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FDA: Cosmetics >> FDA Withdraws Anti-Aging Import Alert and Continues Oversight Over Cosmetics Claims

May 24, 2018

In late 2017, the U.S. Food and Drug Administration (FDA) officially withdrew Import Alert 66-38, "Skin Care Products Labeled as Anti-Aging Creams" (IA 66-38), potentially opening the doors for cosmetics manufacturers and marketers to make stronger anti-aging claims.

For the past 30 years, IA 66-38 was used to detain imported skin care and cosmetic products with labels containing claims that the product would affect the aging process, including by rejuvenating, repairing or restructuring the skin. The FDA said such claims would categorize the product as a "drug," resulting in a denial of entry into the United States. This posed a problem for products manufactured abroad, which could not bear claims similar to domestically manufactured products.

While the FDA did not provide a basis for withdrawing IA 66-38, it may be a sign that the FDA now considers certain claims indicating a product’s efficacy in addressing the appearance of aging are appropriate, as they are currently included on domestic products. However, a product label claiming that it will affect a structure or function of the skin, such as by repairing or rejuvenating the skin, should continue to be viewed with caution for all skin care and cosmetic products.

Additionally, the Trump administration has continued to oversee the regulation of cosmetics, including through the issuance of multiple warning letters. In the letters, the FDA singled out claims that products had "anti-inflammatory" or "anti-redness" properties or are appropriate for skin with rosacea, eczema or psoriasis. The FDA found that these claims rendered the products to be new and unapproved drugs.

Key Takeaways:

  • The FDA’s withdrawal of IA 66-38 may open the doors for imported skin care or cosmetic products claiming anti-aging properties.
  • Despite the FDA’s withdrawal, companies should avoid making any claims that a product will affect a structure or function of the body.
  • Companies should continue to vet all product packaging, marketing and websites to ensure compliance with FDA regulations and review claims through a conservative lens.