The recent “cluster” of warning letters to cosmetics companies for overreaching claims is “worth paying attention to” but not necessarily a sign that the agency is ramping up its enforcement efforts, according to EAS Consulting Group Expert Consultant John Bailey, previously chief scientist at the Personal Care Products Council and a former director of FDA’s cosmetics program.

Oct. 5 warning letters to Avon Products, Inc. – citing claims on the firm’s website for Anew anti-aging facial products, among others – and Blacksburg, Va.-based Bioque Technologies are the latest in the spate of letters to cosmetics firms over a roughly 30-day period Also see "FDA Serves Up More Warnings: Avon Cited For Touting Druglike Benefits" - HBW Insight, 22 October, 2012..

In September, FDA issued warning letters in pairs, targeting L’Oreal S.A.’s luxury Lancome division and Greek Island Labs LLC with Sept. 7 letters, and Janson Beckett Inc. and Andes Natural Skin Care LLC Sept. 21.

“If FDA continues to issue warning letters at this pace, it may signal a more aggressive policy initiative and could trigger more attention from industry.” – John Bailey, ex-director of FDA’s cosmetics program and former chief scientist at the Personal Care Products Council

In each case, the agency has identified claims made by the company for cosmetic products online that violate food and drug law by suggesting an impact on the structure or function of the human body and/or implying potential usefulness in treating or preventing disease.

Among such claims are statements for skin-care products suggesting anti-aging benefits from accelerated cell turnover, others promising future skin protection in addition to immediate damage repair, and claims by the handful referring to increased collagen production for more youthful-looking skin (see chart of example claims).

In short, they are the types of cosmetic claims that FDA has come down on in the past, but they also are fairly representative of claims being used industry-wide in today’s competitive marketplace.

The rash of warning letters raises questions as to why these companies in particular were singled out by FDA at this time, how industry should perceive FDA’s flurry of enforcement activity and whether firms should expect more warnings to come.

Bailey provided some perspective in an Oct. 11 interview. “Basically, the agency’s approach in the past has been to occasionally send out a few warning letters as sort of a notice to industry that it still believes these are inappropriate claims for cosmetics, [so] if you’re going to make these claims, you run the risk of receiving a warning letter from the agency.”

As for the specific claims cited, he stated: “They seem pretty typical to me. These are the old cosmetic-versus-drug issues.”

Under the Federal Food, Drug & Cosmetic Act, cosmetics are items intended “for cleansing, beautifying, promoting attractiveness or altering the appearance.” The law defines drugs as products designed to help diagnose or address disease or to affect the structure or function of the body.

A greater burden of premarket safety substantiation is required for companies marketing pharmaceuticals as opposed to cosmetics. “Cosmeceutical” remains an unrecognized term under current regulations, FDA notes on its website.

Claims Cited In September/October Warning Letters To Cosmetics Firms

Avon Products

“Helps tighten the connections between skin's layers.” (Anew Clinical Thermafirm Face Lifting Cream)
“Improve fine and deep wrinkles up to 50%. Immediately plumps out wrinkles and fine lines. Within 48 hours begins boosting collagen production.” (Anew Clinical Advanced Wrinkle Corrector)

L’Oreal/Lancome

“Has been shown to improve the condition around the stem cells and stimulate cell regeneration to reconstruct skin to a denser quality.” (Absolue Precious Cells Advanced Regenerating and Reconstructing Cream SPF 15 Sunscreen)
“Boosts the activity of genes and stimulates the production of youth proteins.” (Genifique Youth Activating facial products)

Janson Beckett

“SepiLift counteracts wrinkled, un-toned lips by stimulating collagen production, preventing enzyme destruction.” (BeautiFull Lips Lip Plumper)
“Helps to protect against and repair environmental skin damage and signs of aging while stimulating collagen synthesis.” (Vitamin C&C Facial Serum)

Andes Natural Skin Care

"Triggers your body's own skin-regeneration activators." (BioSkinCare)
"Promotes cell proliferation and new synthesis of collagen and elastin." (Bio Skin Rejuvenation)

Greek Island Labs

“Helps promote the development of collagen.” (Athena Nightly Renewal Cream)
“Clinically proven to reduce breakouts and blemishes by 84%.” (Complexion Control Serum)

Bioque Technologies

“Protection powerhouse C-Plus fends off UVA and UVB rays ... and improves skin’s immune system.” (C-Plus Moisturizing Cream)
“Delivers a formula rich in peptides and active botanicals to fuel the rebuilding of skin structure and elasticity.” (Rejuvenating Day Cream)

Watch Your Website (Because FDA Is)

Bailey noted that the string of FDA warnings over the recent 30-day period pales in comparison to an agency initiative in the late 1980s when it issued warnings to more than 20 cosmetic firms for what it contended were excessive anti-aging claims suggesting physiological changes to the body.

But that is not to say that the recent surge isn’t noteworthy. “If FDA continues to issue warning letters at this pace, it may signal a more aggressive policy initiative and could trigger more attention from industry,” Bailey said.

He pointed out that FDA’s warnings last month all stemmed from observations in examining firms’ websites. “I think that is probably the most significant point that I would take away from this,” he said. “They’re basically visiting websites, looking at claims being made for products and then using those claims as a basis for sending warning letters.”

The ex-FDAer noted that while all warning letters require a level of commitment from the agency in terms of allocating resources for potential follow-up activities, those based on website reviews “are much easier to do” than others requiring field investigations or facility inspections, for example.

For website-based warnings, FDA officials “can sit at their desks, put them together and then all they need is the office of chief counsel to agree. ... I guess it’s a more efficient process from their perspective,” he said.

Claims Include New Science

Bailey characterized the warning letters as “interesting” not only due to their delivery as a “cluster” and their focus on websites, but also because they touch on cutting-edge cosmetics science cited in product claims – specifically research and innovations related to genes and stem cells.

In its warning to L’Oreal’s Lancome unit, the agency cites the brand’s assertions that technology in its Genifique Youth Activating Concentrate, Genifique Youth Activating Eye Concentrate and Genifique Youth Activating Cream Serum “boosts the activity of genes and stimulates the production of youth proteins” Also see "FDA Warns Lancome For Gene/Stem-Cell Claims: A Signal To Marketplace?" - HBW Insight, 17 September, 2012..

Statements for Lancome’s Absolue Precious Cells Advanced Regenerating and Reconstructing Cream SPF 15 Sunscreen also came under scrutiny. According to FDA, claims that the product’s key actives can “improve the condition around stem cells and stimulate cell regeneration to reconstruct skin to a denser quality” render the product a drug.

In recent years, claims regarding stem-cell maintenance, gene expression and/or DNA repair have been growing increasingly prevalent in anti-aging cosmetics marketing as firms race to deliver more meaningful benefits to consumers Also see "Universe Of Skin Care Targeting Stem Cells, DNA Continues To Grow" - HBW Insight, 27 February, 2012..

Companies dabbling in such technology and associated claims include industry leaders with some of the biggest R&D programs, most innovative marketing and ambitious performance claims.

For example, in promotional materials for the Estee Lauder Companies’ Advanced Night Repair Synchronized Recovery Complex, the firm discusses the “clock genes” in skin cells “that when in sync with each other, help skin maximize DNA repair.” While aging and environmental stressors can de-synchronize these genes, Advanced Night Repair’s Chronolux technology “supports the natural synchronization of skin’s repair and protection processes,” the firm says Also see "Lauder Synchronizes Genetic Skin Cell Clocks For Optimal Night Repair" - HBW Insight, 20 July, 2009..

Avon makes no mention of genes or stem cells in the claims highlighted by FDA’s warning, but it does boast innovations that harness skin’s innate ability to repair itself at the molecular level – another area of increasing focus for anti-aging skin-care brands.

In claims supporting two 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.”

Claims suggesting skin reconstruction “have always been on FDA’s radar screen,” Bailey said, so it’s difficult to tell if FDA is taking a heightened interest in claims language specifically pertaining to DNA, genes and stem cells.

But its letters to Avon and L’Oreal/Lancome could be interpreted as a statement, the consultant suggested.

“Certainly targeting a large company attracts attention across the industry, so maybe this is just sort of like the cop stopping the one speeder out of many on the road with the idea that [the example] will impact on more people. And that’s typical for enforcement agencies to do that.”

Broader Look Reveals Possible Red Flags

Looking at the broader pictures offered by the warning letters provides possible clues as to why FDA targeted six companies specifically among the mobs of cosmetic brands whose claims of increased cell-renewal rates, skin plumping or “turning back the clock,” for example, could conceivably be construed as unlawful drug statements implying impacts on body structure and/or function.

FDA has made it clear in its communications to the cosmetics industry that comparisons to prescription products or procedures will not be tolerated, so Greek Island Labs’ claim for the Athena 7 Minute Lift, characterizing the product as “a safe and effective alternative to BOTOX,” may have been the first red flag that subjected the company’s other claims to rigorous scrutiny.

Avon’s website included a similar claim for the Anew Clinical Advanced Wrinkle Corrector – “The at-home answer to wrinkle-filling injections” – and Bioque was cited for a handful of BOTOX comparisons, including: “Provides BOTOX-like results without needles.”

Claims infringing on over-the-counter drug turf covered by FDA monographs may also have drawn FDA’s attention to companies’ webpages, with more anodyne claims sustaining more or less collateral damage.

Andes Natural’s website contained statements for its BioSkinCare products including “Takes away all imperfections and blemishes: acne, scars, keratosis bumps, razor nicks and burns, actinic keratosis lesions, ... eczema, dermatitis [and] the effects on the skin of radiotherapy for cancer."

Products marketed as treating acne and dermatitis must use ingredients that are generally recognized as safe and effective (GRASE) under FDA monographs.

Greek Island Labs’ claim that the eucalyptus in its Adonia LashAlive and BrowRevive serums offers “antibacterial, anti-inflammatory benefits and can help to stimulate blood circulation on the scalp, encouraging hair growth,” suggests that the products run afoul of FDA regulations for nonconformity to two monographs: those for antimicrobial substances and hair-growth ingredients.

Bailey commented: “There probably is [agency] interest in making sure that someone doesn’t use this product in place of a true antibacterial and thereby run a risk of infection or missing an effective treatment that they should have. That kind of moves up the safety ladder somewhat.”

On the other hand, he said, “if you’re just talking about wrinkles and penetrating cells and being an antioxidant and that sort of thing – the typical anti-aging [language] – that has far less health connotations, so anything that would perhaps divert a consumer away from important treatments would be of greater interest to the agency.”

Bailey noted that the warning letters generally have raised labeling issues rather than safety issues, and said that companies “just need to be aware,” adding: “They have great resources for deciding what to do in a very competitive market, so they are certainly watching this just as we are.”

Rash Of FDA Warning Letters Raises Questions For Cosmetics Industry

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