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2015 Lessons Learned, 2016 Practical Tips

FDA >> FDA Scrutinizes Cosmetics Claims, Continues to Evaluate Imports

April 19, 2016

The Food and Drug Administration (FDA) continued to exercise its increasingly conservative approach to cosmetics claims by issuing numerous warning letters to cosmetics companies and continuing to carefully scrutinize imported products. The FDA’s agenda demonstrates that regulating cosmetics has become an increasingly important priority for the agency.

The FDA was particularly concerned with claims for cosmetic products that indicated that the product could affect a structure or function of the human body or treat, prevent, or mitigate a disease or its symptoms, as these types of claims indicated that the product was a drug rather than a cosmetic. The FDA issued several warning letters to major cosmetics manufacturers for claims that products could “reduce visible redness,” “treat dark spots and discolorations,” “change the anatomy of a wrinkle,” “provid[e] noticeable lift,” and “stimulate collagen production.” In the warning letters, the FDA indicated that such claims rendered the products new and unapproved drugs. Companies reacted to the FDA’s actions by reviewing and examining product claims.

The FDA also detained significant numbers of cosmetic shipments that it believed were not in compliance with the law — particularly those containing claims that a product could remove wrinkles, reduce hyperpigmentation, or prevent the appearance of dark spots. In addition, the FDA focused on detaining products that it believed might contain illegal color additives that were unsafe for use in cosmetics products.

To enhance the FDA’s authority in the cosmetics area, a bill was introduced that, if enacted, would require cosmetics companies to register their facilities with the FDA, submit ingredient statements, and allow the FDA to prohibit a cosmetic’s distribution if the FDA determined that the product might cause serious health consequences.

Looking Ahead

  • Properly vet all new product packaging, advertising, and websites to ensure compliance with FDA regulations and, in light of increased scrutiny, review already existing packaging and claims through a more conservative lens.
  • When importing FDA-regulated products, companies should anticipate the FDA’s increased scrutiny.
  • Keep an eye out for new Congressional bills related to cosmetics.