FDA Considers Significantly Expanding Red Book Food Safety Testing Guidance to Cover Dietary Ingredients, Food Contact Substances, and Cosmetics

By Wes Siegner –

In the October 30 Federal Register, FDA announced that it will hold a public meeting on December 9 to consider significant changes to its guidance titled  “Toxicological Principles for the Safety Assessment of Food Ingredients,” or “Redbook”.  FDA also invited comment to be submitted by February 9, 2015.

FDA’s Redbook has for decades provided a system of tiered recommendations for the animal toxicological studies that FDA would expect to see in a submission requesting approval of a food or color additive.  The implications of applying the Redbook or a similar process to other regulated product categories are not clear.  On the positive side, guidance could make review and approval, or in the case of new dietary ingredient notifications, “filing,” more streamlined.  However, as happens all too often with FDA guidance, new guidance may effectively require additional animal testing that would erect costly new barriers to market access. 

Participation of the affected industries in this process will, therefore, be essential to assuring FDA’s expansion does not become a hindrance to market access and have negative impacts on public health.