Bundesgesundheitsbl Gesundheitsforsch - Gesundheitsschutz 2001 · 44:214–218 © Springer-Verlag 2001

Leitthema: Funktionelle Lebensmittel I. Ringel Heller1 · B. Silverglade2 1Center for Science in the Public Interest,Washington,DC,USA 2International Association of Consumer Food Organizations,Washington,DC,USA

Functional Foods Health Boon or Quackery?

Abstract The potential for enhancing foods with ingredients that can prevent disease is enormous.But some functional foods fail to provide genuine health benefits and some may even pose safety problems.New product lines make misleading claims and many of these products contain herbal medicines, which the U.S.Food and Drug Administration (FDA) does not consider to be safe for use in foods.There is no regulatory category for “functional foods”under U.S.law, and the marketing of such products has presented the FDA with a multitude of controversial regulatory issues.The FDA should address these problems by first prohibiting the addition of medicinal herbs to foods.In addition, the FDA should close a variety of loopholes in the law that manufacturers use to justify the marketing of questionable products.The FDA should e.g.issue new regulations requiring that structure/function claims for foods be based on universally recognized factual statements concerning known effects of a substance on the structure or functioning of the body.The FDA must also work more closely with the Federal Trade Commission (FTC) which regulates claims in advertising.It is crucial that functional foods are sold on the basis of regulatory initiatives developed by government health authorities, not marketing strategies generated by companies hoping to capitalize on the latest health fad.Otherwise, functional foods will fail to realize their public health potential and amount to little more than 21st century quackery. Keywords Functional foods · Health claims · Regulatory issues · FDA

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unctional foods have become an increasingly popular phenomenon in the United States. The potential for enhancing foods with ingredients that can prevent disease is enormous. For example, products such as orange juice with added calcium offer important health benefits for consumers who are unable or unwilling to consume dairy products. Unfortunately, not all functional foods provide genuine health benefits and some may even pose safety problems. New products – ranging from breakfast cereals to snack foods – promise to cure almost every ailment under the sun. Many of these products contain ingredients such as echinacea, gotu kola, kava kava and St. John’s wort which, according to the U. S. Food and Drug Administration (FDA), have not been determined to be safe for use in food products.

“Not all functional foods provide genuine health benefits and some may even pose safety problems.” For example, consumers in the U.S. can buy “Herbal Brain Power” a breakfast cereal with ginkgo and gotu kola or “ARx Stress Relief Elixir,” an ice tea drink with kava kava. Although functional foods were originally seen as a niche market for smaller companies, multinational giants such as Procter & Gamble have begun marketing functional foods such as “Spire Energy”, a so-called energy drink with ginseng that claims to “deliver smooth, steady sustained energy”. To date, except for deceiving consumers with misleading claims, functional foods have not caused any harm.

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However, some of the most popular herbal ingredients have been associated with a number of adverse effects when taken in supplement pill form [1]: ◗ The FDA issued a Public Health Advisory on the risk of drug interactions with St. John’s wort, a popular herb for the treatment of depression. The notice followed the report of a National Institutes of Health study published in The Lancet. Researchers discovered a significant interaction between the supplement and protease inhibitors used to treat HIV infection. Based on this study and reports in the medical literature, the FDA advised health care practitioners to alert patients to the fact that St. John’s wort may also interact with other drugs that are similarly metabolized. The Agency warned that potential drug interaction may occur with respect to drugs used for heart disease, depression, seizures, transplant rejection, and contraception. (FDA, Public Health Advisory, Subject: Risk of Drug Interactions with St. John’s Wort and Indinavir and Other Drugs, Feb. 10, 2000.) ◗ Kava kava can cause over-sedation and increase the effects of substances that depress the nervous system. It has also been associated with

Ms.Heller is a senior staff attorney at the Center for Science in the Public Interest (CSPI), a non-profit consumer advocacy organization that specializes in food safety and nutrition issues.Mr.Silverglade is President of the International Association of Consumer Food Organizations, a coalition of consumer organizations that work on food policy.Both CSPI and IACFO are based in Washington DC.

Bundesgesundheitsbl Gesundheitsforsch - Gesundheitsschutz 2001 · 44:214–218 © Springer-Verlag 2001

I. Ringel Heller · B. Silverglade Funktionelle Lebensmittel. Profit für die Gesundheit oder einfach nur Quacksalberei? Zusammenfassung Funktionelle Lebensmittel erfreuen sich in den USA wachsender Beliebtheit.Das Potential Lebensmittel mit Ingredienzien anzureichern, die möglicherweise Krankheiten verhindern, ist enorm.Zum Beispiel bietet ein Orangensaft mit Kalzium-Zusatz durchaus gesundheitliche Vorteile für Verbraucher, die nicht in der Lage sind, Milchprodukte zu verzehren oder es nicht wollen.Aber andere funktionelle Lebensmittel bieten keinen solchen erkennbaren Vorteil und einige von ihnen könnten sogar schädlich sein.Neue Produktlinien arbeiten mit irreführenden Werbeaussagen, und viele dieser Produkte enthalten Kräuter bzw.Kräuterextrakte, deren Verwendung in Lebensmitteln eine Behörde wie die US Food and Drug Administration (FDA) nicht als unbedenklich ansieht.Bis heute ist keine spezielle rechtliche Kategorie für funktionelle Lebensmittel im amerikanischen Recht geschaffen worden, und die Vermarktung dieser Produkte hat die FDA vor eine Vielzahl von regulatorischen Problemen gestellt.Die FDA sollte sich vor allem des Problems annehmen, dass sie den Zusatz medizinischer Kräuter zu Lebensmitteln verhindert.Zusätzlich sollte die FDA eine Reihe von andern Schlupflöchern im Gesetz schließen, die die Hersteller zur Rechtfertigung fraglicher Produkte nutzen.Nach derzeit gültigem US-Recht ist es Lebensmittel-Herstellern untersagt, Hinweise auf krankheitsverhütende Eigenschaften, sogenannte “health claims”, zu geben, es sei denn, ein solcher “health claim”ist von der FDA explizit zuge-

tremors, muscle spasms or abnormal movements that may interfere with the effectiveness of drugs prescribed for the treatment of Parkinson’s disease. (JC Almeida & EW Grimsley, Coma from the health food store: interaction between kava and alprazolam, 125 ANN INTERN MED 940 (1996).) ◗ Ginkgo can act as a blood thinner. Taking it with other anticoagulants may increase the risk of excessive bleeding or stroke [1].

lassen.Aber Hersteller nutzen eine seit langem bestehende (wenn auch bislang selten genutzte) Ausnahmeregelung im FFDCA, die den Hinweis erlaubt, dass ein Produkt einen Einfluss auf die Struktur oder Funktion des menschlichen Organismus hat, ohne dass dafür eine Zulassung seitens der FDA erforderlich wäre.Derartige Aussagen sind implizit “health claims”.Weil sie nicht der Zulassung bedürfen, werden viele dieser “structure/function claims”gemacht, obwohl sie bei genauer Nachprüfung als unbewiesen und daher irreführend anzusehen sind.Die FDA sollte sicherstellen, dass bei “structure/function claims”nur für Lebensmittel allgemein anerkannte Feststellungen benutzt werden, die bekannte Effekte einer Substanz auf die Struktur/Funktion des menschlichen Organismus betreffen.Die Hersteller versuchen auch, die FDA-Zulassungsbedingungen zu umgehen, indem sie funktionelle Lebensmittel als “medical foods”anbieten.Die Anbieter vermarkten solche Produkte immer häufiger direkt an Verbraucher, und nur um dem Gesetz genüge zu tun, bringen sie auf dem Etikett die Feststellung,“unter ärztlicher Aufsicht”zu verzehren an.Die FDA sollte dabei enger mit der Wettbewerbsbehörde zusammenarbeiten, die die Werbung und Anzeigen überwacht.Es erscheint aus allen diesen Gründen bedeutsam, funktionelle Lebensmittel unter amtlichen Regularien zu vermarkten, nicht allein geleitet von Marketing-Strategien.Ansonsten werden funktionelle Lebensmittel das Gesundheitspotential, das sie vielleicht für die Bevölkerung bieten, nicht ausschöpfen und zu nichts anderem werden als zur Quacksalberei des 21.Jahrhunderts. Schlüsselwörter Funktionelle Lebensmittel · Gesundheitliche Wirkungen · Zulassungsregelungen · FDA

It may only be a matter of time before subgroups of consumers with hypersensitivities suffer serious adverse reactions from functional ingredients. Health problems may also arise when trivially small or dangerously large amounts of a beneficial substance are used.

Regulation of Functional Foods in the United States There is no regulatory category for “functional foods” under U. S. law. Such

products fall into the grey areas between “foods”, “drugs”, and “dietary supplements” [2].1 This problem has presented the FDA with a multitude of controversial regulatory issues.

Regulation of Ingredient Safety Under the Federal Food, Drug and Cosmetic Act [3], food manufacturers must obtain pre-market approval for food additives or demonstrate that such ingredients are “Generally Recognized As Safe” (GRAS). General recognition of safety must be based on the views of experts throughout the scientific community who have common knowledge, based on accepted scientific procedure, that a substance is safe. However, in the case of substances used in food prior to 1958, general recognition of safety can simply be based on common experience gained from use of the substance in food within or outside of the U. S. If a manufacturer does not consider the ingredient to be GRAS [4],2 or if its GRAS determination is challenged by the FDA, the company must submit a food additive petition establishing the safety of the ingredient under the conditions of its expected use before the FDA will grant approval [5]. Because the filing of a food additive petition can be costly and take several years, both the food and dietary supplement industries have pressed Congress to deregulate the process. The supplement industry has been more successful in that effort than the food industry. After a grass-roots consumer letter-writing campaign largely organized by the industry, Congress enacted the Dietary Supplement Health and Education Act of 1994 (DSHEA) [6]. That law prevents dietary supplements from being subjected to the approval re-

1The definition of “drug”includes “articles in-

tended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals”. 2Pesticides, pesticide residues, color addi-

tives,“prior-sanctioned”ingredients, new animal drugs, and dietary supplement ingredients are exempted from the food additive classification. Prior sanctions exist for specific uses of particular substances that were explicitly approved by FDA on an informal basis prior to the passage of the 1958 Food Additives Amendment.

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Leitthema: Funktionelle Lebensmittel quirements applied to food additives. New dietary ingredients may be marketed 75 days after the manufacturer provides notice and substantiation to the FDA that the ingredient can “reasonably be expected to be safe” [7]. FDA approval, however, is not required. Ingredients marketed prior to October 15, 1994 are exempt from even this minimal requirement. In order to escape strict FDA regulation of the safety of functional ingredients, some manufacturers try to market functional foods as dietary supplements rather than as conventional foods with added ingredients.

Label Claims Problems with label claims first surfaced in 1984 when the Kellogg Company printed the U. S. National Cancer Institute’s dietary recommendation regarding a low-fat, high-fiber diet on AllBran cereal boxes. Under the law at that time, such a claim constituted an impermissible disease prevention claim, referred to in the U. S. as a “health claim”. Technically, the product was an illegal, unapproved new drug. However, the FDA did not challenge the claim and instead began experimenting with allowing health claims for conventional foods without requiring pre-market approval by the agency. The result was a few truthful claims followed by a flood of products making misleading claims.

“In the US, health claims for foods must be approved by the FDA prior to marketing.” In response, the U.S. Congress passed the Nutrition Labeling and Education Act of 1990 (NLEA), which required that health claims – i. e., claims that would otherwise cause the product to fall within the definition of a drug – be approved by the FDA prior to marketing. Under the NLEA, health claims for foods could only be approved if the FDA conducted an administrative rulemaking proceeding during which the public was given an opportunity to comment. The NLEA required that after the public comment period, the FDA can only permit a health claim if it concludes that “based on the totality of the publicly available scientific evidence”, there is “significant scien-

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tific agreement” that the claim is scientifically valid [8]. A 1997 amendment to the health claim provisions provided that health claims could be based upon authoritative statements published by a scientific body of the U. S. government about the “relationship between a nutrient and a disease or health-related condition to which the claim refers”. Such claims do not require approval from the FDA, although use of a claim can be prohibited if FDA objects to it within 120 days after the manufacturer notifies the agency of the prospective health claim. Under the NLEA, the FDA has approved health claims concerning the relationships between: ◗ calcium and osteoporosis, ◗ sodium and hypertension, ◗ dietary fat and cancer, ◗ dietary saturated fat and cholesterol and coronary heart disease, ◗ fiber-containing grain products, fruits and vegetables and cancer, ◗ fruits, vegetables and grain products that contain fiber, particularly soluble fiber, and coronary heart disease, ◗ fruits and vegetables and cancer, ◗ folate and neural tube defects, ◗ dietary sugar alcohols and dental caries, ◗ soluble fiber from whole oat or psyllium products and coronary heart disease, ◗ whole grains and heart disease and certain cancers, ◗ soy protein and coronary heart disease, ◗ plant stanol and sterol esters and coronary heart disease. The FDA has been proactive in implementing the NLEA in a competent and fair manner. Food companies, however, still have sought ways to avoid the agencys approval requirements and make even more claims.

Companies Are Using Loopholes in the Law to Market Questionable Products Marketing Functional Foods as Dietary Supplements to Evade Safety Requirements One major loophole in the law permits manufacturers to attempt to market functional foods as dietary supplements.

Bundesgesundheitsbl - Gesundheitsforsch - Gesundheitsschutz 3•2001

Companies use this loophole to take advantage of weak regulatory standards that apply to the use of supplement ingredients which, unlike food ingredients, need not, in most cases, be demonstrated to be safe before they are sold. The distinction between dietary supplements and functional foods was most publicly aired in official letters that the FDA sent to McNeil Consumer Products, a division of Johnson & Johnson, in connection with its Benecol margarine spread that contains added plant stanol esters to prevent the absorption of cholesterol. Initially, McNeil, planned to market Benecol spread as a dietary supplement. The FDA concluded that despite the fact that the product stated on its label that it was a “dietary supplement”, the product was a conventional food. As a conventional food, Benecol was subject to requirements that all ingredients intentionally added to foods be Generally Recognized as Safe (GRAS) by scientific experts or approved as a food additive by the FDA [9]. The plant stanol esters in Benecol were not authorized by a food additive regulation. Therefore, after prohibiting McNeil from marketing Benecol as a dietary supplement, the FDA told McNeil that if it wanted to sell the product, it had to provide evidence to the agency demonstrating that the plant stanol esters were GRAS [10]. McNeil sent FDA data supporting its GRAS determination, and ultimately the FDA did not object to McNeil’s conclusion. The product, therefore, is now marketed legally as a food. The FDA handled this case relatively well and prevented McNeil from marketing a food as a dietary supplement in order to avoid compliance with the laws governing the safety of added ingredients to food. Overall, however, the FDA’s enforcement efforts have been inadequate and numerous other companies continue to exploit this loophole in the law.

Companies Are Making Structure/ Function Claims in order to Avoid Pre-Market Approval Requirements for Health Claims Companies also exploit loopholes in the law that allow them to make label claims not approved by the FDA. The FDA was able to effectively administer the premarket approval requirements for health claims contained in the NLEA until the

U.S. Congress in 1994 passed DSHEA, which, among other things, permitted dietary supplement manufacturers to claim that products affect the structure or a function of the body without obtaining pre-market approval from the FDA. Structure/function claims, in essence, are implied health claims; they include statements such as “vitamin A is necessary for good vision”. The NLEA did not address the use of such claims [11].3

“Companies exploit loopholes in the law that allow them to make unapproved label claims.” After the passage of DSHEA, consumer sales of dietary supplements soared from $ 9.8 billion in 1995 to an estimated $ 14.7 billion in 1999 [12]. The food industry, seeking to mimic the success of the dietary supplement industry, has increasingly availed itself of a rarely used provision in the law that allows food manufacturers to also make structure/function claims. This loophole in the law has contributed to the growth of questionable claims for functional foods [13].4 For example, when the FDA reviewed the use of plant stanol esters in Benecol, the agency informed McNeil that the claim that Benecol “promotes healthier lower cholesterol levels”was an unauthorized health claim requiring FDA pre-market approval. Under the law, however, the company was still free to make structure/function claims. Consequently, McNeil merely changed its labeling to say “Benefits Cholesterol”. By modifying just a few words on the label,

3The definition of a “drug”also encompasses

an article “intended to affect a structure or function of the body”. However, foods are expressly exempted from this provision [10]. 4Under an FDA final rule for structure/func-

tion claims for dietary supplements, which provides useful guidance for food, the Agency has drawn hairsplitting distinctions between permissible and impermissible statements. For example, a supplement may claim that it “helps to maintain cholesterol levels that are already within normal range”. A supplement cannot, however claim to “lower cholesterol”or “maintain healthy cholesterol”because those are viewed as disease prevention claims [12]. Such distinctions are lost on consumers.

the company was able to transform a health claim into a structure/function claim and avoid going through the premarket approval process.

Companies Are Making Unregulated Claims in Advertising to Avoid Restrictions on Label Claims Furthermore, McNeil continued to make express health claims regarding the cholesterol-lowering ability of Benecol in advertising. McNeil was permitted to do so because the Federal Trade Commission (FTC), which has jurisdiction over advertising, does not require pre-market approval of health claims and employs weaker substantiation standards than the FDA. Ultimately, the company decided to stop taking advantage of loopholes in the law and petitioned the FDA for approval of a health claim for stanol esters and coronary heart disease.

products are marketed directly to consumers, the products may be used without a physician’s knowledge. Such products are often marketed on the basis of misleading claims. Medical foods that have been marketed include CardiaSalt (a salt alternative); Nitebite (a snack bar designed to reduce diabetics’ risk of developing hypoglycemia; and HeartBar (“for the dietary management of vascular disease”). These products bear little resemblance to bona fide medical foods. The FDA is slowing reevaluating its approach to regulating medical foods; it issued an advance notice of proposed rulemaking in November 1996. In the notice, the agency recognized the need to require pre-market approval of health claims for medical foods [15]. However, no further action has been taken by the FDA.

Enforcement is Inadequate “Companies make implied health claims without FDA approval by phrasing statements as structure/function claims.” The agency recently granted the company’s petition and health claims for Benecol can now be made legally [14]. While this particular company ultimately decided to adhere to both the letter and the spirit of the law, many other companies continue to make implied health claims without FDA approval by phrasing such statements as structure/function claims. Many of these claims are poorly substantiated or otherwise misleading.

Companies’ Use of the Medical Foods Exemption to Make Unregulated Claims Some companies are selling functional foods as “medical foods” in order to evade regulatory requirements. Medical foods are intended for consumption under the direct supervision of a physician and for that reason are exempt from provisions requiring pre-market approval of health claims. Manufacturers, however, market such products directly to consumers and, in a specious effort to comply with the law, merely state on the label “use under the supervision of a physician”. But given the fact that these

The FDA and state consumer agencies initially allowed companies to completely ignore the law. In September 1999, however, the FDA began issuing official warning letters to manufacturers of functional foods. The letters demanded that the companies change their practices or risk being sued by the agency in court. The FDA primarily cited two kinds of violations of the law: (1) failure to demonstrate safety – the products contained herbal medicines and other ingredients that are not GRAS for use in food or approved by the FDA as a food additive, and (2) the use of unapproved health claims [16].5 The FDA also told the companies that any claimed effects for the functional ingredients must be linked to their nutritive value and not to pharmacological effects.

5Another type of violation – the use of un-

authorized nutrient–content claims – was also cited. Id.The FDCA permits claims regarding the level of a nutrient in a product so long as the FDA issues a regulation permitting designation of that ingredient and specifies the qualifiers that may be used to describe the amount of the nutrient in the product, e. g. good source, high, low, etc.

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Leitthema: Funktionelle Lebensmittel Welcome as they are, the FDA’s enforcement efforts have been after–the–fact and spotty. The Center for Science in the Public Interest (CSPI), a consumer advocacy group, filed complaints with the FDA urging the agency to halt the sale of over 100 functional foods that contain ingredients that the FDA does not believe are GRAS and/or that make misleading claims. It remains to be seen whether the FDA will invoke its power to remove these products from the marketplace [17].7

Recommendations and Conclusions A report from the U. S. General Accounting Office, the investigatory arm of the U.S. Congress, concluded that:“FDA’s efforts and federal laws provide limited assurances of the safety of functional foods”. The report stated that although the extent to which unsafe foods reach consumers is unknown, companies should be required to notify the FDA before using new “functional” ingredients. The report also stated that the FDA should protect the public by halting misleading claims and by requiring label warnings where appropriate. The FDA could implement these recommendations by taking the following actions.

“FDA should protect the public by halting misleading claims and by requiring label warnings where appropriate.” The FDA should insist that manufacturers notify the agency before using functional ingredients and announce that it is prohibiting the use of medicinal herbs in foods. Scientifically, there is no difference between medicinal herbs and drugs. No one would think of adding Prozac to snack chips or Viagra to fruit juice drinks. Yet, this is essentially what many manufacturers of functional foods are doing. The FDA should also prohibit functional foods from masquerading as dietary supplements or medical foods in

6The state of Connecticut has begun an

investigation of functional foods, asking several companies to provide the state Attorney General with substantiation for their claims.

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order to evade safety and health claim approval requirements. The FDA should issue regulations controlling structure/function claims for foods. Some food companies are trying to evade FDA’s pre-market approval requirements for health claims by making structure/function claims that in essence are implied health claims. The FDA should end that abusive practice by requiring that structure/function claims for foods be based on universally recognized factual statements concerning known effects of a substance on the structure or functioning of the body. For example, claims such as “calcium is necessary for bone growth and development”could be permitted, while claims that “anti-oxidants may play an important role in slowing changes that occur with normal aging”or that “lycopene may help ensure normal functioning of the prostate gland” should be prohibited until those relationships have been established. The FDA should also stringently enforce the requirement that all claims be based on ingredients in food that provide nutritive, not pharmacological, value. Functional foods raise other questions often associated with the sale of drugs, such as: who should consume the product, how much should be contained in a serving and how much should be consumed per day, are side effects possible, and can the product be safely consumed in combination with other foods and drugs? The FDA should issue regulations addressing these issues. The FDA must also work more closely with the Federal Trade Commission (FTC) which regulates claims in advertising. The FTC does not require pre-market approval of claims and employs weaker substantiation standards than the FDA. Such double standards do not serve the interests of the consumer. Advertisements that make unapproved health claims, or poorly substantiated structure/function claims, undermine the FDA’s efforts to protect consumers from misleading labeling claims. It is crucial that functional foods be sold on the basis of regulatory initiatives developed by government health authorities, not marketing strategies generated by companies hoping to capitalize on the latest health fad. Otherwise, the full potential benefits of functional foods will not be realized and such products will amount to little more than 21st century quackery.

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A Fugh-Berman (1998) Herb-drug interactions, 355 Lancet 134 Federal Food, Drug and Cosmetic Act (FDCA) ∋ 201(g), 21 U.S.C.∋ 321(g) Pub.L.No.75–717, 52 Stat.1040 (1938), as amended, 21 U.S.C.∋ 301 et.seq. FDCA ∋ 20l(s), 21 U.S.C.∋ 321(s).FDA has published a list of prior-sanctioned substances, and manufacturers may petition for the recognition of additional prior sanctions.21 C.F.R. Part 181 21 U.S.C.∋ 348 Pub.L.No.103–417, 108 Stat.4325 (codified at 21 U.S.C.∋ 321 et seq.) 21 U.S.C.∋ 350b. 21 U.S.C.∋ 343(r)(3)(B).Food and Drug Modernization Act, Pub.L.No.105–115, 111 Stat 2296 (codified at 21 U.S.C.∋ 434(r)(C) and (D)). FDCA ∋ 201(s), 21 U.S.C.∋ 321(s). Letter from Joseph A.Levitt, Director, Center for Food Safety and Applied Nutrition, FDA to Mr. Brain D.Perkins, President McNeil Consumer Products Co.(Oct.28, 1998) FDCA ∋ 201(g)(1)(C), 21 U.S.C.∋ 321(g)(1)(C) U.S.General Accounting Office, Food Safety Improvements Needed in Overseeing the Safety of Dietary Supplements and “Functional Foods”(July 2000) 65 Fed.Reg.999 (Jan.6, 2000) 65 Fed.Reg.54686 (Sept.8, 2000) 61 Fed.Reg.60,66l, 60,663 (Nov.29, 1996). Warning Letters from John B.Foret, Dir., Division of Compliance and Enforcement.to: South Beach Beverage Company (Feb.1, 2000), Robert’s American Gourmet (Jan.27, 2000), Langer Juice Co.(Sept.28, 1999) FDCA ∋ 403(r), 21 U.S.C.∋ 343(r), 21 C.F.R.∋ 101.54 et seq.