An updated page on FDA's website compiles warning letters issued to firms for unapproved drug claims on products marketed as cosmetics, including the latest to Pharmagel International, and offers insight into the harder line the agency is taking on anti-aging skin-care claims in recent years.

The page – "Warning Letters Address Drug Claims Made for Products Marketed as Cosmetics" – appears in the cosmetics section of FDA's website and was updated July 7 with the Pharmagel warning.

It traces warning letters issued as far back as a decade ago, which collectively "illustrate an important legal distinction, the difference between a cosmetic and a drug," the agency says.

Notably, the bulk of the warnings went out to companies starting in 2012, and the majority target marketers for skin-care claims.

In the case of Chatsworth, Calif.-based Pharmagel, FDA cites the firm for claims ranging from anti-inflammatory statements to assertions regarding sun-damage repair, acne relief, wound healing and cellulite reduction, all of which promote uses that identify its products as unapproved drugs under the Federal Food, Drug and Cosmetic Act, according to the agency.

Products at issue include the company's Beta-C "super anti-aging complex," Bio-A Concentrate for "age-minimizing effects," Eye Firme, Pharma Clear Medicated Moisturizer and Slender Shaper, according to the May 22 letter, which posted to FDA's cite in early July.

By its name alone, Pharmagel may have invited scrutiny of its products and their regulatory status. The firm bills its offerings as "pharmaceutical grade anti-aging skin care."

According to its website, pharmagel products contain pharmaceutical-grade ingredients "rarely seen in cosmetic formulations" that "are remarkably effective and have immediate and lasting results."

For example, Eye Firme contains panthenol, which "promotes the regeneration of damaged skin," allantoin, which "helps heal wounds," and Echinacea, which "stimulates white blood cells [and] enhances the immune and lymphatic system," the firm claims.

Pharma Clear is formulated with copper peptide, a "powerful skin regeneration agent that effectively treats acne" while also stimulating collagen and elastin formation, it says.

Meanwhile, Slender Shaper is described by the company as a formula rich in DMAE, alpha lipoic acid, seaweed extract and "high-potency herbal actives" that "wake[s] up circulation" and causes "fatty areas of the body, neck and chin melt away as fat and water are excreted from skin cells."

Body-shaping claims regarding reduction of cellulite and stretch marks were included among violations highlighted in the earliest warning letters to appear on FDA's roundup.

Basic Research, LLC (then distributor of the Strivectin cosmeceutical brand) and Hydroderm Beverly Hills were hit with warnings in January and September of 2005.

The Strivectin-SD marketer's offending claims included promises to "repair" stretch marks, diminishing their appearance in terms of "length, depth, texture and discoloration," as well as "reduce wrinkles by as much as 68%" and "improve" scars from acne, burns, chicken pox and old injuries. Basic Research also compared its product to pharmaceutical Botox, a marketing strategy that FDA has made a point of stamping out.

Hydroderm claimed its Body Shape Cellulite Toning Lotion could "decreas[e] the fat layer on certain parts of the body … dehydrating the fat cells, reducing that 'cottage cheese' appearance," while suggesting that its Fast-Acting Wrinkle Reducer "may reduce wrinkle length and width nearly by a combined 50%."

Slimming claims and related body-shaping statements for topical skin-care products are well-known no-noes by now. In addition to FDA, the Federal Trade Commission has made such claims an enforcement priority Also see "FTC Settles With DermaTend, DERMAdoctor Firms For Unsupported Claims" - HBW Insight, 5 January, 2015..

References to disease treatment and conditions covered by FDA's over-the-counter drug monographs, such as acne, are recognized risks in cosmetic marketing as well when products deviate from ingredient use generally recognized as safe and effective.

A warning letter issued to Freedom Plus Corporation in March 2007 cited claims around acne and wound healing, as well as suggested product use for treating psoriasis, a condition covered by its own OTC drug monograph.

It's no secret that cosmetic firms claiming to physically reduce wrinkles, rather than the "appearance" of wrinkles, also are playing with fire.

Collagen, Elastin Claims In FDA's Crosshairs

FDA was cracking down on collagen- and elastin-building claims as well in the earliest letters it highlights. However, at that time, such claims seemed almost incidental to the main enforcement message the agency was sending about more serious violations, such as disease-treatment statements.

Compare Strivectin's 2005 letter with FDA's warning to the company a decade later.

The first warning letter pointed to some 50 claims across five products, including Mamralin-ARa, touted as "the best way to avoid diet-induced breast sag and shrinkage," and TestroGel, a "verified alternative to prescription performance enhancers" that could improve sexual stamina and lead to "more muscle mass, more strength and less body fat," according to the firm.

Among such claims, statements about collagen synthesis were virtually lost and seemed tame by comparison.

The more recent letter to the company, dated Feb. 12, 2015, offered just six examples of claims – four of which deal with elastin and collagen stimulation – for two products the agency says violate the FDCA Also see "Will Cosmeceutical Pioneer Turn Its Wagons Around? FDA Warns Strivectin" - HBW Insight, 11 March, 2015..

Granted, the agency may have less patience with repeat offenders, and greater incentive to target them with follow-up enforcement measures.

However, a March 31, 2015 warning to Beverly Hills cosmetic surgeon Ronald Moy, creator of the DNAEGF Renewal protocol, also zeroed in on collagen- and elastin-production claims among five examples in total. The marketing pertained to a single product, DNA Eye Renewal, which may have drawn attention initially because of its name, with gene-related claims on FDA's radar Also see "FDA Warns Former AAD President For DNA Eye Renewal Claims" - HBW Insight, 31 March, 2015..

California-based companies Skin Authority, LLC and Cell Vitals also have received warnings in 2015 for collagen-related skin-care claims, among others Also see "FDA Shows Skin Authority Who’s Boss With Warning For Drug Claims" - HBW Insight, 7 April, 2015..

L'Oreal USA claims for two La Roche-Posay products were central to a warning letter issued by FDA in February. According to the agency, claims touting benefits related to redness reduction and hyperpigmentation render products unapproved drugs.

Generally, FDA seems intent on demonstrating a zero-tolerance policy when it comes to skin-care claims suggesting effects beyond moisturizing and the cleansing and beautifying benefits expressly permitted by the FDCA.

The agency's stance challenges further growth in the anti-aging skin-care market on the basis of escalating benefit claims ([A#02150713005]).

FDA Warns Pharmagel, Updates Webpage On Drug-Claim Violations

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