FDA warns Lancome about cosmetic claims: What you can learn

FDA warns Lancome about cosmetic claims: What you can learn

Lancome recently received an FDA warning letter for its antiaging skin care claims. Here's how to avoid the same fate by remaining compliant with the Federal Food, Drug and Cosmetic Act.

Oops. A leading cosmetic manufacturer made a boo boo—or multiple—prompting the Food and Drug Administration (FDA) to issue a warning letter targeting some of the company’s claims on antiaging skin care products. L'Oreal-owned Lancome uses marketing that depicts the products as drugs rather than cosmetics.

The letter, sent to Lancome on Sept. 7, stated that Lancome’s claims “indicate that these products are intended to affect the structure or any function of the human body,” meaning they’re in violation of the FDA’s Federal Food, Drug and Cosmetic Act.

Lancome's non-compliant cosmetic claims 

These claims made on Lancome’s website about Genefique skin creams and other products refer to the activity of genes, stem cells and collagen in ways that are not compliant with current FDA regulations.

  • “[B]oosts the activity of genes and stimulates the production of youth proteins.”
  • “[B]oosts the activity of genes.”
  • “A powerful combination of unique ingredients—Reconstruction Complex and Pro-Xylane, a patented scientific innovation—has been shown to improve the condition around the stem cells and stimulate cell regeneration to reconstruct skin to a denser quality.”
  • “See significant deep wrinkle reduction in UV damaged skin, clinically proven.
  • “A powerful combination of unique ingredients—Reconstruction Complex and Pro-Xylane, a patented scientific innovation—has been shown to improve the condition around the stem cells and stimulate cell regeneration to reconstruct skin to a denser quality.”
  • “Immediate lifting, lasting repositioning. Inspired by eye-lifting surgical techniques helps recreate a younger, lifted look in the delicate eye area.”   
  • “[U]nique R.A.R.E. oligopeptide helps to re-bundle collagen.”

What not to say on cosmetics

Any company showing at one of New Hope Natural Media’s Natural Products Expos or advertising with a New Hope publication (such as newhope360.com) must pass through the Standards Department, which evaluates cosmetic claims such as these. After reviewing the FDA letter to Lancome, the department offered this advice to cosmetics manufacturers to avoid such incidences.

The New Hope Standards Department follows the regulations set forth by the FDA for topical and cosmetic products. In the simplest terms, structure/function claims that are permitted for supplements (which must be ingested) are not permitted for topical or other cosmetics. The FDA’s warning letter to Lancome makes this point very clear.

Standards often refers to the FDA’s Guidance, Compliance and Regulatory Information entitled “Is it a Cosmetic, a Drug, or Both? (Or is it a Soap?). This is a great resource for determining the marketing claims for a cosmetic. The FDA defines cosmetics by their intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body... for cleansing, beautifying, promoting attractiveness, or altering the appearance."

Note that while cosmetics may alter the appearance of the body, they may not alter the structure or function of the body. For example, a company can claim that a product “reduces the appearance of fine lines on the face,” but can’t say that it “reduces cellulite and fat cells to slim down your thighs.”

Here’s a list of over-the-counter categories from FDA.

Takeaway for natural cosmetics companies 

The natural products industry has been largely focused on criticizing the absence of strict regulations set forth by the Food, Drug and Cosmetic Act, which doesn’t require premarket ingredient safety testing or enforce product recalls if a cosmetic is found to be dangerous.

But natural brands, just like conventional companies such as Lancome, need to be very aware of what this act does enforce: that a cosmetic cannot be marketed as a drug.

This issue is becoming increasingly relevant to this industry as more and more natural brands seek clinical research and focus on efficacy. Skin care, particularly antiaging skin care, is becoming one of the most promising categories in the natural personal care industry. 

Natural brands should continue to pursue research-backed ingredients and strive for finished-product clinical testing. But regardless of how effective the products are, learn from Lancome’s mistakes and market these products to meet FDA requirements.

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