FDA Warning To Skin Care Firm Shows Perils Of Cosmetics-To-OTC Transition

FDA's warning letter saying skin care product firm MW Laboratories marketed unapproved new drugs illustrates the potentially perilous transition from offering cosmeceuticals to marketing OTC drugs.

In a ¹ letter to the Savannah, Ga., company posted June 1 on FDA's website, the agency stated the firm's claims for numerous skin care products addressing acne, inflammation and scarring made the products unapproved new drugs that require pre-market approval via new drug application.

The letter submitted Dec. 9 addressed the company's Ocean Cosmeceuticals and Inflammation Rx acne products.

FDA also found the products are misbranded because they "do not bear the indications, directions and warnings required" by OTC drug monographs and because the labels failed to distinguish active from inactive ingredients.

Additionally, the agency cited "numerous deviations" from OTC good manufacturing practices during an inspection at the firm's manufacturing facility Dec. 9-11.

Firm Acknowledges Oversight

CEO Michael Warshaw said MW Labs has marketed skin care products for 25 years but "was not up to speed" on making claims for products addressing acne, arthritis pain and scarring.

Warshaw suggested the oversight stemmed from formulating new products with the same natural ingredients the company has sourced for years, but at higher concentrations and with different label and marketing claims.

He added that with most of the company's products marketed via word-of-mouth and with few complaints and no recalls, until now the brands and claims have not raised red flags with FDA.

By the standards of the Food, Drug and Cosmetic Act, the firm's claims suggest that use of the products is intended in the "diagnosis, cure, mitigation, treatment or prevention" of disease or to affect the structure or function of the body, which exceeds the definition of "cosmetic" and renders the products as drugs.

For example, in an online brochure for Rx Acne Care Lotion, MW Labs stated the product "offers a powerful combination of antioxidants, anti-inflammatory and healing agents that help reduce the stress and inflammation of the skin."

The brochure also stated the product "accelerates healing of sores and open lesions, promotes normal skin function and regulates sebaceous output."

The skin care marketer has reworked some of its online marketing claims and is preparing to submit revised labels that bring the products into compliance with OTC monographs, Warshaw said in an interview.

"We have answered their letter and have put in some controls for new equipment to do validation testing so we can be compliant with making those OTC [claims] and follow their guidelines for correct labeling," he said.

The effort includes designating on labels that some ingredients are active and others non-active, and adjusting the levels of active ingredients or adding others so the formulas comply with OTC monographs. "The challenge is some of the actives are not compatible with some of the additives that go into the cream," Warshaw said.

The products FDA cited for violative claims are Inflammation Rx Acne Care Lotion, Acne Cleanser, Deep Pain Care Cold, Deep Pain Care Hot, Deep Tissue Care, Post Op Lotion, Protection Lotion and Scratch Stopper; and Ocean Cosmeceuticals J Hansyd Acne Care Serum, Acne Care Lotion and Hand and Nail, according to the letter.

Among the first products that will be launched as OTCs are lotions for skin protection and healing, for pain treatment lotion and for bruising. Warshaw said he has not decided on brands for the products.

Some products, such as Inflammation Rx Post Op Lotion, are discontinued indefinitely. "Until I can figure out how I can redesign it to work with an active, that's what I'm doing," he said.

Emerging Cosmeceutical Regulation

FDA's warning to MW Labs tracks expectations that the agency would tighten scrutiny of cosmeceutical claims under Commissioner Margaret Hamburg.

The agency's regulatory approach is tied to the definition it uses to separate cosmetics from non-cosmetic products. The definition codified in the Food, Drug, and Cosmetic Act identifies cosmetics as "articles intended to be rubbed, poured ... or otherwise applied to the human body ... for cleansing, beautifying, promoting attractiveness or altering the appearance" (² (Also see "Cosmeceutical Claims May Be Headed Into FDA's Radar" - Pink Sheet, 10 Aug, 2009.)).

Further, dermatology researchers say there are gaps in data supporting topical vitamins' claims of prevention and treatment of skin aging, the basis for many claims made by OTC cosmeceuticals on the market (³ (Also see "Data Leave Holes In Cosmeceutical Vitamin Claims - Study" - Pink Sheet, 12 Apr, 2010.)).

Inspection Prompts Improvements

FDA's inspection of MW Labs documented "numerous" deviations from GMP regulations for finished pharmaceuticals in the manufacturing of OTC drug products.

Those violations included failure to test each component for conformity with all appropriate written specifications or perform an identity test, and to test each batch of drug product for satisfactory conformance to final specifications.

FDA said the firm also failed to "assure all drug products meet applicable standards of identity, strength, quality and purity at the time of use by establishing an expiration date."

Warshaw said the company addressed FDA's concerns. "We actually have more sophisticated instrumentation not just to make sure FDA is happy, but to make sure all herbs and extracts that come in here, to make sure they are the quality that suppliers say they are."

"So we are doing more checks now than ever before to make sure that everyone is honest and to make sure the quality is [what it claims to be]. We're very happy to have stepped up the bar to ensure quality across the board for cosmetic as well as OTC products."

- Eileen Francis