrsid10274 \tab Part VII of the Note then discusses the growth of the commercial speech doctrine in the food and drug law context. The Part focuses on a number of recent cases in which speech regulations of foods or drugs have been invalidated under t he commercial speech doctrine. It also discusses how the burgeoning scope of the commercial speech doctrine has been placing increasing constraints on food and drug law regulation. \par }\pard \s17\ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\insrsid10274 Finally, Part VIII of the Note explores the road ahead \emdash if protection for commercial speech continues to become more stringent and is elevated to the strict scrutiny, what would be the consequences for food and drug law? 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lurk}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{ \f0\fs24\insrsid10274 just}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 outside}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 the}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 current}{ \f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 boundaries}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 of}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 the}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{ \f0\fs24\insrsid10274 First}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 Amendment,}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 and}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 they}{ \f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 are}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 difficult}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 to}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{ \f0\fs24\insrsid10274 distinguish}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 in}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 principle}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 from}{ \f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 commercial}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 speech.}{\cs15\fs24\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0 \widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\cs21\i\insrsid10274 See}{ \expnd1\expndtw5\insrsid10274 }{\insrsid10274 Schauer,}{\expnd1\expndtw5\insrsid10274 }{\cs21\i\insrsid10274 supra}{\expnd1\expndtw5\insrsid10274 }{\insrsid10274 note}{\expnd1\expndtw5\insrsid10274 }{\insrsid10274 4,}{\expnd1\expndtw5\insrsid10274 }{ \insrsid10274 at}{\expnd1\expndtw5\insrsid10274 }{\insrsid10274 1777\endash 82;}{\expnd1\expndtw5\insrsid10274 }{\i\insrsid10274 id.}{\expnd1\expndtw5\insrsid10274 }{\insrsid10274 at}{\expnd1\expndtw5\insrsid10274 }{\insrsid10274 1780}{ \expnd1\expndtw5\insrsid10274 }{\insrsid10274 (noting}{\expnd1\expndtw5\insrsid10274 }{\insrsid10274 that}{\expnd1\expndtw5\insrsid10274 }{\insrsid10274 \'93claims}{\expnd1\expndtw5\insrsid10274 }{\insrsid10274 that}{\expnd1\expndtw5\insrsid10274 }{ \insrsid10274 the}{\expnd1\expndtw5\insrsid10274 }{\insrsid10274 entire}{\expnd1\expndtw5\insrsid10274 }{\insrsid10274 scheme}{\expnd1\expndtw5\insrsid10274 }{\insrsid10274 of}{\expnd1\expndtw5\insrsid10274 }{\insrsid10274 securities}{ \expnd1\expndtw5\insrsid10274 }{\insrsid10274 regulation}{\expnd1\expndtw5\insrsid10274 }{\insrsid10274 needed}{\expnd1\expndtw5\insrsid10274 }{\insrsid10274 to}{\expnd1\expndtw5\insrsid10274 }{\insrsid10274 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\f0\fs24\insrsid10274 even}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 more}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 strain.}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 In}{ \f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 other}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 words,}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 putting}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 commercial}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 speech}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 in}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 the}{ \f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 category}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 of}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 \'93clearly}{ \f0\fs24\expnd2\expndtw10\insrsid10274 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}{\f0\fs24\insrsid10274 in}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 areas}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 such}{ \f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 as}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 antitrust}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 or}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{ \f0\fs24\insrsid10274 securities}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 law,}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 this}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 \'93upwards-pull \'94}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 of}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 First}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 Amendment}{ \f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 doctrine}{\f0\fs24\expnd2\expndtw10\insrsid10274 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preventing}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 a}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 sharp}{ \f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 drop-off}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 between}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 the}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 more}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 extreme}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 doctrines}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 of}{ \f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 rational}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 basis}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 review}{ \f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 and}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 strict}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 scrutiny}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 and}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 preventing}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 other}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 types}{ \f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 of}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 marginal}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 speech}{\f0\fs24\expnd2\expndtw10\insrsid10274 } {\f0\fs24\insrsid10274 from}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 falling}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 into}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 the}{ \f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 wrong}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 category}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{\f0\fs24\insrsid10274 of}{\f0\fs24\expnd2\expndtw10\insrsid10274 }{ \f0\fs24\insrsid10274 protection. \par }\pard\plain \s2\ql \li0\ri0\sb480\sa120\sl480\slmult1\keepn\widctlpar\noline\tx0\tx317\tx619\hyphpar0\aspalpha\aspnum\faauto\outlinelevel1\adjustright\rin0\lin0\itap0 \i\f287\fs22\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 { \i0\scaps\f0\fs24\insrsid10274 VI. History of the Regulation of Speech in the Food and Drug Law Context \par }\pard\plain \ql \fi317\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid10274 \tab Having situated commercial speech within the general framework of hybrid speech, the remainder of this Note applies some of the insights of the previous Parts in the context of food a nd drug law, particularly focusing on labeling and advertising of food and drug products. This Part begins the case study by exploring how, like most forms of regulation, the government increasingly began to regulate speech in the food and drug context o ver the course of the twentieth century. \par }\pard\plain \s1\ql \li0\ri0\sb360\sl480\slmult1\keepn\widctlpar\noline\tx0\tx317\tx619\hyphpar0\aspalpha\aspnum\faauto\outlinelevel0\adjustright\rin0\lin0\itap0 \scaps\f287\fs22\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 { \i\scaps0\f0\fs24\insrsid10274 A. Early Regulation of Speech Related to Food and Drug Law \par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid10274 \tab The first comprehensive federal food and drug statute \emdash the Federal Food and Drugs Act of 1906 (the \'93Wiley Act\'94)}{\cs15\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\insrsid10274 \tab }{\cs16\super\insrsid10274 \chftn }{\insrsid10274 34 Stat. 768 (1906). }}}{\insrsid10274 \emdash prohibited the interstate commerce \'93of any article of food or drugs which is adulterated or misbranded.\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 Id.}{\insrsid10274 \'a7 2. The Act defined \'93misbranded\'94 as: \par }\pard \s22\ql \li720\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 {\insrsid10274 \'93 [A]ll drugs, or articles of food, or articles which enter into the composition of food, the package or label of which shall bear any statement, design, or device regarding such article, or the ingre dients or substances contained therein which shall be false or misleading in any particular, and to any food or drug product which is falsely branded as to the State, Territory, or country in which it is manufactured or produced.\'94 \par }\pard \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\i\insrsid10274 Id.}{\insrsid10274 \'a7 8.}}}{\insrsid10274 After the Supreme Court held in }{\i\insrsid10274 U.S. v. Johnson}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 221 U.S. 488, 495, 498 (1911) (holding that the Act did not prevent a manufacturer from making a knowing false representation that a medicine cured cancer).}}}{\insrsid10274 that the Act did not prohibit the making of false therapeutic claims,}{ \cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 Id.}}}{\insrsid10274 Congress quickly passed the Sherley Amendment in 1912 to overrule the Court.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 Act of Aug. 23, 1912, ch. 352, \'a7 8, 37 Stat. 416 (1912).}}}{\insrsid10274 Congress then passed the Gould Amendment in 1913, which required that food package content be \'93 plainly and conspicuously marked on the outside of the package in terms of weight, measure, or numerical count.\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline \tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 37 Stat. 732 (1913); }{\i\insrsid10274 see also}{\insrsid10274 Peter B. Hutt and Peter B. Hutt II, }{\i\insrsid10274 A History of Government Regulation of Adulteration and Misbranding of Food}{\insrsid10274 , 39 }{\scaps\insrsid10274 Food Drug Cosm. L.J.}{\insrsid10274 2, 58 (1984).}}}{\insrsid10274 In 1924, the Supreme Court expanded the scope of the 1906 Act in }{\i\insrsid10274 U.S. v. 95 Barrels}{\insrsid10274 ,}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline \tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 265 U.S. 438 (1924).}}}{\insrsid10274 in which it held that the Act \'93condemn[s] every statement, design and device which may mislead or deceive. Deception may result from the use of statements not technically false or which may be literally true.\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{ \i\insrsid10274 Id.}{\insrsid10274 at 442\endash 43.}}}{\insrsid10274 Thus, even before the New Deal, regulation of speech related to food and drugs had steadily grown. \par }\pard\plain \s1\ql \li0\ri0\sb360\sl480\slmult1\keepn\widctlpar\noline\tx0\tx317\tx619\hyphpar0\aspalpha\aspnum\faauto\outlinelevel0\adjustright\rin0\lin0\itap0 \scaps\f287\fs22\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 { \i\scaps0\f0\fs24\insrsid10274 B. The Federal Food, Drug and Cosmetic Act of 1938 and the Wheeler-Lea Act \par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid10274 \tab Despite the increased speech regulations on food and drugs in the early t wentieth century, the limitations of the regulatory regime established by the 1906 Act were becoming increasingly apparent. One major shortcoming was that under the Act, there was a \'93 lack of jurisdiction over false or misleading claims not made on food labels.\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline \tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 Hutt & Hutt, }{\i\insrsid10274 supra}{\insrsid10274 note 116, at 62.} }}{\insrsid10274 Another problem was that even after the Sherley Amendment, the revised Act still required the government to prove that false therapeutic claims were fraudulently made for them to be illegal, thus making prosecutions difficult.}{ \cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 See}{\insrsid10274 Richard A. Merrill, }{\i\insrsid10274 Symposium on Regulating Medical Innovation: The Architecture of Government Regulation of Medical Products}{\insrsid10274 , 82 }{ \scaps\insrsid10274 Va. L. Rev.}{\insrsid10274 1753, 1760\endash 61 (1996) (noting that the even after the Sherley Amendment, the 1906 Act suffered \'93the fundamental deficiency\'94 that \'93the government had to prove actual knowledge by the seller that the claims it made were false.\'94).}}}{\insrsid10274 Furthermore, with the exception of the minimal mandatory labeling requirements created by the Gould Amendment, the 1906 Act \'93 did not require any form of affirmative label statement.\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 Hutt & Hutt, }{\i\insrsid10274 supra}{\insrsid10274 note 116, at 58.}}}{\insrsid10274 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\insrsid10274 Recognizing these shortcomings, the FDA in 1933 recommended a total revision of the 1906 Act.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 Id.}{\insrsid10274 at 62.}}}{\insrsid10274 Five years later, Congress passed the Federal Food, Drug and Cosmetic Act of 1938 (FD&C Act).}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0 \widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 52 Stat. 1040 (1938) (codified at 21 U.S.C. \'a7 321 et seq. (1976)) [hereinafter \'93FD&C Act\'94]. Congress finally passed the statute in 1938 after many children died the previous year from the drug Elixir of Sulfanilamide, which contained a poisonous compound. }{\i\insrsid10274 See}{ \insrsid10274 Comment, Joseph G. Contrera, }{\i\insrsid10274 The Food and Drug Administration and the International Conference on Harmonization: How Harmonious Will International Pharmaceutical Regulations Become?}{\insrsid10274 , 8 }{ \scaps\insrsid10274 Admin. L.J. Am. U.}{\insrsid10274 927, 934 n.26 (1995).}}}{\insrsid10274 The FD&C Act authorized regulation of many different types of commercial speech that were previously outside the FDA\rquote s regulatory control. In particular, the Act set forth various labeling requirements for food and drug products traveling in interstate commerce to prevent misbranding,}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{ \i\insrsid10274 See}{\insrsid10274 FD&C Act, \'a7\'a7 403, 502, 52 Stat. 1040 (1938).}}}{\insrsid10274 and it defined \'93labeling\'94 more broadly than its lay meaning.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{ \i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 id.}{\insrsid10274 \'a7 201(m).}}}{\insrsid10274 In fact, the Supreme Court has interpreted the FD&C Act as not requiring a label to be physically connected to a product, thereby allowing convictions for misbranding in \'93circulars and pamphlets distributed to consumers.\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{ \i\insrsid10274 See }{\insrsid10274 Kordel v. United States, 335 U.S. 345, 346, 350 (1948).}}}{\insrsid10274 The Act also made prosecutions for misbranding easier by eliminating the Sherley Amendment\rquote s requirement that the government must show fraudulent intent in drug misbranding cases, and instead declaring that \'93A drug or device shall be deemed to be misbranded [if] its labeling is false in any particular.\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{ \insrsid10274 }{\i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 id.}{\insrsid10274 \'a7 502(a). A similar provision applies for food. }{\i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 also}{\insrsid10274 }{\i\insrsid10274 id.}{ \insrsid10274 \'a7 403(a) (\'93A food shall be deemed to be misbranded [if] its labeling is false or misleading in any particular.\'94).}}}{\insrsid10274 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\insrsid10274 In 1938, Congress passed the Wheeler-Lea Act, which was another important statute pertaining to government regulation of speech in the food and drug context.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline \tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 52 Stat. 111 (1938).}}}{\insrsid10274 This Act specifically enabled the Federal Trade Commission (FTC) to seek injunctions for false advertisements of foods, drugs, cosmetics, or devices.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0 \widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 Id.}{\insrsid10274 \'a7\'a7 52 \endash 55.}}}{\insrsid10274 Although the FTC already had possessed the power to regulate misleading advertising and labeling of FDA-regulated products under its organic statute,}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{ \i\insrsid10274 See}{\insrsid10274 }{\scaps\insrsid10274 Peter Barton Hutt & Richard A. Merrill}{\insrsid10274 , }{\scaps\insrsid10274 Food and Drug Law: Cases and Materials}{\insrsid10274 1328 (2nd ed. 1991) (citing Federal Trade Commission Act, 38 Stat. 717 (1914), as amended, 15 U.S.C. \'a7\'a7 41 et seq.).}}}{\insrsid10274 the Wheeler-Lea Act clarified that the FTC, not the FDA, had jurisdiction to pursue such claims.}{ \cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 id.}{\insrsid10274 at 43.}}}{\insrsid10274 Because of this Act, the FTC regulates most advertising of food and drug products, except for advertising of prescription drugs, which were exempted from FTC regulation and instead are policed by the FDA under the Kefauver-Harris Amendments of 1962.}{ \cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 id.}{\insrsid10274 at 1328 (citing 76 Stat. 780 (1962)). The Kefauver-Harris Amendments also added the requirement that \'93 manufacturers must disclose the generic name of the active ingredient of their products in labeling and in advertising.\'94 }{\i\insrsid10274 Id.}{\insrsid10274 at 452.}}}{\insrsid10274 Additionally, advertising of restricted medical devices is regulated by the FDA under the Medical Device Amendments of 1976.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline \tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 id.}{ \insrsid10274 (citing 90 Stat. 539 (1976)). Other agencies may regulate food and drug advertising in a manner that implicates the commercial speech doctrine. For example, in }{\i\insrsid10274 Rubin v. Coors Brewing Co.}{\insrsid10274 , 514 U.S. 476 (1995), the Bureau of Alcohol, Tobacco, and Firearms (BATF) denied \'93proposed labels and advertisements that disclosed the alcohol content of . . . beer\'94 because of a federal statute that prohibited such disclosure. }{\i\insrsid10274 Id.}{\insrsid10274 at 478.}}}{\insrsid10274 \par }\pard\plain \s1\ql \li0\ri0\sb360\sl480\slmult1\keepn\widctlpar\noline\tx0\tx317\tx619\hyphpar0\aspalpha\aspnum\faauto\outlinelevel0\adjustright\rin0\lin0\itap0 \scaps\f287\fs22\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 { \i\scaps0\f0\fs24\insrsid10274 C. Congressional Regulation of Speech After the FD&C Act \par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid10274 \tab After passing the FD&C Act, Congress has periodically expanded the scope of the FDA\rquote s power to regulate product labeling. In 1960, Congress passed the Federal Hazardous Substances Labeling Act,}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline \tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 74 Stat. 372 (1960) (codified as amended at 15 U.S.C. \'a7\'a7 1261 \endash 1276 (2000))}}}{\insrsid10274 which required the use of clear warning labels on hazardous household chemicals. In 1966, the Fair Packaging and Labeling Act}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 80 Stat. 1296 (1966), as amended, 15 U.S.C. \'a7\'a7 1451\endash 1461 (2000).}}}{\insrsid10274 was passed, which requires honest and informative labeling for all consumer products in interstate commerce, and which permits FDA to enforce provisions for foods, drugs, cosmetics, and medical devices.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\i\insrsid10274 See}{\insrsid10274 U.S. Food and Drug Administration, }{\i\insrsid10274 Milestones in U.S. Food and Drug Law History}{\insrsid10274 , }{\i\insrsid10274 at}{\insrsid10274 http://www.fda.gov/opacom/backgrounders/miles.html (last visited March 29, 2005) [hereinafter }{\i\insrsid10274 Milestones}{\insrsid10274 ].}}}{\insrsid10274 In 1990, Congress passed the Nutrition Labeling and Education Act (NLEA),}{ \cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid10274 \chftn }{\insrsid10274 104 Stat. 2353 (1990) (codified at 21 U.S.C. \'a7 343 (2000)).}}}{\insrsid10274 which requires nutrition labeling on all packaged foods,}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{ \i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 Milestones}{\insrsid10274 , }{\i\insrsid10274 supra}{\insrsid10274 note 136.}}}{\insrsid10274 and in 1994 it passed the Dietary Supplement Health and Education Act,}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{ \insrsid10274 108 Stat. 4325 (1994) (codified at 21 U.S.C. \'a7 301 note).}}}{\insrsid10274 which set forth labeling requirements for dietary supplements.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0 \widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 See}{\insrsid10274 }{ \i\insrsid10274 Milestones}{\insrsid10274 , }{\i\insrsid10274 supra}{\insrsid10274 note 136.}}}{\insrsid10274 Most recently, Congress passed a broad reform of the FD&C Act in the Food and Drug Modernization Act (FDAMA), which includes provisions to \'93regulate advertising of unapproved uses of approved drugs and devices, and regulate health claims for foods.\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline \tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 id.}}}{ \insrsid10274 \par }\pard\plain \s1\ql \li0\ri0\sb360\sl480\slmult1\keepn\widctlpar\noline\tx0\tx317\tx619\hyphpar0\aspalpha\aspnum\faauto\outlinelevel0\adjustright\rin0\lin0\itap0 \scaps\f287\fs22\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 { \i\scaps0\f0\fs24\insrsid10274 D. Examples of Speech Regulations Promulgated by the FDA \par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid10274 \tab The FDA also has promulgated many regulations of speech under the FD&C Act. In 1970, the FDA first mandated the use of patient package inserts (PPI\rquote s) with oral contraceptives.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 Statement of Policy Concerning Oral Contraceptive Labeling Directed to Users, 35 Fed. Reg. 9001 (June 11, 1970).}}}{\insrsid10274 The PPI\rquote s were intended to provide, among other things, \'93 a brief notice of the nature of the drugs, the fact that continued medical supervision is needed for safe and effective use, [and] that the drugs may cause side effects and are contraindicated in some cases.\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{ \insrsid10274 }{\i\insrsid10274 Id.}{\insrsid10274 at 9002.}}}{\insrsid10274 Although the FDA later revoked its entire PPI program,}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline \tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 Prescription Drug Products: Revocation of Patient Package Insert Requirements, 47 Fed. Reg. 39147 (Sept. 7, 1982).}}}{\insrsid10274 manufacturers voluntarily continue to provide PPI\rquote s for \'93 a number of drugs which present unique safety questions.\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\scaps\insrsid10274 Hutt & Merrill}{\insrsid10274 , }{\i\insrsid10274 supra}{\insrsid10274 note 130, at 450.}}}{\insrsid10274 \par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\insrsid10274 \tab The FDA has also promulgated a number of restrictions on prescription drug advertising.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 See generally}{\insrsid10274 21 C.F.R. \'a7 202.1.}}}{\insrsid10274 For example, it has banned advertisements that \'93 feature inert or inactive ingredients in a manner that creates an impression of value greater than their true functional role in the formulation.\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0 \widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 Id.}{\insrsid10274 \'a7 202.1(a)(4).}}}{\insrsid10274 It has also banned advertisements that are or may be false, lacking in fair balance or otherwise misleading.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0 \widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 Id.}{\insrsid10274 \'a7\'a7 202 .1(e)(6)\endash 202.1(e)(7).}}}{\insrsid10274 Such advertisements include, for example, those that \'93use[] a quote or paraphrase out of context to convey a false or misleading idea,\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{ \i\insrsid10274 Id.}{\insrsid10274 \'a7 202.1(e)(6)(ix).}}}{\insrsid10274 and those that \'93contain[] information from . . . reports or opinions falsely or misleadingly represented or suggested to be authentic or authoritative.\'94}{ \cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 Id.}{\insrsid10274 \'a7 202.1(e)(7)(xiii).}}}{\insrsid10274 In recent decades, the FDA has encouraged advertising of prescription drugs to consumers as a way to promote competition among prescription drug manufacturers.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{ \i\insrsid10274 See}{\insrsid10274 }{\scaps\insrsid10274 Hutt & Merrill}{\insrsid10274 , }{\i\insrsid10274 supra}{\insrsid10274 note 130, at 465\endash 66.}}}{\insrsid10274 \par }\pard\plain \s1\ql \li0\ri0\sb480\sa120\sl480\slmult1\keepn\widctlpar\noline\tx0\tx317\tx619\hyphpar0\aspalpha\aspnum\faauto\outlinelevel0\adjustright\rin0\lin0\itap0 \scaps\f287\fs22\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 { \f0\fs24\insrsid10274 VII. The Rise of the Commercial Speech Doctrine in the Food and Drug Context \par }\pard\plain \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid10274 As described in Part II of this Note, the commercial speech doctrine has been shaped by the tension between the government\rquote s expanding regulatory powers and a growing set of First Amendment rights. Furthermore, as discusse d in Part V-B, courts have been protecting commercial speech with increasing vigor in recent years. This Part details how the burgeoning commercial speech doctrine has placed increasing constraints in recent years on the regulation of speech related to f oods and drugs. Furthermore, the Part ties each of the cases below in some way into the theoretical framework described earlier in this Note. \par }\pard\plain \s20\ql \li0\ri0\sb360\sl480\slmult1\widctlpar\noline\tqr\tx6725\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \f287\fs22\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\i\f0\fs24\insrsid10274 A. Alcohol Content on Beer Labeling and Advertising \par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid10274 \tab As protection for commercial speech grew, regulators of food s and drugs lost a number of important cases beginning in the 1990s. In }{\i\insrsid10274 Rubin v. Coors Brewing Co.}{\insrsid10274 ,}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline \tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 514 U.S. 476 (1995).}}}{\insrsid10274 the Supreme Court invalidated a federal regulatory scheme that prohibited brewers from disclosing the alcohol content of beer on their labeling or in advertising.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{ \i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 id.}{\insrsid10274 at 478, 486. The regulatory scheme included the Federal Alcohol Administration Act, and various regulations promulgated by the Bureau of Alcohol, Tobacco, and Firearms (BATF). }{ \i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 id.}{\insrsid10274 at 480\endash 81.}}}{\insrsid10274 The Court first rejected the government\rquote s argument that it should have \'93broader latitude [than that allowed by }{\i\insrsid10274 Central Hudson}{\insrsid10274 ] to regulate speech that promotes socially harmful activities, such as alcohol consumption.\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline \tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 Id.}{\insrsid10274 at 482.}}}{\insrsid10274 It then chose to apply }{\i\insrsid10274 Central Hudson}{\insrsid10274 to the regulation, because \'93Both parties agree[d] that the information on beer labels constitutes commercial speech.\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{ \i\insrsid10274 Id.}{\insrsid10274 at 481.}}}{\insrsid10274 \par \tab Turning to the first prong of }{\i\insrsid10274 Central Hudson}{\insrsid10274 , the Court evaluated the government\rquote s interest in the ban, which was to prevent \'93strength wars\'94 among brewers.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 id.}{\insrsid10274 at 485.}}}{\insrsid10274 Although the Court acknowledged that this interest was substantial,}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{ \i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 id.}}}{\insrsid10274 it also noted that \'93the general thrust of federal alcohol policy appears to favor greater disclosure of information, rather than less.\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{ \insrsid10274 }{\i\insrsid10274 Id.}{\insrsid10274 at 484. Citing to the Nutrition Labeling and Education Act of 1990, the Court continued, \'93This also seems to be the trend in federal regulation of other consumer products as well.\'94 }{ \i\insrsid10274 Id.}}}{\insrsid10274 More important, the Court determined that the ban failed the third and fourth prongs of }{\i\insrsid10274 Central Hudson}{\insrsid10274 because it was being applied less stringently for advertising than for labeling.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline \tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 id.}{ \insrsid10274 at 488.}}}{\insrsid10274 This disparate application, according to the Court, \'93makes no rational sense if the Government\rquote s true aim is to suppress strength wars.\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{ \i\insrsid10274 Id.}}}{\insrsid10274 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\i\insrsid10274 Coors}{\insrsid10274 demonstrates that labeling of food products can be considered commercial speech, and thus subject to the requirements of }{\i\insrsid10274 Central Hudson}{\insrsid10274 . As two commentators have noted, \'93}{\i\insrsid10274 Coors}{\insrsid10274 represents the Court's first commercial speech decision directly to address product labeling controls. As such, it may have important implications for other federal limitations on the inclusion of truthful information in labeling.\'94}{ \cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid10274 \chftn }{\insrsid10274 Lars Noah & Barbara A. Noah, }{\i\insrsid10274 Liberating Commercial Speech: Product Labeling Controls and the First Amendment}{\insrsid10274 , 47 }{\scaps\insrsid10274 Fla. L. Rev.}{\insrsid10274 63, 89 (1995).}}}{\insrsid10274 This expansion of the commercial speech doctrine to include labeling fits with the general trend of according more protection to commercial speech, as discussed in Part V-B. \par }\pard\plain \s1\ql \li0\ri0\sb360\sl480\slmult1\keepn\widctlpar\noline\tx0\tx317\tx619\hyphpar0\aspalpha\aspnum\faauto\outlinelevel0\adjustright\rin0\lin0\itap0 \scaps\f287\fs22\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 { \i\scaps0\f0\fs24\insrsid10274 B. Promotion of Off-Label Uses of Prescription Drugs \par }\pard\plain \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid10274 The FDA lost a number of cases involving speech regulation in lowe r courts toward the end of the 20}{\super\insrsid10274 th}{\insrsid10274 century. }{\i\insrsid10274 Washington Legal Foundation v. Friedman}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0 \widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 13 F. Supp. 2d 51 (D.D.C. 1998).}}}{\insrsid10274 involved FDA restrictions on the promotion of off-label uses for drugs. An off-label use occurs when a physician prescribes a drug for a use other than for which FDA approval was obtained.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{ \i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 id.}{\insrsid10274 at 55.}}}{\insrsid10274 Although off-label uses were (and still are) legal, the FDA was wary of them, and thus it was concerned that manufacturers were actively encouraging physicians to prescribe such unapproved uses.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{ \i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 id.}{\insrsid10274 at 56\endash 58.}}}{\insrsid10274 Accordingly, the FDA promulgated Gui dance Documents that prevented manufacturers from promoting off-label uses at continuing medical education (CME) seminars,}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline \tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 id.}{ \insrsid10274 at 57\endash 58. The guidance document includes twelve factors for determining whether a CME was not subject to regulation because it was \'93independent\'94 of the control of the manufacturer of the drug with the off-label use. }{ \i\insrsid10274 Id.}}}{\insrsid10274 and from disseminating to physicians \'93enduring\'94 materials that address off-label uses.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline \tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 id.}{ \insrsid10274 at 58. Enduring materials are defined as \'93textbook excerpts and article reprints from medical and scientific journals.\'94 }{\i\insrsid10274 Id.}}}{\insrsid10274 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\insrsid10274 On a First Amendment challenge to these provisions, the federal district court for the District of Columbia rejected the FDA\rquote s argument that these provisions were not a form of speech but instead merely a restraint upon conduct, which it defined as the off-label prescription of drugs.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{ \i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 id.}{\insrsid10274 at 59.}}}{\insrsid10274 In particular, the court noted, \'93[T]he activities at issue in this case are only \lquote conduct\rquote to the extent that moving one\rquote s lips is \lquote conduct,\rquote or to the extent that affixing a stamp and distributing information through the mails is \lquote conduct.\rquote \'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0 \widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 Id.}}}{\insrsid10274 Similar to the analysis suggested above in Part II, the court thus focused on the means of communication \emdash the spoken word \emdash as an indication that this was a form of speech, and not conduct. \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\insrsid10274 Furthermore, the court rejected the FDA\rquote s contention that the First Amendment did not ap ply to the speech at issue in this case because the food and drug industry is extensively regulated, observing, \'93Since the }{\i\insrsid10274 Central Hudson}{\insrsid10274 decision, the Supreme Court has consistently applied a speech analysis . . . to cases involving statutes and/or regulations in areas subject to extensive state or federal regulation.\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{ \i\insrsid10274 Id.}{\insrsid10274 at 60.}}}{\insrsid10274 Nonetheless, the court determined that the speech at issue was just commercial speech and not core speech under the factors set forth by the Supreme Court in }{\i\insrsid10274 Bolger}{ \i\expnd1\expndtw5\insrsid10274 }{\i\insrsid10274 v.}{\i\expnd1\expndtw5\insrsid10274 }{\i\insrsid10274 Youngs}{\i\expnd1\expndtw5\insrsid10274 }{\i\insrsid10274 Drug}{\i\expnd1\expndtw5\insrsid10274 }{\i\insrsid10274 Products}{ \i\expnd1\expndtw5\insrsid10274 }{\i\insrsid10274 Corp}{\insrsid10274 .}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 id.}{\insrsid10274 at 62\endash 65; }{\i\insrsid10274 see}{\insrsid10274 }{ \i\insrsid10274 also}{\insrsid10274 }{\i\insrsid10274 supra}{\insrsid10274 note 46.}}}{\insrsid10274 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\insrsid10274 The court then invalidated both of the guidance documents as being more extensive than necessary and thus violating the fourth prong of the }{\i\insrsid10274 Central Hudson}{\insrsid10274 test.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{ \i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 Friedman}{\insrsid10274 , 13 F. Supp. 2d}{\i\insrsid10274 }{\insrsid10274 at 73.}}}{\insrsid10274 It noted that \'93full, complete, and unambiguous disclosure by the manufacturer\'94 is a \'93 less-burdensome alternative[] to this restriction on commercial speech\'94 that \'93deals more precisely with the concerns of the FDA and Congress.\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0 \widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 Id.}}}{\insrsid10274 Among other things, the court argued that full disclosure, \'93assuages concerns that the message communicated is inherently or potentially misleading\'94and \'93 still leaves more than adequate incentives compelling drug manufacturers to get new uses approved by the FDA.\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline \tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 Id.}}}{\insrsid10274 Moreover, the court noted approvingly that full disclosure also \'93comports with the Supreme Court's preference for combating potentially problematic speech with more speech.\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{ \i\insrsid10274 Id.}}}{\insrsid10274 \par Shortly after the court\rquote s decision, the FDAMA went into effect, which supplanted the Guidance Document on enduring materials with a similar provision.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0 \widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 See}{\insrsid10274 Washington Legal Found. v. Henney, 56 F. Supp. 2d 81, 83 (D.D.C. 1999) (noting that the FDAMA permits a drug manufacturer to disseminate enduring materials under certain specific conditions).}}}{\insrsid10274 The FDA unsuccessfully tried to amend the court\rquote s previous decision concerning the constitutionality of its policy, and the FDAMA and its implementing regulations were held to be unconstitutional.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{ \i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 id.}{\insrsid10274 at 82.}}}{\insrsid10274 On appeal, the FDA changed its position concerning the Guidance Documents, asserting that \'93they established nothing more than a \lquote safe harbor \rquote ensuring that certain forms of conduct would not be used against manufacturers in misbranding and \lquote intended use\rquote enforcement actions.\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 Washington Legal Found. v. Henney, 202 F.3d 331, 335 (2000).}}}{\insrsid10274 Accordingly, the Court of Appeals declined to reach the constitutionality of the FDAMA and vacated the lower court judgment.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 id.}{\insrsid10274 at 335\endash 37.}}}{\insrsid10274 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\insrsid10274 The FDA then issued a Notice, contending that despite the fact that the Guidance Documents set forth a safe harbor, the FDA could \'93 proceed, in the context of case-by-case enforcement, to determine from a manufacturer\rquote s written materials and activities how it intends that its products be used.\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 Notice, Decision in }{\i\insrsid10274 Washington Legal Foundation v. Henney}{\insrsid10274 , 65 Fed. Reg. 14286 (Mar. 16, 2000).}}}{\insrsid10274 It also noted that \'93 if the agency brings an enforcement action, a manufacturer may raise a First Amendment defense.\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline \tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 Id.}}}{\insrsid10274 A challenge to this Notice in the district court was subsequently denied.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline \tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 Washingto n Legal Found. v. Henney, 128 F. Supp. 2d 11, 15 (D.D.C. 2000).}}}{\insrsid10274 Thus, although the constitutionality of the FDA limitations on manufacturer speech through CMEs and enduring materials remains questionable, the district court noted that the issue \'93remains 100% unresolved.\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{ \insrsid10274 }{\i\insrsid10274 Id.}{\insrsid10274 ; }{\i\insrsid10274 see generally}{\insrsid10274 Peggy Chen, }{\i\insrsid10274 Education or Promotion?: Industry-Sponsored Continuing Medical Education (CME) as a Center for the Core/Commercial Speech Debate}{\insrsid10274 , }{\i\insrsid10274 at}{\insrsid10274 http://leda.law.harvard.edu/leda/data/591/ChenP.rtf.}}}{\insrsid10274 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\insrsid10274 Some guidance on this issue may have come from the recent case of }{\i\insrsid10274 U.S. v. Caputo}{\insrsid10274 ,}{ \cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid10274 \chftn }{\insrsid10274 288 F.Supp.2d 912 (N.D. Ill. 2003).}}}{\insrsid10274 in which a federal district court upheld the FDA\rquote s prohibition on manufacturer promotion of off-label uses against a commercial speech challenge.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline \tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 id.}{ \insrsid10274 at 922.}}}{\insrsid10274 The case involved defendants who were moving to dismiss charges that they had violated the FD&C Act by marketing and selling a modified version of a medical device sterilization system.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 id.}{\insrsid10274 at 915}}}{\insrsid10274 Unlike the original version of the sterilization system, the modified version had not been approv ed by the FDA, and the court characterized its use as an off-label one.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 id.}{\insrsid10274 at 915, 922.}}}{\insrsid10274 Applying }{\i\insrsid10274 Central Hudson}{\insrsid10274 , the court noted that \'93unlike }{\i\insrsid10274 Washington Legal Foundation}{\insrsid10274 , Defendants' First Amendment challenge strikes at the very heart of the FDA's ability to proscribe m anufacturer promotion of off-label uses,\'94 and that a successful challenge by the defendants \'93would severely frustrate the FDA's ability to evaluate the effectiveness of off-label uses.\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{ \i\insrsid10274 Id.}{\insrsid10274 at 922.}}}{\insrsid10274 Furthermore, the court noted that it was \'93unable to identify a less burdensome alternative that would advance the government's substantial interest.\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{ \insrsid10274 }{\i\insrsid10274 Id.}}}{\insrsid10274 Accordingly, the court rejected the defendant\rquote s commercial speech argument.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline \tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 id.}}}{ \insrsid10274 Although }{\i\insrsid10274 Caputo}{\insrsid10274 certainly is not determinative, it indicates that the district courts are divided as to the constitutionality of FDA restrictions on the promotion of off-label uses. \par }\pard\plain \s1\ql \li0\ri0\sb360\sl480\slmult1\keepn\widctlpar\noline\tx0\tx317\tx619\hyphpar0\aspalpha\aspnum\faauto\outlinelevel0\adjustright\rin0\lin0\itap0 \scaps\f287\fs22\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 { \i\scaps0\f0\fs24\insrsid10274 C. FDA\rquote s Rejection of Health Claims for Dietary Supplements \par }\pard\plain \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid10274 In another set of commercial speech cases, courts invalidated FDA regulations dealing with health claims by manufacturers of dietary supplements. Under the NLEA, Congress delegated to the FDA the ability to regulate such claims.}{ \cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 See}{\insrsid10274 21 U.S.C. \'a7 343(r)(5)(D) (2005).}}}{\insrsid10274 The FDA specified that a dietary supplement health claim should be approved only if there is \'93 significant scientific agreement . . . that the claim is supported by [the totality of publicly available scientific] evidence.\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline \tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 See}{\insrsid10274 21 C.F.R. \'a7 101.14(c) (2005). In the NLEA, Congress had adopted this same standard for health claims for food. 21 U.S.C. \'a7 343(r)(3)(B)(i) (2005).}}}{\insrsid10274 Using this standard, the FDA promulgated regulations denying four specific types of health claims, contending that the evidence in support of them was inconclusive and that the claims might confuse consumers.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 Pearson v. Shalala, 164 F.3d 650, 653, 659 (D.C. Cir. 1999). The health claims at issue were: \par \tab \tab (1) \lquote Consumption of antioxidant vitamins may reduce the risk of certain kinds of cancers.\rquote \par \tab \tab (2) \lquote Consumption of fiber may reduce the risk of colorectal cancer.\rquote \par \tab \tab (3) \lquote Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease.\rquote \par }\pard \s22\ql \li317\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin317\itap0 {\insrsid10274 \tab (4) \lquote .8 mg of folic acid in a dietary supplement is more e ffective in reducing the risk of neural tube defects than a lower amount in foods in common form.\rquote \'94 \par }\pard \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\i\insrsid10274 Id.}{\insrsid10274 at 651\endash 52.}}}{\insrsid10274 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\insrsid10274 In }{\i\insrsid10274 Pearson v. Shalala}{\insrsid10274 ,}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 14 F. Supp. 2d 10 (D.D.C. 1998).}}}{\insrsid10274 manufacturers, distributors, and organizations of consumers of dietary supplements challenged these regulations as violating the commercial speech doctrine.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 id.}{\insrsid10274 at 12, 14.}}}{\insrsid10274 Although the federal district court rejected this argument,}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{ \i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 id.}{\insrsid10274 at 21\endash 22.}}}{\insrsid10274 the D.C. Circuit reversed.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline \tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 Pearson}{\insrsid10274 , 164 F.3d at 651 (D.C. Cir. 1999).}}}{\insrsid10274 Disagreeing with the FDA that the health claims were inherently misleading, the court found that the regulations failed the last prong of }{\i\insrsid10274 Central Hudson}{\insrsid10274 , because there was no \'93reasonable fit\'94 between the FDA regulations and the agency\rquote s goal of preventing consumer fraud.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline \tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 id.}{ \insrsid10274 at 657.}}}{\insrsid10274 The court noted that Supreme Court precedent indicated that \'93disclaimers [are] constitutionally preferable to outright suppression,\'94 and that \'93when government chooses a poli cy of suppression over disclosure \emdash at least where there is no showing that disclosure would not suffice to cure misleadingness \emdash government disregards a \lquote far less restrictive\rquote means.\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{ \insrsid10274 }{\i\insrsid10274 Id.}{\insrsid10274 at 658.}}}{\insrsid10274 Moreover, the court held that the FDA\rquote s \'93significant scientific agreement\'94 standard was too vague to be acceptable under the Administrative Procedure Act.}{ \cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 id.}{\insrsid10274 at 660.}}}{\insrsid10274 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\insrsid10274 In response to this decision, the FDA clarified the meaning of the \'93significant scientific agreement\'94 standard.}{ \cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 See}{\insrsid10274 Guidance for the Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements, 64 Fed. Reg. 71794 (Dec. 22, 1999).}}}{\insrsid10274 Nonetheless, it still refused to allow dietary suppleme nt manufacturers to make the health claims.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 See}{\insrsid10274 Whitaker v. Thompson, 248 F. Supp. 2d 1, 6\endash 7 (D.D.C. 2002).}}}{\insrsid10274 These manufacturers brought suit, and once again, the FDA lost on commercial speech grounds.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline \tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 id.}{ \insrsid10274 at 17 (D.D.C. 2002) (forcing FDA to allow a claim involving antioxidants and ordering it to draft whatever disclaimer is necessary for the claim); Pearson v. Shalala, 130 F. Supp.2d 105, 120\endash 21 (D.D.C. 2001) (same f or a claim involving folic acid).}}}{\insrsid10274 Accordingly, the agency was forced to acquiesce and allow the dietary supplement manufacturers to make the health claims. \par Like }{\i\insrsid10274 Coors}{\insrsid10274 , }{\i\insrsid10274 Pearson}{\insrsid10274 demonstrates the courts\rquote willingness to apply the commercial speech doctrine to claims made on labeling. Furthermore, }{\i\insrsid10274 Pearson}{\insrsid10274 suggests that courts are much more likely to uphold disclaimers or full disclosure requirements from a challenge on commercial speech grounds than flat bans on speech. This preference for more limited speech restrictions correlates with the general trend of increasing commercial speech protection. \par }\pard\plain \s1\ql \li0\ri0\sb360\sl480\slmult1\keepn\widctlpar\noline\tx0\tx317\tx619\hyphpar0\aspalpha\aspnum\faauto\outlinelevel0\adjustright\rin0\lin0\itap0 \scaps\f287\fs22\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 { \i\scaps0\f0\fs24\insrsid10274 D. Advertising of Tobacco Products \par }\pard\plain \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid10274 Federal governmental a gencies are not the only ones whose speech regulations in the food and drug context have been invalidated; state governmental agencies have faced such difficulties too. In }{\i\insrsid10274 Lorillard Tobacco Co. v. Reilly}{\insrsid10274 ,}{ \cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\insrsid10274 533 U.S. 525 (2001).}}}{\insrsid10274 the Supreme Court invalidated outdoor advertising restrictions on smokeless tobacco and cigars promulgated by Massachusetts\rquote s Attorney General. }{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 id.}{\insrsid10274 at 566\endash 67. The Massachusetts regulations also restricted cigarette advertising, but the Court held that the Federal Cigarette Labeling and Advertising Act (FCLAA) preempted these regulat ions, and thus it did not deal with the constitutional issues that they raised. }{\i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 id.}{\insrsid10274 at 553.}}}{\insrsid10274 The regulations \'93 prohibit[ed] any smokeless tobacco or cigar advertising within 1,000 feet of schools,\'94 which the Court noted \'93would constitute nearly a comple te ban on the communication of truthful information about smokeless tobacco and cigars to adult consumers [in some geographical areas].\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline \tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 Id.}{\insrsid10274 at 561.}}}{\insrsid10274 Although the Court conceded that the state\rquote s interest in preventing underage smoking was \'93compelling,\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline \tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 id.}{ \insrsid10274 at 564.}}}{\insrsid10274 it held that the regulations violated the fourth factor of }{\i\insrsid10274 Central Hudson}{\insrsid10274 , because the \'93broad sweep of the regulations indicates that the Attorney General did not \lquote carefully calculate the costs and benefits associated with the burden on speech imposed\rquote by the regulations.\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline \tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 Id.}{\insrsid10274 at 561 (quoting }{ \i\insrsid10274 Cincinnati v. Discovery Network, Inc.}{\insrsid10274 , 507 U.S. 410, 417 (1993) (internal quotation marks omitted)).}}}{\insrsid10274 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\insrsid10274 Massachusetts also had regulations that prevented indoor advertising for smokeless tobacco and cigars from being placed within five feet of the floor of any store that was within one thousand feet of a school or playground.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 id.}{\insrsid10274 at 566.}}}{\insrsid10274 The Court held that these provisions violated both the third and fourth steps of }{\i\insrsid10274 Central Hudson}{\insrsid10274 because the \'945 foot rule does not seem to advance [the] goal [of preventing underage smoking].\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline \tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 Id.}}}{\insrsid10274 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\insrsid10274 Despite these setbacks, the Court upheld another set of Massachusetts regulations that \'93 bar[red] the use of self-service displays and require[d] that tobacco products be placed out of the reach of all consumers in a location accessible only to salespersons.\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{ \i\insrsid10274 Id.}{\insrsid10274 at 567.}}}{\insrsid10274 Citing to }{\i\insrsid10274 O'Brien}{\insrsid10274 , the Court noted that \'93Massachusetts seeks to regulate the placem ent of tobacco products for reasons unrelated to the communication of ideas.\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline \tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 Id.}{\insrsid10274 at 569.}}}{\insrsid10274 It then concluded, \'93The means chosen by the State are narrowly tailored to prevent access to tobacco products by minors.\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline \tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 Id.}{\insrsid10274 at 570.}}}{\insrsid10274 \par }\pard\plain \s20\ql \li0\ri0\sl480\slmult1\widctlpar\noline\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \f287\fs22\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\f0\fs24\kerning0\insrsid10274 \tab }{\i\f0\fs24\insrsid10274 Lorillard }{\f0\fs24\insrsid10274 illustrates two interesting points that ar e consistent with the theoretical framework established in the previous Parts of this Note. First, the case demonstrates that even when the Court believes that the government has a compelling interest, it is willing to invalidate a regulation on the basi s of the commercial speech doctrine. The Court\rquote s willingness to overturn regulations of such importance provides support for the proposition that protection for commercial speech doctrine has been gaining in strength in recent years, as posited in Part V-B above. \par }\pard \s20\ql \fi720\li0\ri0\sl480\slmult1\widctlpar\noline\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\f0\fs24\insrsid10274 Second, the Court indicated that it would be more likely to invalidate regulations that restrict linguistic means of expression rather than non-linguistic ones. The Court held that the advertisements, which presumably relied on the written word, w ere protected by the commercial speech doctrine, but that the placement of the tobacco products, which could be characterized as a non speech sales activity, was not protected. Accordingly, the mechanism by which speech having a commercial purpose is exp ressed is important to the Court in determining whether the commercial speech doctrine has any bite. Restrictions on commercial \'93speech\'94 that operate via non-linguistic means are much more likely to be upheld than restrictions on commercial speech that operate via linguistic means. \par }\pard\plain \s1\ql \li0\ri0\sb360\sl480\slmult1\keepn\widctlpar\noline\tx0\tx317\tx619\hyphpar0\aspalpha\aspnum\faauto\outlinelevel0\adjustright\rin0\lin0\itap0 \scaps\f287\fs22\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 { \i\scaps0\f0\fs24\insrsid10274 E. Promotion of Drug Compounding Services by Pharmacies \par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid10274 \tab In }{\i\insrsid10274 Thompson v. W. States Med. Ctr.}{\insrsid10274 ,}{ \cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid10274 \chftn }{\insrsid10274 535 U.S. 357 (2002).}}}{\insrsid10274 the Supreme Court\rquote s most recent case involving commercial speech in the food and drug context, the Court invalidated a provision of th e FDAMA that banned advertising for compounded drugs.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 id.}{\insrsid10274 at 360.}}}{\insrsid10274 Compounded drugs are medications tailored to the needs of an individual patient with ingredients that have been mixed or altered by a pharmacist or doctor.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0 \widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 See}{\insrsid10274 }{ \i\insrsid10274 id.}{\insrsid10274 at 360\endash 61.}}}{\insrsid10274 The FDA was concerned that \'93some pharmacists were manufacturing and selling drugs under the guise of compounding,\'94 which enabled them to avoid the FDA\rquote s rigorous drug approval requirements.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 id.}{\insrsid10274 at 362.}}}{\insrsid10274 Accordingly, when Congress passed the FDAMA, it included a provision that exempted compounded drugs from the drug approval requirements \'93 as long as the providers of those drugs . . . refrain[ed] from advertising or promoting particular compounded drugs.\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline \tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 Id.}{\insrsid10274 at 360.}}}{\insrsid10274 A group of licensed pharmacists then brought suit, challenging the provision under the First Amendment.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline \tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 id.}{ \insrsid10274 at 365.}}}{\insrsid10274 \par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\insrsid10274 \tab Because both parties agreed that the expression at issue was commercial speech, the Court applied }{\i\insrsid10274 Central Hudson}{ \insrsid10274 .}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 id.}{\insrsid10274 at 366\endash 68.}}}{\insrsid10274 The government asserted the advertising ban served the substantial governmental interest of channeling drugs produced on a large-scale through the FDA\rquote s drug approval process while preserving the availability of compounded drugs for individual patients.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline \tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 id.}{ \insrsid10274 at 368\endash 71.}}}{\insrsid10274 In particular, the government used \'93advertising as the trigger for requiring FDA approval\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0 \widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 Id.}{\insrsid10274 at 370.}}}{ \insrsid10274 because it serves as a \'93fair proxy for actual or intended large-scale manufacturing.\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline \tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 Id.}{\insrsid10274 at 371 (internal quotation marks omitted) (quoting Brief for Petitioners, 35).}}}{\insrsid10274 The Court rejected this argument. Noting the availability of several, equivalent non-speech-related means, it stated, \'93 If the First Amendment means anything, it means that regulating speech must be a last \emdash not first \emdash resort.\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline \tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 Id.}{\insrsid10274 at 372\endash 73.}}}{ \insrsid10274 \par \tab Moreover, the Court noted that the advertising ban would not be justifiable even if the government had asserted that its substantial interest was in preventing consumers from convincing doctors to prescribe compounded drugs that they did not need.}{ \cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 id.}{\insrsid10274 at 374.}}}{\insrsid10274 The Court noted, \'93 We have previously rejected the notion that the Government has an interest in preventing the dissemination of truthful commercial information in order to prevent members of the public from making bad decisions with the information.\'94}{ \cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 Id.}}}{\insrsid10274 The Court quoted }{\i\insrsid10274 Virginia Board of Pharmacy}{\insrsid10274 approvingly, noting that \'93 an alternative to this highly paternalistic approach . . . is to assume . . . that people will perceive their own best interests if only they are well enough informed, and that th e best means to that end is to open the channels of communication rather than to close them.\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline \tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 Id.}{\insrsid10274 at 375 (quoting }{ \i\insrsid10274 Virginia State Board of Pharmacy v. Virginia Citizens Consumer Council, Inc.}{\insrsid10274 , 425 U.S. 748, 770 (1976).}}}{\insrsid10274 \par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\insrsid10274 \tab Like }{\i\insrsid10274 Pearson}{\insrsid10274 , }{\i\insrsid10274 Western States}{\insrsid10274 reiterates that courts prefers full disclosure requirements to speech bans when dealing with commercial speech cases in the food and drug context. Also, as discussed in greater detail in Part VIII-C below, }{\i\insrsid10274 Western States }{ \insrsid10274 also demonstrates the Court\rquote s preference for analogous, non-speech-related means of regulating activity instead of speech-related ones. \par }\pard\plain \s4\ql \li0\ri0\sb360\sl480\slmult1\keepn\widctlpar\noline\tx0\tx317\tx619\aspalpha\aspnum\faauto\outlinelevel3\adjustright\rin0\lin0\itap0 \i\f287\fs22\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\f0\fs24\insrsid10274 F. The FDA\rquote s Response to These Cases \par }\pard\plain \s17\ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid10274 Although it is not yet clear whether other speech regulations in the food and drug context will be susceptible to First Amendment challenge, the FDA seems concerned about this possibility. In response to the commercial speech cases, the agency pr omulgated a Request for Comment, seeking guidance from the public on various First Amendment issues.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline \tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 FDA\rquote s Request for Comment on First Amendment Issues, 67 Fed. Reg. 34,942 (May 16, 2002).}}}{\insrsid10274 Noting that \'93[t]he Supreme Court has increasingly recognized the value of speech proposing a commercial transaction,\'94 the Request observed the challenge FDA faced in \'93balanc[ing] the need and right of Americans to speak and hear information vital to their every day lives against the need to ensure that people are not misled.\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{ \insrsid10274 }{\i\insrsid10274 Id.}{\insrsid10274 at 34,943.}}}{\insrsid10274 The Request then asked a number of questions, such as \'93Are there arguments for regulating speech about drugs more comprehensively than, for example, about dietary supplements?\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline \tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 Id.}{\insrsid10274 at 34,943.}}}{\insrsid10274 and \'93Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority?\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0 \widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 Id.}{\insrsid10274 at 34,944.}}}{ \insrsid10274 As of yet, it is unclear what the answers to these questions are. What seems clear, however, is that as protection for commercial speech continues to grow \emdash potentially reaching the level of strict scrutiny \emdash the FDA and other regulatory bodies will increasingly have to take heed of the First Amendment implications of their regulations. \par }\pard\plain \s1\ql \li0\ri0\sb480\sa120\sl480\slmult1\keepn\widctlpar\noline\tx0\tx317\tx619\hyphpar0\aspalpha\aspnum\faauto\outlinelevel0\adjustright\rin0\lin0\itap0 \scaps\f287\fs22\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 { \f0\fs24\insrsid10274 VIII. The Road Ahead for Food and Drug Regulation of Speech \par }\pard\plain \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid10274 Part V of this Note discussed how protection for commercial speech has moved steadily toward strict scrutiny. Part VII explored h ow recent commercial speech cases have placed increasing limitations on speech regulations in the food and drug law context. Parts VIII-A and VIII-B below highlight some arguments that regulators could employ in light of these cases, to prevent speech re gulations in the food and drug context from being subject to strict scrutiny. Part VIII-C then discusses alternatives to speech regulation. \par }\pard\plain \s5\ql \li0\ri0\sb360\sa120\sl480\slmult1\keepn\widctlpar\aspalpha\aspnum\faauto\outlinelevel4\adjustright\rin0\lin0\itap0 \i\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid10274 A. Slippery Slope Argument \par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid10274 \tab A general argument against providing strict scrutiny for commercial speech could focus on the slippery slope concerns discussed in Part V-E above. Regulators might assert that by protecting commercial speech with strict scrutiny, the Court might force itself to provide heightened First Amendment protection for other, more marginal categori es of speech that are difficult to distinguish}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 in}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 principle}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 from}{\expnd2\expndtw10\insrsid10274 }{ \insrsid10274 commercial}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 speech, such as speech regulated under securities or antitrust laws.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0 \widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 See}{\insrsid10274 }{ \i\insrsid10274 supra}{\insrsid10274 note 110.}}}{\insrsid10274 Although the Court may \'93solve\'94 one problem by removing commercial speech from the category of intermediate scrutiny,}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{ \i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 supra}{\insrsid10274 Part V-C for reasons why many members of the current Court dislike intermediate scrutiny.}}}{\insrsid10274 it would create another one, by likely providing a new}{ \expnd2\expndtw10\insrsid10274 }{\insrsid10274 category}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 of}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 speech}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 with}{\expnd2\expndtw10\insrsid10274 }{ \insrsid10274 quasi-protected}{\expnd2\expndtw10\insrsid10274 }{\insrsid10274 status. To prevent this \'93upwards-pull\'94 of First Amendment doctrine, regulators could argue that protection for commercial speech should remain in the in termediate scrutiny range. \par }\pard\plain \s1\ql \li0\ri0\sb360\sl480\slmult1\keepn\widctlpar\noline\tx0\tx317\tx619\hyphpar0\aspalpha\aspnum\faauto\outlinelevel0\adjustright\rin0\lin0\itap0 \scaps\f287\fs22\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 { \i\scaps0\f0\fs24\insrsid10274 B. Categorical Exclusion for Food and Drug Law from Strict Scrutiny \par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid10274 \tab If commercial speech shifts to strict scrutiny, regulators of speech in the food and drug context could still request a categorical exclusion for their field. The argument would be that although strict scrutiny applies to most restrictions on commercial speech, restrictions in areas of pressing national concern \emdash such as food and drug law \emdash should receive lower levels of scrutiny. Such an argument would emphasize the vital nature of the government\rquote s interest in regulating food and drugs, which the Supreme Court recognized in }{\i\insrsid10274 Lorillard}{\insrsid10274 when it observed, \'93The State's interest in preventing underage tobacco use is substantial, and even compelling.\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline \tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 Lorillard Tobacco Co. v. Reilly, 533 U.S. 525, 564 (2001).}}}{ \insrsid10274 Moreover, the Court already recognized a different form of this argument in }{\i\insrsid10274 United States v. Park}{\insrsid10274 ,}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\qj \li0\ri0\sl-190\slmult0\widctlpar\noline \tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 421 U.S. 658 (1975).}}}{\insrsid10274 where it upheld a conviction of a corporate officer for violation of the FD&C Act on strict liability grounds by noting that \'93the public interest in the purity of . . . food is so great as to warrant the imposition of the highest standard of care on distributors.\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\qj \li0\ri0\sl-190\slmult0\widctlpar\noline \tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 Id.}{\insrsid10274 at 671 (quoting }{ \i\insrsid10274 Smith v. California}{\insrsid10274 , 361 U.S. 147, 152 (1959)) (internal quotation marks omitted).}}}{\insrsid10274 \par \tab A related argument would be that the highly regulated nature of the food and drug law industry dictates that regulators of speech in this context should recei ve more leeway. Regulators could bolster their argument by analogizing to other areas of the law where constitutional protection has been diminished in fields of pervasive regulation. For example, the Court has held that Fourth Amendment protection from searches and seizures is diminished in automobiles, partly because they \'93are subjected to police stop and examination to enforce \lquote pervasive\rquote governmental controls \lquote as an everyday occurrence.\rquote \'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 Wyoming v. Houghton, 526 U.S. 295, 303 (1999) (quoting }{\i\insrsid10274 South Dakota v. Opperman}{\insrsid10274 , 428 U.S. 364, 368 (1976)).}}}{\insrsid10274 Similarly, the FDA might argue that pervasive regulation of f oods and drugs via the FD&C Act diminishes First Amendment commercial speech protection in this context. This argument could also build on a variant of an argument the Court countenanced in }{\i\insrsid10274 Posadas }{\insrsid10274 \emdash that the greater power to ban implies the lesser power to regulate.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 Posadas de Puerto Rico Assocs. v. Tourism Co. of Puerto Rico, 478 U.S. 328, 345\endash 46 (1986).}}}{\insrsid10274 \par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\insrsid10274 \tab A third argument that could be employed to create a categorical exclusion to strict scrutiny would be that this type of review would put in flux all sorts of basic food and drug regulations. Applying strict scrutiny to commercial speech, th e argument would go, would jeopardize many actions taken by the FDA, FTC, and other agencies, such as the regulation of labeling, promotional materials, and advertising. Moreover, this problem would be especially severe in the food and drug law context, b ecause the regulation of information is one of the main tools of control in this field. Furthermore, creating this stringent level of protection would discourage the FDA and other agencies from promulgating some speech regulations in the first place, bec ause they would be unwilling or unable to bear the burden of defending the regulations in court against commercial speech challenges. \par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\insrsid10274 \tab The problems with all of these arguments are that some lower courts have already rejected them as defenses to commercial s peech challenges, and the Supreme Court seems inhospitable to them as well. For example, in }{\i\insrsid10274 Lorillard}{\insrsid10274 , notwithstanding the compelling governmental interest at stake, the Court still invalidated the regulation banning tobacco advertising.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline \tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 Lorillard Tobacco Co.}{\insrsid10274 , 533 U.S. at 566\endash 67.}}}{\insrsid10274 And in }{\i\insrsid10274 Friedman}{\insrsid10274 , the court dispensed with the argument that the highly regulated nature of the food and drug industry reduced the First Amendment protection of drug manufacturers.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 Washington Legal Found. v. Friedman, 13 F. Supp. 2d 51, 60 (D.D.C. 1998).}}}{\insrsid10274 \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\insrsid10274 Nonetheless, food and drug regulators might be more successful in employing these argument s to create a categorical exclusion than they were in the past. These arguments highlight that the \'93regulable\'94 aspects of commercial speech are considerably stronger in the food and drug law context \emdash government already regulates this field to a large ext ent and it has a compelling interest in doing so. Although a move to strict scrutiny for any type of commercial speech clashes with its hybrid nature, this problem is especially severe in the food and drug law context, where the \'93regulable\'94 aspects of commercial speech are particularly important. Thus, an argument for a categorical exclusion from strict scrutiny for speech related to food and drug law would seem to be relatively strong. \par }\pard\plain \s1\ql \li0\ri0\sb360\sl480\slmult1\keepn\widctlpar\noline\tx0\tx317\tx619\hyphpar0\aspalpha\aspnum\faauto\outlinelevel0\adjustright\rin0\lin0\itap0 \scaps\f287\fs22\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 { \i\scaps0\f0\fs24\insrsid10274 C. Non Speech Regulations or Disclaimers as Alternatives \par }\pard\plain \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid10274 If strict s crutiny were applied to commercial speech and a categorical exclusion for food and drug law were denied, government regulators could still avoid the commercial speech problem altogether by relying less on speech regulation and instead employing analogous, non speech means to regulate.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 The FDA recognized that using non-speech alternatives might be useful in its Request for Comment, where it asked, \'93 Are there other alternative approaches that FDA could pursue to accomplish [its public health concerns] with fewer restrictions on speech?\'94 }{\i\insrsid10274 Id.}{\insrsid10274 at 34,944.}}}{\insrsid10274 This issue was crucial to the result in }{ \i\insrsid10274 Western States}{\insrsid10274 , where the Court contended that the government could have achieved its objectives in other non speech restrictive ways.}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{ \i\insrsid10274 See}{\insrsid10274 Thompson v. W. States Med. Ctr., 535 U.S. 357, 372 (2002).}}}{\insrsid10274 Instead of banning advertising of drug compounding, the Court suggested, for example, that Congress could have instead \'93 capp[ed] the amount of any particular compounded drug, either by drug volume, number of prescriptions, gross revenue, or profit that a pharmacist or pharmacy may make or sell in a given period of time\'94 or \'93 limit[ed] the amount of compounded drugs, either by volume or by numbers of prescriptions, that a given pharmacist or pharmacy sells out of State.\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0 \widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 Id.}}}{\insrsid10274 In many situations, such alternatives might be feasible, and regulators can avoid t he commercial speech issue altogether. Furthermore, under this view, the increase in commercial speech protection could have the salutary effect of channeling the government into using equivalent, non speech regulations. \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\insrsid10274 The problem with relying solely on analogous non speech regulations, however, is that sometimes they cannot achieve the same policy objectives as speech regulations. In his dissent in }{\i\insrsid10274 Western States}{\insrsid10274 , Justice Breyer noted that contrary to the majority \rquote s suggestion, he did not believe that \'93Congress could have achieved its safety objectives in significantly less restrictive ways.\'94}{\cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0 \widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 {\cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 Id.}{\insrsid10274 at 385.}}}{ \insrsid10274 He then proceeded to rebut each of the non speech alternatives presented by the majority, explaining why each was an inferior policy choice for the FDA as compared to the restriction on drug compounding advertisements.}{ \cs16\super\insrsid10274 \chftn {\footnote \pard\plain \s22\ql \li0\ri0\sb20\sa20\sl-200\slmult0\widctlpar\noline\tqr\tx317\tx403\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 { \cs16\super\insrsid10274 \chftn }{\insrsid10274 }{\i\insrsid10274 See}{\insrsid10274 }{\i\insrsid10274 id.}{\insrsid10274 at 385\endash 86.}}}{\insrsid10274 Thus, it is not clear whether and to what extent non speech regulations can be used to avoid commercial speech problems. \par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\insrsid10274 More realistically, instead of switching totally to non speech regulations, government regulators will likely rely more on less restrictive forms of speech regulation. One of the main reasons why the courts in }{\i\insrsid10274 Friedman}{\insrsid10274 , }{\i\insrsid10274 Pearson}{\insrsid10274 , and }{\i\insrsid10274 Western States}{\insrsid10274 struck down speech regulations was that they rejected the paternalistic argument t hat banning certain commercial speech is necessary to prevent consumers from becoming confused and making bad decisions. These courts placed greater faith in consumers\rquote decisionmaking abilities. Instead of banning advertisements and thus reducing the amo unt of speech, these courts suggested that regulators should encourage more speech, such as by mandating full disclosure or the use of disclaimers. Although disclaimers and full disclosure requirements may not achieve all of the policy objectives of regu l ators, they provide different regulatory options that are more likely to survive a commercial speech challenge. Thus, as the scope of the commercial speech doctrine continues to expand, these less restrictive forms of speech regulation are likely to beco me more common. \par }\pard\plain \s1\qc \li0\ri0\sb480\sa120\sl480\slmult1\keepn\widctlpar\noline\tx0\tx317\tx619\hyphpar0\aspalpha\aspnum\faauto\outlinelevel0\adjustright\rin0\lin0\itap0 \scaps\f287\fs22\lang1033\langfe1033\kerning12\cgrid\langnp1033\langfenp1033 { \f0\fs24\insrsid10274 Conclusion \par }\pard\plain \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid10274 The commercial speech doctrine has created serious concerns for food and drug regulators in recent years. Although commercial speech is a form of hybrid expression that shares some features with expressive conduct and other chara cteristics with fully regulable \'93speech\'94 such as exterior product designs, courts have been increasingly treating commercial speech like core First Amendment expression. Consequently, many food and drug regulations have been invalidated in recent years on commercial speech grounds. \par }\pard\plain \s17\ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid10274 If this doctrinal shift continues, speech that is widely thought to be wholly outside the First Amendment\rquote s coverage, such as the speech regulated by securities law, may become protected. Even if this radical shift does not occ ur, heightened protection for commercial speech still prevents the regulation of foods and drugs in a number of beneficial ways. Accordingly, food and drug regulators will have to use creative strategies and clever arguments to immunize themselves from t he commercial speech doctrine and to achieve their policy objectives. \par }}