An April 18 FDA warning letter to Lifetech Resources LLC demonstrates that cosmetics firms will be held accountable when their websites feature third-party claims and testimonials that cross into drug marketing territory.

The agency takes issue with claims made on the firm’s websites for eyelash and eyebrow growth brands RapidLash, NeuLash and NeuveauBrow, that make their products unapproved and misbranded new drugs.

By FDA’s definition, drugs are articles intended to affect the structure or function of the body, whereas cosmetics are products applied for the purposes of cleansing or beautifying. “Inducing eyelash and eyebrow growth” would qualify a product as a drug under those terms, the agency says.

In a statement, Chatsworth, Calif.-based Lifetech says the items in question “are not claimed to be growth-inducing drugs”; rather, they are “cosmetic conditioners designed to improve the appearance of eyelashes and eyebrows,” the firm says.

But FDA points to statements made online that suggest the products’ effects are more dramatic. For example, the company claims that “this formula is designed to lengthen and thicken lashes in 30 days. Your lashes and your eyebrows grow thicker and faster.”

Testimonials include: “I began to notice a change with my eyelashes in less than 4 weeks of using it. In 6 weeks, my eyelashes were back to the original length of my younger days” (see table for more extensive list).

Overreaching Eyelash-Enhancer Claims

“This formula is designed to lengthen and thicken lashes in 30 days. Your lashes and your eyebrows grow thicker and faster”
“I began to notice a change with my eyelashes in less than 4 weeks of using it. In 6 weeks, my eyelashes were back to the original length of my younger days”
“After eight weeks my lashes were curlier, darker, longer and thicker than before”
“It took about 6 weeks for me to see anything, but lo and behold, I looked in the mirror one morning and saw MANY new hairs filling in my brows”

Lifetech maintains that the majority of the targeted claims were made by third parties and that the firm “does not endorse any claims that may be construed as misleading or exceed those made by our company.”

It adds: “Nevertheless, we at Lifetech Resources bear the responsibility for any and all statements made, publications and other communications about our products.”

Measures are being taken to ensure that no company affiliates make claims that could mislead consumers about the “capabilities” of its products, Lifetech says.

RapidLash sells online for $49.95 for 0.1 oz. NeuLash is available in 0.1 oz. and 0.2 oz. sizes for $85 and $150, respectively, while NeuveauBrow costs $100 for 0.2 oz.

NeuLash and NeuveauBrow are also carried by upscale department stores, such as Saks Fifth Avenue, Neiman Marcus and Bloomingdale’s.

Latisse-Like Active Ingredient Raises Flags

RapidLash, NeuLash and NeuveauBrow also run afoul of cosmetic regulations because they contain an Rx active ingredient – isopropyl cloprostenate (Also see "In Brief" - HBW Insight, 25 April, 2011.).

Isopropyl cloprostenate is one of a class of synthetic prostaglandin analogs, which “are well known to have an effect on the structure or function of the body,” according to FDA.

The compound is related to bimatoprost, the active ingredient in Allergan’s Lumigan drug, indicated to lower intraocular pressure in glaucoma patients, and in the pharma giant’s Latisse drug for treating “inadequate” eyelashes, which it developed after Lumigan users began reporting an unexpected side effect – eyelash growth.

The presence of a prostaglandin analog in Lifetech’s products, coupled with the company’s aggressive claims, make its eyelash enhancers misbranded and unapproved new drugs, FDA says.

Interestingly, the agency cited Allergan in 2009 for promoting its newly approved Latisse drug too much like a cosmetic without due mention of the risks it carries (Also see "FDA Cites Latisse Web Site For Implying Eyelash Growth Drug Is A Cosmetic" - HBW Insight, 28 September, 2009.).

Allergan has been vigilant in enforcing its patents associated with bimatoprost, filing infringement suits in past years against cosmetics companies including Jan Marini Skin Research.

Around the same time, JMSR took a hit when FDA seized more than 12,000 tubes of its bimatoprost-based Age Intervention Eyelash product for being unapproved and misbranded drugs. Ultimately, the company determined peptides a safer route than prostaglandins, launching Marini Lash Eyelash Conditioner for “extraordinary eyelash and brow enhancement” (Also see "Jan Marini Explores Anti-Aging Hair-Care Frontier With Revamped Conditioner" - HBW Insight, 8 September, 2008.).

Not wanting to be boxed out of the trendy eyelash enhancement category altogether, other firms have begun formulating products with peptides to enhance lashes while staying within cosmetic bounds.

Recent entrants include Beauty Biosciences with Lash Allure MD, Markwins’ wet n wild brand with MegaLash Clinical Serum and MegaLash Clinical Mascara, and MyChelle Dermaceuticals with Ultimate Lash and Brow Serum Also see "Held Off By Latisse, Lash Allure Touts Results In A Blink At Low Price Point" - HBW Insight, 2 November, 2009.; Also see "Markwins' Wet N Wild To Offer Value-Priced Lash-Growth Products In 2011" - HBW Insight, 21 June, 2010.; and Also see "MyChelle To Answer Natural Product Efficacy Questions With Imaging System" - HBW Insight, 21 March, 2011.).

Some are already capitalizing on FDA’s warning to Lifetech, touting their products as “prostaglandin-free” and “drug-free.” Instead of drugs, Chella Skin Care’s new Lash Full-Fillment Conditioning Treatment contains amino acids, vitamins, peptides, bio-based molecules and antioxidants, while QB Labs’ bioLASHX3 features bioBOOST Complex, a blend of bio-available pentapeptide, marine vegetal actives and ginger root extract.

Product Risks Not Clearly Delineated – FDA

Lifetech’s failure to note on product labeling the risks incurred in using RapidLash, NeuLash and NeuveauBrow also misleads consumers, FDA asserts.

The potential consequences of product use are not adequately presented, the agency says. Possible adverse events include ocular irritation, hyperemia, iris color change, macular edema, ocular inflammation and “interference with intraocular pressure reduction therapy,” according to FDA.

On the website for RapidLash, Lifetech notes that the product “is not intended to darken the skin” but “a small number of consumers have reported a faint darkening of the lash line, similar to eyeliner.”

Lifetech advises consumers to discontinue product use “if the effect bothers you.”

FDA holds that RapidLash and NeuLash should be prescription drugs because they are “not safe for use except under the supervision of a practitioner licensed by law to administer them.”

The agency directs Lifetech to take “prompt action” and to inform the agency within 15 days of the April 18 letter of the steps it is taking to correct the violations.

Lifetech says it “is and will continue to cooperate and fully comply with the FDA in this matter.”

By Lauren Nardella

FDA’s Warning To Lash-Growth Firm Shows Risks In Third-Party Claims

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