FDA closes out 2015 with two warning letters to doctor-founded skin-care companies, signaling that overreaching website claims identifying purported cosmetic products as unapproved drugs likely will remain on FDA's radar going into the new year.

The recipients, Cosmetic Dermatology, Inc. and Episciences, Inc., market their respective dr. brandt and epionce lines with authoritative dermatologic positioning.

Dr. Brandt skin care is described as the "natural evolution" of late celebrity dermatologist Fredric Brandt's professional practice and clinical research. "He created a technologically advanced skin-care line to repair and prevent damage to the skin, while making it healthy and beautiful," the company explains on its website.

Episciences, founded and led by Fruitland, Idaho-based CT Derm practitioner Dr. Carl Thornfeldt, sells its "highly effective, non-prescription dermatological product line" through dermatologists' offices, plastic surgeons and other skin-care professionals."

The Safe Cosmetics Modernization Act proposed in the US House would revise the regulatory definition for "cosmetic" in a way that could permit collagen-boosting claims such as those cited in the dr. brandt warning letter.

Both brands emphasize clinical research in their messaging to consumers.

Dr. Brandt notes that its founder's Miami-area Dermatology Research Institute performs pivotal clinical trials for multinational pharmaceutical and medical-device companies, as well as research on cosmetic ingredients and treatments.

"For you, this means direct access to the latest innovations and revolutionary treatments for beautiful, healthy skin," the brand says.

According to Episciences, "Epionce products are rooted in hard science," buttressed by clinical tests that "are unique in the industry as they adhere to the highest standards for clinical studies."

The firm elaborates: "We go beyond the traditional qualitative (i.e., how people think they feel) clinical results that most cosmetic companies follow, to scientifically validated quantitative (i.e., what the trained investigator can definitely measure) clinical results."

However, no amount of professional medical backing or airtight clinical study results changes the fact that companies promoting cosmetics with disease or structure/function claims are in violation of the Federal Food, Drug and Cosmetic Act, which renders such claims the exclusive prerogative of approved drug marketers.

In its Dec. 2 warning letter to Episciences' Thornfeldt, FDA says statements at Epionce.com suggest that its products are intended to treat a range of skin diseases and other conditions, including acne, dermatitis/eczema, diabetes-related symptoms, hyperpigmentation, keratosis pilaris, psoriasis, radiation dermatitis, rosacea and skin aging.

The agency points specifically to a page of the website titled "How Epionce Helps" – which appears to have been taken down, as of Dec. 16 – that listed such ailments and linked to other pages recommending Epionce products as part of a treatment regimen.

For example, the company positioned its Milky Lotion Cleanser, Lytic Gel Cleanser "for very scaly and/or infected skin" and Extreme Barrier Cream as potential relief for eczema sufferers. Specific claims on those products that flagged them as unapproved drugs from FDA's perspective included:

"Epionce is the perfect solution to quickly hydrate and restore skin barrier function while reducing inflammatory factors that worsen the symptoms of eczema. Regular use helps reduce the severity of dryness, scaling and itching.”
“Using a topical anti-inflammatory and barrier repair system like Epionce can help improve barrier function by restoring the correct ratio of key fatty acids found in healthy skin.”

Episciences proposed that similar selections of its products could be beneficial components of regimens for Improving psoriasis symptoms – "Epionce is the perfect solution to help relieve the symptoms of psoriasis," the company says – or as treatments for diabetes patients. Specifically, the firm claimed:

“Epionce is the perfect solution to help improve the visible skin conditions associated with diabetes.”
“Regular use of a topical anti-inflammatory … like Epionce strengthens the skin’s natural ability to repair and protect itself. A healthy skin barrier will help reduce the severity of skin conditions that are common with diabetes."

Epionce Lite Lytic Tx, among other offerings, can be useful for rosacea sufferers, the company suggested, noting that its formula "improves the skin by reducing redness/flushing, irritation and bumps.”

Finally, regimens for improving radiation dermatitis could be enhanced with Epionce offerings including Medical Barrier Cream, the firm indicated. It characterized recommended protocols as "the perfect solution to help prepare and improve skin function before, during and after cancer therapy."

FDA cites other resources linked through the Epionce website – including clinical trial summaries – as well as the brand's Facebook page, as bearing further evidence that its products are intended for use as drugs.

Agency Cites 27 Dr. Brandt Products

FDA issued a warning to Cosmetic Dermatology/dr. brandt Dec. 3, identifying a laundry list of the company's products as unapproved drugs due to associated disease-treatment and structure/function claims.

The large number of cited products – 27 in total – is primarily due to how the brand's website is organized. Using the brand's "Shop by Concern" tab turns up numerous products for each complaint, along with general information about how dr. brandt formulas can be useful in addressing the complaint. FDA appears to have attributed embedded claims that it deemed overreaching to all products featured on the page.

For example, searching the website for "dry skin" solutions takes shoppers to a page showcasing an ample selection of dr. brandt products – including Do Not Age with dr. brandt dream night cream, oxygen facial flash recovery mask, extend your youth dual fusion water and BB cream with signature FLEXITONE – which FDA connected to the claim "Seborrheic dermatitis can lead to dry patches, itchy skin, flaking and/or scaling."

Similarly, browsers concerned about "mature skin, deep wrinkles" land on a page with information about why wrinkles form and how dr. brandt ingredients and products address them, as well as shoppable links to around 20 of the brand's offerings. FDA isolated one claim in particular, which seems to have been removed: "Advanced collagen boosters and Botox alternatives that actually work."

The agency relates the company's glow line to a similar collagen-boosting statement. Claims regarding increased collagen production and variations on the theme have been highlighted in other warning letters to cosmetic companies, including doctor skin-care brands, in 2015 Also see "FDA Warns Former AAD President For DNA Eye Renewal Claims" - HBW Insight, 31 March, 2015..

Trade group Independent Cosmetic Manufacturers and Distributors is among industry stakeholders seeking greater flexibility for structure/function claims on cosmetics. The proposed Safe Cosmetics Modernization Act, introduced in November by Rep. Pete Sessions, R-Texas, with ICMAD's support, would revise the regulatory definition for cosmetics in the US to include articles that "temporarily" have structure/function effects on skin, which could allow for collagen-stimulating claims ([A#02151130001]).

Other dr. brandt lines and products named in the warning letter run afoul of the FDCA, the agency says, due to claims such as:

"Helps breakdown fat deposits" (Cellusculpt)
"Repairs damaged skin” (Do Not Age with dr. brandt triple peptide eye cream)
“Will protect it from inflammation… and inhibit bacterial reactions” (xtend your youth dual fusion water)
"An emergency solution for post laser, peeling or injections” (Save Our Skin)
“Antibacterial action” (pores no more pore refiner primer)

Finally, FDA finds that dr. brandt dark circles away is marketed in violation of the law due to statements suggesting that the product "helps fade dark circles by stimulating microcirculation," "reduces puffiness by draining excess fluids" and "helps reduce under-eye bags by breaking down abnormal fatty deposits."

Cosmetic Dermatology and Episciences each have 15 days from receipt of their warning to respond to FDA with planned corrective actions.

FDA issued warning letters to cosmetic firms in at least seven months of 2015 for safety and labeling violations and use of unapproved color additives, in addition to overstepping product claims.

FDA's Naughty List This Holiday Season Includes Doctor Skin-Care Brands

More from Archive

More from HBW Insight