The potential impact of Section 912 of the US Food and Drug Administration Amendments Act has been described as "chilling" by ingredients suppliers. Whole classes of ingredients could be restricted, including industry bright spots probiotics and fish oils.
Section 912, which passed in 2007, creates a new section of the Federal Food, Drug, and Cosmetic Act: Section 301, entitled 'Prohibition against foods to which drugs or biologics are added.' This prevents the use of a substance in a food or supplement if it has been subjected to substantial clinical testing that has been made public. Questions remain. Does this mean that ingredients already in foods can remain, but not at new levels? Can only the probiotics currently on the market be included in foods, but not the newly developed patented stains, that seem to be introduced on a monthly basis? If so, this would literally stifle innovation across the industry. And in the current economy, innovation is at a premium.
The FDA has been seeking views on implementing Section 912, and some have warned it could be interpreted in such a way that the marketing of certain ingredients in functional foods and supplements is banned.
In its submission to the FDA, Sabinsa warned that a broad interpretation of Section 912 would potentially force off the market any functional ingredients which have undertaken the New Dietary Ingredient notification process.
It would also put up a major barrier to entry into the mainstream food market for responsible companies that undertook serious investigations of the health benefits provided by the ingredients they develop, Sabinsa claimed.
"This has a potentially chilling effect on companies investing in science relating to dietary supplements," said Sabinsa CEO Jeff Lind. "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."
Industry regulatory attorney Marc Ullman, who drafted Sabinsa's submission to the FDA, added: "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 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."
In its submission to the FDA, Sabinsa said it had conducted nine clinical studies on its Garcinia cambogia, for which it holds two patents. This was example of a product which could be negatively impacted by a broad interpretation of Section 912, it argued.
The American Herbal Products Association also expressed its concern about the possible interpretation of the Act.
"FDA must look to the intent of Congress, and narrow its implementing rules to ensure that the intended prohibitions are in place and that incentives are maintained for companies to establish the clinical efficacy of drugs and biological products," said AHPA President Michael McGuffin. "Too broad an interpretation of this statute, however, 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."
The Council for Responsible Nutrition said it believed Congress had not intended for the Act to prejudice functional ingredients in supplements and foods. But it also said it feared too broad an interpretation could encourage mischief.
"It would create the opportunity for almost anyone to conduct a few clinical trials for a supposedly 'drug' purpose on any ingredient under development for inclusion in food and effectively thwart the ability of food manufacturers to market a product containing that ingredient," wrote President and CEO Steve Mister. "To discourage rigorous examination and study of new food and dietary ingredients certainly could not have been the intent of Congress in enacting this provision."