FDA Considers New Approach Toward Regulation of Dietary Supplements

Regulatory NewsRegulatory News
| 31 October 2014 | By Alexander Gaffney, RAC

When you think of the word "book," chances are good it conjures of images of libraries and well-worn tomes. But at the US Food and Drug Administration (FDA), the word is more often associated with several databases used to keep track of critical information about the products regulated by the agency. Its "Orange Book," for example, keeps track of information regarding which products are bioequivalent to other drugs, while its newly launched Purple Book is set to do the same for biosimilar products.

Somewhat lesser known within healthcare product regulation circles is FDA's Red Book. The book, technically a guidance formally known as Toxicological Principles for the Safety Assessment of Food Ingredients, is meant to be a how-to guide for companies to show their food products and additives are safe (i.e. non-toxic) for human consumption. FDA's Center for Food Safety and Applied Nutrition (CFSAN) is required by law to approve all new food or color additives prior to their entry into the market, and evaluates those products based on their probable safety.

The Red Book is, by the standards of other FDA products, updated infrequently. Last updated in 2007, the book has undergone just a handful of updates since its launch in the early 1980s. But now FDA is planning to revisit the document, and potentially broaden its scope to include dietary supplements on a more prominent basis.

New Approach Floated

In a Federal Register announcement on 30 October 2014, FDA said it will begin soliciting comments regarding its Red Book guidance with the explicit intent of "possibly expanding the scope of the Redbook to include chemical safety assessments for all products over which CFSAN has statutory authority including … dietary supplement ingredients [and] food contaminants."

"We are interested in expanding the scope of the Red Book to emphasize the principles of safety and risk assessment that are shared across different regulatory contexts," FDA explains in the announcement.

Regulators invited comments from the public on four questions:

  1. What components of the Red Book should receive priority for review and update?
  2. What aspects of the safety and risk assessment of food ingredients or other CFSAN-regulated products are not addressed and should be considered for incorporation in the Red Book?
  3. How can the Red Book be updated to more fully support the development and submission of safety assessments for substances introduced into food?
  4. How should we balance the desire for transparency and consistency in risk assessment as described in the Red Book, with the goal of flexibility in applying the most appropriate analysis for specific contexts?

FDA's Red Book meeting will be held on 9 December 2014. Comments on the proposal are due to FDA by 9 February 2015.


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