Newly proposed Section 912 of the FDA Amendments Act (FDAAA), entitled “Prohibition Against Foods to Which Drugs or Biologics Are Added,” creates the new §301(ll), which addresses the regulation of foods containing substances that have undergone clinical trials, but not without a high dose of controversy. The section prohibits the interstate transport of food products if they contain “an approved drug or biological product for which substantial clinical investigations have been instituted and the existence of those clinical investigation have been made public, unless the food was marketed first.”

Although it was most likely intended to prevent ingredients prohibited in dietary supplements from making an appearance in functional foods, the lack of clarity in Section 912 has the food, drug and supplements industries feeling a little nervous. Specifically, it is not clear as to whether the provision includes dietary supplements. If so, §301(ll) would be in conflict with certain pre-existing standards outlined for dietary supplements under §201(ff) of the Dietary Supplement Health & Education Act (DSHEA). Though DSHEA also prohibits ingredients authorized for investigation as a new drug from inclusion in a dietary supplement, the FDAAA (unlike DSHEA) does not require that the investigations be authorized by FDA.

According to a statement from the National Health Federation (NHF), this difference is important. What’s missing in the FDAAA is “that these clinical investigations have been authorized by the FDA pursuant to an attempt by the sponsor to have the product approved as a new drug. This is an expensive, lengthy process that cannot just be launched on a whim.” The risk, the group says, is that anyone (like a pharmaceutical company or competitor supplement maker) could do a clinical trial on an ingredient, publish the information and then say it is a drug, not a dietary supplement. Or, the FDA could decide that a supplement ingredient with numerous published trials may be treated as a drug, not a supplement.

Comments sent to FDA on behalf of Mitsubishi Gas Chemical Company, Inc. determined, “Pursuant to the rules of statutory constriction and important considerations of public policy, the FDA must conclude that §301(ll) does not apply to dietary supplements and that §201(ff) remains the applicable regulation with regard to these products.”

The comments invited by the FDA regarding Section 912 garnered other strong reactions from the natural products industry. Industry regulatory attorney Mark Ullman (who prepared Mitsubishi’s comments) stated, “That this would apply to supplements is nonsensical. A product can be a dietary ingredient even if you have had clinical investigation, as long as no one has filed an IND [Investigational New Drug] application. If Congress intended otherwise, it would have said so at the time it put Section 912 in place for ‘foods.’ Any other outcome would be especially ironic in light of the constant criticisms of our industry that we do not conduct enough research.” Also, the American Herbal Products Association (AHPA) stated its position that the law should not include supplements and should be implemented for other food categories in a manner that does not adversely affect inquiry into the safety, benefits or functional effect of products or substances added to them.

A broad interpretation of the law could limit the marketing of vitamins, minerals, probiotics, sweeteners and fish oils, as well as fermented cheeses, yogurt and fortified milk and baked goods. Consumers would also be affected because of reduced access to many of these products. AHPA president Michael McGuffin has stated, “Too broad an interpretation of this statute would be a disservice to American consumers if such a regulatory approach curtailed access to newly-developed beneficial food ingredients any time a marketer conducts research on its ingredients.” Considering recent growth in consumer demand for functional foods with included health benefits as well as desires to cross-market and create combination products among food, pharmaceutical and supplement industries, Section 912 might have dire consequences for all.

In addition, the provision could impede research, innovation and clinical investigation. Notes Sabinsa CEO Jeff Lind, “This has a potentially chilling effect on companies investing in science relating to dietary supplements. Sabinsa believes that if the new law is applied to dietary supplements, manufacturers will be forced to make a ‘Hobson’s choice’ between conducting research on their products and marketing them as ‘food.’”

Nonetheless, the NHF has made the case that the FDA has not yet decided to implement these rules and regulations that conflict with DSHEA: “The FDA has not taken that stand yet.  Should it, then the firestorm that would descend upon FDA—let alone the lawsuits—would and will be enormous.” For the time being, the group advised industry to “Be concerned and alert to future developments. But don’t be stampeded into panic.”
Published in WholeFoods Magazine, January 2009