FDA Cracks Down on Spurious Marketing Claims for Cosmetic Products

Posted 02 October 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) is increasingly cracking down on the marketing claims used by some cosmetic companies, firing off at least three warning letters in as many weeks regarding allegedly unfounded claims used to market various products.

In an opening salvo, released in the form of an 11 September warning letter, FDA alleged French cosmetic giant L'Oreal's US subsidiary, Lancôme USA, was using a number of improper marketing claims that caused the products to be drugs under the Federal Food, Drug and Cosmetic Act (FD&C Act).

Many of those claims had to do with the cosmetics' interaction-purportedly-with the body at a cellular and genetic level. Lancôme's claims included that some of its products boosted the activity of genes, improved the condition around stem cells and existing cells and re-bundled collagen. In a subsequent response to Regulatory Focus, L'Oreal spokeswomanRebecca Caruso said the company is, "Committed to complying fully with all laws and regulatory standards," and would be replying to FDA's concerns.

Though FDA has not yet released any updated information regarding Lancôme's claims, on 2 October it released two additional warning letters against cosmetic companies using similar claims to market their products.

In one letter to Andes Natural Skin Care, a Nevada-based company, FDA alleges many of the company's products-seven in all-violate the FD&C Act based on a number of claims.

Those claims include that the company's products regenerate skin, repair damaged skin tissue, heal scars, cure numerous skin conditions, act to inhibit pathogenic bacteria, boost the immune system and form new capillaries in the skin.

Those are bold claims, but not ones cleared by FDA or evaluated by regulators, the letter says. FDA called on the company to stop marketing its products using the highlighted claims.

Another company, New Jersey-based Janson Beckett, Inc., also received a warning letter highlighting similar claims. Eight of Janson's products were identified by FDA as having been marketed using claims reserved for pharmaceutical products and for which Janson did not obtain new drug approval.

As with Andes and L'Oreal, Janson's claims run afoul of FDA regulations banning any therapeutic claims made for cosmetic products.

Janson's website claimed its products are capable of reducing the skin's electrical charge, blocking nerve signals, lowering "synaptic voltage," extending the results of a Botox injection, preventing future skin damage and reversing "sluggish cell energy."

The letter could mark the start of a trend for FDA, which has not devoted many warning letters to cosmetic products over the last year. The one exception is for "Brazilian Blowout" hair products, which FDA said contained poisonous substances which could be harmful to consumers.

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