Mirror, Mirror on the Wall: Nothing Magical about FDA Warning Letters for Cosmetics with Age-Related Claims

The evil queen sucks the life out of young maidens to sustain her flawless complexion in the movie Snow White and the Huntsman.  If you are wondering how the U.S. Food and Drug Administration (FDA) might regulate the claims for a product with such regenerative properties (minus the grisly maiden death), look no further.

Source: Snow White and the Huntsman Official Site

In early September 2012, FDA posted a warning letter to Lancôme USA and yesterday posted warning letters to Andes Natural and Janson Beckett Inc.   In all three letters, FDA objected to anti-aging claims that (magically) turned these cosmetic products into unapproved new drugs in violation of the Federal Food, Drug and Cosmetic Act (FDC Act).

Objectionable claims on the companies’ respective websites included:

  • “[B]oosts the activity of genes and stimulates the production of youth proteins” (Lancôme USA);
  • “[U]nique R.A.R.E. oligopeptide helps to re-bundle collagen”  (Lancôme USA);
  • "Alpha Lipoic Acid, the most potent antioxidant on the market today, helps repair aged skin while preventing future damage" (Janson Beckett);
  • "[H]elps to protect against and repair environmental skin damage and signs of aging while stimulating collagen synthesis" (Janson Beckett);
  • "[S]timulate collagen growth and cellular regeneration thereby improving ... sagging, reduction of imperfections and blemishes ... " (Andes Natural); and
  • "Stimulates the formation of glycosaminoglycans ... helps to thicken the dermis resulting in a lessening of sagging and less fine lines and wrinkles"  (Andes Natural).

The FDA also took Andes Natural to task for products bearing acne claims which either must be subject to New Drug Applications under section 505 of the FDC Act, or must be labeled and formulated consistent with the final monograph for over-the-counter acne drugs.

It is sometimes a murky line between drugs that affect the structure or function of the body and cosmetics that alter appearance.  Cosmetics cannot make structure/function claims under the FDC Act.   Longstanding FDA policy classifies moisturizers as cosmetics, even though they arguably achieve their purpose by affecting the structure or function of the body.  As any woman of a certain age knows (of whom I am one) anti-aging claims are very common in the cosmetics aisle.  FDA issued an import alert for cosmetics making anti-aging claims in 1988.  Signaling that it was becoming impatient with the continued aggressive marketing, FDA began steadily adding companies to its watch list in 2009 and 2010, and finally re-issued the import alert in March 2012.  The warning letters seem to be another step in the agency’s efforts to make the claims on cosmetic moisturizers a little less magical.

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