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FDA starts Redbook update process

The U.S. Food and Drug Administration has begun the process of updating its current guidance on food ingredient safety assessment, commonly referred to as the Redbook, and is requesting input from the public. The agency said it is interested in developing a framework that incorporates the assessment of ingredients present in various products regulated by the […]

The U.S. Food and Drug Administration has begun the process of updating its current guidance on food ingredient safety assessment, commonly referred to as the Redbook, and is requesting input from the public.

The agency said it is interested in developing a framework that incorporates the assessment of ingredients present in various products regulated by the FDA’s Center for Food Safety and Applied Nutrition (CFSAN). Examples include food additives, food contact substances, ingredients that are generally regarded as safe (GRAS), new plant varieties, dietary supplements and new dietary ingredients, cosmetic ingredients, as well as unavoidable chemical contaminants other than microbial pathogens.

The FDA said it is particularly interested in comments on:

• Which parts of the Redbook should be updated, and how FDA should prioritize updates.
• The scope of the revised guidance, and what other guidance documents could be addressed or incorporated by reference.
• New assays, test methods, and endpoints that could be useful for safety assessment, with justifications for why and how these proposed new methods should be considered.
• Key studies and considerations for study interpretation for each of the regulatory categories of food and cosmetic ingredients and chemical contaminants overseen by CFSAN.
• Ways to make the guidance more useful to stakeholders.
• Ways to make our processes and criteria for safety assessment clearer to stakeholders.

Specific examples, precise wording, or other clear and direct suggestions that address these issues are particularly welcome.