FDA seems intent on demonstrating that companies large and small, as well as board-certified dermatologists, are susceptible to being slapped with warning letters for unapproved drug claims on products marketed as cosmetics.

The latest such warning letter posted to the agency’s website is addressed to Beverly Hills cosmetic surgeon Ronald Moy, creator of the DNAEGF Renewal protocol and 2011 president of the American Academy of Dermatology.

Currently a partner at Moy-Fincher-Chipps Facial Plastics & Dermatology medical group and a senior vice president at the Skin Cancer Foundation, Moy’s DNAEGF Renewal line features DNA repair enzymes and epidermal growth factor derived from a barley plant strain to “help regulate cell proliferation and health.”

According to DNAEGFRenewal.com, the line “marks the culmination of [Moy’s] passion to create a clinically proven regimen that effectively repairs photo-damaged aging skin.”

At least one item in the collection, however, is promoted with structure/function claims that identify the product as a drug, FDA says in a Feb. 12 warning letter recently published on its website.

DNA Eye Renewal, priced at $70 for 0.7 oz., is a “quick-absorbing formula [that] targets immediate eye-area concerns (dark circles, puffiness, fine lines, crow’s feet) and combats aging factors to rejuvenate delicate under-eye skin,” Moy’s site notes.

FDA holds that a number of ingredient claims for the product exceed recognized cosmetic benefits under federal food and drug law, including:

“Helps stimulate collagen production for added strength to the dermal matrix” (beta glucan);
“Control[s] inflammation” (willowherb);
“Inhibit[s] muscle fibers from contracting” (Spanish lavender);
“Stimulating the production of collagen, elastic, and hyaluronic acid and decreasing cell damage caused by glycation and inflammation” (Matrixyl 3000);
“Mimic[s] the activity of the youth hormone thymopoietin ... reinforcing the cutaneous immune defenses in the skin. ... Stimulate[s] the growth of new cells in the epidermis” (tetrapeptide).

“Your DNA Eye Renewal product is not generally recognized as safe and effective for the above-referenced uses and, therefore, the product is a ‘new drug’” requiring approval via FDA’s new drug application pathway, the agency asserts.

The warning to Moy/DNAEGF Renewal is the third published warning letter that FDA issued Feb. 12, with Strivectin and L’Oreal S.A. receiving the other two. The agency cited Strivectin for overreaching anti-aging skin-care claims and L’Oreal for statements about La Roche-Posay products’ ability to reduce redness and address hyperpigmentation Also see "Will Cosmeceutical Pioneer Turn Its Wagons Around? FDA Warns Strivectin" - HBW Insight, 11 March, 2015..

FDA’s enforcement activity in the cosmetics arena has picked up over the past four months, targeting companies with warnings largely for website claims that violate the Federal Food, Drug and Cosmetic Act.

Irvine, Calif.-based biotech firm Invitrx Therapeutics Inc., doing business as Cell Vitals, drew a warning in late November 2014 for claims made online, while DBA Essential Wholesale & Labs and Chaga Mountain, Inc. were targeted in November 2014 and January 2015 for website claims examined subsequent to facility inspections (Also see "‘Revolution’ Quelled? FDA Warns Firm For ReLuma Stem-Cell Claims" - HBW Insight, 3 December, 2014.and[A#02141215003]).

Linda Katz, director of the Office of Cosmetics and Colors, recently affirmed that cracking down on unapproved drugs marketed as cosmetics is a focus area for the agency Also see "FDA Remains Focused On Cosmetics Carrying Drug Claims – OCAC Director" - HBW Insight, 5 March, 2015..

At the same time, FDA is working to inform the public about the issue, publishing a consumer update to its website March 23 noting that “sometimes [cosmetic] promises go too far.”

In the update, the agency cites claims regarding increased collagen and elastin production, reduction of inflammation, regeneration of cells and gene-boosting activity among promotional statements FDA has identified in the cosmetic marketplace that flag products as drugs Also see "FDA Cautions Consumers On Cosmetics Carrying Drug Claims" - HBW Insight, 24 March, 2015..

Moy/DNAEGF Renewal had 15 days from receipt of the warning letter to respond with proposed corrective measures.

Industry and legal experts have noted in recent interviews with “The Rose Sheet” that warning letters can be costly and burdensome to resolve. However, they also acknowledge that cosmetics firms, particularly those with a stake in skin care, often are compelled to assume some level of regulatory risk in order to be competitive Also see "Regulatory Roulette: Playing In Today’s Skin-Care Market A Gamble" - HBW Insight, 17 March, 2015..

FDA Warns Former AAD President For DNA Eye Renewal Claims

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