Regulatory Issues: FDA considers functional foods

Existing requirements for functional foods meet a very high standard; any additional requirements would exceed FDA’s statutory authority.

By David Joy, Contributing Editor

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The FDA in December held a public hearing on functional foods. Currently, there is no formal regulatory definition associated with that term. Word coined by the food industry, functional foods generally refer to foods that provide a health benefit beyond basic nutrition. Examples include tea infusions designed to promote tranquility and energy drinks designed to combat fatigue.

The purpose of FDA's meeting was twofold. First, the agency wanted to explain the existing regulatory framework governing these foods. Second, the agency wanted to solicit information and comments on how these foods should be regulated - if at all differently - under FDA's existing legal authority.

The existing regulatory framework for functional foods is the same basic framework that applies to foods in general. This means the ingredients used in functional foods, including the functional ingredients, must either be used in accordance with a food additive regulation issued by FDA or must qualify as "generally recognized as safe" (GRAS).

It also means that claims appearing on the labels of functional foods must be truthful. More specifically, any label claim that is false or misleading will render the food "misbranded" and subject to seizure by FDA.

In addition to the general prohibition against false or misleading claims, certain types of claims are subject to additional requirements. Nutrient content claims, such as "high in vitamin C," must satisfy FDA's regulations governing nutrient content claims. Health claims, which associate a food ingredient with a reduced risk of disease, must be authorized by FDA or must be based on an authoritative statement made by certain scientific bodies of the federal government or by the National Academies.

Drug claims, which generally deal with the prevention, treatment or cure of disease, cannot be made on food products, including functional foods. However, non-drug claims regarding the effect of a food or ingredient on the structure or function of the body can be made without any FDA review or clearance. These claims are referred to as structure/function claims. A classic example is "calcium helps build strong bones."

FDA's public hearing and request for public comments follows calls for functional foods to be regulated more strictly. A report issued by the General Accounting Office in 2000 called for more federal oversight over functional foods.

In 2002, the Center for Science in the Public Interest (CSPI) petitioned FDA to establish regulations dealing specifically with functional foods. CSPI asked FDA to require food companies to notify the agency about the use of "novel ingredients." CSPI also asked FDA to require food companies to notify the agency 30 days before marketing a conventional food bearing a structure/function claim if such food contains a novel ingredient.

The idea of ingredient notifications and claim notifications is inspired by the manner in which dietary supplements are regulated under the Dietary Supplement Health and Education Act (DSHEA). Ironically, DSHEA represented an effort to deregulate dietary supplements, particularly with respect to the legal status of dietary ingredients.

The existing requirement that ingredients used in functional foods be either GRAS or regulated food additives is a very high standard. Any additional requirement that functional food ingredients be notified to FDA would exceed FDA's statutory authority, because ingredients properly deemed GRAS do not require pre-market review. Furthermore, such a program would confusingly duplicate the existing, voluntary GRAS notification program applicable to all food ingredients.

The idea of a notification program for structure/function claims on functional foods is also questionable. Congress has given FDA specific authority to regulate nutrient content claims and health claims on all foods, including functional foods. However, because structure/function claims do not deal with diseases, basic nutrition or a reduction of disease risk, Congress has wisely determined that scarce government resources need not be devoted to pre-market review of these claims. Clearly, FDA would require new statutory authority to institute a structure/function claim notification program for functional foods, and this would be a questionable expenditure of government resources.

In short, anyone who feels that functional foods need to be regulated differently probably either does not fully understand the existing regulatory framework or perhaps feels that the existing requirements should be enforced more stringently. FDA would certainly not object to any proposals for additional enforcement resources. But FDA must find it frustrating to receive criticism for sensibly overseeing these foods, in the manner required by existing legislation.


David Joy is a partner in the Washington, D.C., office of Keller and Heckman LLP. He specializes in food and drug law with emphasis on the domestic and international regulation of food, food additives, food labeling, antimicrobial pesticides and medical devices. He is a member of the District of Columbia Bar and holds a bachelor's degree in chemistry. For more information about Keller and Heckman, visit the firm's web site at www.khlaw.com.
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