Cracking Down on Anti-Aging Claims….!

FDA is Cracking Down on Anti-Aging Claims, Says SpecialChem Speaker, Dr. Norman Estrin (Estrin Consulting Group LLC) SpecialChem - Apr 5, 2012    On March 27, 2012, the FDA Published a new Import Alert, Alert #66-38 for "Skin Care Products Labeled As Anti-Aging Creams".    

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".    Get expert advice to develop cosmetic claims with a lower regulatory risk:  US Cosmetic Claims: How to be attractive yet non-misleading? Online short course on Thu. May 10, 2012    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"