A popular brand of cosmetics either must prove its products really do plump skin, regenerate collagen and lighten age spots, or stop claiming they do, the Food and Drug Administration said Wednesday.
The FDA said it had issued a warning letter to Reviva Labs over eight different products that also claim to clear up acne-prone oily skin, erase spider veins and help eradicate bruises.
It’s the latest in a series of actions the FDA has started taking against cosmetics companies in recent years. The FDA cannot regulate cosmetics when they’re sold just as cosmetics, but it can act when the makers cross the line in making medical claims.
In this case, the FDA says, New Jersey-based Reviva Labs is making medical claims for a batch of its products sold online and in stores.
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“The claims on your product labels and website indicate establish that the Nasolabial Fold Multi-Peptide Cream, Glycolic Acid Oily Skin Daytime Light Cream Moisturizer, Skin Lightener For Day Fade Cream, DMAE Firming Fluid, Collagen Regeneration Cream, Lighten & Brighten Dark Spot Serum, Spider Vein & Rosacea Day Cream W/Vitamin P, and Vitamin K Cream products are drugs under … the Federal Food, Drug, and Cosmetic Act,” the FDA said in a warning letter.
It cites claims such as: “results for lightening age spots or discoloration like never before” and “helping to fade dark spots”.
“Your above-listed products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are ‘new drugs’."
On its website, Reviva says its Nasolabil Fold + Multi-Peptide Cream is not just ‘excellent for wrinkles’. “ Special new peptides and additional ingredients can help increase the volume of fatty tissue. Thus, it can soften, plump up and help folds look less pronounced. Result? A more youthful look,” it claims.
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If it can do that, it has to register as a new drug and go through the formal approval process, the FDA said.
“Your above-listed products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are ‘new drugs’,” the FDA said.
Many cosmetics make these claims and dermatologists say simply rubbing a product onto the skin cannot make wrinkles go away or regenerate tissue. The best any over-the-counter product can do is help stop the skin from losing moisture and plain old petroleum jelly will do that.
“In addition to the above violation, our inspection revealed insanitary practices that may lead to insanitary conditions that may cause your products to become contaminated with filth or rendered injurious to health,” the FDA said.
Reviva President Stephen Strassler said the company had immediately addressed the "insanitary practices" issue -- which involved some plastic storage tubs and a small leak at a warehouse. He said Reviva was changing the wording on its website. "We are in the process of changing our copy and eliminating all claims to which the FDA refers," Strassler said in an email.
