Cosmetics | Ingredients Safety

FDA cosmetic regulations require that cosmetic ingredients be safe for their intended uses. When FDA evaluates cosmetic products for safety, FDA first analyzes the cosmetic labeling: does the product contain any prohibited ingredients? Except for cosmetic color additives, there is no cosmetic FDA approval required prior to adding a cosmetic ingredient to a product. Instead, FDA uses several regulatory “substitutes” for making safety determinations related to cosmetic ingredients. For instance, FDA cosmetic regulations permit the agency to guide its enforcement discretion by the scientific and safety-related conclusions of industry-based trade groups. Ultimately, under FDA regulations, cosmetic manufacturers must ensure cosmetic ingredient safety. Cosmetics containing unsafe cosmetic ingredients violate federal law and FDA cosmetic regulations. Unsafe cosmetics found in the U.S. domestic market are subject to cosmetic recalls and the manufacturer can become subject to additional legal liability. Imported cosmetics containing unsafe ingredients are subject to FDA import detention and FDA refusal of admission and can subject the importer to additional legal liability. In each of these cases, using unsafe ingredients—ingredients prohibited by FDA cosmetic regulations—costs companies valuable time and money.

By providing a regulatory safety review of your cosmetic ingredients and evaluating the ingredient declarations on the cosmetic labeling, FDA, LLC can help your company avoid costly mistakes involving unsafe cosmetic ingredients.