Tanning Accelerators Dangers

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"Tanning accelerators" are products marketed with claims that they speed up the skin's melanin production, generally by supplying doses of tyrosine (an amino acid) or its derivatives, perhaps in combination with other substances.

In a proposed rule on sunscreens, published May 12, 1993, in the Federal Register (Vol. 58, no. 90, p. 28194 at p. 28293), FDA addressed tanning acceleration claims as follows:

"In the case of accelerators, the tanning process is supposedly hastened by stimulating the production of melanin by ingredients such as tyrosine or tyrosine derivatives. These derivatives supposedly increase the substrate available for tyrosinase enzyme action. Tyrosinase is a key enzyme in melanogenesis. The use of tyrosine is based upon the presumption that it penetrates the skin, increases the tyrosine content of the melanocytes, and thus enhances melanin formation. This effect has not been convincingly substantiated in the scientific literature. The agency notes that any product purporting to 'accelerate the tanning process' or 'stimulate the production of melanin' is claiming to affect the structure and function of the body and therefore is a drug. The agency is not aware of any data demonstrating that tyrosine or its derivatives are effective in stimulating the production of melanin. Thus, any product containing tyrosine or its derivatives and claiming to accelerate the tanning process is an unapproved new drug."

FDA addressed tanning accelerators again in the final rule on sunscreens, published in the Federal Register May 21, 1999 (Vol. 64, no. 98, p. 27666 at p. 27668):

"Products that claim to accelerate or stimulate the tanning process are claiming, either expressly or impliedly, to stimulate the production of melanin in the body. Such a claim to affect the structure or function of the body renders the product subject to regulation as a drug under section 201(g)(1) of the act." "The act" refers to the Food, Drug and Cosmetic Act (FD&C Act).

FDA has issued Warning Letters to various manufacturers who have marketed such products and has seized some of the violative products. A seizure is currently being litigated in the courts.

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