Date: Jan 08, 1999
The Food and Drug Administration may be attempting to restrict the sale of functionalfoods as dietary supplements. In response to the declared intention of McNeil ConsumerProducts Company's (McNeil), Fort Washington, PA, to market its cholesterol loweringspread--"Benecol"--as a dietary supplement, the FDA has concluded that Benecolis being promoted as a conventional food that may be subject to the food additiveprovisions of the Food, Drug and Cosmetic Act (FDC Act). The FDA's recent response toMcNeil regarding Benecol represents a high stakes game for the functional food industry,as it moves forward with marketing products that are clearly not conventional food, but donot necessarily fit easily into the definition of a dietary supplement. What is at stake?
With the enactment of the Dietary Supplement Health and Education Act of 1994 (DSHEA),Congress significantly changed the landscape of how dietary supplements are regulated.Prior to DSHEA, FDA attempted to regulate dietary supplements as unapproved new drugs orthe ingredients in the products as unapproved food additives. DSHEA implements Congress'intent to curtail FDA's authority over supplements in several ways:
Like dietary supplements, functional foods are food products that improve performanceor provide a health benefit beyond meeting the basic nutritional needs of humans. However,functional foods are also consumed for their taste or aroma--unlike dietary supplements.For functional food manufacturers or distributors to avail themselves of DSHEA'slimitations on FDA regulation, they must find a way to market their products as dietarysupplements.
Dietary supplements are products containing one or more dietary ingredients intended tosupplement the diet through ingestion. Dietary supplements may not be represented for useas a conventional food or as the sole item of a meal or diet (FDC Act §201(ff)(1)).Dietary ingredients are vitamins, minerals, herbs, botanicals, amino acids--alone or incombination--or any other dietary substance intended to supplement the diet by increasingthe total dietary intake of that ingredient (FDC Act §201(ff)(1)). Dietary ingredientsalso include concentrates, metabolites, constituent parts and extracts.
Arguably, under DSHEA, a functional food that appears in conventional food form andcontains dietary ingredients may be marketed as a dietary supplement as long as theproduct is not represented as a conventional food. FDA's response to McNeil regarding itsintention to market Benecol as a dietary supplement suggests that the agency does notnecessarily endorse that interpretation. FDA apparently contends that a functional foodthat appears in conventional food form--e.g., a spread--cannot be marketed as a dietarysupplement.
FDA's position regarding the marketing of functional foods as dietary supplements canbe summed up as follows :
Under FDA's narrow interpretation of DSHEA, the label and labeling of a supplementcannot prominently highlight the supplement's flavor, texture or taste. If they do, theproducts will be considered conventional food. For example, FDA claims in its letter toMcNeil that Benecol is not a dietary supplement because Benecol's prototype label:
In essence, FDA appears to be saying that dietary supplements must be bland, tastelessproducts that are to be ingested, but certainly not enjoyed. Nowhere in DSHEA does such arequirement exist for dietary supplements. The only limiting factor in the law is that adietary supplement cannot be represented as a conventional food or the sole item of a mealor diet. There is nothing in DSHEA or its legislative history to suggest that the label orlabeling of a dietary supplement cannot highlight the supplement's conventional foodcharacteristics. Thus, a functional food that is represented as a dietary supplement onthe product label should not be considered a conventional food simply because its labelhighlights its flavor, taste or texture. Under FDA's strict interpretation, manyfunctional foods now being marketed as dietary supplements potentially could be deemedadulterated food under the FDC Act as amended by DSHEA. This was not Congress' intentionwhen it enacted DSHEA.
Under the FDC Act, an ingredient may only be used in a food if it is generallyrecognized as safe (GRAS) or being used in accordance with an FDA food additiveregulation. The same would be true for functional foods that are stripped of their dietarysupplement status. Thus, functional foods that contained commonly used dietary ingredientssuch as echinacea, St. John's Wort or CoQ10 would be subject to regulatory action if theywere not used in accordance with an approved food additive regulation or were not GRAS, atleast in part because of the regulatory risk that FDA could deem certain herbs,botanicals, amino acids and other nutrients to be neither an approved food additive norGRAS. However, many companies have chosen to market their functional food products asdietary supplements. Indeed, these products are dietary supplements because their primarypurpose is to increase the dietary intake of these dietary ingredients and they are notintended for use as a conventional food. Yet, FDA seeks to limit their use on the groundsthat the products have taste, texture, flavor and aroma, in addition to their healthbenefits. Besides, marketing dietary supplements provides the company with a greateropportunity to make broader structure/function claims that may be considered impermissibledrug claims if they appear on product labels.
FDA also briefly touches on the type of claims that may appear on the label andlabeling of conventional food products. In this regard, FDA reiterates its position thatstructure/function claims for conventional food products must be based on the"nutritive value" of the food. For example, FDA would likely consider astructure/function claim for a conventional food product containing St. John's Wort to bean impermissible drug claim because in FDA's opinion, the action of St. John's Wort isbased on its pharmacological value, not its nutritive value. Of course, contrary to FDA'sposition, the FDC Act does not require that a structure/function claim for conventionalfoods to be based on the nutritive value of the food. The Agency would likely have asimilar view of claims made for ingredients added to pet food.
If FDA continues down this path and cannot otherwise be deterred, Congress shouldfurther amend the FDC Act to make it clear that a dietary supplement's conventional foodcharacteristics do not cause the supplement to be a conventional food subject to the foodadditive provision of the FDC Act.
This article appeared in the January-February issue of NutraceuticalsWorld (Rodman Publishing Corporation). For further information, please contact Melvin S. Drozen at 202-434-4222 or firstname.lastname@example.org.