Applying structure/function claims: the rules for structure/function claims can be tricky, particularly as they pertain to foods.
Outside of the dietary supplement context, FDA has provided little guidance as to what constitutes a permissible structure/function claim for food. Historically, FDA has permitted structure/function claims for well-known nutrients and the traditional role they play in the body. For example, FDA would not object to the claim "calcium builds strong bones and teeth," regardless of whether it was made for a calcium supplement or skim milk.
Since the passing of the Dietary Supplement Health and Education Act (DSHEA) in 1994, conventional food companies have been utilizing structure/function claims to market their products and to compete with dietary supplements. As far as FDA is concerned, the agency has long held the view that structure/function claims must be based on a food's nutritive (or nutritional) value. Although FDA does not provide a definition of nutritive value in the context of structure/function claims, it has defined it in the context of health claims as having a "value in sustaining human existence by such processes as promoting growth, replacing loss of essential nutrients, or providing energy" [21 C.F.R. [section] 101.14(a)(3)].
In the context of structure/function claims, this means that the food must provide necessary or essential nutrients to the body, and that it is these nutrients that affect the structure or function of the body. Under this rationale, a claim such as "vitamin C helps maintain the body's natural defenses" would be considered a permissible structure/function claim because it is based on the known nutritional role vitamin C plays in the body. However, the claim "CoQ10 helps maintain a healthy heart" may be considered a drug claim for a conventional food because FDA may not agree that the action of CoQ10 is based on its nutritional value.
The Food, Drug & Cosmetic (FD & C) Act does not limit the definition of a food to its nutritive value, nor do the courts. The courts have generally defined a good "as an article primarily consumed for reasons of taste, aroma or nutritional value." This interpretation presumes that a food is consumed for other purposes, including health benefits unrelated to a food's so-called nutritional value. Furthermore, the FD & C Act exempts any food, including components thereto, that is intended to affect the structure or function of the body of a human or animal from the definition of a drug [see FD & C Act [section] 201(g)]. Thus, a structure/function claim based on an ingredient that is generally recognized as safe (GRAS), or is an approved food additive, should, consistent with the FD & C Act, be permitted to appear on the label and labeling of foods whether or not the claim is based on the nutritional value of the ingredient.
Yet, under FDA's restrictive view of permissible structure/function claims, an otherwise permissible structure/function claim would be considered an impermissible drug claim if the claim is based on the ingredient's physiological or pharmacological properties rather than its nutritional properties. Thus, there continues to be a heightened regulatory risk involved in making structure/function claims for functional foods that are not explicitly based on the food's nutritional benefits. To avoid this risk, many manufacturers and distributors of functional foods have decided to market their products as dietary supplements, in an attempt to avoid FDA's restrictive view of permissible structure/function claims for foods.
Food vs. Drug
Except for FDA-permitted health claims and certain publications used to promote dietary supplements, the label and labeling of functional foods and dietary supplements may not bear health-related claims that suggest the food is useful in the cure, treatment, or prevention of disease or health-related conditions, i.e., "drug" or "disease" claims. If disease claims appear on the label and labeling of a food, which includes dietary supplements, FDA will consider the food misbranded and possibly an unapproved new drug subject to the FD & C Act's new drug approval provisions. However, FDA's final rules for dietary supplement structure/function claims do permit a variety of dietary supplement claims that were previously reserved for drugs.
In the 1980s, controversy surfaced over various bean extract products--now referred to as "starch blockers"--that were sold in tablet, capsule and liquid form. The products were reputed to reduce the metabolism of carbohydrates and thereby aid in weight reduction. The manufacturers of the starch blockers argued that the products were foods because they were made from beans, a common food substance. FDA, however, argued that starch blockers were drugs, not foods, because they were not consumed for their taste, aroma or nutritional value. The courts agreed with FDA, holding that a product that is consumed primarily for its effect on the structure or function of the body, rather than its taste, aroma, or nutritive value, is a drug [Nutrilab Inc. v. Schwieker, 547 F. Supp. 880 (N.D. Ill. 1982), aff'd 713 F.2d 335 (7th Cir. 1983); American Health Products v. Hayes, 574 F. Supp. 1498 (S.D.N.Y. 1983), aff'd 744 F.2d 912 (2d Cir. 1984)].
With the enactment of DSHEA, manufacturers and distributors of dietary supplements gained the ability to make structure/function claims for dietary supplements regardless of whether the supplement is consumed for its taste, aroma, or nutritional value. DSHEA, however, does not apply to food products marketed as conventional foods. Thus, the question persists as to whether the label and labeling of conventional food products may contain structure/function claims that are not based on the nutritional benefits of the product. As indicated previously, FDA's present position is that structure/function claims for conventional foods must be based on their nutritive value and not their pharmacological or physiological value.
FDA, however, has indicated that the scope of dietary supplement structure/function claims does provide guidance on the permissible claims for conventional foods.
Analysis of Final Rules
While, at first blush the final rules seem to be quite generous in the breadth of permissible claims, they are not without limitations, and recent FDA courtesy letters indicate that FDA is drawing a thin line between permissible and impermissible claims. Indeed, FDA continues to take the position that references to signs and symptoms that are so associated with a particular disease may not be made.
In particular, FDA still considers "cholesterol reduction" claims to be impermissible because elevated cholesterol levels are associated with an increase risk of coronary heart disease. FDA, however, would permit certain cholesterol claims because cholesterol is necessary "for specific bodily functions, and is only associated with coronary heart disease if it is elevated." However, FDA believes that the claim "helps maintain healthy cholesterol levels" is misleading because consumers may believe the reference is to HDL cholesterol levels, rather than LDL or overall cholesterol levels. Thus, FDA believes that cholesterol claims should be limited to "helps maintain cholesterol levels that are already within the normal range." While this distinction appears to be somewhat meritless, there is some regulatory risk involved if a cholesterol claim is made in this manner.
Similarly, FDA would not permit the use of the "heart symbol" on product labels because consumers associate the symbol with the prevention of cardiovascular disease unless it is related to an approved health claim. This position is tenuous; especially considering that FDA agrees that the claim "helps maintain a healthy heart" is a permissible structure/function claim. Moreover, the use of the product term "Heart" as part of the product's name is permissible, as long as any additional claims would not indicate that the product is useful in the treatment or prevention of heart disease. Thus, FDA's distinction appears to be less supportable in this regard. Indeed, it is difficult to believe that FDA will be willing to take action against a product because it carries the heart symbol on its packaging, but it could well do that.
Other examples of signs and symptoms that FDA would consider impermissible include "increase bone density," "nervous tension headaches," "anti-inflammatory" or "inflammation," "alcohol intoxication," "prevent bone fragility in post-menopausal women," and "improves joint mobility and reduces joint inflammation and pain." The final rules also continue to prohibit the use of drug names (e.g., "herbal Prozac") and classes of drugs (e.g., "herbal antidepressant") to be part of the product name, or explain the product's uses.
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IF YOU WANT TO KNOW WHAT YOU CAN AND CAN'T SAY WHEN MARKETING YOUR DIETARY SUPPLEMENT PRODUCTS, VISIT THE JANUARY ONLINE EDITION TO SEE AN EXPANDED LIST OF PERMISSIBLE AND IMPERMISSIBLE STRUCTURE/FUNCTION CLAIMS.
Todd Harrison is partner with Venable, which is located in Washington, D.C. He advises food and drug companies on a variety of FDA and FTC matters, with an emphasis on dietary supplement, functional food, biotech, legislative, adulteration, labeling and advertising issues. He can be reached at 575 7th St. NW, Washington, D.C. 20004; 202-344-4724; E-mail: firstname.lastname@example.org.