Q: What is a medical food and how does this category differ from dietary supplements?
A: Medical foods constitute a narrow category of nutritional food products intended to address the "distinctive nutritional requirements" of people with particular diseases. Unlike dietary supplements, a medical food is intended for use under medical supervision, for a particular disease or dietary condition, and may be all a patient eats. While dietary supplements labels may contain structure/function claims (accompanied by the required disclaimer), medical food labels may contain disease claims. Finally, in addition to having a medical purpose, versus supplementing the diet and maintaining good health and normal functions, medical foods have different labeling requirements than do dietary supplements.
Q: In what sense is a medical food a food?
A: The first requirement for a medical food is that it provide nutrition administered enterally. This means it is taken by mouth and absorbed by the gastrointestinal tract, or it is administered through a tube and nutrients are delivered directly to the stomach or small intestine.
Q: Is a medical food a drug?
A: No, it is neither a prescription drug nor an over-the-counter drug, but it must be used with a physician's supervision.
Q: What is the intended use of medical foods?
A: A medical food is intended to be used by patients with specific nutriional requirements who are managing a disease or a condition under medical supervision.
Q: Is there a Food and Drug Administration statute that defines medical food?
A: Medical food is defined at 21 U.S.C. § 360ee(b)(3) as "a food ... which is formulated to be consumed or administered enterally [by mouth] ... under the supervision of a physician ... and which is intended ... for the specific management of a disease or condition ... for which distinctive nutritional requirements ... based on scientific principles ... are established by medical evaluation." This definition is incorporated by 21 C.F.R. § 101.9(j)(8)(i)-(v), the FDA's nutrition information regulation. That regulation exempts medical foods from the nutrition information labeling requirements (e.g., the Nutrition Facts box) that are applicable to all other foods, except for dietary supplements, which must have a Supplements Facts box.
Q: What laws govern medical foods?
A: Although the FDA has published extensive commentary about medical foods, the law consists only of the statute and regulation cited above. Medical foods are also exempt from the requirements of the Federal Food, Drug and Cosmetic Act with respect to nutrient content and health claims, and do not have to comply with any dietary supplement labeling regulations.
Q: What are some examples of medical foods, and what forms may they take?
A: Medical foods are typically liquids or powdered drink mixes. Examples include formulas for infants or those with metabolic disorders; oral rehydration products for those with chronic diarrhea; and special nutritional formulas for patients with diabetes, AIDS or kidney disease.
Q: What claims are permissible for medical foods, and what level of substantiation is required for these claims?
A: Companies may claim how the medical food product meets the distinctive nutritional requirements of a patient with a disease or condition. However, the product must be formulated based on sound science; efficacy or effectiveness for the claim must be based on scientific evidence. The FDA does not require premarket approval for medical foods or the claims made for them, and no substantiation standard has been set. While the substantiation should be stronger than the "significant scientific agreement" standard used for health claims, it need not be as rigorous as the "substantial evidence" standard (backed by human clinical trials) required for drugs.
Q: In general, what are the rules governing medical food labeling?
A: The label must state that the product is to be taken under a physician's supervision. In general, medical foods are exempted from the food labeling regulations in 21 CFR § 101.9. However, they must contain the mandatory information that all food labels must bear, e.g., net contents, and manufacturer's name and address.
Q: How should the ingredients be listed on the label? In particular, what should be included in the section "Each Serving Contains"?
A: The FDA provides guidance on how medical foods' ingredients should be listed. However, pursuant to the FDA's general principles, the ingredient listing must be readable, understandable and not misleading to the consumer. I recommend the "Each Serving Contains" include all the major "dietary" ingredients and any proprietary blends. Below that section, the label should have a paragraph titled "Other Ingredients," which lists only fillers, flavorings and excipients.
Q: Are there any format regulations? For example, is a panel printed with light type on a dark background permissible?
A: Yes, provided that the contrast is sharp and the letters are large and readable. Both the Nutrition Facts box for conventional foods and the Supplement Facts box for dietary supplements are required to be black or dark print on a white or neutral background. There is no such format regulation for a medical food. One FDA senior analyst with the Office of Special Nutritionals said that a medical food label's format is judged on a case-by-case basis with the main criteria being: Is it false or misleading to the consumer?
Q: How should a proprietary blend be listed on a medical food label?
A: Under the name of the blend, indented and in paragraph form, list all the ingredients within the blend. Do not list the blend ingredients in the "Other Ingredients" section because this would be both inaccurate and misleading to the consumer. The proprietary blend ingredients must be listed in descending order by weight on a dietary supplements label. Although there is no comparable regulation for declaring such a blend in a medical food, I would recommend that order.
Susan D. Brienza is an attorney in the Denver office of the national Washington, D.C.-based law firm Patton Boggs LLP. She practices in the area of regulatory compliance, in food and drug law (including DSHEA) and FTC law. If you have a question, her e-mail address is [email protected]
*This column is not meant, and should not be construed, as a legal opinion, or legal advice, but rather is intended to provide general principles and some examples as to various aspects of FDA law.
Natural Foods Merchandiser volume XXIII/number 3/p. 104, 106