Yesterday marked the last day of comment to Section 912, which forms part of the FDAAA enacted by Congress last September.
Section 912 establishes a new provision of the Federal Food, Drug, and cosmetic Act (FDCA), § 301 (ll), and prohibits the shipment in interstate commerce of foods to which certain articles have been added.
Concerns about the provision are based on the fact that it could prevent products from being marketed as dietary supplements if they contain a substance that has been subject to clinical investigations if these have been made public.
However, the potential impact on the food and supplements industry is essentially due to a lack of understanding in the clarity of the act, and how far-reaching its scope actually is.
To listen to a brief description of what Section 912 is, click here.
Potential impact
A broad interpretation of the act could restrict the marketing of a range of products, including fish oil, probiotics and vitamins and minerals.
As well as supplements, other products that could be impacted include fermented milks, cheeses and yogurt. Milk fortified with vitamins (vitamin A and D) could also be affected, as well as breads fortified with vitamins, minerals or other functional components such as fiber if these have been investigated in the past for therapeutic uses.
Probiotics at risk
The International Probiotics Association (IPA) yesterday filed comments outlining how probiotics could be negatively impacted by the act, as the healthy bacteria may be subject to regulation as biological products under the Public Health Services (PHS) Act.
The group said that a broad interpretation of § 301 (ll) could discourage clinical research on the health benefits of probiotics.
It would also threaten to reduce consumer access to “convenient and affordable products with health benefits”, it said.
Additionally, a broad interpretation could result in a lack of consistency with European – and potentially other – regulatory schemes, which seek to encourage efficacy studies to establish health benefits of substances marketed as food or dietary ingredients.
IPA added its voice to calls for FDA to continue regulating supplements consistent with the provisions of § 201 (ff) of the FDCA, and not extend § 301 (ll) to include dietary supplements.
Supplements and food
In comments also filed yesterday, the supplement trade association Council for Responsible Nutrition (CRN) highlighted that a wrong interpretation of the act would discourage innovation and new product development for the full range of products considered to be ‘food’ under the FDCA.
“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,” it wrote.
The group is confident Congress did not intend to dissuade research on food and supplement ingredients, as that would be inconsistent with previous laws it has enacted to encourage such research. These include the Nutrition Labeling and Education Act (NLEA) of 1990, and the Dietary Supplement Health and Education Act (DSHEA).
FDA has recorded 80 comments on Section 912.
To access the original Federal Register notice, click here.
To access comments filed, click here.