# FDA WARNING_LETTER - Avon Products, Inc. (U.S. Headquarters) - August 31, 2012

Source: https://www.keypedia.com/records/warning_letter/avon-products-inc-us-headquarters/1bb0e6ad-d717-4765-85ba-aab1037afba3

> FDA WARNING_LETTER for Avon Products, Inc. (U.S. Headquarters) on August 31, 2012. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Avon Products, Inc. (U.S. Headquarters)
- Inspection Date: 2012-08-31
- Product Type: Drugs
- Office Name: Department of Health and Human Services
- Summary: The FDA issued a Warning Letter to Avon Products, Inc. on October 5, 2012, following a review of their website in August 2012. The FDA determined that five Avon products—Anew Clinical Advanced Wrinkle Corrector, Anew Reversalist Night Renewal Cream, Anew Reversalist Renewal Serum, Anew Clinical Thermafirm Face Lifting Cream, and Solutions Liquid Bra Toning Gel—are marketed with claims that cause them to be classified as unapproved new drugs under sections 201(g)(1)(C) and 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act).

The claims, such as "rebuild collagen," "stimulate elastin," "regenerate hydroproteins," "boost Activin," "fortify damaged tissue with new collagen," and "tighten the connections between skin's layers," indicate the products are intended to affect the structure or function of the human body. Since these products are not generally recognized as safe and effective for their claimed uses, they are considered new drugs requiring an approved New Drug Application (NDA) under section 505(a) of the Act before legal marketing in the U.S.

Avon is required to take prompt action to correct all violations and notify the FDA in writing within 15 working days of receipt of the letter, detailing the specific steps taken to correct the violations and prevent recurrence. Failure to

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