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CFSAN issued this press release recently that announces the publication in the Federal Register of a notice (73 FR 43937; July 29, 2008) requesting comment on Section 912 of the Food and Drug Administration Amendments Act of 2007 (FDAAA).

Here is FDA’s summary of this new provision:

Section 912 of FDAAA 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.

The text of the statute is set out in the FR notice cited above.

Section 912 is very puzzling. It seems to be focused on regulating foods/supplements that contain drugs/biologicals. However, the FR notice says that there was no legislative history of this provision at all.

The total lack of information as to why Congress passed this is a concern. It is not apparent what this was supposed to deal with or why this was enacted. It appears that FDA is scratching its head on this as well.

The only thing I can think of as an example of a practice that this would target would be putting sildenafil or its analogues in “male enhancement” supplements. However, this is already illegal under FDCA and FDA has all the same enforcement authority as is in this new act.

So Congress didn’t really pass a totally useless piece of legislation, did it?  The lack of any explanation by the FDA in the FR notice of what this is supposed to address suggests to me that they have no idea why this was enacted either.

If any readers have any more info on this please comment. The Food Law Prof Blog appears to be at a loss for words too.


Joel B. Rothman represents clients in intellectual property infringement litigation involving patents, trademarks, copyrights, trade secrets, defamation, trade libel, unfair competition, unfair and deceptive trade practices, and commercial matters. Joel’s litigation practice also includes significant focus on electronic discovery issues such as e-discovery management and motion practice relating to e-discovery.