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    What are GRAS ingredients?

    Another way cosmetics insure their safety is by adhering to a list of substances known as GRAS ingredients. GRAS stands for “Generally Recognized as Safe” and indicates ingredients that are currently widely used in the marketplace without safety issues. Products using only these ingredients do not require as extensive testing since safety can be assumed from prior exposure, nevertheless quality companies test every new formulation whether it contains GRAS ingredients or not.

    Recently, the FDA proposed regulation of the cosmetic industry by considering the filing of a document similar to an NDA (New Drug Application) for all new cosmetic ingredients. For example, if a new silicone derivative were introduced beyond dimethicone that is currently in the marketplace, it would require approval via some sort of filing. This would slow down cosmetic innovation and probably dramatically increase the cost of cosmetic products. It is also doubtful that much improvement in consumer safety would result as few problems have occurred in the past. The added government regulation would be costly, but it might also provide a new government income stream, as surely a filing fee would be assessed similar to that currently paid by pharmaceutical companies wishing to obtain approval of a new drug.

    Zoe Diana Draelos, M.D.
    Zoe Diana Draelos, M.D., is a consulting professor of dermatology, Duke University School of Medicine, Durham, N.C. She is investigator, ...


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