FDA is dusting off the Red Book to update the guidance document and consider whether it might be useful for regulating more than just food and color additive safety. Formally known as Toxicological Principles for the Safety Assessment of Food Ingredients, FDA's Red Book was originally published in the 1980s as guidance to industry and other stakeholders regarding the information CFSAN used to evaluate the safety of food and color additives during the premarket review process. Although the Red Book has often languished between updates, in a public meeting announcement published last week, FDA announced it would be revising the document and expressed interest in expanding the scope of the guidance to cover chemical safety assessments for new dietary ingredients, food contact substances, and cosmetics, among others. FDA will hold a public meeting on December 9, 2014, in College Park, Maryland, to collect public input, although interested parties may submit comments through February 9, 2015.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
