• FDA has issued a record high 19 Warning Letters to cosmetics/personal care product companies in 2016.
  • Companies should promote cosmetics on the Internet with the understanding that FDA may be actively monitoring company websites.

FDA continues to maintain an aggressive enforcement stance against cosmetics/personal care product companies and has already issued a record 19 Warning Letters to such companies so far in 2016. Indeed, FDA has issued a total of 16 Warning Letters to companies for marketing cosmetics with claims that FDA views as “drug” claims. In addition, three other personal care product companies also received FDA Warning Letters in 2016–one for marketing an “acne” pen that FDA deemed to be a device; a second company for marketing microbial contaminated personal-care products; and a third company for marketing topical/oral care products containing high levels of lead. A link to the Warning Letters can be found here. Examples of product claims cited by FDA as objectionable include, in part, claims such as:

  • “Reduces wrinkles;”
  • “Promotes cell renewal;”
  • “Controls hyperpigmentation;”
  • “Stimulates collagen growth;”
  • “Promotes cellular metabolism;”
  • “Supports the synthesis of new skin fibers;”
  • “Ideal for treating sun spots, age spots, acne scarring;”
  • “Evening Primrose: anti-inflammatory;”
  • “Ideal for Rosacea too;” and
  • “A natural alternative to Botox.”

FDA’s above noted 2016 Warning Letters also include performance claims and claim terminology that is generally consistent with FDA’s Import Alert (IA) 66-38, “Skin Care Products Labeled as Anti-aging Creams.” IA 66-38 notes that product claims that include terms like “retard,” “control,” “rejuvenate,” “repair,” “restructure,” and “lift wrinkles upward” can be deemed to be “drug claims” depending on how the claim is worded. In addition, product claims that reference skin conditions like “Rosacea” and “hyperpigmentation” are also subject to FDA enforcement, as the Agency has long held that any reference to a medical condition is an implied drug claim.

FDA last took this type of aggressive enforcement action against cosmetics companies back in 2012 when the Agency issued similar Warning Letters to 8-10 cosmetics companies for also marketing cosmetics what FDA viewed to be “drug” claims. Part of the problem is that cosmetic formulations have evolved over time. Many newer cosmetics are now formulated with ingredients (e.g., peptides, collagen, novel plant extracts, hyaluronic acid, etc.) that can potentially provide therapeutic benefits to the surface of the skin. Thus, while many cosmetics companies want to promote improved product benefits based on the inclusion of modern ingredients in product formulations, including therapeutic and structure/function benefits, FDA objects to the use of these types of claims for promoting cosmetics.

FDA may be subjecting the industry to aggressive enforcement because the Agency has been unable to get Congress to pass cosmetics reform legislation the past decade. Legislation would expand FDA’s regulatory requirements for cosmetics by requiring, for example, company/product registrations, disclosure of product formulations, mandatory adverse event reporting, expanded enforcement authority, etc. With such regulatory reform tools currently unavailable to FDA, the Agency may be using its enforcement arm to discourage use of therapeutic claims as much as possible. Further, given Agency resources, most recent enforcement activity appears to focus on product labeling over the Internet, which is very easy for FDA to actively police. Thus, companies should promote cosmetics on the Internet with the understanding that FDA may be actively monitoring company websites.