FDA Warns Another 'Stem Cell' Skin Care Marketer On Drug Claims

Stem cell-related claims on cosmetics may capture consumers' imagination, but they are grabbing FDA's attention as well. Hollywood Skincare International, which markets its DermaSet Stem Cell 3D Renewal cream online, is the latest player in this game to receive a warning letter from the agency.

Cosmetic products with "stem cell" in their names continue to draw FDA scrutiny and may even be a focus of its keyword searching as it monitors the web for unapproved drug claims.

Hollywood Skincare International Inc., marketer of the DermaSet Stem Cell 3D Renewal cream, is the latest company to receive an FDA warning letter for structure/function claims on its website identifying its offering as an unapproved drug in the agency's view.

The Hollywood, Fla., company describes DermaSet as "a specially formulated emulsion designed to release powerful plant stem cells and organic elements [to] provide deep moisture, visibly firmer skin … even skin texture and a visibly smoother 'air-brushed' appearance."

FDA's warning, issued in April and posted to the agency's website June 8, highlights the company's "Removes wrinkles instantly" claim, which clearly communicates a drug if not magical effect.

The agency also cites claims promoting the anti-aging cream's active ingredients for intended uses that have not been determined generally recognized as safe and effective (see table).

The claims touch on use indications that associate DermaSet with OTC monographs, including statements about UV protection and skin lightening. Others purport benefits that FDA considers body structure/function effects, such as collagen production, aligning DermaSet with the regulatory definition of a drug.

Ingredient Claims Cited By FDA In Hollywood Skincare Warning Letter
Sea Fennel Stem Cell	"Has the effect of lightening the skin"; "Tests … have shown a clear reduction in uneven pigmentation"; "…offering protection against UVB-induced free radicals."
Apple Stem Cell	"Provides amazing benefits to our skin by … stimulating regeneration of cell tissues."
Dimethylmethoxy chromanyl palmitate (Chromabright)	"DHP is a new synthetic peptide that has revolutionized the process of skin lightening"; "[E]liminating the harsh effects that were once associated with previous lightening procedures"; "Reverses the signs of aging caused by UV rays."
Palmitoyl oligopeptide & palmitoyl tetrapeptide 7 (Matrixyl 3000)	"Increases cell communication and gene activation for the skin healing; thus it plays a fundamental role in the reconstruction of the skin tissue."
Acetyl hexapeptide 8 (Argireline)	"Works in a similar way to Botox treatments"; "AH8 blocks the message that commands the face to tense up, thus interfering with the message being sent to the brain. In doing so, the facial muscles remain relaxed, and wrinkles are kept at bay."
Tetrahexyldecyl ascorbate (BV-OSC)	"A super anti-oxidant … eliminates age spots, contains protection from ultraviolet A and B and boosts collagen synthesis."

All of the claims appeared on Hollywood Skincare's website. FDA increasingly has been scanning the web for overreaching cosmetic claims and issuing warning letters accordingly, a strategy that enables the agency to assert its enforcement authority with minimal resource expenditure.

Stem-cell references and health claims for cosmetic products have proliferated in recent years. While suggesting powerful anti-aging effects and advanced technology use that may excite consumers' imagination – even when the stem cell source is a plant – the buzzword seems to be capturing FDA's attention as well.

The agency warned Crescent Health Center Inc. in April for website claims promoting its Ageless Derma Stem Cell and Peptide Anti-Wrinkle Cream (Also see "FDA Warning Cites Ageless Derma's Anti-Wrinkle, Brightening Claims" - HBW Insight, 9 May, 2016.).

L'Oreal S.A. for ReLuma and Cell Vitals for Lancome also have drawn warnings for stem cell-related claims on skin-care offerings (Also see "‘Revolution’ Quelled? FDA Warns Firm For ReLuma Stem-Cell Claims" - HBW Insight, 3 Dec, 2014.).

Hollywood Skincare sells DermaSet through an automatic enrollment program that offers the product to consumers for a 30-day trial period at the cost of shipping and handling. Unless customers cancel through the company's customer care department, their credit cards are charged $179 at the end of the trial period and ongoing every 30 to 60 days for automatic reorders and shipments.

The "negative option" model is subject to a Federal Trade Commission requirement for clear and conspicuous disclosure of billing terms, and the agency in recent years has stepped up enforcement to crack down on violations.

Companies with negative-option platforms also are being targeted by a growing number of class actions in California and other states that have passed legislation to protect consumers against deceptive programs that charge them for continuing product shipments without their express consent (Also see "Cosmetics E-tailers At Risk Amid Trending Auto-Renewal Class Actions" - HBW Insight, 16 Apr, 2015.).

[Editor's note: "The Rose Sheet" also published this article. "The Tan Sheet" brings selected complementary coverage from our sister publications to our subscribers.]