The U.S. Food and Drug Administration (FDA) will host a public meeting and
is soliciting public input on whether to expand the products included in its
guidance, titled “Toxicological Principles for the Safety Assessment of Food
Ingredients”—also known as the “Redbook.”

The agency is apparently considering this expansion “to include chemical
safety assessments for all products over which FDA’s Center for Food Safety
and Applied Nutrition (CFSAN) has statutory authority including regulatory
contexts such as food additives, food contact substances, dietary supplement
ingredients, food contaminants, and cosmetics.” According to FDA,
“The Redbook would describe toxicological principles which apply across
regulatory categories while still providing specific guidance for applying
these principles within each particular context. The safety of foods containing
microbial contaminants will continue to remain outside of the scope of the

The meeting will take place December 9, 2014, in College Park, Maryland, and
those wishing to participate in person must register by December 2. Those
wishing to make oral presentations must submit their requests by November
21, and written comments are requested by February 9, 2015. See Federal
Register, October 30, 2014


Issue 543

About The Author

For decades, manufacturers, distributors and retailers at every link in the food chain have come to Shook, Hardy & Bacon to partner with a legal team that understands the issues they face in today's evolving food production industry. Shook attorneys work with some of the world's largest food, beverage and agribusiness companies to establish preventative measures, conduct internal audits, develop public relations strategies, and advance tort reform initiatives.