By Mark L. Itzkoff
In the October 30 Federal Register, FDA that it will hold a public meeting to receive public input on updating its commonly known as “the Redbook.” The meeting will be held on December 9. Requests to make oral comments during the meeting must be submitted to FDA by November 21, 2014. Written comments must be submitted by February 9, 2015.
In the October 30 Federal Register, FDA announced that it will hold a public meeting to receive public input on updating its Guidance for Industry “Toxicological Principles for the Safety Assessment of Food Ingredients,” commonly known as “the Redbook.” The meeting will be held on December 9. Requests to make oral comments during the meeting must be submitted to FDA by November 21, 2014. Written comments must be submitted by February 9, 2015.
The Redbook provides FDA’s “current” guidance on toxicity testing for new food and color additives. It also provides guidance for the evaluation of food ingredients that are generally recognized as safe (GRAS). The most recent revisions to the Redbook were made in 2007, and much of the guidance is essentially unchanged since the draft of Redbook II was released in 1993. The Redbook sets forth a 3-tier approach to evaluating the safety of food ingredients with increased toxicology requirements for substances with higher concern levels and higher dietary intakes. The recommended tests are focused on acute toxicity, carcinogenicity, and mutagenicity.
We expect that the meeting will include discussion on how FDA should address safety concerns beyond the factors listed above, such as long-term impacts on consumers’ health and the interaction of a new food ingredient with other substances. FDA has already indicated that safety determinations may need to address these additional concerns. For example, on November 13, 2013, FDA issued a tentative determination that partially hydrogenated oils are not GRAS due to chronic health risks associated with the consumption of trans fats and in 2009 FDA issued warning letters to producers of caffeinated alcoholic beverages questioning the GRAS status of caffeine in these products due to behavioral effects caused by the interaction of caffeine and alcohol. Since these issues are not addressed in the current Redbook, it is likely that they will be discussed in the upcoming meeting.
FDA has also indicated that it is considering expanding the scope of the Redbook to include guidance on chemical safety assessments for all areas over which the agency’s Center for Food Safety and Applied Nutrition (CFSAN) has regulatory oversight – including food contact substances, dietary ingredients used in dietary supplements, food contaminants, and cosmetics.
