Another FDA Warning Letter & the FDA’s Consumer Outreach Initiative

The FDA closed out March with one more Warning Letter, this one to Skin Authority, LLC.  Per the March 25, 2015, letter, the claims on the company’s website “provide evidence that [the cosmetic] products are intended for use as drugs.”  The challenged claims included: “improve anti-inflammatory response,” “help stimulate collagen,” “help inhibit cellular breakdown,” open follicles and reduce oil production,” and “stimulate blood flow.”  As with other recent Warning Letters, the FDA emphasized that based on the claims, the company’s associated creams, scrubs, serum, eye cream, and elixir were not generally recognized as safe and effective for the claimed uses, and therefore were new drugs.  As new drugs, a new drug application must be submitted to the FDA so it may evaluate the basis of scientific data.  In addition, addressing the claims associated with Skin Authority’s Wrinkle Reversing Serum, e.g., “help activate wound healing fostering new skin growth, to help reduce scar tissue, and to help form stronger blood vessels,” FDA stated the product:

“is offered for a condition that is not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use this drug safely for its intended purposes. Thus, this drug is misbranded within the meaning of section 502(f)(1) of the Act, in that the labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)].”

As previously discussed in prior blogs (More FDA Warning Letters: Strong Enforcement Continues in 2015 and FDA Warning Letters: cleansers, creams, moisturizers deemed drugs by FDA), the FDA’s priorities in 2015 include increased enforcement related to cosmetics.  To this end, the agency reorganized its website in a manner that makes finding information easier for consumers and industry, include the new webpage “What’s New in Cosmetics” which provides a month by month description of the FDA’s activities relating to cosmetics, with links to additional information pages and consumer updates.

For example, in an updated issued in March 2015, “Are Some Cosmetics Promising Too Much?“, Dr. Linda Katz is quoted:

“Consumers need to know that these drug claims have not been proven to FDA when they are making a decision to purchase one of these products,” says Linda M. Katz, M.D., MPH, director of FDA’s Office of Cosmetics and Colors. “These products must be evaluated by FDA as drugs before the companies can make claims about changing the skin or treating disease.”

Some of the drug claims have included promises to increase production of collagen and elastin, resulting in skin that is more elastic and firmer, with fewer wrinkles.

Some get even more specific, such as claims that products reduce inflammation, regenerate cells, prevent facial muscle contractions, boost activity of genes, or give you the same results as injections or surgery. Others promise to treat medical conditions, such as acne, rosacea, eczema, and psoriasis.

Take away…What does this mean for industry?  On one hand, it means information is easier to find for even the most junior compliance officer or marketing manager.  On the other hand, with increased consumer education on the topic, there may be an increase in disenchanted consumers that are upset that the $20 – $120 eye cream they purchased didn’t eliminate their wrinkles and reverse the years –which may lead to even more class action litigation.  What can a company do to minimize the risk? I will be discussing this topic at Looking Good in the Eyes of the Law: 2015 Cosmetics Compliance Seminar, in San Francisco, on April 17-18.  In-person  registration is closed, but attendance by webinar is still available.  For more information, check it out here.

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