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The Mariposa Blog

Tuesday, April 10, 2012

Sharing FDA Yellow List Alert

 

On March 27, 2012, the FDA Published a new Import Alert, Alert #66-38 for "Skin Care Products Labeled As Anti-Aging Creams".

The FDA established a "Yellow List" in 1988 of companies with exaggerated "anti-aging" claims. The list has grown since then and now includes multiple products from companies from 17 countries. At that time, "the FDA Associate Commissioner for Regulatory Affairs informed the manufacturers that any products found to be in substantial violation of the new drug and misbranding provisions of the Federal Food, Drug, and Cosmetic Act and may be subject to regulatory action without prior notice". Some companies, at the time, did receive regulatory letters but nothing much appeared to happen until now.

The FDA alerted district staff that, "All entries of skin care products imported by the firms or manufactured/shipped by the firms on the Yellow List until for this alert should continue to be checked for drug claims until a district is convinced the firm's products are in compliance". Furthermore, The district was advised that, "Surveillance of entries of skin care products from other importers is also indicated".

The new Import alert includes an updated Yellow List, which identifies those firms that more recently received regulatory letters because FDA believes they may be importing these skin care products with drug claims.

The "exaggerated anti-aging" claims include:

  • "counteract", "retard", or "control" the aging process
  • "rejuvenate", "repair", or "restructure" the skin
  • "molecules absorb and expand, exerting upward pressure to 'lift' wrinkles upward"

About Dr. Norman Estrin

Dr. Norman F. Estrin is a recognized authority in the medical device and cosmetic industries. He has had over 25 years of experience in directing scientific and technical programs in these industries. As President of Estrin Consulting Group LLC, Norm has built upon and added to his experience and contacts while Vice President, Science & Technology at the Health Industry Manufacturers Association (HIMA).

About FDA

The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.

Source: Dr. Norman Estrin (Estrin Consulting Group LLC)

 

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