WASHINGTON — Food companies evaluating ingredients with potential health benefits encountered a new obstacle to commercialization in the form of a provision in the Food and Drug Administration Amendments Act of 2007 (F.D.A.A.A.) enacted in September of last year. Section 912 of the act is a "prohibition against food to which drugs or biological products have been added" and was inserted in the bill without debate or discussion, catching most of the food industry unaware.
Section 912, which amends Section 301 of the Federal Food, Drug & Cosmetic Act (F.D.&C. Act) prohibits the marketing of any food to which an approved drug or licensed biological product has been added and of anyfood to which was added a "drug or biological product for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public."
Diane B. McColl of the law firm of Hyman, Phelps & McNamara, who moderated a "late breaking" session on Section 912 during the recent annual meeting of the Institute of Food Technologists in New Orleans, said the legislation imposed an immense burden on companies developing food ingredients with health benefits. First, the companies must make certain ingredient they’re evaluating wasn’t previously approved or licensed by the F.D.A. More problematic, the companies must be certain the drug or biological product was never the subject of a "substantial" clinical investigation.
Ms. McColl gave the example of a substance for which a clinical investigation was instituted in 2000 but not made public until 2008. In the meantime, a food ingredient company with no knowledge of an ongoing clinical investigation evaluated the same substance and commercialized it for addition to food in 2007. Under the legislation, the food company would find itself in violation of Section 301 of the F.D.&C. Act and would have to withdraw the ingredient or food from the market.
The example was not so hypothetical, as certain foods currently on the market might be affected, she noted.
She said Section 912 raised many questions. For instance, it seemed the "exception" allowing the use of a drug or biological product in food when its purpose is to enhance the safety of the food could be interpreted to apply only to microbials. But what if a fat substitute is developed that made a food more "safe" for the consumer without conveying "independent biological or therapeutic effects on humans"? So much depends on the F.D.A.’s interpretation of Section 912, she said.
Ms. McColl said Section 912 creates "a race to the market" pitting food ingredient companies against pharmaceutical companies evaluating the same substance. She cautioned if the F.D.A. is too broad or aggressive in its interpretation and application of Section 912, development of "functional foods" could be threatened.
Dr. Ashley Roberts, vice-president of food and nutrition at Cantox Health Science International, Mississauga, Ont., who also was a member of the I.F.T. panel, said Section 912 is unworkable in its present form.
"Much of it simply doesn’t make sense," Mr. Roberts said. He pointed out it was necessary for a company to conduct a clinical investigation if it wanted a product to qualify for a health claim, but such a clinical trial itself might trigger Section 912 and result in the product’s prohibition.
"It could potentially prevent future trials for health claims," he said. "Things will have to be ironed out."
In the meantime, companies evaluating substances for generally recognized as safe status (GRAS) or potential health claims will have to try to design trials in a manner that does not invoke Section 912 and certainly design trials differently from pharmaceutical companies.
Mr. Roberts said Section 912 probably was not an issue for a food additive undergoing F.D.A. pre-market evaluation. It was potentially an issue for GRAS substances using substantial clinical investigations to support their safety. Worse, it could undermine clinical research for health claims.
Ms. McColl said the F.D.A. indicated it wanted to be reasonable in implementing Section 912, and industry should provide advice regarding possible ramifications of an overly broad interpretation.
Exceptions to the rule
Section 912 allows for four narrow exceptions to the prohibition.
1.The drug or biological product was marketed in food before being approved or licensed by the F.D.A. and before any substantial clinical investigations involving the drug or biological product was instituted.
2.The Secretary of Health and Human Services issued a regulation, after notice and comment, approving the use of the drug or biological product in food.
3.The use of the drug or biological product in the food is to enhance the safety of the food to which it was added or applied and the drug or biological product does not have independent biological or therapeutic effects on humans, and the use is in conformity with one of the following criteria: a food additive approval regulation; a generally recognized as safe (GRAS) listing regulation; a GRAS notice for which F.D.A. has not issued a letter questioning the safety determination; an effective food contact substance notification; or such drug or biological product was marketed for smoking cessation prior to Sept. 27, 2007.
4.The drug is a new animal drug whose use is not unsafe.