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MAKING SENSE OF COMMERCIAL SPEECH:

A THEORETICAL FRAMEWORK AND A CASE STUDY IN FOOD AND DRUG LAW

Neel Sukhatme

Harvard Law School

Class of 2005

Third Year Written Work Requirement

April 22, 2005

ABSTRACT

This Note creates a theoretical framework 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 “speech” 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.

INTRODUCTION

Under First Amendment doctrine, many types of speech receive the most stringent levels of constitutional protection, whereas other types receive no protection at all. For example, some categories of speech, such as political or religious speech, are viewed as being at the core of the First Amendment.[1] Restrictions on these forms of speech receive strict scrutiny, and consequently, they are rarely upheld.[2] Other categories of speech, such as obscenity, receive no protection under the First Amendment,[3] and any restrictions on such speech are subject to only rational basis review under the due process clause.[4]

But not all speech fits neatly within this dichotomy. Commercial speech is a prominent category of speech that receives an intermediate level of First Amendment protection. In 1976, the Supreme Court in Virginia State Board of Pharmacy v. Virginia Citizens Consumer Council, Inc. [5] first recognized that restrictions on commercial speech are subject to intermediate scrutiny.[6] Four years later, in Central Hudson Gas & Electric Corp. v. Public Service Commission of New York ,[7] the Court formalized its analysis of commercial speech by adopting a four-factor test.[8]

This Note provides a new way of understanding commercial speech by relating it to expressive conduct, which is another category of speech that is evaluated under a four-factor intermediate scrutiny test.[9] Part I describes how commercial speech and expressive conduct are different forms of “hybrid” speech — each has a different mixture of “protected” elements that merit a heightened level of First Amendment protection and of “regulable” elements that deserve only rational basis review. More specifically, this Part asserts that while expressive conduct generally has a protected purpose but a regulable method of expression, commercial speech typically has a regulable purpose but a protected method of expression.

Part II then explores how the hybrid nature of commercial speech and expressive conduct affected the development of their respective doctrines. The Part explains how the Court’s general expansion of First Amendment protection and its increased deference to government regulation during the twentieth century came into tension in the context of hybrid speech. The Part suggests that the Court resolved this tension by adopting intermediate scrutiny for restrictions on commercial speech and incidental restraints on expressive conduct.

Part III of the Note further develops the framework for analyzing commercial speech and expressive conduct by exploring their similarities with “non speech sales activities,” which are defined here as actions designed to increase consumer demand that do not operate linguistically or use a conventional form of media to communicate. Focusing in particular on the exterior designs of products as prominent examples of non speech sales activities, Part III demonstrates that such designs share a regulable purpose with commercial speech: to sell products by making them more attractive to consumers. This Part then illustrates how exterior product designs also share a regulable method of operation with expressive conduct, in that neither form of expression uses spoken or written words. Finally, the Part explores why product designs do not receive First Amendment protection and how this distinction clarifies the framework within which both commercial speech and expressive conduct fit.

Part IV of the Note then examines how the type of governmental regulation at issue can affect the level of review. In particular, this Part explores how the framework established in the Note helps explain why content-based restrictions receive strict scrutiny in the expressive conduct context but not in the commercial speech context.

Part V of the Note examines why, although commercial speech and expressive conduct are both “hybrid” speech evaluated under similar four-part intermediate scrutiny tests, the actual level of review applied to restrictions on these types of speech has diverged in recent years, with protection for commercial speech moving toward strict scrutiny, and protection for expressive conduct drifting toward rational basis review. This Part suggests two possible reasons for this shift — the current Court’s affinity for bright-line rules rather than standards and a perception that modern commercial speech contains more expressive content than in the past. The Part also describes problems that would result if either form of hybrid speech is removed from the realm of intermediate scrutiny.

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 over the past century.

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 the 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.

Finally, Part VIII of the Note explores the road ahead — 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? This Part suggests arguments that food and drug regulators could press to prevent the highest level of scrutiny from being applied to their regulations.

I. THE HYBRID NATURE OF COMMERCIAL SPEECH AND EXPRESSIVE CONDUCT

Although commercial speech and expressive conduct are both forms of hybrid speech, they each contain different “protected” and “regulable” elements. To understand this difference, it is important to analyze separately the purpose of expression and the method by which expression occurs. For the paradigmatic examples of commercial speech, the primary purpose of expression is to persuade consumers to buy goods.[10] After the fall of Lochner , laws burdening commercial activities became subject to mere rational basis review and the government accordingly gained the power to regulate most activities directed toward a commercial purpose.[11] Thus, the government can, to a large extent, regulate or ban particular goods or services without violating the Constitution,[12] and the Court has held that this power justifies greater regulation of commercial speech.[13] The Court also has recognized the regulable purpose of commercial speech by holding that “[s]ince advertising is the sine qua non of commercial profits, there is little likelihood of its being chilled by proper regulation and forgone entirely.”[14]

Even though commercial speech might have a regulable purpose, the method by which most commercial speech is communicated is presumptively protected. Most commercial speech uses some form of the spoken or written word, or equivalent symbolism.[15] Although some uses of words are not covered under the First Amendment,[16] this method of communication generally receives some form of heightened First Amendment protection.[17] Moreover, commercial speech is usually voiced through media that convey other types of information that are protected by the First Amendment, such as newspapers, magazines, radio, television or billboards. Thus, for most commercial speech, the purpose of expression is regulable, but the mechanism of expression is protected.

Expressive conduct, on the other hand, works in precisely the opposite way. The purpose of expression for most recognized forms of expressive conduct usually is political or social[18] — purposes that lie at the core of the First Amendment and that typically receive the highest levels of protection. Despite this privileged goal, the method by which “symbolic speech” occurs — through conduct rather than words — is presumptively regulable by the state under its police power.[19] Thus, for most expressive conduct, the purpose of expression is protected, but the method of expression is regulable. Figure 1 summarizes the different regulable and protected elements for paradigmatic examples of commercial speech and expressive conduct.

FIGURE 1. HYBRID ELEMENTS OF COMMERCIAL SPEECH AND EXPRESSIVE CONDUCT


Purpose of expression
Method of expression
Commercial speech
Regulable
Protected
Expressive conduct
Protected
Regulable

Although both of these types of “hybrid” speech have different protected and regulable elements, restrictions on commercial speech and incidental restraints on expressive conduct both receive some form of intermediate scrutiny under the First Amendment. As demonstrated below, the adoption of intermediate scrutiny for these types of restrictions can best be described as a compromise between the competing interests in the regulable and protected elements.

II. THE EVOLUTION OF INTERMEDIATE SCRUTINY FOR HYBRID SPEECH

The development of the intermediate scrutiny standard for commercial speech and expressive conduct can be clarified by exploring two competing trends in the Supreme Court’s twentieth-century jurisprudence. First, the Court generally expanded the constitutional protection for individual liberty interests.[20] Among other things, the Court held that the Fourth, Fifth, and Sixth Amendments provide new procedural rights for criminal defendants[21] and that substantive due process protects personal privacy and intimate relationships.[22] Most germane to this Note, the Court also expanded the protection of speakers under the First Amendment.[23]

Second, during the last half of the twentieth century, the Court weakened its oversight of laws that regulate economic and property interests. During the Lochner era, the Court had often invoked substantive due process, the Contracts Clause, or limitations on Congress’s commerce power to strike down government regulations.[24] After the death of Lochner in 1937,[25] the Court changed its approach and became relatively deferential toward federal and state laws that regulated economic activity.[26] Moreover, during this period, the Court continued to recognize that the state retained the ability to regulate many forms of conduct under its police power.[27]

These two jurisprudential trends came into conflict with one another in the context of hybrid speech because of its protected and regulable elements. Thus, when confronted with cases involving direct restrictions on commercial speech or incidental restraints on expressive conduct, the Court was faced with the difficult choice of following the trend of expanding First Amendment coverage or instead deferring to government’s power to regulate. The Court chose intermediate scrutiny as a compromise for these types of restrictions, allowing government to retain significant power to regulate in these areas but acknowledging that the First Amendment still provides some protection.[28] Part V of this Note explores whether this compromise has since been altered as the actual level of protection for commercial speech and expressive conduct has diverged in recent years.

A. Incidental Restraints on Expressive Conduct and the O’Brien Test

In United States v. O’Brien ,[29] the Supreme Court established an intermediate scrutiny test for determining whether an incidental restraint on expressive conduct violated the First Amendment.[30] The case involved a Vietnam War protester who was convicted of violating a federal statute that proscribed the destruction of draft cards.[31] Although the statute created only an incidental restraint on the protester’s expressive conduct, the Court recognized that a balance had to be struck between the government’s power to regulate and an individual’s right to free speech: “[W]hen ‘speech’ and ‘nonspeech’ elements are combined in the same course of conduct, a sufficiently important governmental interest in regulating the nonspeech element can justify incidental limitations on First Amendment freedoms.”[32] The Court then set forth a four-factor test for determining whether a law that incidentally burdens expressive conduct is constitutional:

[A] governmental regulation is sufficiently justified [1] if it is within the constitutional power of the Government; [2] if it furthers an important or substantial governmental interest; [3] if the governmental interest is unrelated to the suppression of free expression; and [4] if the incidental restriction on alleged First Amendment freedoms is no greater than is essential to the furtherance of that interest.[33]

Applying this intermediate scrutiny test, the Court upheld the protester’s conviction.[34]

In avoiding the extremes of either rational basis review or strict scrutiny, the Court chose a middle path for incidental restrictions on expressive conduct that “reflects an effort to avoid endless inquiries into incidental effect while at the same time invalidating those restrictions that most seriously threaten free expression.”[35] This “uneasy but not unprincipled compromise”[36] thus respected both the protected purpose of symbolic speech and the regulable mechanism by which such speech is expressed. O’Brien ’s intermediate scrutiny test is still the law governing incidental restraints on expressive conduct, though it has been considerably weakened in its application, as described in Part V.

B. Restraints on Commercial Speech and the Central Hudson Test

For some time, commercial speech received no protection under the First Amendment, and it was thoroughly regulable by the government. For instance, shortly after Lochner was put to rest, the Court in Valentine v. Chrestensen [37] upheld a New York statute that prohibited the distribution of advertising materials and handbills on the street.[38] The Court viewed advertising not as a form of protected speech but rather as merely another regulable activity, declaring that there was “no [First Amendment] restraint on government as respects purely commercial advertising.”[39]

In the 1960s, the Court’s attitude toward commercial speech began to change. In New York Times Co. v. Sullivan ,[40] the Court held that a paid advertisement describing the struggle for civil rights in Alabama was protected by the First Amendment despite being published for profit.[41] It noted that the fact that “the Times was paid for publishing the advertisement is as immaterial in this connection as is the fact that newspapers and books are sold.”[42] In 1975, the Court inched closer to providing First Amendment protection for commercial speech in Bigelow v. Virginia ,[43] holding that Virginia could not criminalize advertisements in its newspapers for abortions in New York.[44]

Finally, in the 1976 case of Virginia State Board of Pharmacy v. Virginia Citizens Consumer Council, Inc. ,[45] the Court expressly held that the First Amendment provides some protection for commercial speech, which it defined to include “speech which does ‘no more than propose a commercial transaction.’”[46] The Court invalidated a statute that prohibited Virginia pharmacists from advertising the prices of prescription drugs, holding that the government may not “completely suppress the dissemination of concededly truthful information about entirely lawful activity, fearful of that information’s effect upon its disseminators and its recipients.”[47] The Court, however, recognized the hybrid nature of commercial speech, and noted that although it “is protected, we of course do not hold that it can never be regulated in any way.”[48] In particular, the Court observed that “false or misleading” commercial speech could be proscribed,[49] and it disclaimed any suggestion that its holding prevented states from outlawing advertisements for illegal transactions.[50]

In 1980, the Court in Central Hudson [51] again acknowledged the hybrid status of commercial speech, holding that “[t]he Constitution . . . accords a lesser protection to commercial speech than to other constitutionally guaranteed expression.”[52] The case involved a ban intended to prevent an increase in demand for electricity on certain promotional advertising by electric utilities.[53] In a manner reminiscent of its approach to expressive conduct, the Court formalized its commercial speech analysis by establishing a four-factor test:

[1] [W]e must determine whether the expression is protected by the First Amendment. For commercial speech to come within that provision, it at least must concern lawful activity and not be misleading. [2] Next, we ask whether the asserted governmental interest is substantial. [3] If both inquiries yield positive answers, we must determine whether the regulation directly advances the governmental interest asserted, and [4] whether it is not more extensive than is necessary to serve that interest.[54]

The Court then applied this test to the advertising ban, holding that the restriction was invalid because it failed the fourth prong.[55]

In creating the test for commercial speech, the Court followed in the footsteps of O’Brien .[56] The Central Hudson test has many textual similarities to the O’Brien test: they are both four-factor, intermediate scrutiny tests that turn heavily on the asserted government interest in regulating the speech and on the scope of the government regulation.[57] Furthermore, the Central Hudson test, like the O’Brien test, reflects a compromise between the competing regulable and protected elements that constitute hybrid speech.[58]

Despite Central Hudson ’s continuing vitality, the fundamental tension in this area — between an individual’s right to free speech and the state’s power to regulate — has not been resolved, and commercial speech remains a fault line in constitutional law. Some judges and scholars have favored broad latitude for the government to enact economic regulations, and therefore have sought to remove constitutional protection for commercial speech.[59] Some of these scholars have argued that recognition of commercial speech rights is a throwback to the Lochner era.[60] Others (including an increasingly vocal group on the Supreme Court[61] ) have argued that the distinctions between commercial speech and traditionally protected speech are not justifiable, either in principle or in practice.[62] Some of these individuals would elevate protection of commercial speech to the level of core First Amendment expression. As discussed in Part V, commercial speech doctrine seems to be following this second route, as the protections it affords to commercial speech have been considerably strengthened in recent years.

III. NON SPEECH SALES ACTIVITIES AND THEIR RELATION TO HYBRID SPEECH

Commercial speech and expressive conduct can be better understood by noting their similarities to “non speech sales activities,” which are defined here as actions that increase consumer demand for a product or service but which do not operate linguistically or use a conventional form of media to communicate.[63] To illustrate these similarities more clearly, this Part focuses specifically on the exterior designs of products as paradigmatic examples of non speech sales activities.[64] As shown below, exterior product designs share a regulable purpose and effect with commercial speech. Additionally, exterior product designs are similar to expressive conduct because they operate via regulable, non linguistic mechanisms. The Part concludes by situating exterior product designs within the overall speech framework, clarifying why intermediate scrutiny is applied to restrictions on commercial speech and incidental restraints on expressive conduct.[65]

A. Commercial Speech and Exterior Product Designs Share a Regulable Purpose and Effect

Although commercial speech may take a variety of forms,[66] its primary purpose and effect are similar to those of exterior product designs. First, from the perspective of speaker intent, commercial speech always, at least to some degree, has a regulable purpose: to sell goods or services to a consumer.[67] Exterior product designs share this regulable purpose. Companies design advertisements, products, and packaging with the goal of making a product more attractive and thereby increasing sales revenue. Whether through an attractive shape, a cool structure, an eye-catching package, or a soothing color scheme, the exterior design of a product can persuade a consumer to purchase an item.[68] Although companies might consider a host of other factors when deciding how a product looks,[69] creating a pleasing appearance for consumers remains an important priority.

Second, from the perspective of effect on audiences, commercial speech and exterior product designs often rely on non cognitive responses to achieve their goal of increasing consumer demand. Rather than persuading a person to act based on reason, modern advertising often communicates by appealing to emotion.[70] Whether an advertisement features Britney Spears drinking Pepsi, “regular guys” having Budweisers while watching football, or euphoric Claritin users dancing in a pastoral landscape, commercial speech often tries to create emotional attachments between consumers and products. Philosopher Roger Shiner has commented on this phenomenon of “lifestyle advertising”:[71]

A great deal — perhaps even almost all — corporate advertising expression does not have anything at all to do with the transmission of information. It has rather to do with the creation of emotional associations, especially associations that will help induce a favourable, and even a desirous, attitude towards the product in question.[72]

Shiner contends that “[t]he paradigm examples of persuasive advertising are . . . advertisements whose content is primarily not informative but symbolic, portraying ways of living in acts of endorsement or advocacy that do not involve discursive promotion of a product.”[73]

Similarly, exterior product designs rely on creating emotional responses to sell products. The external design of products often acts seductively on a consumer by tugging on his emotions (and with any luck, his wallet). Consumers often purchase items impulsively, with factors such as packaging and exterior design playing an important role in their purchasing decisions.[74] Thus, exterior product designs are similar to commercial speech in the response that they evoke from consumers.[75]

B. Exterior Product Designs and Expressive Conduct Share a Regulable Method of Expression

In a different sense, exterior product designs are also similar to expressive conduct: neither of these “activities” relies on conventional forms of media or uses spoken or written words to convey their messages. On the surface, the design of the latest iPod and the burning draft card in O’Brien have little in common — certainly both forms of “expression” serve different purposes and have different effects on their respective audiences. Despite these obvious differences, these activities are similar in that they both communicate primarily through non linguistic means. Accordingly, because their mechanisms of communication generally do not fall into the category of behavior conventionally called “speech,” the method by which exterior product designs and expressive conduct communicate can generally be regulated. To some extent, external product designs, and non speech sales activities in general, can be considered a form of expressive conduct with a commercial purpose, which shares a regulable mechanism of communication with expressive conduct and a regulable purpose with commercial speech.

C. Purposes and Methods: The First Amendment Framework

Despite their expressive characteristics and similarities to both commercial speech and expressive conduct, exterior product designs currently do not receive any First Amendment protection.[76] This lack of protection might be attributable to two reasons. First, any action has some expressive quality; in order to count as “expressive conduct,” the expressive content of the action must reach a certain threshold of significance.[77] Although the availability of design patent and trade dress protection for exterior product designs indicates that they do have some “expressive” content,[78] the lack of First Amendment protection implies that these commercial acts are not viewed as having as much expressive content as linguistic forms of communication or expressive conduct that is directed toward core First Amendment goals.

More importantly, the lack of protection for exterior product designs supports the framework of purpose and mechanism established for commercial speech and expressive conduct in Part I. As demonstrated above, the commonalities that exterior product designs (and non speech sales activities in general) share with commercial speech and expressive conduct are generally regulable ones. Like commercial speech, exterior product designs have the regulable purpose and effect of persuading consumers to buy a product or service. Like expressive conduct, these commercial activities employ the regulable method of using a non linguistic form of communication. Thus, exterior product designs receive rational basis protection because they only share regulable characteristics with forms of speech that receive intermediate scrutiny. Additionally, the relationships that commercial speech and expressive conduct have with exterior product designs illustrate in a tangible way the “regulable” aspects of these hybrid forms of speech.

Figure 2 summarizes a framework of purpose and method that relates core First Amendment speech, commercial speech, expressive conduct, and exterior product designs. As the diagram illustrates, commercial speech shares a regulable purpose of expression with exterior product design, and a protected means of expression with core speech. On the other hand, expressive conduct shares a protected purpose of expression with core speech, but a regulable method of expression with exterior product design. Finally, exterior product design has both a regulable purpose and a regulable method.

FIGURE 2. PURPOSE AND METHOD FRAMEWORK FOR MAPPING SPEECH [79]

IV. ADDING THE PURPOSE OF GOVERNMENT REGULATION TO THE FRAMEWORK

As demonstrated above, commercial speech and expressive conduct have received a baseline level of intermediate scrutiny because both are forms of hybrid speech with a combination of protected and regulable elements. One important aspect of First Amendment jurisprudence that has not been discussed thus far in this Note, however, is what role the purpose of the government regulation at issue plays in determining the standard of review. Much of First Amendment jurisprudence focuses on this factor rather than on the purpose or mechanism of the speech.[80]

The purpose of government regulation plays different roles in the expressive conduct and commercial speech contexts. For expressive conduct, the purpose of regulation can determine the standard of review. Under O’Brien , incidental restraints on expressive conduct — that is, content-neutral restrictions — receive intermediate scrutiny. Restraints targeting the expressive content of symbolic speech — content-based restrictions — receive strict scrutiny.[81] In contrast, under Central Hudson , commercial speech receives the same form of intermediate scrutiny regardless of the purpose of government restriction at issue.

The framework developed in this Note helps explain why content bias matters in the expressive conduct context but not with regard to commercial speech. As discussed earlier, the purpose of expressive conduct generally is “protected” and is at the core of the First Amendment. Hence, content-based regulations are targeting expressive conduct on the axis in which it is similar to core political speech; accordingly, such restrictions receive strict scrutiny.[82] On the contrary, the purpose of commercial speech generally is regulable. Hence, content-based restrictions that target this “regulable” purpose receive intermediate scrutiny because they restrict commercial speech along a regulable axis. Thus, it is the difference in purposes of expression between these two types of hybrid speech that explains why content bias produces different levels of scrutiny.[83]

V. THE FRAMEWORK SHIFTS: RECENT CHANGES IN THE EXPRESSIVE CONDUCT AND COMMERCIAL SPEECH DOCTRINES

The analysis in Parts I and II demonstrates how expressive conduct and commercial speech are analytically similar, as they are both forms of “hybrid speech” governed by four-factor intermediate scrutiny tests that are textually similar. Yet despite these structural similarities, the Court has increasingly applied a more relaxed form of intermediate scrutiny to incidental restraints on expressive conduct, while applying a stricter form of intermediate scrutiny to restrictions on commercial speech.[84] This Part explores how the Court’s preference for bright-line rules and an altered societal conception of commercial speech help explain this shift. This Part also examines how a complete shift to rational basis review or strict scrutiny is problematic for either expressive conduct or commercial speech.

A. Expressive Conduct Receives Diminished First Amendment Protection in Practice

Although the O’Brien test remains good law, the Court has never used it to invalidate laws that incidentally burden expressive conduct.[85] In fact, the Court has created a waivable presumption that such laws do not violate the First Amendment.[86] One scholar has noted, “By the 1990s . . . O’Brien intermediate scrutiny provided little First Amendment protection against a government regulation that could be said to advance a content-neutral goal, regardless of the law’s actual motivation towards application on or effects on free speech.”[87]

The Court’s hesitation to apply O’Brien expansively may stem from a concern that this course of action would force courts to review almost every governmental action for First Amendment violations, because almost every law is bound to have some incidental effect on a form of expressive conduct.[88] Additionally, over the years, O’Brien might have become diluted because the Court has applied it to a wider variety of contexts.[89] Moreover, the actual O’Brien test — particularly its content neutrality and narrow-tailoring requirements — also may have been weakened during this time period.[90] Whatever the reason, O’Brien ’s intermediate scrutiny test does not provide the level of intermediate scrutiny for incidental restraints on expressive conduct that the test’s language suggests.

B. Commercial Speech Marches Toward Strict Scrutiny

Like O’Brien , Central Hudson remains good law.[91] But unlike in the expressive conduct context, where the actual level of First Amendment protection seems weaker than the O’Brien test would suggest, scrutiny in the commercial speech arena seems to be rising, with more protection offered to commercial speech than Central Hudson seems to indicate. In 44 Liquormart, Inc. v. Rhode Island ,[92] the Court struck down a statute that prohibited any advertising of prices of alcoholic beverage except “for price tags or signs displayed with the merchandise within licensed premises and not visible from the street.”[93] The Court noted that “when a State entirely prohibits the dissemination of truthful, nonmisleading commercial messages for reasons unrelated to the preservation of a fair bargaining process, there is far less reason to depart from the rigorous review that the First Amendment generally demands.”[94] Further, the Court has continued to invalidate laws regulating commercial speech, even provisions regulating activities of important national concern such as food and drug law.[95] Justices Stevens and Thomas have joined many scholars in calling for the highest level of protection for certain types of commercial speech.[96] Thus, the trend in recent years has been toward a stronger commercial speech doctrine, with a possible shift to full First Amendment protection coming in the future.

C. Preference for Bright-Line Rules Explains the Shift From Intermediate Scrutiny

One reason why the levels of review for commercial speech and expressive conduct are moving away from intermediate scrutiny may be that at least four current Supreme Court Justices favor bright-line rules over multi-factor standards.[97] Unlike strict scrutiny, which is often fatal in fact, and rational basis review, under which very few laws are held unconstitutional, intermediate scrutiny is the level of review that provides judges with the most discretion in assessing the constitutionality of a law. Critics assert that by giving this discretion to unelected judges, intermediate scrutiny is undemocratic.[98] Supporters urge that intermediate scrutiny provides judges with the flexibility that they need to decide difficult cases correctly, and that by not forcing rigid decisionmaking, intermediate scrutiny actually facilitates democratic deliberation.[99]

For better or for worse, the Court seems to have adopted a less charitable view toward balancing modes of analysis such as intermediate scrutiny, and has been pushing for a jurisprudence more centered on bright-line rules. Justice Scalia has been one of the most prominent advocates of this approach. He has urged that “[balancing] modes of analysis be avoided where possible” and “that the Rule of Law, the law of rules , be extended as far as the nature of the question allows.”[100] In Employment Division v. Smith ,[101] Justice Scalia imported this form of analysis into the free exercise context,[102] and he has indicated a willingness to import it into the expressive conduct context as well.[103] In particular, the Court’s trend may be toward applying rational basis review for all content-neutral regulations (which would include incidental restraints on expressive conduct),[104] and strict scrutiny for all content-based regulations (which would include commercial speech regulations).[105] Although some Justices may not share a distaste of the balancing mode of analysis, some of the shift away from intermediate scrutiny in the commercial speech and expressive conduct contexts likely reflects this jurisprudential approach.

D. Changed View of Advertising Shifts Commercial Speech Toward Strict Scrutiny

Another possible reason why the Court has increased commercial speech’s First Amendment protection is that the boundary between commercial and noncommercial purposes is blurring. Advertising, more than ever before, is integrated into other forms of entertainment. For example, the music video is a type of speech whose commercial and noncommercial aspects seem inextricably intertwined.[106] Product placement in movies is another example of “blended” commercial speech. As advertising becomes more “lifestyle” oriented and focuses on eliciting an emotional response from consumers,[107] it begins to look more like a form of art. Thus, because advertising is becoming more expressive in its methods of communication — even though it retains a primarily commercial purpose — the Court may increasingly view it as a form of core First Amendment speech.

E. Potential Problems With Shifting to Strict Scrutiny or Rational Basis Review

Despite the current drift of commercial speech doctrine toward strict scrutiny, and expressive conduct toward rational basis review, the Court will face difficulties if it shifts the doctrines to either extreme. As described earlier, intermediate scrutiny was adopted for these types of speech because the Court recognized that they were “hybrid” in nature. Accordingly, a shift to rational basis review or strict scrutiny would create a tension between the legal doctrine and the inherent characteristics of these types of speech.

In the expressive conduct context, a move to rational basis review would establish a simpler test, but it would leave vulnerable forms of speech that probably deserve First Amendment protection.[108] Although the Court has never used O’Brien to strike down laws, the test still provides the Court with that power, which it could exercise in egregious circumstances. In addition, the shadow of O’Brien may deter legislatures from passing such laws. A shift to rational basis review would minimize or possibly even eliminate these beneficial effects.

A move all the way to strict scrutiny in the commercial speech context would be problematic for other reasons. First, it would prevent legislatures and agencies from regulating advertising in potentially beneficial ways.[109] Second, it might result in First Amendment protection for “speech” normally thought outside of the Amendment entirely. Some forms of unprotected “speech” — such as speech currently regulated under securities or antitrust law — lurk just outside the current boundaries of the First Amendment, and they are difficult to distinguish in principle from commercial speech.[110] If commercial speech receives core First Amendment protection, this tenuous distinction will come under even more strain. In other words, putting commercial speech in the category of “clearly protected” speech may merely spur courts to provide a new category of speech with quasi-protected status. To the extent that one feels the First Amendment does not belong in areas such as antitrust or securities law, this “upwards-pull” of First Amendment doctrine would be disconcerting. On this view, intermediate scrutiny for commercial speech represents a buffer, preventing a sharp drop-off between the more extreme doctrines of rational basis review and strict scrutiny and preventing other types of marginal speech from falling into the wrong category of protection.

VI. HISTORY OF THE REGULATION OF SPEECH IN THE FOOD AND DRUG LAW CONTEXT

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 and 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 over the course of the twentieth century.

A. Early Regulation of Speech Related to Food and Drug Law

The first comprehensive federal food and drug statute — the Federal Food and Drugs Act of 1906 (the “Wiley Act”)[111] — prohibited the interstate commerce “of any article of food or drugs which is adulterated or misbranded.”[112] After the Supreme Court held in U.S. v. Johnson [113] that the Act did not prohibit the making of false therapeutic claims,[114] Congress quickly passed the Sherley Amendment in 1912 to overrule the Court.[115] Congress then passed the Gould Amendment in 1913, which required that food package content be “plainly and conspicuously marked on the outside of the package in terms of weight, measure, or numerical count.”[116] In 1924, the Supreme Court expanded the scope of the 1906 Act in U.S. v. 95 Barrels ,[117] in which it held that the Act “condemn[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.”[118] Thus, even before the New Deal, regulation of speech related to food and drugs had steadily grown.

B. The Federal Food, Drug and Cosmetic Act of 1938 and the Wheeler-Lea Act

Despite the increased speech regulations on food and drugs in the early twentieth 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 “lack of jurisdiction over false or misleading claims not made on food labels.”[119] 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.[120] Furthermore, with the exception of the minimal mandatory labeling requirements created by the Gould Amendment, the 1906 Act “did not require any form of affirmative label statement.”[121]

Recognizing these shortcomings, the FDA in 1933 recommended a total revision of the 1906 Act.[122] Five years later, Congress passed the Federal Food, Drug and Cosmetic Act of 1938 (FD&C Act).[123] The FD&C Act authorized regulation of many different types of commercial speech that were previously outside the FDA’s regulatory control. In particular, the Act set forth various labeling requirements for food and drug products traveling in interstate commerce to prevent misbranding,[124] and it defined “labeling” more broadly than its lay meaning.[125] 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 “circulars and pamphlets distributed to consumers.”[126] The Act also made prosecutions for misbranding easier by eliminating the Sherley Amendment’s requirement that the government must show fraudulent intent in drug misbranding cases, and instead declaring that “A drug or device shall be deemed to be misbranded [if] its labeling is false in any particular.”[127]

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.[128] This Act specifically enabled the Federal Trade Commission (FTC) to seek injunctions for false advertisements of foods, drugs, cosmetics, or devices.[129] Although the FTC already had possessed the power to regulate misleading advertising and labeling of FDA-regulated products under its organic statute,[130] the Wheeler-Lea Act clarified that the FTC, not the FDA, had jurisdiction to pursue such claims.[131] 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.[132] Additionally, advertising of restricted medical devices is regulated by the FDA under the Medical Device Amendments of 1976.[133]

C. Congressional Regulation of Speech After the FD&C Act

After passing the FD&C Act, Congress has periodically expanded the scope of the FDA’s power to regulate product labeling. In 1960, Congress passed the Federal Hazardous Substances Labeling Act,[134] which required the use of clear warning labels on hazardous household chemicals. In 1966, the Fair Packaging and Labeling Act[135] 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.[136] In 1990, Congress passed the Nutrition Labeling and Education Act (NLEA),[137] which requires nutrition labeling on all packaged foods,[138] and in 1994 it passed the Dietary Supplement Health and Education Act,[139] which set forth labeling requirements for dietary supplements.[140] Most recently, Congress passed a broad reform of the FD&C Act in the Food and Drug Modernization Act (FDAMA), which includes provisions to “regulate advertising of unapproved uses of approved drugs and devices, and regulate health claims for foods.”[141]

D. Examples of Speech Regulations Promulgated by the FDA

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’s) with oral contraceptives.[142] The PPI’s were intended to provide, among other things, “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.”[143] Although the FDA later revoked its entire PPI program,[144] manufacturers voluntarily continue to provide PPI’s for “a number of drugs which present unique safety questions.”[145]

The FDA has also promulgated a number of restrictions on prescription drug advertising.[146] For example, it has banned advertisements that “feature inert or inactive ingredients in a manner that creates an impression of value greater than their true functional role in the formulation.”[147] It has also banned advertisements that are or may be false, lacking in fair balance or otherwise misleading.[148] Such advertisements include, for example, those that “use[] a quote or paraphrase out of context to convey a false or misleading idea,”[149] and those that “contain[] information from . . . reports or opinions falsely or misleadingly represented or suggested to be authentic or authoritative.”[150] In recent decades, the FDA has encouraged advertising of prescription drugs to consumers as a way to promote competition among prescription drug manufacturers.[151]

VII. THE RISE OF THE COMMERCIAL SPEECH DOCTRINE IN THE FOOD AND DRUG CONTEXT

As described in Part II of this Note, the commercial speech doctrine has been shaped by the tension between the government’s expanding regulatory powers and a growing set of First Amendment rights. Furthermore, as discussed 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 foods and drugs. Furthermore, the Part ties each of the cases below in some way into the theoretical framework described earlier in this Note.

A. Alcohol Content on Beer Labeling and Advertising

As protection for commercial speech grew, regulators of foods and drugs lost a number of important cases beginning in the 1990s. In Rubin v. Coors Brewing Co. ,[152] the Supreme Court invalidated a federal regulatory scheme that prohibited brewers from disclosing the alcohol content of beer on their labeling or in advertising.[153] The Court first rejected the government’s argument that it should have “broader latitude [than that allowed by Central Hudson ] to regulate speech that promotes socially harmful activities, such as alcohol consumption.”[154] It then chose to apply Central Hudson to the regulation, because “Both parties agree[d] that the information on beer labels constitutes commercial speech.”[155]

Turning to the first prong of Central Hudson , the Court evaluated the government’s interest in the ban, which was to prevent “strength wars” among brewers.[156] Although the Court acknowledged that this interest was substantial,[157] it also noted that “the general thrust of federal alcohol policy appears to favor greater disclosure of information, rather than less.”[158] More important, the Court determined that the ban failed the third and fourth prongs of Central Hudson because it was being applied less stringently for advertising than for labeling.[159] This disparate application, according to the Court, “makes no rational sense if the Government’s true aim is to suppress strength wars.”[160]

Coors demonstrates that labeling of food products can be considered commercial speech, and thus subject to the requirements of Central Hudson . As two commentators have noted, “Coors 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.”[161] 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.

B. Promotion of Off-Label Uses of Prescription Drugs

The FDA lost a number of cases involving speech regulation in lower courts toward the end of the 20th century. Washington Legal Foundation v. Friedman [162] 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.[163] 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.[164] Accordingly, the FDA promulgated Guidance Documents that prevented manufacturers from promoting off-label uses at continuing medical education (CME) seminars,[165] and from disseminating to physicians “enduring” materials that address off-label uses.[166]

On a First Amendment challenge to these provisions, the federal district court for the District of Columbia rejected the FDA’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.[167] In particular, the court noted, “[T]he activities at issue in this case are only ‘conduct’ to the extent that moving one’s lips is ‘conduct,’ or to the extent that affixing a stamp and distributing information through the mails is ‘conduct.’”[168] Similar to the analysis suggested above in Part II, the court thus focused on the means of communication — the spoken word — as an indication that this was a form of speech, and not conduct.

Furthermore, the court rejected the FDA’s contention that the First Amendment did not apply to the speech at issue in this case because the food and drug industry is extensively regulated, observing, “Since the Central Hudson 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.”[169] 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 Bolger v. Youngs Drug Products Corp .[170]

The court then invalidated both of the guidance documents as being more extensive than necessary and thus violating the fourth prong of the Central Hudson test.[171] It noted that “full, complete, and unambiguous disclosure by the manufacturer” is a “less-burdensome alternative[] to this restriction on commercial speech” that “deals more precisely with the concerns of the FDA and Congress.”[172] Among other things, the court argued that full disclosure, “assuages concerns that the message communicated is inherently or potentially misleading”and “still leaves more than adequate incentives compelling drug manufacturers to get new uses approved by the FDA.”[173] Moreover, the court noted approvingly that full disclosure also “comports with the Supreme Court's preference for combating potentially problematic speech with more speech.”[174]

Shortly after the court’s decision, the FDAMA went into effect, which supplanted the Guidance Document on enduring materials with a similar provision.[175] The FDA unsuccessfully tried to amend the court’s previous decision concerning the constitutionality of its policy, and the FDAMA and its implementing regulations were held to be unconstitutional.[176] On appeal, the FDA changed its position concerning the Guidance Documents, asserting that “they established nothing more than a ‘safe harbor’ ensuring that certain forms of conduct would not be used against manufacturers in misbranding and ‘intended use’ enforcement actions.”[177] Accordingly, the Court of Appeals declined to reach the constitutionality of the FDAMA and vacated the lower court judgment.[178]

The FDA then issued a Notice, contending that despite the fact that the Guidance Documents set forth a safe harbor, the FDA could “proceed, in the context of case-by-case enforcement, to determine from a manufacturer’s written materials and activities how it intends that its products be used.”[179] It also noted that “if the agency brings an enforcement action, a manufacturer may raise a First Amendment defense.”[180] A challenge to this Notice in the district court was subsequently denied.[181] 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 “remains 100% unresolved.”[182]

Some guidance on this issue may have come from the recent case of U.S. v. Caputo ,[183] in which a federal district court upheld the FDA’s prohibition on manufacturer promotion of off-label uses against a commercial speech challenge.[184] 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.[185] Unlike the original version of the sterilization system, the modified version had not been approved by the FDA, and the court characterized its use as an off-label one.[186] Applying Central Hudson , the court noted that “unlike Washington Legal Foundation , Defendants' First Amendment challenge strikes at the very heart of the FDA's ability to proscribe manufacturer promotion of off-label uses,” and that a successful challenge by the defendants “would severely frustrate the FDA's ability to evaluate the effectiveness of off-label uses.”[187] Furthermore, the court noted that it was “unable to identify a less burdensome alternative that would advance the government's substantial interest.”[188] Accordingly, the court rejected the defendant’s commercial speech argument.[189] Although Caputo 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.

C. FDA’s Rejection of Health Claims for Dietary Supplements

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.[190] The FDA specified that a dietary supplement health claim should be approved only if there is “significant scientific agreement . . . that the claim is supported by [the totality of publicly available scientific] evidence.”[191] 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.[192]

In Pearson v. Shalala ,[193] manufacturers, distributors, and organizations of consumers of dietary supplements challenged these regulations as violating the commercial speech doctrine.[194] Although the federal district court rejected this argument,[195] the D.C. Circuit reversed.[196] Disagreeing with the FDA that the health claims were inherently misleading, the court found that the regulations failed the last prong of Central Hudson , because there was no “reasonable fit” between the FDA regulations and the agency’s goal of preventing consumer fraud.[197] The court noted that Supreme Court precedent indicated that “disclaimers [are] constitutionally preferable to outright suppression,” and that “when government chooses a policy of suppression over disclosure — at least where there is no showing that disclosure would not suffice to cure misleadingness — government disregards a ‘far less restrictive’ means.”[198] Moreover, the court held that the FDA’s “significant scientific agreement” standard was too vague to be acceptable under the Administrative Procedure Act.[199]

In response to this decision, the FDA clarified the meaning of the “significant scientific agreement” standard.[200] Nonetheless, it still refused to allow dietary supplement manufacturers to make the health claims.[201] These manufacturers brought suit, and once again, the FDA lost on commercial speech grounds.[202] Accordingly, the agency was forced to acquiesce and allow the dietary supplement manufacturers to make the health claims.

Like Coors , Pearson demonstrates the courts’ willingness to apply the commercial speech doctrine to claims made on labeling. Furthermore, Pearson 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.

D. Advertising of Tobacco Products

Federal governmental agencies 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 Lorillard Tobacco Co. v. Reilly ,[203] the Supreme Court invalidated outdoor advertising restrictions on smokeless tobacco and cigars promulgated by Massachusetts’s Attorney General.[204] The regulations “prohibit[ed] any smokeless tobacco or cigar advertising within 1,000 feet of schools,” which the Court noted “would constitute nearly a complete ban on the communication of truthful information about smokeless tobacco and cigars to adult consumers [in some geographical areas].”[205] Although the Court conceded that the state’s interest in preventing underage smoking was “compelling,”[206] it held that the regulations violated the fourth factor of Central Hudson , because the “broad sweep of the regulations indicates that the Attorney General did not ‘carefully calculate the costs and benefits associated with the burden on speech imposed’ by the regulations.”[207]

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.[208] The Court held that these provisions violated both the third and fourth steps of Central Hudson because the ”5 foot rule does not seem to advance [the] goal [of preventing underage smoking].”[209]

Despite these setbacks, the Court upheld another set of Massachusetts regulations that “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.”[210] Citing to O'Brien , the Court noted that “Massachusetts seeks to regulate the placement of tobacco products for reasons unrelated to the communication of ideas.”[211] It then concluded, “The means chosen by the State are narrowly tailored to prevent access to tobacco products by minors.”[212]

Lorillard illustrates two interesting points that are 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 basis of the commercial speech doctrine. The Court’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.

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, were 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 expressed is important to the Court in determining whether the commercial speech doctrine has any bite. Restrictions on commercial “speech” that operate via non-linguistic means are much more likely to be upheld than restrictions on commercial speech that operate via linguistic means.

E. Promotion of Drug Compounding Services by Pharmacies

In Thompson v. W. States Med. Ctr. ,[213] the Supreme Court’s most recent case involving commercial speech in the food and drug context, the Court invalidated a provision of the FDAMA that banned advertising for compounded drugs.[214] 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.[215] The FDA was concerned that “some pharmacists were manufacturing and selling drugs under the guise of compounding,” which enabled them to avoid the FDA’s rigorous drug approval requirements.[216] Accordingly, when Congress passed the FDAMA, it included a provision that exempted compounded drugs from the drug approval requirements “as long as the providers of those drugs . . . refrain[ed] from advertising or promoting particular compounded drugs.”[217] A group of licensed pharmacists then brought suit, challenging the provision under the First Amendment.[218]

Because both parties agreed that the expression at issue was commercial speech, the Court applied Central Hudson .[219] The government asserted the advertising ban served the substantial governmental interest of channeling drugs produced on a large-scale through the FDA’s drug approval process while preserving the availability of compounded drugs for individual patients.[220] In particular, the government used “advertising as the trigger for requiring FDA approval”[221] because it serves as a “fair proxy for actual or intended large-scale manufacturing.”[222] The Court rejected this argument. Noting the availability of several, equivalent non-speech-related means, it stated, “If the First Amendment means anything, it means that regulating speech must be a last — not first — resort.”[223]

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.[224] The Court noted, “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.”[225] The Court quoted Virginia Board of Pharmacy approvingly, noting that “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 the best means to that end is to open the channels of communication rather than to close them.”[226]

Like Pearson , Western States 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, Western States also demonstrates the Court’s preference for analogous, non-speech-related means of regulating activity instead of speech-related ones.

F. The FDA’s Response to These Cases

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 promulgated a Request for Comment, seeking guidance from the public on various First Amendment issues.[227] Noting that “[t]he Supreme Court has increasingly recognized the value of speech proposing a commercial transaction,” the Request observed the challenge FDA faced in “balanc[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.”[228] The Request then asked a number of questions, such as “Are there arguments for regulating speech about drugs more comprehensively than, for example, about dietary supplements?”[229] and “Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority?”[230] 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 — potentially reaching the level of strict scrutiny — the FDA and other regulatory bodies will increasingly have to take heed of the First Amendment implications of their regulations.

VIII. THE ROAD AHEAD FOR FOOD AND DRUG REGULATION OF SPEECH

Part V of this Note discussed how protection for commercial speech has moved steadily toward strict scrutiny. Part VII explored how 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 regulations in the food and drug context from being subject to strict scrutiny. Part VIII-C then discusses alternatives to speech regulation.

A. Slippery Slope Argument

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 categories of speech that are difficult to distinguish in principle from commercial speech, such as speech regulated under securities or antitrust laws.[231] Although the Court may “solve” one problem by removing commercial speech from the category of intermediate scrutiny,[232] it would create another one, by likely providing a new category of speech with quasi-protected status. To prevent this “upwards-pull” of First Amendment doctrine, regulators could argue that protection for commercial speech should remain in the intermediate scrutiny range.

B. Categorical Exclusion for Food and Drug Law from Strict Scrutiny

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 — such as food and drug law — should receive lower levels of scrutiny. Such an argument would emphasize the vital nature of the government’s interest in regulating food and drugs, which the Supreme Court recognized in Lorillard when it observed, “The State's interest in preventing underage tobacco use is substantial, and even compelling.”[233] Moreover, the Court already recognized a different form of this argument in United States v. Park ,[234] where it upheld a conviction of a corporate officer for violation of the FD&C Act on strict liability grounds by noting that “the public interest in the purity of . . . food is so great as to warrant the imposition of the highest standard of care on distributors.”[235]

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 receive 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 “are subjected to police stop and examination to enforce ‘pervasive’ governmental controls ‘as an everyday occurrence.’”[236] Similarly, the FDA might argue that pervasive regulation of foods 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 Posadas — that the greater power to ban implies the lesser power to regulate.[237]

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, the 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, because 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, because they would be unwilling or unable to bear the burden of defending the regulations in court against commercial speech challenges.

The problems with all of these arguments are that some lower courts have already rejected them as defenses to commercial speech challenges, and the Supreme Court seems inhospitable to them as well. For example, in Lorillard , notwithstanding the compelling governmental interest at stake, the Court still invalidated the regulation banning tobacco advertising.[238] And in Friedman , 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.[239]

Nonetheless, food and drug regulators might be more successful in employing these arguments to create a categorical exclusion than they were in the past. These arguments highlight that the “regulable” aspects of commercial speech are considerably stronger in the food and drug law context — government already regulates this field to a large extent 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 “regulable” 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.

C. Non Speech Regulations or Disclaimers as Alternatives

If strict scrutiny 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.[240] This issue was crucial to the result in Western States , where the Court contended that the government could have achieved its objectives in other non speech restrictive ways.[241] Instead of banning advertising of drug compounding, the Court suggested, for example, that Congress could have instead “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” or “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.”[242] In many situations, such alternatives might be feasible, and regulators can avoid the 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.

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 Western States , Justice Breyer noted that contrary to the majority’s suggestion, he did not believe that “Congress could have achieved its safety objectives in significantly less restrictive ways.”[243] 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.[244] Thus, it is not clear whether and to what extent non speech regulations can be used to avoid commercial speech problems.

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 Friedman , Pearson , and Western States struck down speech regulations was that they rejected the paternalistic argument that banning certain commercial speech is necessary to prevent consumers from becoming confused and making bad decisions. These courts placed greater faith in consumers’ decisionmaking abilities. Instead of banning advertisements and thus reducing the amount 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 regulators, 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 become more common.

CONCLUSION

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 characteristics with fully regulable “speech” 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.

If this doctrinal shift continues, speech that is widely thought to be wholly outside the First Amendment’s coverage, such as the speech regulated by securities law, may become protected. Even if this radical shift does not occur, 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 the commercial speech doctrine and to achieve their policy objectives.


[*] Neel Sukhatme is a John M. Olin Fellow in Law and Economics at Harvard Law School and acknowledges support from the School’s John M. Olin Center for Law, Economics, and Business. A variant of Parts I–V of this Note will be published in the June 2005 issue of the Harvard Law Review .

1 See, e.g. , Kingsley Int’l Pictures Corp. v. Regents of the Univ. of the State of N.Y., 360 U.S. 684, 688–89 (1959) (noting that the First Amendment protects ideas that might be “contrary to the moral standards, the religious precepts, and the legal code of its citizenry” and that “in the realm of ideas it protects expression which is eloquent no less than that which is unconvincing”); Yates v. United States, 354 U.S. 298, 318 (1957) (overturning conviction of certain Communists, and noting that “[t]he distinction between advocacy of abstract doctrine and advocacy directed at promoting unlawful action is one that has been consistently recognized in the opinions of this Court . . . .”).

[ 2 ] See, e.g. , Brandenburg v. Ohio, 395 U.S. 444, 447–48 (1969) (per curiam) (invalidating crime syndicalism conviction, and setting forth speech-protective test for incitement cases). Arguably, the Brandenburg test is even more stringent than other forms of strict scrutiny. See Eugene Volokh, Freedom of Speech, Permissible Tailoring and Transcending Strict Scrutiny , 144 U. PA. L. REV. 2417, 2445 (1996) (arguing that “Brandenburg ’s protection of the advocacy of bad conduct can’t fit within the strict scrutiny framework” and that “[s]ubversive speech is protected regardless of whether the restriction is narrowly tailored to a compelling interest.”).

[ 3 ] See Miller v. California, 413 U.S. 15, 36 (1973) (“[O]bscene material is not protected by the First Amendment.”).

[ 4 ] See Frederick Schauer, The Boundaries of the First Amendment: A Preliminary Exploration of Constitutional Salience , 117 HARV. L. REV. 1765, 1775–76 (2004).

[ 5 ] 425 U.S. 748 (1976).

[ 6 ] See id. at 770–73.

[ 7 ] 447 U.S. 557 (1980).

[ 8 ] See id. at 566.

[ 9 ] See United States v. O’Brien, 391 U.S. 367, 377 (1968) (involving the burning of a draft card in violation of a federal statute). Expressive conduct is also known as “symbolic speech,” and has been described as the “communication of ideas by conduct.” See id. at 376 (internal quotation marks omitted). For most of this Note, any reference to a restriction on expressive conduct should be understood to mean an incidental, content-neutral restraint by the government on such activity. Content-based restrictions on expressive conduct receive strict scrutiny, and are discussed in Part IV. See also LAURENCE H. TRIBE, AMERICAN CONSTITUTIONAL LAW §12-2, at 791–92 (2d ed. 1988) (describing two “tracks” of First Amendment protection for speech, with content-based regulations receiving strict scrutiny under track one and content-neutral regulations receiving intermediate scrutiny under track two). See generally John Hart Ely, Flag Desecration: A Case Study in the Roles of Categorization and Balancing in First Amendment Analysis , 88 HARV. L. REV. 1482 (1975); Frederick Schauer, The Aim and the Target in Free Speech Methodology , 83 NW. U. L. REV. 562 (1989).

[ 10 ] One such example would be a newspaper advertisement that describes a product and provides its price. Commercial speech can also exist in more “mixed” forms and have other purposes, such as artistic or political goals. Music videos are an example of “mixed” commercial speech, having both artistic and commercial purposes. See Alex Kozinski & Stuart Banner, Who’s Afraid of Commercial Speech , 76 VA. L. REV. 627, 638–42 (1990). Regulation of this type of “commercial speech” seems much more problematic, but to the extent that a commercial purpose remains primary, the analysis in this Part still applies. A discussion of “mixed” commercial speech would be largely speculative, because the Supreme Court has not specified the kind of review that such speech would receive. In Nike, Inc. v. Kasky , 123 S. Ct. 2554 (2003), the Court dismissed certiorari as improvidently granted on a case that arguably included a form of “mixed” commercial speech. See id. at 2554–55 (Stevens, J., concurring) (noting that the case involved an unfair and deceptive practices suit against Nike, which had sent out press releases and letters to refute allegations that it was mistreating its foreign workers).

[ 11 ] See United States v. Carolene Prods. Co., 304 U.S. 144, 152 (1938) (“[R]egulatory legislation affecting ordinary commercial transactions is not to be pronounced unconstitutional unless in the light of the facts made known or generally assumed it is of such a character as to preclude the assumption that it rests upon some rational basis within the knowledge and experience of the legislators.”).

[ 12 ] Of course, rational basis review is still applied to such regulations, but in practice, almost any government action will meet this level of scrutiny. See, e.g. , Williamson v. Lee Optical Co., 348 U.S. 483, 490–91 (1955) (applying rational basis review to uphold a restriction on advertising).

[ 13 ] See 44 Liquormart, Inc. v. Rhode Island, 517 U.S. 484, 499 (1996) (plurality opinion); Posadas de Puerto Rico Assocs. v. Tourism Co. of P.R., 478 U.S. 328, 345–46 (1986) (noting in an opinion by Chief Justice Rehnquist that “the greater power to completely ban casino gambling necessarily includes the lesser power to ban advertising of casino gambling . . . .”).

[ 14 ] Va. State Bd. of Pharmacy v. Va. Citizens Consumer Council, Inc., 425 U.S. 748, 772 n.24 (1976).

[ 15 ] For example, a magazine advertisement with just the Nike “Swoosh” logo on it presumably would still be commercial speech.

[ 16 ] In Chaplinsky v. New Hampshire , 315 U.S. 568 (1942), the Court explained that “fighting words” — “those which by their very utterance inflict injury or tend to incite an immediate breach of the peace,” id. at 572 — are not protected by the First Amendment. The Court more generally noted: “There are certain well-defined and narrowly limited classes of speech, the prevention and punishment of which have never been thought to raise any Constitutional problem. These include the lewd and obscene, the profane, the libelous, and the insulting or ‘fighting’ words . . . .” Id. at 571–72.

[ 17 ] See R.H. Coase, Advertising and Free Speech , 6 J. LEGAL STUD. 1, 15 (1977) (“Advertising is in a curious position. On the one hand, it takes the form of speech or writing and one would expect therefore to find it protected by the First Amendment. It involves ‘expression’ rather than ‘action’ . . . . But, of course, advertising is connected with the market for goods, the domain of the businessman, which is treated as ‘action.’”). One might think that a lay understanding of the First Amendment also would reflect this view.

[ 18 ] See, e.g. , Texas v. Johnson, 491 U.S. 397, 399 (1989) (invalidating conviction for burning flag during the Republican National Convention); Tinker v. Des Moines Indep. Cmty. Sch. Dist., 393 U.S. 503, 514 (1969) (invalidating regulation that prevented students from wearing black armbands in protest of the Vietnam War); United States v. O’Brien, 391 U.S. 367, 369–71 (1968) (burning draft card to protest the Vietnam War); see also Stromberg v. California, 283 U.S. 359, 369–70 (1931) (invalidating statute that prohibited public display of a red flag as a symbol of opposition to organized government).

[ 19 ] See Barnes v. Glen Theatre, Inc., 501 U.S. 560, 569 (1991) (plurality opinion) (“The traditional police power of the States is defined as the authority to provide for the public health, safety, and morals, and we have upheld such a basis for legislation.”); see also id. at 571 (upholding public indecency statute as not suppressing free expression and as within the state’s police power).

[ 20 ] See, e.g. , Calvin Massey, The New Formalism: Requiem for Tiered Scrutiny? , 6 U. PA. J. CONST. L. 945, 948 (2004) (“[T]he twentieth century became the historical moment in which the constitutional law of individual liberties, like the cosmos, seemed to be an ever-expanding universe.”). Of course, this statement reflects only a general trend; the Court has limited or reduced individual liberty interests in some cases this century. Compare, e.g. , Sherbert v. Verner, 374 U.S. 398, 402–04 (1963) (requiring creation of an exemption to a generally applicable law because of the Free Exercise Clause), with Employment Div. v. Smith, 494 U.S. 872, 879–82 (1990) (establishing that the Free Exercise Clause does not mandate the creation of an exception to a facially neutral, generally applicable law).

[ 21 ] See, e.g. , Miranda v. Arizona, 384 U.S. 436, 467–70 (1966); Massiah v. United States, 377 U.S. 201, 206 (1964); Mapp v. Ohio, 367 U.S. 643, 655 (1961). Some of these liberty interests have been cut back in the last few decades, at least to some extent. See Carol S. Steiker, Counter-Revolution in Constitutional Criminal Procedure? Two Audiences, Two Answers , 94 MICH. L. REV. 2466, 2470 (1996) (“[T]he Burger and Rehnquist Courts have accepted to a significant extent the Warren Court’s definitions of constitutional ‘rights’ while waging counter-revolutionary war against the Warren Court’s constitutional ‘remedies’ of evidentiary exclusion and its federal review and reversal of convictions.”).

[ 22 ] See, e.g. , Roe v. Wade, 410 U.S. 113, 164–65 (1973); Griswold v. Connecticut, 381 U.S. 479, 485–86 (1965). But see Washington v. Glucksberg, 521 U.S. 702, 727–28 (1997) (finding no right to die under substantive due process because it is not “so deeply rooted in our history and traditions, or so fundamental to our concept of constitutionally ordered liberty, that [it is] protected by the Fourteenth Amendment”).

[ 23 ] See, e.g. , N.Y. Times Co. v. United States, 403 U.S. 713, 714 (1971) (per curiam) (rejecting validity of prior restraint on publication of classified study); Cohen v. California, 403 U.S. 15, 26 (1971) (preventing state from criminalizing public display of a four-letter word); Brandenburg v. Ohio, 395 U.S. 444, 448 (1969) (per curiam) (invalidating crime syndicalism conviction, and setting forth speech-protective test for incitement cases); N.Y. Times Co. v. Sullivan, 376 U.S. 254, 279–80 (1964) (establishing “actual malice” requirement for defamation of a public figure).

[ 24 ] See Lochner v. New York, 198 U.S. 45, 64 (1905) (holding that a state’s police power did not enable it to limit the working hours of bakers); see also Adair v. United States, 208 U.S. 161, 175–76 (1908) (using Fifth Amendment “liberty of contract” rationale to invalidate a statute protecting railroad unions).

[ 25 ] See NLRB v. Jones & Laughlin Steel Corp., 301 U.S. 1, 37–41 (1937) (upholding National Labor Relations Act against a substantive due process challenge and as within Congress’s interstate commerce power).

[ 26 ] See, e.g., United States v. Carolene Prods. Co., 304 U.S. 144, 152 (1938) (upholding under the interstate commerce power a federal statute prohibiting the interstate shipment of “filled” milk). Even though this deferential view toward such regulations arguably has been tempered in recent years, see, e.g. , United States v. Morrison, 529 U.S. 598, 601–02 (2000) (invalidating the Violence Against Women Act as beyond Congress’s interstate commerce power), the federal government still has much more power to regulate industry than it had one hundred years ago.

[ 27 ] See, e.g. , Barsky v. Bd. of Regents of the Univ. of the State of N.Y., 347 U.S. 442, 449 (1954) (“It is elemental that a state has broad power to establish and enforce standards of conduct within its borders relative to the health of everyone there. It is a vital part of a state’s police power.”).

[ 28 ] See Nat Stern, In Defense of the Imprecise Definition of Commercial Speech , 58 MD. L. REV. 55, 146 (1999) (“The Supreme Court’s inability to encase commercial speech within unwavering definitional boundaries is not the product of ineptitude, but rather the unavoidable incident of commercial speech’s position at the blurry crossroads of expressive and economic activity.”); cf. Kathleen M. Sullivan, Post-Liberal Judging: The Roles of Categorization and Balancing , 63 U. COLO. L. REV. 293, 297 (1992) (arguing that intermediate scrutiny is used by the Court in cases that create “a crisis in analogical reasoning” and “that just can’t be steered readily onto the strict scrutiny or the rationality track.”).

[ 29 ] 391 U.S. 367 (1968).

[ 30 ] See id. at 377.

[ 31 ] See id. 369–71.

[ 32 ] Id. at 376; see also Ely, supra note 9, at 1496 (“Burning a draft card to express one’s opposition to the draft is an undifferentiated whole, 100% action and 100% expression, and to outlaw the act is therefore necessarily to regulate both elements.”); Keith Werhan, The O’Briening of Free Speech Methodology , 19 ARIZ. ST. L.J. 635, 636 (1987) (“Laboring under the weight of the speech-conduct distinction, the Justices could not fully accept the idea of expressive conduct implicated by O’Brien’s silent burning. . . . Yet, the Court could not bring itself to rule that O’Brien’s burning wholly lacked expressive value or that Congress’s anti-destruction law was incapable of serving as a tool of repression.” (footnote omitted)).

[ 33 ] See O’Brien , 391 U.S. at 377.

[ 34 ] See id. at 372.

[ 35 ] Geoffrey R. Stone, Content-Neutral Restrictions , 54 U. CHI. L. REV. 46, 114 (1987).

[ 36 ] Id.

[ 37 ] 316 U.S. 52 (1942).

[ 38 ] See id. at 54–55.

[ 39 ] Id. at 54. The Court’s dismissive attitude toward commercial speech was further evidenced by its concession that the statute would have violated the First Amendment had it banned noncommercial speech. See id. The Court reaffirmed the Valentine holding in Breard v. Alexandria , 341 U.S. 622 (1951), where it upheld a town ordinance that proscribed the door-to-door solicitation of magazine subscriptions. See id. at 644–45 (“We think those communities that have found these methods of sale obnoxious may control them by ordinance. It would be, it seems to us, a misuse of the great guarantees of free speech and free press to use those guarantees to force a community to admit the solicitors of publications to the home premises of its residents.”).

[ 40 ] 376 U.S. 254 (1964).

[ 41 ] See id. at 265–66; see also Pittsburgh Press Co. v. Pittsburgh Comm’n on Human Relations, 413 U.S. 376, 389 (1973) (upholding regulation of advertisements that aided an unlawful employment practice while suggesting that advertising for legal commercial activity might receive some First Amendment protection); Ginzburg v. United States, 383 U.S. 463, 474 (1966) (“[C]ommercial activity, in itself, is no justification for narrowing the protection of expression secured by the First Amendment.”).

[ 42] Sullivan , 376 U.S. at 266.

[ 43 ] 421 U.S. 809 (1975).

[ 44 ] See id. at 829.

[ 45 ] 425 U.S. 748 (1976).

[ 46] Id. at 762 (quoting Pittsburgh Press , 413 U.S. at 385). Later, in Bolger v. Youngs Drug Products Corp. , 463 U.S. 60 (1983), the Court slightly clarified the boundary between core and commercial speech. The Court noted three factors that in combination were sufficient to determine that a form of speech was commercial rather than core: that the expression was “conceded to be an [an] advertisement[],” that it had a “reference to a specific product,” and that the speaker “ha[d] an economic motivation.” Id. at 66–67.

[ 47 ] Va. State Bd. of Pharmacy , 425 U.S. at 773. Although the statute limited advertising by pharmacists, the challenge was brought by prescription drug consumers, who claimed that the statute hurt them because it prevented price competition among pharmacists. See id. at 753, 763–64.

[48 ] Id. at 770. The Court also noted that it was not deciding how restrictions on advertising would be treated for other professions. See id. at 773 n.25.

[ 49] See id. at 771–72.

[ 50] See id. at 772. The Court further stated that time, place, and manner restrictions on price advertising could be constitutional. See id. at 771.

[ 51] Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n, 447 U.S. 557 (1980).

[ 52] Id. at 562–63 (citation omitted). The Court also noted, “[O]ur decisions have recognized ‘the “commonsense” distinction between speech proposing a commercial transaction, which occurs in an area traditionally subject to government regulation, and other varieties of speech.’” Id. at 562 (quoting Ohralik v. Ohio State Bar Assn. , 436 U.S. 447, 455–56 (1978)).

[ 53] See id. at 568.

[ 54] Id. at 566. The Court characterized these four factors as having developed in prior commercial speech cases. See id.

[ 55] See id. 569–72. The Court later clarified that the fourth prong requires “a fit that is not necessarily perfect, but reasonable.” Bd. of Trs. of the State Univ. of N.Y. v. Fox, 492 U.S. 469, 480 (1989).

[ 56 ] See Stern, supra note 28, at 142 (suggesting that “the O’Brien standard and prevailing commercial speech doctrine roughly converge”); Werhan, supra note 32, at 666 (“[T]he ‘critical inquiry’ of Central Hudson rings familiar to those accustomed to the O’Brien methodology . . . .”); id. at 668 (“Seeking to fill the gap between full and no protection, the Court reached for compromise, and O’Brien was there.”).

[ 57 ] See Susan Dente Ross, Reconstructing First Amendment Doctrine: The 1990s [R]Evolution of the Central Hudsonand O’BrienTests , 23 HASTINGS COMM. & ENT. L.J. 723, 740 (2001) (“The Court and numerous scholars have suggested that this test is virtually indistinguishable from the O’Brien test.”).

[ 58 ] See Werhan, supra note 32, at 673 (“The Court’s frequent resort to O’Brien is the result of a perceived need to compromise seemingly intractable first amendment problems. This was most apparent in the Court’s use of O’Brien balancing to calibrate intermediate scrutiny for commercial speech.”).

[ 59 ] See, e.g. , Va. State Bd. of Pharmacy v. Va. Citizens Consumer Council, Inc., 425 U.S. 748, 787 (1976) (Rehnquist, J., dissenting) (“It is undoubtedly arguable that many people in the country regard the choice of shampoo as just as important as who may be elected to local, state, or national political office, but that does not automatically bring information about competing shampoos within the protection of the First Amendment.”); Vincent Blasi, The Pathological Perspective and the First Amendment , 85 COLUM. L. REV. 449, 488 (1985) (suggesting that there is “reason to exclude commercial advertising from the protection of the first amendment”).

[ 60 ] See Thomas H. Jackson & John Calvin Jeffries, Jr., Commercial Speech: Economic Due Process and the First Amendment , 65 VA. L. REV. 1, 30–31 (1979) (“One might have thought, as the Court has so often proclaimed, that demanding judicial review of economic legislation was a concern of the past. . . . Instead, economic due process is resurrected, clothed in the ill-fitting garb of the first amendment . . . .  In short, the Supreme Court has reconstituted the values of Lochner v. New York as components of freedom of speech.” (footnotes omitted)); see also Charles Fried, The Supreme Court, 1994 Term — Foreword: Revolutions? , 109 HARV. L. REV. 13, 33 n.105 (1995) (“[T]he commercial speech doctrine, which was unknown during the whole of the Lochner period, . . . contains discernible hints of Lochner ’s economic libertarianism.”).

[ 61 ] Justices Stevens and Thomas, not known for occupying the same side of the political spectrum, are among the strongest advocates for increased First Amendment protection for commercial speech. See infra note 96 and accompanying text.

[ 62] See, e.g. , Daniel A. Farber, Commercial Speech and First Amendment Theory , 74 NW. U. L. REV. 372, 374 (1979) (contending that “an obvious tension exists between present commercial speech doctrine and the principle of content neutrality”); Martin H. Redish, The First Amendment in the Marketplace: Commercial Speech and the Values of Free Expression , 39 GEO. WASH. L. REV. 429, 431 (1971) (“[N]o adequate justification exists for omitting certain types of commercial speech from the scope of the first amendment . . . .”).

[ 63] For example, non-speech sales activities do not communicate via newspapers, flyers, billboards, television, radio, or magazines.

[ 64] Other examples of non-speech sales activities are the layout of a store or the uniform of a person providing a service.

[65] Professor Daniel Farber has recognized a different connection between commercial speech and expressive conduct. Recognizing “the intuitive belief that commercial speech is somehow more akin to conduct than are other forms of speech,” he has proposed a bifurcated approach to dealing with commercial speech. Farber, supra note 62, at 389. He suggests that the O’Brien test should be applied to restrictions pertaining to “the contractual aspects of the speech,” whereas content-neutrality should be required when government regulates the other aspects of commercial speech. Id. at 388; cf. Edward J. Eberle, Practical Reason: The Commercial Speech Paradigm , 42 CASE W. RES. L. REV. 411, 462 (1992) (“Subjugating commercial speech to a secondary status might arguably be justified on the ground that commercial speech involves speech-plus-conduct. . . . Commercial speech can be construed as a form of speech-plus-conduct because of the nexus between the speech proposing a commercial transaction and the subsequent transactions in which sellers and buyers engage.” (footnote omitted)).

[66 ] See supra note 10.

[67] Consider one of the definitions of “advertise”: “to call public attention to especially by emphasizing desirable qualities so as to arouse a desire to buy or patronize.” WEBSTER’S THIRD NEW INTERNATIONAL DICTIONARY 31 (1986). To the extent advertising is successful, it also has a regulable effect: it causes consumers to buy goods or services.

[68 ] See Jay Dratler, Jr., Trademark Protection for Industrial Designs , 1988 U. ILL. L. REV. 887, 890 (“Certainly a major goal of industrial design is to make products look good, to provide an attractive appearance that makes consumers want to buy and use them.”); Gerard N. Magliocca, Ornamental Design and Incremental Innovation , 86 MARQ. L. REV. 845, 845 (2003) (noting that “sleek styles undoubtedly add value to many consumer goods”).

[69 ] See Dratler, supra note 68, at 890 (“[In addition to making products look good,] designers have other equally important goals. A good industrial designer also wants to make products easy (and perhaps even fun) to use, safe to have and to operate, easy and cheap to manufacture, and simple to repair.”).

[70 ] See, e.g. , Scot Silverglate, Comment, Subliminal Perception and the First Amendment: Yelling Fire in a Crowded Mind? , 44 U. MIAMI L. REV. 1243, 1262 (1990) (“Clever advertising executives appeal to a consumer’s emotional or psychological needs and seem to promise, either explicitly or implicitly, that their product will fill these needs.”).

[71 ] ROGER A. SHINER, FREEDOM OF COMMERCIAL EXPRESSION 309 (2003).

[72 ] Id. at 308. Shiner acknowledges that some advertising may be purely informational, such as a flyer that says “I will sell you X product at Y price.” Id. at 308. He also notes that some commercial expression might mix informational and persuasive advertising. See id. at 309 (noting that lifestyle advertisements “rely for their effect and for their ‘message’ far more on visual or auditory imagery and emotional association than on language and explicit content”).

[73 ] Id. at 309; see also Sarah C. Haan, Note, The “Persuasion Route” of the Law: Advertising and Legal Persuasion , 100 COLUM. L. REV. 1281, 1281 (2000) (“[A]dvertising research shows that consumers do not seek out or use product information contained in advertisements, and that less-informative advertising may actually be more persuasive than advertising containing a lot of information.”). The primarily non cognitive effect of commercial speech might distinguish it from other speech that operates via rational persuasion and receives greater First Amendment protection under theories that privilege “the marketplace of ideas” or the importance of democratic self-governance. See GEOFFREY R. STONE ET AL. , THE FIRST AMENDMENT 9–14 (2d ed. 2003). Of course, some highly protected speech, such as art, may operate primarily via emotion, so this observation does not totally explain why commercial speech receives less protection than paradigmatically core speech.

[74 ] See Silverglate, supra note 70, at 1261 n.153 (“[I]n the buying situation the consumer generally acts emotionally and compulsively, unconsciously reacting to the images and designs which in the subconscious are associated with the product.” (quoting VANCE PACKARD , THE HIDDEN PERSUADERS 7–8 (1957) (quoting Louis Cheskin, Market Researcher))).

[75 ] Even if certain types of advertising and exterior product designs have important noncommercial purposes, or do not rely on creating emotional responses in consumers, the analysis in this section is not necessarily affected. Rather, the main point here is that as long as advertising and exterior product designs have a similar purpose and effect — regardless of what that purpose and effect are — they are, to a large extent, functionally similar.

[76 ] Searches through Westlaw and Lexis did not unearth any cases where First Amendment protection had been granted or even claimed for an exterior product design.

[77 ] See United States v. O’Brien, 391 U.S. 367, 376 (1968) (“We cannot accept the view that an apparently limitless variety of conduct can be labeled ‘speech’ whenever the person engaging in the conduct intends thereby to express an idea.”).

[78 ] Design patents encourage this form of expression by allowing companies to obtain property rights only in external industrial designs that are primarily “ornamental” rather than functional in nature. See Magliocca, supra note 68, at 845, 855; see also id. at 850 (“Design patents are the primary tool for encouraging the development of commercial art in the United States.”). Moreover, one might observe that if Andy Warhol’s depictions of Campbell’s soup cans and Coca-Cola bottles constitute art, then surely the designs of the cans and bottles themselves have some expressive value.

[79 ] A more comprehensive diagram would include a third dimension — the purpose of government restriction. In this dimension, the diagram would indicate that content-based restrictions on expressive conduct receive strict scrutiny, whereas content-neutral restrictions (i.e., incidental restraints) receive intermediate scrutiny. See Part IV. The indifference curves in this diagram are intended solely for illustrative purposes, and no conclusions should be drawn from their particular shape.

[80 ] See, e.g. , Jed Rubenfeld, The First Amendment’s Purpose , 53 STAN. L. REV. 767, 777 (2001) (exploring why “the distinction between ‘content-based’ and ‘content-neutral’ regulations is so important to First Amendment law”).

[81 ] See, e.g. , Texas v. Johnson, 491 U.S. 397, 412 (1989) (holding that a law proscribing flag burning was content-based and therefore unconstitutional).

[82] See id. at 406 (“The government generally has a freer hand in restricting expressive conduct than it has in restricting the written or spoken word. It may not, however, proscribe particular conduct because it has expressive elements.” (citations omitted)).

[83] Additionally, this analysis explains why content-neutral regulations that target symbolic speech along its “regulable” axis of method of expression only receive intermediate scrutiny. Justice Scalia has suggested that even a lower standard — rational basis review — might be appropriate for such content-neutral restrictions. See Barnes v. Glen Theatre, Inc., 501 U.S. 560, 576 (1991) (Scalia, J., concurring in the judgment) (“Since the [regulation at issue] is a general law not specifically targeted at expressive conduct, its application to such conduct does not in my view implicate the First Amendment.”). This approach differs from the one provided in this Note, which asserts that even incidental restraints on expressive conduct merit intermediate scrutiny because of the hybrid nature of the speech.

[84 ] See Kathleen M. Sullivan, Cheap Spirits, Cigarettes, and Free Speech: The Implications of 44 Liquormart, 1996 SUP. CT. REV. 123, 148 n.93 (“[Although the Central Hudson ] test closely resembles the equally canonical O’Brien test for review of content-neutral regulations, . . . the Court rarely invalidates a content-neutral regulation of noncommercial speech, but has found a number of commercial speech regulations wanting.”).

[85 ] See Stone, supra note 35, at 52 n.23 (“The Court has applied . . . the O’Brien test . . . to five content-neutral restrictions and upheld them all.”); see also Clark v. Cmty. for Creative Non-Violence, 468 U.S. 288, 289, 292 (1984) (upholding a ban on overnight sleeping in a public park against an expressive conduct challenge); id. at 293 (“[R]estrictions of this kind are valid provided that they are justified without reference to the content of the regulated speech, that they are narrowly tailored to serve a significant governmental interest, and that they leave open ample alternative channels for communication of the information”).

[86 ] See Stone, supra note 35, at 114 (“The general presumption is that incidental restrictions do not raise a question of first amendment review. The presumption is waived, however, whenever an incidental restriction either has a highly disproportionate impact on free expression or directly penalizes expressive activity. And the latter exception is applied quite liberally whenever the challenged restriction significantly limits the opportunities for free expression.”).

[87 ] Ross, supra note 57, at 725.

[88 ] The O’Brien Court itself was aware of this problem. See United States v. O’Brien, 391 U.S. 367, 376 (1968); see also Frederick Schauer, Cuban Cigars, Cuban Books, and the Problem of Incidental Restrictions on Communications , 26 WM. & MARY L. REV. 779, 784 (1985) (“To be concerned significantly, in a constitutional sense, with incidental effects is to be committed to judicial scrutiny of an enormous range of government decisions. Even if the outcome of that scrutiny is upholding the government’s action, the very imposition of close scrutiny ought to be of some concern as long as we consider judicial review the exception rather than the rule. Virtually every government decision is likely to have some incidental effect on some constitutionally protected value. ” (emphasis added)).

[89 ] See Ross, supra note 57, at 730 (observing that although O’Brien was originally confined to symbolic speech, the Court has applied or referenced it more than one hundred times in a variety of other contexts).

[90 ] See id. at 733–34 (arguing that the Court interpreted the content-neutrality prong to be triggered only when the government disagreed with the message conveyed, and the narrow-tailoring prong not to require the government to use the least restrictive or intrusive means).

[91 ] Thompson v. W. States Med. Ctr., 535 U.S. 357, 367–68 (2002) (applying Central Hudson , after acknowledging that several members of the Court have expressed doubts about it).

[92 ] 517 U.S. 484 (1996).

[93 ] Id. at 489.

[94 ] Id. at 501. But see Posadas de Puerto Rico Assocs. v. Tourism Co. of P.R., 478 U.S. 328, 331–32, 344 (1986) (upholding Puerto Rican statute that legalized certain casino gambling but prohibited advertising of casino gambling directed toward Puerto Rico residents).

[95 ] See, e.g. ,Thompson , 535 U.S. at 377 (2002) (invalidating federal ban on pharmacists’ advertising of compounded drugs); Lorillard Tobacco Co. v. Reilly, 533 U.S. 525, 566–67 (2001) (invalidating Massachusetts’s outdoor advertising restrictions on smokeless tobacco and cigars); Rubin v. Coors Brewing Co., 514 U.S. 476, 486 (1995) (invalidating federal ban on including alcohol content on beer labeling); United States v. United Foods, Inc., 533 U.S. 405, 415–16 (2001) (invalidating a federal statute that compelled a mushroom company to fund certain advertisements); id. at 410 (“[E]ven viewing commercial speech as entitled to lesser protection, we find no basis . . . to sustain the compelled assessments sought in this case.”).

[96 ] See, e.g. , 44 Liquormart , 517 U.S. at 503 (1996) (plurality opinion) (“The First Amendment directs us to be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good. That teaching applies equally to state attempts to deprive consumers of accurate information about their chosen products . . . .”); see id. at 518 (Thomas, J., concurring in part and concurring in the judgment) (arguing that where “the government’s asserted interest is to keep legal users of a product or service ignorant in order to manipulate their choices in the marketplace, the balancing test adopted in Central Hudson . . . should not be applied, in my view. Rather, such an ‘interest’ is per se illegitimate . . . .” (citation omitted)); see also Kozinski & Banner, supra note 10, at 628 (arguing that “the commercial/noncommercial distinction makes no sense”); Redish, supra note 62, at 431.

[97] Monroe E. Price & John F. Duffy, Technological Change and Doctrinal Persistence: Telecommunications Reform in Congress and the Court , 97 COLUM. L. REV. 976, 1006–07 (1997) (characterizing Justices Scalia, Kennedy, Thomas, and Ginsburg as demonstrating a preference for rule-based approaches).

[98] See, e.g., George C. Hlavac, Interpretation of the Equal Protection Clause: A Constitutional Shell Game , 61 GEO. WASH. L. REV. 1349, 1375 (1993) (“The Court should abolish the intermediate-scrutiny test not only because it has no firm roots in any of our constitutional history, but [also] because the Court leaves open the door for the creation of even more shells for judges to hide the ball under by continuing to use the test.”).

[99 ] See Jay D. Wexler, Defending the Middle Way: Intermediate Scrutiny as Judicial Minimalism , 66 GEO. WASH. L. REV. 298, 303 (1998) (“[I]ntermediate scrutiny can be a form of judicial minimalism that can appropriately resolve [analogical] crises over time because it invites democratic deliberation, allows for moral evolution, promotes societal education, and provides judges with greater opportunities to consider the details . . . .”).

[100 ] Antonin Scalia, The Rule of Law as a Law of Rules , 56 U. CHI. L. REV. 1175, 1187 (1989).

[101 ] 494 U.S. 872 (1990).

[102 ] See id. at 884–85; see also Sullivan, supra note 28, at 303 (“Smith is not the United States v. O’Brien of religion law; that case established heightened (although not the strictest) scrutiny for facially content-neutral laws that incidentally impair the free exercise of speech. O’Brien would have been a natural analogue to turn to. Justice Scalia’s failure to do so suggests an antipathy towards balancing and a preference for the categorical tendencies of a two-tier tracking system.”).

[103 ] See Barnes v. Glen Theatre, Inc., 501 U.S. 560, 572 (1991) (Scalia, J., concurring in the judgment) (“[T]he challenged regulation must be upheld, not because it survives some lower level of First Amendment scrutiny, but because, as a general law regulating conduct and not specifically directed at expression, it is not subject to First Amendment scrutiny at all.”).

[104 ] See id.

[105 ] Cf. 44 Liquormart, Inc. v. Rhode Island, 517 U.S. 484, 501 (1996) (plurality opinion) (“Our commercial speech cases have recognized the dangers that attend governmental attempts to single out certain messages for suppression.”); Farber, supra note 62, at 374 (noting that “[m]ost regulation of advertising blatantly violates” the First Amendment principle of content neutrality).

[106 ] See Kozinski & Banner, supra note 10, at 641 (“Music videos serve one overriding purpose: to promote record sales. But they are nevertheless a form of expression we instinctively think of as deserving as much protection as full-length films.”).

[107 ] See supra Part III-A.

[108 ] See, e.g. , Stone, supra note 35, at 107 (“The potential restrictive effect of such laws [that incidentally burden expressive conduct] is simply too great to disregard them entirely.”).

[109 ] See Blasi, supra note 59, at 488 (“Were courts to grant commercial speech the same high level of protection now accorded political speech, regulatory objectives long considered important and legitimate would be frustrated, engendering in all probability a weakening of public respect for the first amendment quite a bit more severe than that now caused by the Court’s middle-of-the-road approach.”).

[110 ] See Schauer, supra note 4, at 1777–82; id. at 1780 (noting that “claims that the entire scheme of securities regulation needed to be tested against First Amendment standards became more common” after the creation of the commercial speech doctrine).

[ ] 111 34 Stat. 768 (1906).

[112] Id. § 2. The Act defined “misbranded” as:

“[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 ingredients 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.”

Id. § 8.

[113] 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).

[114] Id.

[115] Act of Aug. 23, 1912, ch. 352, § 8, 37 Stat. 416 (1912).

[116] 37 Stat. 732 (1913); see also Peter B. Hutt and Peter B. Hutt II, A History of Government Regulation of Adulteration and Misbranding of Food , 39 FOOD DRUG COSM. L.J. 2, 58 (1984).

[117] 265 U.S. 438 (1924).

[118] Id. at 442–43.

[119] Hutt & Hutt, supra note 116, at 62.

[120] See Richard A. Merrill, Symposium on Regulating Medical Innovation: The Architecture of Government Regulation of Medical Products , 82 VA. L. REV. 1753, 1760–61 (1996) (noting that the even after the Sherley Amendment, the 1906 Act suffered “the fundamental deficiency” that “the government had to prove actual knowledge by the seller that the claims it made were false.”).

[121] Hutt & Hutt, supra note 116, at 58.

[122] Id. at 62.

[123] 52 Stat. 1040 (1938) (codified at 21 U.S.C. § 321 et seq. (1976)) [hereinafter “FD&C Act”]. 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. See Comment, Joseph G. Contrera, The Food and Drug Administration and the International Conference on Harmonization: How Harmonious Will International Pharmaceutical Regulations Become? , 8 ADMIN. L.J. AM. U. 927, 934 n.26 (1995).

[124] See FD&C Act, §§ 403, 502, 52 Stat. 1040 (1938).

[125] See id. § 201(m).

[126] See Kordel v. United States, 335 U.S. 345, 346, 350 (1948).

[127] See id. § 502(a). A similar provision applies for food. See also id. § 403(a) (“A food shall be deemed to be misbranded [if] its labeling is false or misleading in any particular.”).

[128] 52 Stat. 111 (1938).

[129] Id. §§ 52–55.

[130] See PETER BARTON HUTT & RICHARD A. MERRILL , FOOD AND DRUG LAW: CASES AND MATERIALS 1328 (2nd ed. 1991) (citing Federal Trade Commission Act, 38 Stat. 717 (1914), as amended, 15 U.S.C. §§ 41 et seq.).

[131] See id. at 43.

[132] See id. at 1328 (citing 76 Stat. 780 (1962)). The Kefauver-Harris Amendments also added the requirement that “manufacturers must disclose the generic name of the active ingredient of their products in labeling and in advertising.” Id. at 452.

[133] See id. (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 Rubin v. Coors Brewing Co. , 514 U.S. 476 (1995), the Bureau of Alcohol, Tobacco, and Firearms (BATF) denied “proposed labels and advertisements that disclosed the alcohol content of . . . beer” because of a federal statute that prohibited such disclosure. Id. at 478.

[134] 74 Stat. 372 (1960) (codified as amended at 15 U.S.C. §§ 1261–1276 (2000))

[135] 80 Stat. 1296 (1966), as amended, 15 U.S.C. §§ 1451–1461 (2000).

[136] See U.S. Food and Drug Administration, Milestones in U.S. Food and Drug Law History , at http://www.fda.gov/opacom/backgrounders/miles.html (last visited March 29, 2005) [hereinafter Milestones ].

[137] 104 Stat. 2353 (1990) (codified at 21 U.S.C. § 343 (2000)).

[138] See Milestones , supra note 136.

[139] 108 Stat. 4325 (1994) (codified at 21 U.S.C. § 301 note).

[140] See Milestones , supra note 136.

[141] See id.

[142] Statement of Policy Concerning Oral Contraceptive Labeling Directed to Users, 35 Fed. Reg. 9001 (June 11, 1970).

[143] Id. at 9002.

[144] Prescription Drug Products: Revocation of Patient Package Insert Requirements, 47 Fed. Reg. 39147 (Sept. 7, 1982).

[145] HUTT & MERRILL , supra note 130, at 450.

[146] See generally 21 C.F.R. § 202.1.

[147] Id. § 202.1(a)(4).

[148] Id. §§ 202.1(e)(6)–202.1(e)(7).

[149] Id. § 202.1(e)(6)(ix).

[150] Id. § 202.1(e)(7)(xiii).

[151] See HUTT & MERRILL , supra note 130, at 465–66.

[152] 514 U.S. 476 (1995).

[153] See id. 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). See id. at 480–81.

[154] Id. at 482.

[155] Id. at 481.

[156] See id. at 485.

[157] See id.

[158] Id. at 484. Citing to the Nutrition Labeling and Education Act of 1990, the Court continued, “This also seems to be the trend in federal regulation of other consumer products as well.” Id.

[159] See id. at 488.

[160] Id.

[161] Lars Noah & Barbara A. Noah, Liberating Commercial Speech: Product Labeling Controls and the First Amendment , 47 FLA. L. REV. 63, 89 (1995).

[162] 13 F. Supp. 2d 51 (D.D.C. 1998).

[163] See id. at 55.

[164] See id. at 56–58.

[165] See id. at 57–58. The guidance document includes twelve factors for determining whether a CME was not subject to regulation because it was “independent” of the control of the manufacturer of the drug with the off-label use. Id.

[166] See id. at 58. Enduring materials are defined as “textbook excerpts and article reprints from medical and scientific journals.” Id.

[167] See id. at 59.

[168] Id.

[169] Id. at 60.

[170] See id. at 62–65; see also supra note 46.

[171] See Friedman , 13 F. Supp. 2d at 73.

[172] Id.

[173] Id.

[174] Id.

[175] See 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).

[176] See id. at 82.

[177] Washington Legal Found. v. Henney, 202 F.3d 331, 335 (2000).

[178] See id. at 335–37.

[179] Notice, Decision in Washington Legal Foundation v. Henney , 65 Fed. Reg. 14286 (Mar. 16, 2000).

[180] Id.

[181] Washington Legal Found. v. Henney, 128 F. Supp. 2d 11, 15 (D.D.C. 2000).

[182] Id. ; see generally Peggy Chen, Education or Promotion?: Industry-Sponsored Continuing Medical Education (CME) as a Center for the Core/Commercial Speech Debate , at http://leda.law.harvard.edu/leda/data/591/ChenP.rtf.

[183] 288 F.Supp.2d 912 (N.D. Ill. 2003).

[184] See id. at 922.

[185] See id. at 915

[186] See id. at 915, 922.

[187] Id. at 922.

[188] Id.

[189] See id.

[190] See 21 U.S.C. § 343(r)(5)(D) (2005).

[191] See 21 C.F.R. § 101.14(c) (2005). In the NLEA, Congress had adopted this same standard for health claims for food. 21 U.S.C. § 343(r)(3)(B)(i) (2005).

[192] Pearson v. Shalala, 164 F.3d 650, 653, 659 (D.C. Cir. 1999). The health claims at issue were:

(1) ‘Consumption of antioxidant vitamins may reduce the risk of certain kinds of cancers.’

(2) ‘Consumption of fiber may reduce the risk of colorectal cancer.’

(3) ‘Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease.’

(4) ‘.8 mg of folic acid in a dietary supplement is more effective in reducing the risk of neural tube defects than a lower amount in foods in common form.’”

Id. at 651–52.

[193] 14 F. Supp. 2d 10 (D.D.C. 1998).

[194] See id. at 12, 14.

[195] See id. at 21–22.

[196] Pearson , 164 F.3d at 651 (D.C. Cir. 1999).

[197] See id. at 657.

[198] Id. at 658.

[199] See id. at 660.

[200] See 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).

[201] See Whitaker v. Thompson, 248 F. Supp. 2d 1, 6–7 (D.D.C. 2002).

[202] See id. 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, 120–21 (D.D.C. 2001) (same for a claim involving folic acid).

[203] 533 U.S. 525 (2001).

[204] See id. at 566–67. The Massachusetts regulations also restricted cigarette advertising, but the Court held that the Federal Cigarette Labeling and Advertising Act (FCLAA) preempted these regulations, and thus it did not deal with the constitutional issues that they raised. See id. at 553.

[205] Id. at 561.

[206] See id. at 564.

[207] Id. at 561 (quoting Cincinnati v. Discovery Network, Inc. , 507 U.S. 410, 417 (1993) (internal quotation marks omitted)).

[208] See id. at 566.

[209] Id.

[210] Id. at 567.

[211] Id. at 569.

[212] Id. at 570.

[213] 535 U.S. 357 (2002).

[214] See id. at 360.

[215] See id. at 360–61.

[216] See id. at 362.

[217] Id. at 360.

[218] See id. at 365.

[219] See id. at 366–68.

[220] See id. at 368–71.

[221] Id. at 370.

[222] Id. at 371 (internal quotation marks omitted) (quoting Brief for Petitioners, 35).

[223] Id. at 372–73.

[224] See id. at 374.

[225] Id.

[226] Id. at 375 (quoting Virginia State Board of Pharmacy v. Virginia Citizens Consumer Council, Inc. , 425 U.S. 748, 770 (1976).

[227] FDA’s Request for Comment on First Amendment Issues, 67 Fed. Reg. 34,942 (May 16, 2002).

[228] Id. at 34,943.

[229] Id. at 34,943.

[230] Id. at 34,944.

[231] See supra note 110.

[232] See supra Part V-C for reasons why many members of the current Court dislike intermediate scrutiny.

[233] Lorillard Tobacco Co. v. Reilly, 533 U.S. 525, 564 (2001).

[234] 421 U.S. 658 (1975).

[235] Id. at 671 (quoting Smith v. California , 361 U.S. 147, 152 (1959)) (internal quotation marks omitted).

[236] Wyoming v. Houghton, 526 U.S. 295, 303 (1999) (quoting South Dakota v. Opperman , 428 U.S. 364, 368 (1976)).

[237] Posadas de Puerto Rico Assocs. v. Tourism Co. of Puerto Rico, 478 U.S. 328, 345–46 (1986).

[238] See Lorillard Tobacco Co. , 533 U.S. at 566–67.

[239] Washington Legal Found. v. Friedman, 13 F. Supp. 2d 51, 60 (D.D.C. 1998).

[240] The FDA recognized that using non-speech alternatives might be useful in its Request for Comment, where it asked, “Are there other alternative approaches that FDA could pursue to accomplish [its public health concerns] with fewer restrictions on speech?” Id. at 34,944.

[241] See Thompson v. W. States Med. Ctr., 535 U.S. 357, 372 (2002).

[242] Id.

[243] Id. at 385.

[244] See id. at 385–86.