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FDA Warns Cosmetics Makers About Overstated Claims for Wrinkle Creams

Apr 14, 2015

In a series of warning letters to cosmetics manufacturers, the Food and Drug Administration (FDA) is warning the industry about claims being made for wrinkle creams. Five warnings letters have been sent to companies since November, the latest of which addressed claims for StriVectin.

StriVectin markets a number of wrinkle creams sold nationwide at retailers including Costco and Nordstrom, the Today show reports. The FDA objects to language in the company's advertising that, under the Federal Food, Drug and Cosmetic Act, makes the products seem like drugs, not cosmetics. The ad language includes:

  • "Clinically proven to change the anatomy of a wrinkle"
  • "This superb age-fighting serum is super charged with … potent elastin stimulating peptides"
  • "Potent elastin-stimulating peptides help enhance skin structure"

There are important differences in the FDA's treatment of cosmetics versus drugs. Products intended to make people more attractive are generally considered cosmetics, according to the FDA. Cosmetics must be safe when used according to label instructions or in the way such products are customarily used. The law does not require cosmetics to have FDA approval before going on the market. A moisturizer, for example, is intended to make lines and wrinkles less noticeable by hydrating the skin and therefore is a cosmetic. Similarly, makeup products make the signs of aging less noticeable by hiding them and are also considered cosmetics.

But a product intended to affect the "structure or function of the body," is considered a drug, and must have FDA approval for both safety and effectiveness before it can go on the market. A product that claims it can remove wrinkles or increase the skin's collagen production is a drug and must go through the testing and clearance process.

According to the FDA's February 12 letter to StirVectin, "The claims on your website indicate that the products are intended to affect the structure or any function of the human body, rendering them drugs under the (Federal Food, Drug, and Cosmetic) Act. When StriVectin claims its "Advanced Tightening Neck Cream," can "restore the elastin fiber architecture, providing noticeable lift and improving resistance to gravity," the FDA says the company is actually claiming the product is a drug but StriVectin has not been through the FDA's review process. A "new drug," under section 505(a) of the Act [21 U.S.C. § 355(a)], may not be legally marketed in the U.S. without prior approval from FDA in the form of an approved New Drug Application (NDA), the FDA explains in the letter.

In response to the FDA's letter, StriVectin has changed the wording on its web site. It now reads, in part, "Over time, the visible effects of gravity appear reversed for even more refined and toned definition of the neck line, profile, and décolleté." There is no longer any mention of "restoring" elastin fiber. Emmy Brooks, a vice president at StriVectin, said in an email, "We stand by the efficacy of our products which is proven by scientific testing and clinical trials," according to Today. Brooks said the company is "doing everything in our power to ensure that our communication to the public complies with the Federal Food, Drug & Cosmetic Act."

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