FDA has received comments regarding the implementation of section 912 of the FDA Amendments Act (FDAAA), which would effectively prohibit certain substances from use in foods and dietary supplements.

Specifically, section 912 creates the new section 301 (II) of the Federal Food, Drug and Cosmetic Act (FFDCA), banning—with certain exceptions—interstate commerce of foods to which approved drugs or licensed biologic products have been added.

Further, it prohibits the addition of a drug or biologic product for which “substantial clinical investigations” have been instituted and made public.

The American Herbal Products Association (AHPA), Silver Spring, MD, said in its written comments to FDA that section 912 should be implemented “in a manner that does not in any way disincentivise or adversely impact incentives for investigations of the safety, functional effect or health benefits of substances that may be added to foods.”

AHPA also stated its position that section 301 (II) should not replace or amend DSHEA, as not to affect dietary supplements. Moreover, “FDA should refrain from developing new definitions for terms that are already defined in the FFDCA, such as ‘drug,’ or for which the common language meaning is perfectly clear, such as ‘marketed.’

Michael McGuffin, president of AHPA, said he doesn’t believe it to be Congress’ or FDA’s intention to stifle innovation or research, or limit consumer access to beneficial food ingredients.

However, taking too broad an interpretation of the statute would threaten incentives to conduct meaningful research while potentially disallowing legitimate products from the marketplace, he said, stressing that any enforcement must “maintain incentives to establish the efficacy and safety of substances added to food.”

Ultimately, Mr. McGuffin said the provision “makes sense for the food industry,” by restricting the addition of unsafe drugs. AHPA argues the law should be implemented for other food categories, such as conventional foods, foods for special dietary use, medical foods, etc.