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TIGHTENING THE BELT

ON

THE WEIGHT-LOSS INDUSTRY

FINAL EXAM: FOOD & DRUG LAW, WINTER 1994 STUDENT l.D. # 103 8580 60

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FINAL EXAM: FOOD & DRUG LAW, WINTER TERM, 1994 STUDENT IDENTIFICATION # 103 8580 60

QUESTION #1

"LOSE WEIGHT FAST WITHOUT GOING HUNGRY."

"LOSE WEIGHT WHILE YOU SLEEP..."

Americans dole out $33 billion dollars a year to cure their weight problems,1 as every year the market is flooded with food and drug products that promise a fast, easy way to a new, slimmer you. Unfortunately, while there is not a fast and easy solution to regulating America's weight problem, something must be done by the Federal Drug Administration ("F.D.A.") to better regulate the weight-loss industry.

Weight and weight-loss issues cover a range of social, psychological and health issues2 . It is well documented that being overweight significantly increases an individual's risk for disease; heart disease, hypertension and strokes to name a few3 . Additionally, recent studies report larger or overweight people face overt discrimination in pay, advancement and other opportunities in life'. Therefore, it is not surprising that many millions of Americans facing a continued problem of excess poundage will spend billions of dollars a year on food and drug products to help them shed those extra pounds, only to face the prospect

Rose Dosti, Weight-Loss Diets Believed Harmful , LOB Angeles Times, April 19, 1990, Part H at 39.

2 Mike Granberry, Fightino Fat: Obesity is a Serious Threat. But It's a Struggle to Lose , Los Angeles Times, April 8, 1985, S5 at 1.

Id.

Id .

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for repeated failure, given as success rate of only two percent5 . Obviously, such a potentially vulnerable audience will attract both

legitimate and illegitimate purveyors offering cures and quick weight-loss remedies. The weight-loss industry churns out such products as diet pills, low calorie liquid diets, Dream Away diet pills (lose fat while you sleep!), La Cream (melt fatty deposits when applied under layers of plastic food wrap), Le Patch (a skin patch that promises to release an appetite suppressant under the skin), and the Fat-Magnet Pills which released thousands of tiny magnetic particles to attract and flush fat particles out of the body6 . This list does not include the thousands of products that promise to be 'low—fat', 'reduced calorie' or 'lite'.

This paper examines the policy issues of whether there should be increased F.D.A. regulation in this segment. The debate over the role of the F.D.A. in regulation of the weight-loss industry centers around continued focus on prevention and removal of "dangerous" products or on improved efforts to protect consumers from pseudo—medicines that may be technically safe, but are ineffective and suck away millions of dollars a year, and in the end do more harm than good.

Before discussing the arguments favoring or opposing increased F.D.A. regulation in more detail, some background information highlighting recent F.D.A. regulatory action is reviewed. However, because of space limitation, this review is not intended to be an exhaustive review of F.D.A.'s actions in this area of food and drug law.

Id .

6 ~~j• Diamond, Public is Aware of Diet Frauds , Los Angeles Times, November 1,

1991, Part D at 1.

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• FINAL EXAM: FOOD & DRUG LAW, WINTER TERM, 1994 STUDENT IDENTIFICATION # 103 8580 60

I. F.D.A.'S TRACK RECORD OF EFFECTIVE INTERVENTION IN THE WEIGHT-LOSS INDUSTRY.

As with all issues, there are many perspectives on F.D.A. effectiveness in the area of regulating weight—loss products and drugs. One commentator stated, " The FDA moves, if slowly, against dangerous foods and drugs."7 In 1991, another commentator reacted to an F.D.A. order promulgated banning over 100 chemicals from diet medications on the grounds they were either "not safe or effective."8 Included in the order was a prohibition on caffeine in any weight reduction medication. The observer stated:

"[a) lthough the F.D.A. has been widely criticized over the years for many of its actions, I have the utmost respect for its ability and success in maintaining our food, pharmaceuticals, and cosmetics at probably the highest quality in the world. They may have made errors in judgement at times, and they may have delayed progress in some areas by their extreme caution. In many cases, this has been justified and time has demonstrated the wisdom of many of their decisions. Forbidding caffeine, however, as a diet aid is rather ridiculous, since any heavy weight desiring this agent for weight control can always obtain the required amount in a cup of the brew."9

Despite the criticisms, the F.D.A. has a track record of significant accomplishments when utilizing its authority under 21 U.S.C. §355 to regulate new drugs, such as in 1977 and 1978 when the F.D.A. received reports of 60 deaths believed to be related to the use of low calorie liquid-protein diet products.10 In the 80's, when the F.D.A. received 90 complaints of illnesses allegedly caused by Herbalife liquid diet

Id.

8 Samuel Lee, Coffee-An Apretite Depressant: Food and Drug Administration Ban on Caffeine in Diet Pills. , Tea and Coffee Trade Journal, October 1991, at 3.

Id .

10 Mary Peterson Kauf fold, Fat Chance Liguid Diet Potions Unload Pounds. But at What Price? , Chicago Tribune, August 28, 1988, Section Tempo at 1.

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products,11 it seemed powerless from a regulatory scheme to regulate this growing market. Since the F.D.A. classifies these powders as a food, not a drug, it has less power to regulate their use despite their potential dangers.'2

Despite these limitations, the F.D.A. was able to knock the wind out of the sails of the liquid protein diet market by just issuing a warning in 1977 to consumers that there were dangers associated with liquid protein diets. One company reported " [o]ur sales for the year until November were about $3.5 million, and they were going up. In June alone, we had sales of about $700,000. But in December [after the F.D.A. announcementJ, sales dropped to $57,OO0."'~ In April, 1984, the F.D.A. moved to slow the growth of these products again when it required diet products that provided fewer than 400 calories per day and derived more than 50 percent of their caloric value from protein to carry a warning statement.14 Thus, the moral of the liquid protein story is that the F.D.A. can have a dramatic effect on the weight-loss industry, even when regulating food supplements.

Following a finding that the nation's most popular non-prescription "diet pills" contained too much of a drug which had potentially dangerous side effects, in 1980 the F.D.A. asked the manufacturers to remove their

Robert L. Jackson, Report Criticizes Weight-Loss Products; Four Deaths,

Illnesses Linked to Herbalife, Senate Study Says , Los Angeles Times, May 14,

1985, Part 1 at 5.

12 Kauffold, su~ra note 10.

13 Larry Kramer, Liquid Protein Diet Fears Slashing Sales of Powder , Washington Post, January 18, 1978, Business & Finance at 10.

Kauf fold, supra note 10.

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products from the shelves.15 Products such as Ayds AM/PM, Appetite Suppressant Capsules, Control Drops, Vita-Slim Capsules and Bio Slim T Time—Release Capsules were found to contain high levels of a drug which could cause sudden attacks of very high blood pressure even for young healthy persons.16 The F.D.A. was able to achieve its goals of removal without further actions against most of the manufacturers in the industry.

In 1988, the F.D.A. began looking into La Patch, a "skin-patch" diet aid product that claimed to offer a homopathic substance absorbed through the skin via the patch.17 While there were no reports of consumers injured, the F.D.A. was "deluged with consumer inquiries about patch remedies." The F.D.A. issued a statement that "[n]o manufacturer or distributor has presented evidence that any non—prescription skin patch for any use is safe and effective for any indication. No such products for non-prescription use have been approved by the agency." 18 The distributors of the patch were eventually derailed in 1990, not by the F.D.A. but, by other federal authorities on mail and securities fraud.19 Other agencies' actions aside, the F.D.A. could have pursued removal of the phony patch products from the market under its authority under 21 U.S.C. S360(c) to regulate medical devices.

15 Diet Pills , U.S. News & World Report, May 12, 1980, Newsletter Section at 90.

16 Id .

17 Maria L. La Ganga, FDA Looking Into Skin—Patch Diet Aids. Claims of Two Firms , Los Angeles Times, May 19, 1988, Part 4 at 1.

18 Id .

19 Leslie Berkman, 2 Brothers to Plead Guilty. Aid Diet Patch Inauirv , Los Angeles Times, November 16, 1990, Part D at 5.

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In Nutrilab. Inc. v. Schweiker,20 the court upheld an F.D.A. classification that a product called starch blockers was a 'drug' and not a food. Under Section 321(g) (1), the term drug means:

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"Starch blockers tablets and capsules consist of a protein which is extracted from a certain type of raw kidney bean. That particular protein functions as an alpha-amylase inhibitor; alpha-amylase is an enzyme produced by the body which is utilized in digesting starch. When starch blockers are ingested during a meal, the protein acts to prevent the alpha— amylase enzyme from acting, thus allowing the undigested starch to pass through the body and avoiding the calories that would be realized from its digestion." 21

Apparently the product gained popularity among weight conscious consumers, however, the product seemed to produce severe adverse reactions among some consumers. "By August 1982, the F.D.A. had received seventy— five reports of adverse effects on people who had taken starch blockers, including complaints of gastro—intestinal distress such as bloating, nausea, abdominal pain, constipation and vomiting." 22

Prompted by what appeared to be a mounting crisis, the F.D.A. reacted

20 713 F.2d 335 (1983).
21 Id.

22 Id .

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FINAL EXAM: FOOD & DRUG LAW, WINTER TERM, 1994 STUDENT IDENTIFICATION # 103 8580 60

by classifying the product as a drug and as a result of such classification, the manufacturer is required to file a new drug application pursuant to 21 U.S.C. §355•23 In the absence of such an application, the F.D.A. is empowered to order the products removed from the market until there is F.D.A. approval of the new drug. Thus, under this scheme, the F.D.A. was able to act and control the potentially harmful weight-loss product.

In another case in 1988, the F.D.A. issued a warning that some diet pills, called Diennet, should not be taken because they contain "potentially dangerous levels of prescription drugs and should not be taken." The capsules, while offered as food supplements, the F.D.A. found then to contain an appetite suppressant, and two drugs with sedative and anti—anxiety properties.24 It was not reported what further action was taken by the F.D.A. in the matter. However, 21 U.S.C. §355, in addition to 21 U.S.C. §352 covering false or misleading labels and claims, would authorize the F.D.A. to take further legal action against the firm in this case.

In the early 90's, F.D.A. actions were targeted at eliminating ingredients in diet pills that the manufacturers had not proven either "safe or effective."25 In the fall of 1990, the F.D.A. promulgated an order banning over 100 chemicals from diet medications stating there is no

23 Id .

24 Diet Capsule Warning , Los Angeles Times, August 4, 1988, Part 2 at 2.

25 Lee, supra note 9.

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FINAL EXAM: FOOD & DRUG LAW, WINTER TERM, 1994 STUDENT IDENTIFICATION # 103 8580 60

proof they work and that one may even cause choking.26 Manufacturers are required, pursuant to 21 U.S.C. S355 (b)(1), to submit reports showing a proposed drug "is safe for use and whether such drug is effective in use." Among the ingredients the F.D.A. decided to ban are: alcohol, corn syrup, dextrose, guar gum, kelp, pineapple enzymes, rice polishings, saccharin, salt, sodium bicarbonate, vitamin C and wheat germ.27 One product, guar gum, was linked with causing consumers to choke when used.28 In the months prior to promulgating the ban, the F.D.A. had received 17 reports of throat blockage among people using the product because it is a substance that expands when exposed to water.

The proposed ban, however, may have been more cosmetic than substantial since these ingredients had " little significance in diet pills because they were minor components, manufacturing aids such as fillers, lubricants, disintegrates, etc."29 The actions do however, highlight F.D.A. ability to intercede effectively in the weight-loss industry.

In sum, based on these recent incidents, the F.D.A.'s apparent policy in regulating the weight-loss industry has been very lax. Action, when taken, was slow in coming and in reaction to particular events. While F.D.A.'s actions can be applauded, it appears clear, the F.D.A. does not have a comprehensive, aggressive, strategy for regulating the weight—loss industry; and it is this lack of aggressive intervention, both proactive

26 FDA Seeks Ban on 100 Ingredients in Over-the-Counter Diet Products , Los Angeles Times, October 30, 1990, part A at 18.

27 Id .

28 Id .

29 Lee, supra note 8.

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FINAL EXAM: FOOD & DRUG LAW, WINTER TERM, 1994 STUDENT IDENTIFICATION # 103 8580 60

and reactive that draws cries for formation and reformulation of F.D.A.'s plans for regulating this industry.

II. THE F.D.A. SHOULD INCREASE REGULATION OF THE WEIGHT-LOSS INDUSTRY TO PROTECT THE HEALTH OF MILLIONS OF CONSUMERS.

There are compelling arguments on both sides of the issue. Proponents

for increased F.D.A. regulation assert it is good policy for increased F.D.A. focus because of the serious physical and mental health issues involved in weight-loss. Secondly, the issue of regulation of the weight-loss industry also fits neatly within the F.D.A.'s published mission statement to protect the public health.

Opponents of increased F.D.A. intervention and regulation assert the

F.D.A. should continue to limit intervention by focusing its limited resources on removing dangerous and unsafe products from the market. It is not the role of the F.D.A. to educate the public on strategies for long term weight loss, and any additional efforts by the F.D.A. would result in overinclusive, overreaching regulation. However, the arguments weigh in favor of increased F.D.A. intervention because of the extensive reach and impact of weight-loss issue.

A. Obesity is a Berious Health Problem AffectinQ 34 Million People .

In 1985 a federal panel concluded that weight—loss is as serious a national problem as smoking.30 As many as 34 million Americans are at "significantly higher risk for disease" because of weight.31 Dr. Hirsch, professor at Rockefeller University in New York and chairman of a 14—member National Institutes of Health panel, states obesity "is a disease that

30 Granberry, su~ra note 2.
31 Id.

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FINAL EXAM: FOOD & DRUG LAW, WINTER TERM, 1994 STUDENT IDENTIFICATION # 103 8580 60

carries an increased risk of mortality. It deserves to be treated and considered just as seriously as any other illness."32 The call for a more serious approach to the disease of obesity is further supported by the recent disclosure of medical theories strongly suggesting that weight problems are biological in nature, not just a behavioral problem.33

Further, many experts warn that weight and weight-loss issues reach beyond physical harms and have significant psychological impacts. "For the person who weighs too much, regardless of labeling, the psychological trauma may be worst."34 Problems cover a range from unhappiness at work to being heckled by one's own children and loved ones. "There's tremendous job bias against fat people, they can't wear the same clothes as others, and, of course, there's the cultural stereotypes of the lazy fat person, which in most cases is just wrong. In fact, they work harder than most to overcome the stigma."35

Because of both the physiological dangers and the psychological trauma involved, many Americans turn to fad diets, diet pills, quick-fix programs and even foolish options such as the giant plastic bag that melts fat as you walk around.36 Weight-loss obsessions induce otherwise intelligent people to fall prey to the many "charlatans" around that exploit their fears.37 One medical professional stated, " For a hustler, it may be the

32 id.

id.

Id.

Id .

36 id.

Id .

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• FINAL EXAM: FOOD & DRUG LAW, WINTER TERM, 1994 STUDENT IDENTIFICATION # 103 8580 60

best gravy train going. ,,38

It is against this background and basic health concerns that there is a call for increased F.D.A. regulation. "The weight—loss business in the United States has gotten out of hand," says Dr. C. Wayne Callaway, an endocrinologist speaking on behalf of the American Board of Nutrition when testifying at a congressional hearing on the weight-loss industry in April 1990.~~ Further, the usual mechanism of industry self-regulation are broken down in this industry. Nancy S. Wellman, Ph.D., a registered dietitian and president of the American Dietetic Assn. states at the same congressional hearing, "too often the emphasis is on the pocketbook not the pauch."40 Many concerned experts conclude the 'warning has been sounded" and " we must better define roles of the FTC and F.D.A. in regulating aspects of the weight-loss industry."41 Finally, congress has thrown "down the gauntlet before the diet industry," when it initiated hearings in 1990 into the "health risks, false advertising and profiteering" that one representative hailed as the "bedrock" of the nation's weight—loss industry •42

Opponents of increased F.D.A. intervention do not deny the seriousness of the weight issue in this country, however they stress there are other, higher priorities the F.D.A., such as nutritional labeling, product

38 Id .

~ Dosti, su~ra note 5.

40 Id .

41 Id .

42 Molly O'Neill, Congress Looking Into the Diet Business , The New York Times, March 28, 1990, Section C at 12.

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tampering, and issuing new regulations on the fish industry. They assert that the limited F.D.A. resources, as they pertain to weight-loss industry, should be focused on specific acts, such as removing dangerous and unsafe products from the market. Informing consumers of the problems of fad diets and the psychological dangers of 'yo-yo' weight loss and weight gain is better left to other agencies.

This argument is not compelling because it relies on the F.D.A. taking a reactive stance and waiting for a disaster to happen before the agency acts. This is dangerous because it creates a huge potential for consumer harm and loss of life before the F.D.A. can act to remove an unsafe or ineffective weight-loss product. Further, it ignores the fact that obesity should be elevated to a higher priorities because the issue of weight-loss is closely related to health and health care in general, currently the first priority for the Clinton Administration. Therefore, increased F.D.A. regulation of the weight-loss industry is wholly consistent with the President's priorities and national agenda. Finally, education and prevention really are the most cost efficient in the long run in terns of allocating resources and in saving lives and preventing human suffering.

B. Protection of Vulnerable Consumers from Abuses in the WeiQht-Loss Industry Fits with the F.D.A.'s Mission and is within its Statutory Authority .

Despite the seriousness of the health threat, the weight—loss industry is largely unregulated, and has operated "like an untamed, runaway horse for decades."43 Consumers seeking relief from their weight problems, either real or perceive, may be too emotionally involved to make rational

Dosti, su~ra note 5.

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decisions and choices, may not have the expertise to evaluate the alternatives, or just find there is a lack of information available on the safety and effectiveness of various products. It is such a combination of the above factors that make this issue ripe for increased F.D.A. intervention and protection based on the F.D.A.'s mission statement, summarized in a Senate report as:

"The mission of the Food and Drug Administration is to ensure that (1) food is safe, pure, and wholesome; (2) cosmetics are safe; (3) human and animal drugs, biological products, and therapeutic devices are safe and effective; and (4) radiological products and use procedures do not result in unnecessary exposure to radiation.""

Increased regulation of the weight-loss industry fits with F.D.A.'s interpretation and execution of its mission and past efforts to promulgate rules and regulations that establish broad public health objectives.'5 Consumers, deluged with products promising to instantly cure their weight problems, need F.D.A. assistance to determine what is safe, effective, and not misleading. Unsuccessful weight-loss programs hurt more than the pocket book and the psyche, get-thin-quick programs and products produce real physical dangers to consumers. Dr. James Ferguson, a psychiatrist and the medical director of the La Jolla Eating Disorders Clinic, states, "[t]he physical danger (of fad diets) is you'll die."46 Thus, only with F.D.A. intervention will there be a saner approach to addressing a problem that may encompass more than )ust a behavioral adjustment on the part of the consumer.

Aoriculture. Rural Development. and Related Agencies Appropriation Bill. 1990 ,

Senate Report No. 101—84, 101st Congress, 2d Session (1989).

See generally United States v. Article of Drug... Bacto—Unidiak , 394 U.S. 784

(1969).

46 Granberry, supra note 2.

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Finally, there is no issue that the F.D.A. has the authority to regulate the weight—loss industry. Section 321(g) (1) (C) was added to the statute in 1938 to expand the definition of 'drug' to include " articles (other than food) intended to affect the structure or any functions of the body of man or other animals", because Congress intended to bring "anti—fat remedies" and "slenderizers" under the statute.47 Additionally, "except for F.D.A. -approved disease prevention claims under the 1990 Nutrition Labeling and Education Act, nothing in section 201(g) precludes F.D.A. from regulating a food as a drug as well."'8

Many opposed to increased F.D.A. intervention assert the current amount of F.D.A. activity is the right amount of protection for consumers. "People may be fat, but they are not stupid."'9 The public does not need the same amount of protection on all weight—loss issues. "Really far—out promotions—-tiny magnets, fat—melting creams-—don't seem worth much time. Although clearly false advertising, they're not very dangerous, and a reasonable person would suspect their falsehood... expert protection is most needed with products whose legitimacy most people can't judge (the diet patch, the starch—blockers) or whose dangers they can't anticipate (the guar gum, the liquid protein)," asserts one advocate for no change in F.D.A.'s efforts to regulate the weight-loss industry.50

Unfortunately, this argument fails to address the problems of lack of

~ Schweiker , 713 F.2d at 335.

48 Peter Barton Hutt & Richard A. Merrill, Food and Drug Law , 2d ed. at 380.

'~ Diamond, su~ra note 6.
50 Diamond, su~ra note 6.

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availability of reliable information on many weight-loss products and the emotional involvement of the consumer, which could limit rational evaluation, even for an otherwise reasonable person.

CONCLUSION

The F.D.A. should re-evaluate its current policies in regulating the weight-loss industry to devise plans that better protect the health and safety of the consumer. Health and health care reform are the nation's top priorities, and weight-loss and obesity are serious threats to the nation's health. The F.D.A. has a mission and the authority to make a positive contribution in ensuring safety in this industry. Obviously, space limitation prevent discussion of specific efforts F.D.A. could undertake. However, given the lax approach in recent years, most anything could represent a move in the right direction.

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