College Park, MD—On December 9, the U.S. Food and Drug Administration (FDA) held a public meeting to hear comments about its proposal for updating the Guidance for Industry, “Toxicological Principles for the Safety Assessment of Food Ingredients,” commonly known as the “Redbook.”
The Redbook is intended to give industry guidance about how FDA’s Center for Food Safety and Applied Nutrition (CFSAN) evaluates the safety of food and color additives by estimating human exposure to a substance and evaluating appropriate toxicological data and other safety information. The GRAS notification process falls under this umbrella.
The agency said in an October 30 Federal Register that it is considering “expanding the scope of the Redbook to include chemical safety assessments for all areas over which the CFSAN has statutory authority,” which includes dietary supplements.
Attorney Marc Ullman, Esq., of the New York firm Ullman, Shapiro & Ullman, spoke at the hearing on behalf of Natural Organics, Inc. (NOI, which does business as Nature’s Plus). Ullman said that if the Redbook were to start treating dietary supplement ingredients as food additives, it would contradict Congress’s expressed will in the Dietary Supplements Health and Education Act (DSHEA) to consider supplement ingredients marketed before October 15, 1994 as safe for their intended uses. Ingredients first marketed after the cut-off require a new dietary ingredient notification.
Ullman stated, “For Agency to even consider placing supplements into the Redbook and within the Food Additive framework provides evidence that we continue to deal with a two decade long institutional temper tantrum over the passage of DSHEA.”
If FDA’s plan were to hold, Ullman said the adoption of a food standard requiring companies to show “reasonable certainty” of safety violates DSHEA and would discourage the development of new dietary supplement ingredients, increase costs and possibly cause the loss of intellectual property protections.
Ullman said NOI wants the agency “to stop the illegal, unproductive waste of resources involved in its apparently never ending effort to dismiss DSHEA and regulate dietary supplements as food additives.” Instead, it should focus its efforts on publishing the promised revised draft guidance for New Dietary Ingredients and enforcing DSHEA.
Published in WholeFoods Magazine, January 2014 (online 12/6/14)