Wednesday, July 30, 2008

DA Seeks Comments on Newly-Enacted Section 301(ll) of the FD&C Act

The U.S. Food and Drug Administration recently published a notice in the Federal Register requesting data, information, and comments relevant to the agency's implementation of Section 912 of the Food and Drug Administration Amendments Act of 2007 (FDAAA). We are issuing this Constituent Update to alert you to this request and to encourage you to submit relevant data, information, and comments. You may submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. You may also submit electronic comments to All comments are to be submitted by October 27, 2008.

Section 912 of FDAAA establishes section 301(ll) in the Food, Drug, and Cosmetic Act, which prohibits the interstate shipment of certain foods to which an approved drug or a licensed biological product has been added. Section 301(ll) also prohibits the interstate shipment of foods containing an added drug or a biological product that has been the subject of substantial clinical investigations, the existence of which has been made public. Foods that may be affected by the provisions of section 301(ll) include human food, including infant formula, medical foods, and dietary supplements, and their ingredients; food contact substances, including most food packaging; and animal feed, including pet food and feed ingredients. We are seeking comments about the impact of section 301(ll) on food in all its forms, including food ingredients, categories of food, and finished food products.

We believe that section 301(ll) presents a number of questions of statutory interpretation for our consideration. So that we may better understand the impact of various interpretations of section 301(ll), we are requesting comments on possible approaches to implementation and the impact of those approaches. We have included in the Federal Register notice a series of questions to guide your responses to our request for comments.

If you have questions about this request for comments, you may contact Catherine Copp at

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