FDA Announces Public Hearing on Conventional Foods Marketed as "Functional Foods"
The Food and Drug Administration (FDA) has issued a notice announcing that it is seeking public comments and has scheduled a public meeting for December 5, 2006 on the regulation of certain conventional foods that companies are marketing as "functional foods."
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The FDA states that the purpose of the hearing is to solicit information and comments from interested persons on how the FDA should regulate these foods under its existing legal authority.
Current Use of the Terms "Conventional Food" and "Functional Foods"
According to the FDA, the Federal Food, Drug, and Cosmetic Act (FFDCA) does not define the term "conventional food". The FDA states that products such as beverages, baked goods, cheeses, milk products, cereal, grain products, pasta, fats and oils, vegetable spreads, snack foods, candy, soups, and infant formula are examples of conventional foods.
The FFDCA does define a dietary supplement, in part, as a product that is "not represented for use as a conventional food". In addition, the FFDCA includes provisions that relate to certain types of conventional food, such as requirements for infant formula in 21 U.S.C. 350a.
(For the purpose of this hearing, FDA notes that it is not considering dietary supplements to be encompassed by the term "functional foods.")
According to the FDA, in recent years, the food industry has developed and marketed foods that it refers to as "functional foods." Although there is no formal definition of what the industry means by "functional food," on March 24, 2005, the Institute of Food Technologists (IFT) issued a report which defined "functional foods" as "foods and food components that provide a health benefit beyond basic nutrition (for the intended population). These substances provide essential nutrients often beyond quantities necessary for normal maintenance, growth, and development, and/or other biologically active components that impart health benefits or desirable physiological effects." Examples of functional foods cited in the report include conventional foods; fortified, and enriched or enhanced foods.
Comments Sought on Regulation of "Functional Foods"
Currently, the FDA has neither a definition nor a specific regulatory category for foods being marketed as "functional foods." The FDA states that it regulates conventional foods being marketed as "functional foods" under the same regulatory framework as other conventional foods.
The FDA states that although it is confident that the existing provisions of the FFDCA are adequate to ensure that conventional foods being marketed as "functional foods" are safe and lawful, it believes that it would be in the best interest of public health to begin a dialog with industry, consumers, and other stakeholders regarding the regulation of these products. (See FDA notice for list of issues on which comments are requested.)
- hearing will be held on December 5, 2006 in College Park, MD
- requests to make an oral presentation are due by November 14, 2006
-all other persons must submit a notice of participation by November 28, 2006
-written or electronic comments may be submitted until January 5, 2007.
| Isabelle Howes (submissions) | (202) 314-4713 |
| Juanita Yates (questions/special requests) | (301) 436-1714 |
FDA Notice, (FR Pub 10/25/06, D/N 2002P-0122) available at http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/pdf/06-8895.pdf