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FDA Issues Warning Letter To Lancome

Gina-Marie Cheeseman
| Monday September 17th, 2012 | 0 Comments

While browsing the counter of Origins, a cosmetics company that bills itself as a “natural skincare” company, the sales lady made some rather remarkable claims about a product. She told me that Plantscription SPF 15 foundation firms skin and smooths out wrinkles. According to Origin’s website, Plantscription SPF 15 is a “patent-pending, clinically proven anti-aging foundation.” Rather big claims for a little bottle of foundation. The implication is that the foundation can do what dermatological prescriptions for wrinkles can do. The Food & Drug Administration (FDA) is getting fed up with such claims.

The FDA reviewed Lancôme’s website and found even bigger claims, including that two of its products “boost the activity of genes.” The FDA wrote a letter to Lancôme, owned by L’Oréal, earlier this month concerning the claims the cosmetics company makes about eight of its products. The letter stated that the products “appear to be promoted for uses that cause these products to be drugs under section 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).” The FD&C Act defines cosmetics, according to the FDA, by their intended use. The FDA’s website states that companies “sometimes violate the law by marketing a cosmetic with a drug claim.”

The FDA letter went on to tell Lancôme that the claims on its website about the eight products “indicate that these products are intended to affect the structure or any function of the human body, rendering them drugs under the Act.” Marketing cosmetics with “these claims evidencing these intended uses violates the Act,” the FDA letter stated. In very certain terms, the letter reminded Lancôme that its products “are not generally recognized among qualified experts as safe and effective for the above referenced uses.” That makes the products “new drugs as defined in section 201(p) of the Act.”

The FDA made it clear that the letter did not serve as an “all-inclusive statement of violations associated with your products or their labeling.” The letter, in fact, does not list all of the products promoted as “intended for uses that cause them to be drugs.” Instead, the letter advised Lancôme to review its website and product labels to make sure that the product claims do not violate the Act.

In addition, the letter asked that Lancôme “take prompt action to correct all violations associated with your products,” and asked the company to respond in writing within 15 days about ways it will correct the violations mentioned. The letter warns Lancôme that not taking “specific steps” to correct the violations “may result in enforcement action without further notice.”

L’Oréal spokesperson, Rebecca Caruso said that the company is aware of the letter to Lancôme, and “will respond to their regulatory concerns in a timely manner.” Caruso added that “Lancôme is committed to complying fully with all laws and regulatory standards.”

Photo: Wikipedia user, BGfun246


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