FDA Seeks Input on Food Reg Interpretation

WASHINGTON—FDA is seeking public comment on its interpretation of an act affecting foods with added biological compounds, posing a series of questions on how this regulation should be interpreted. Section 912 of the FDA Amendments Act of 2007 (FDAAA) establishes section 303(11) in the Federal Food, Drug, and Cosmetic Act (FFDCA), which prohibits the interstate shipment of certain foods to which an approved drug or a licensed biological product has been added. This also prohibits the interstate shipment of foods containing an added drug or a biological product that has been the subject of substantial clinical investigations, which have been made public.

Primarily, FDA wants to know how it should interpret the term "food," for purposes of this regulation, which could affect food and drinks for humans and animals, as well as dietary supplements. Specifically, the agency would like public comment on the likely impact of such a regulation on infant formula, animal feed and dietary supplements. On supplements, FDA is asking if there are ingredients currently or potentially used in supplements that would be affected by this rule. It also would like to know if applying this section of the act to supplements would be effective or less effective regulation.

Also for foods with such added compounds, potentially including functional foods, FDA advises section 301 prohibits foods with added drug or biologic compounds (or ingredients from interstate commerce, even if they were in commerce before FDAAA. However, FDA is soliciting public comment on how many and of what types of "foods" would be affected by applying the broad definition of "food", and what the impact on this regulation would be to businesses that sell such foods. FDA also wants to know how this regulation would affect consumers who use the products.

Comments may be submitted through Oct. 27, 2008. For more information, visit FDA's CFSAN online.