[Avon Products Inc.]becomes one of six cosmetics companies to be hit over the course of a month by FDA warning letters. Like the others, Avon’s letter asserts that products on its website, as marketed, exceed the definition of a cosmetic under the Federal Food, Drug and Cosmetic Act.

“The claims on your website indicate that these products are intended to affect the structure or any function of the human body, rendering them drugs under the Act,” FDA says in the Oct. 5 letter.

Claims language for Avon Anew skin-care products, in particular, takes a hit. Statements behind Anew Clinical Advanced Wrinkle Corrector are meatiest and most ambitious overall:

“The at-home answer to wrinkle-filling injections. Start rebuilding collagen in just 48 hours.”
“4D Wrinkle-Reverse technology is designed to: rebuild collagen to help plump out lines and wrinkles; stimulate elastin to help improve elasticity and resilience; regenerate hydroproteins to help visibly minimize creasing.”
“Formulated to boost shock-absorbing proteins to help strengthen skin's support layers.”
“Improve fine and deep wrinkles up to 50%. Immediately plumps out wrinkles and fine lines. Within 48 hours begins boosting collagen production.”

For Anew Clinical Thermafirm Face Lifting Cream, FDA objects to the firm’s assertion that the product “is formulated to fortify damaged tissue with new collagen. In just 3 days, see tighter, firmer, more lifted skin.”

Collagen-building claims have been a common target in the agency’s other warning letters to cosmetics firms, which went out Sept. 7 to L’Oreal S.A.’s Lancome division and Greek Island Labs LLC, and Sept. 21 to Janson Beckett Inc. and Andes Natural Skin Care LLC.

Avon’s claim that the lifting cream “helps tighten the connections between skin layers” also rubbed FDA the wrong way.

In its claims for a pair of Anew Reversalist products, Avon says: “[W]rinkles are a result of micro-injuries to the skin, so AVON studied how skin heals. As part of the repair process, the body produces activin,” a “key repair molecule.” The firm continues: “Designed to boost activin, ANEW’s Activinol Technology helps reactivate skin’s repair process to recreate fresh skin and help dramatically reverse visible wrinkles.”

Blacksburg, Va.-based Bioque Technologies draws a same-day warning letter for claims comparing its topical skin-care products to Allergan Inc.’s BOTOX injectible wrinkle treatment, which FDA and the Federal Trade Commission both have identified as a cosmetics marketing no-no.

Finally, FDA comes down on a statement promoting Avon’s Solutions Liquid Bra Toning Gel for more collagen/elastin claims. According to Avon, the product – designed to tighten and tone the bust area – is “formulated with pomegranate and fennel extracts to help boost production of collagen and elastin.”

The agency states: “Your products are not generally recognized among qualified experts as safe and effective for the above-referenced uses and, therefore, the products are new drugs” under food and drug law.

Avon had 15 days from receipt of the letter to respond with the corrective measures it is taking or an explanation for why it believes its claims and products are not in violation.

EAS Consulting Group’s John Bailey, who served formerly as chief scientist at the Personal Care Products Council and directed FDA’s cosmetics program from 1991 to 2000, is taking a wait-and-see approach in determining whether the agency’s recent flurry of action represents “a more aggressive policy initiative” or if FDA is merely reminding industry of its long-standing position with regard to structure/function claims in the cosmetics sector (see related story, cover).

Bioque Receives Same-Day Letter

In another Oct. 5 warning letter, FDA takes Blacksburg, Va.-based Bioque Technologies to task for online claims including, for Serum XL: “Long-term repair – 5% each of two additional peptides with antioxidants stimulate production of collagen and elastin ... helping to repair structural damage to deeper layers of the skin.”

The company also makes a number of claims drawing comparisons between its topical skin-care products and Allergan Inc.’s BOTOX injectible wrinkle treatment, which FDA and the Federal Trade Commission both have identified as a cosmetics marketing no-no Also see "How Not To Cross FTC: Attorneys Offer Advice For Cosmeceutical Marketers" - HBW Insight, 14 July, 2008.. Such claims on Bioque’s website include “Puts wrinkles on the rocks, without the BOTOX,” for Bioque Pronto cream containing naturally-derived gamma aminobutyric acid, and “Provides BOTOX-like results without needles.”

The company also says its C-Plus Moisturizing Cream “fends off UVA and UVB rays … and improves skin’s immune system,” among other statements that render its products drugs under the FD&C Act, FDA says.

FDA Serves Up More Warnings: Avon Cited For Touting Druglike Benefits

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