Updating the United States Food and Drug Administration's Redbook

Public commenting period has been extended to May 11, 2015

08 May 2015

The United States Food and Drug Administration (US FDA) is in the midst of updating their guidance for industry, “Toxicological Principles for the Safety Assessment of Food Ingredients” (commonly referred to as the “Redbook”).   This task was undertaken as an initiative by the Center for Food Safety and Applied Nutrition (CFSAN) to systematically update the guidance to reflect advances in toxicological and related sciences, and also in response to a review of the chemical safety program within CFSAN and the Center for Veterinary Medicine (CVM) indicating a need to both modernize and harmonize the risk assessment practices between CFSAN and the CVM.

The Redbook was first issued in 1982 and was intended to outline the recommended approach for determining the need, design, conduct, and review of toxicological studies in assessing the safety of food ingredients.  The US FDA is seeking feedback regarding the refining of the toxicological tests and practices described in the Redbook, reviewing scope and utility of the Guidance, and strategies to integrate scientific and technical updates as they become accepted by the scientific community.

Among some comments that have been received by the US FDA thus far includes the desire to integrate the Threshold of Toxicological Concern (TTC) or Adverse Outcome Pathway (AOP) approach in assessing the need for toxicological data; the use of in vitro,in silico, or computational (QSAR)methods to replace current in vivo methods; replacing some of the traditional toxicological studies to shorter duration studies in transgenics; the consideration of less traditional mechanisms of action for the evaluation of carcinogenic risk (example, endocrine disruption); increased guidance on the interpretation of toxicological findings; and the possibility of expanding the scope of the Redbook to include dietary supplement ingredients and cosmetics.

The public commenting period is extended to May 11, 2015 and feedback from stakeholders are encouraged to be submitted electronically to the US FDA’s Division of Dockets Management.  It is expected that the US FDA will issue a draft table of contents later in 2015, following which, outreach and dialogue will continue through 2016, and draft chapters and chapter groups will be available for public comment towards the end of 2017/early 2018.  The final chapters and chapter groups are expected to be issued in late 2018.

For additional information on safety assessments for food ingredients, please visit http://www.intertek.com/food/consulting/ or email annette.lau@intertek.com.

Today's expert blogger, Annette Lau, is a scientific and regulatory associate with broad experience in preparing safety evaluations for food ingredients/additives, dietary supplement ingredients, consumer products, cosmetic ingredients, and drug excipients. She has compiled application dossiers for submission to various departments of the United States Food and Drug Administration, Health Canada, the European Food Safety Authority, and authoritative bodies in Europe. Her familiarity with the regulatory requirements for substantiating safety in each product category makes her an asset to the Intertek Scientific & Regulatory Consultancy team.