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Last month the FDA held an open meeting to receive input from the public on updating “Redbook,” the agency’s guidance on color and food additives. The FDA is considering significantly expanding the scope of the guidance to include nutritional supplements and supplement ingredients.
The evidentiary standard for dietary ingredients (which includes supplements) is very different from the standard for food additives: dietary ingredients need to have a “reasonable expectation” of safety, whereas food additives must have a “reasonable certainty” of safety. They should not be lumped together. Including supplements in Redbook blurs the line between food additives and dietary ingredients—something Congress explicitly intended to avoid when DSHEA was enacted in 1994.
Tell the FDA that Redbook should not be expanded to include dietary ingredients, and that any safety assessments for dietary ingredients should be addressed strictly in the context of the NDI guidance.
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FDA's Redbook Revision Should Not Include Dietary Ingredients!
Dear [Decision Maker],
Sincerely,[Your Name] [Your Address] [City, State ZIP]