Cosmetic Regulation in the U.S.
Importing cosmetics into the United States can be a very profitable venture for many businesses. However, it is critical that the cosmetic manufacturer or cosmetic importer understand and apply the FDA cosmetic regulations properly to all cosmetic labels, cosmetic ingredients, and cosmetic marketing and advertising.
Like all FDA-regulated products, cosmetics are defined by their "intended uses" as articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance." Cosmetics distributed in the USA must have correct cosmetic labeling, contain safe cosmetic ingredients, and be pure and of high quality. Some U.S. states have additional requirements related to cosmetic ingredient safety. For instance, where there is some evidence that a chemical in a product increases the risk that it is a cancer causing cosmetic, distributors must include additional cosmetic label warnings and report to the state health authorities the quantities of such cosmetics distributed within that state.
Specific FDA cosmetic regulations cover cosmetic labeling, product quality, purity and safety, permitted ingredients, and where, how and for how long a cosmetic may be applied to the body. FDA regulations apply different marketing requirements to cosmetics than to drugs. FDA regulates some products as drugs even though the product manufacturers or importers initially thought the products could be marketed as cosmetics. This often happens because the products contain active drug ingredients or labeling or marketing claims on the cosmetic labeling or in the product's Internet advertising or promotional materials that are drug claims. FDA regulates such products as drugs, which increases the FDA requirements for USA distribution.
The cosmetic label, cosmetic advertising and cosmetic ingredients dictate how FDA will regulate the product. Any claims that a product can prevent disease (for instance, as a sun protection (SPF) cosmetic) or that it will affect the structure or function of the human body (for instance, as an anti-wrinkle cosmetic cream) are drug claims. Such claims are not permitted on cosmetic labels, cosmetic advertising, cosmetic Internet sites or other cosmetic promotional materials. Some common examples of impermissible drug claims include cosmetic hair restoration claims, cosmetic cellulite reduction claims, cosmetic varicose vein treatments, cosmetic skin whiteners, cosmetic wrinkle reducing products or wrinkle removal creams (e.g., anti-wrinkle creams).
Correct cosmetic labels and cosmetic marketing claims are critical to successfully importing cosmetics into the United States. The easiest cosmetic violation for FDA to find is an improper drug claim on a cosmetic product's label or a cosmetic product's Internet site.
Cosmetic marketing companies should know that Internet marketing sites where cosmetics are sold are regulated by both FDA and the Federal Trade Commission (FTC), and are often searched and reviewed by FDA investigators and compliance officers who are on the hunt for false, misleading or unapproved cosmetic claims. Once they find the illegal information, FDA inspectors then look for imported cosmetics from those sites or from the companies who are marketing the products.
We at FDAImports.com, LLC apply all of our expertise and experience in FDA cosmetic labeling regulations and FTC cosmetic marketing regulations to ensure your cosmetics comply with federal requirements while bearing useful claims for marketing purposes. For high quality cosmetic products, we find The Way Through to the U.S. market, helping you to create high quality and successful cosmetic brands.