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Lashing Out: Hair Growth Makers Stir Controversy

Mally Roncal looked bright eyed, and enviably polished during a recent early-morning event at Henri Bendel, where she was updating editors on her cosmetics line, Mally Beauty.

Mally Roncal — celebrity makeup artist, beauty entrepreneur and mother of young twins—— looked bright eyed, and enviably polished during a recent early-morning event at Henri Bendel, where she was updating editors on her cosmetics line, Mally Beauty. Her secret for hiding fatigue? “False eyelashes,” she proclaimed. “They make me look awake and lifted.”

Roncal’s self-proclaimed eyelash obsession is beginning to be shared with a growing legion of consumers, who, after having perfected their pouts, are now turning attention to their eyes.

Last year, prestige mascara sales reached $294 million, surpassing lipstick sales — which totaled $286 million — for the first time, said Karen Grant, senior beauty industry analyst at The NPD Group. Mascara’s growth spurt makes it the third leading prestige makeup category, behind foundation and eye shadow.

“The lip is out, and there is nowhere else to go,” said beauty futurologist Jeanine Recckio, owner of the Mirror Mirror Imagination Group. “We are sick of lip plumpers, and we’re Botoxed to oblivion,” she added, explaining consumers’ interest in Bambi-like lashes.

Women’s renewed focus on the peepers have revived an old category, false eyelashes, and carved out a new, controversial one, eyelash growth products.

The controversy began in November when Allergan Inc., the maker of Botox, filed a patent infringement lawsuit against seven companies alleging that the firms were marketing and selling eyelash growth products with a prostaglandin (a category of compounds) called bimatoprost — the active ingredient in Allergan’s glaucoma drug Lumigan.

The current defendants in the suit include Cayman Chemical Co.; Jan Marini Skin Research Inc., which makes Age Intervention Eyelash Conditioner; Athena Cosmetics Corp., which sells RevitaLash; Intuit Beauty Inc., the manufacturer of MassiveLash, and PhotoMedex Inc., which sells MD Lash Factor. Civic Center Pharmacy, which markets Luxette, settled with Allergan, and DermaQuest Inc., the maker of DermaLash, was dismissed from the suit in December.

Sam Dhatt, founder of DermaQuest, said, “We were the only ones included in the lawsuit whose product did not contain pharmaceutical ingredients,” adding that Cayman Chemical, a supplier of biochemicals, provided the other beauty firms with the chemical in question, prostaglandin. The U.S. Food and Drug Administration combed through DermaQuest files earlier this month, and cleared the firm of the charge that it used drugs in its $90 DermaLash product.

This story first appeared in the February 8, 2008 issue of WWD.  Subscribe Today.

Cayman Chemical’s president, Kirk Maxey, M.D., said his firm — which supplies chemical compounds to the medical and beauty industry — is “pretty much the source of prostaglandins to all companies that need them,” including labs specializing in veterinary medicine and fertility. “That doesn’t mean that we know what companies are going to do with them.”

He commented that for decades it’s been widely known that prostaglandins enhance eyelash growth. Some companies claim that Allergan’s suit may be an attempt to clear out competitors, before it launches an eyelash growth product of its own. “Allergan is trying to do market cleansing,” said Maxey, adding that Cayman filed a dismissal motion on Jan. 31.

Jan Marini agreed, saying: “Allergan, the pharmaceutical giant, has sued virtually everyone in the marketplace….Allergan wants to be the only one to do that type of product.”

When asked if Allergan has plans to introduce a prostaglandin-driven hair growth formula, a company spokeswoman stated, “There are no new products to discuss at this time.”

Allergan may not be the only large company with an interest in the niche segment. On Nov. 13, L’Oréal was granted a U.S. patent for a compound called heterocycle that promotes the growth of hair or eyelashes and slows hair loss.

When asked if the FDA is investigating the companies named in Allergan’s lawsuit, spokeswoman Stephanie Kwisnek stated that it is the FDA’s policy not to discuss whether a company is the subject of an investigation. She noted that products that claim to be able to grow eyelashes would need premarket approval and be regulated as drugs because they affect the structure or function of the body. If approved, however, the product could be sold in the cosmetics aisle. That said, companies often can avoid FDA scrutiny by using softer claims, such as “may grow eyelashes.”

“We have to keep a fine line between drug and cosmetic benefit,” acknowledged Dhatt of DermaQuest.

Jan Marini’s Age Intervention Eyelash Conditioner, a product initially containing bimatoprost, hit the market in November 2005. “After a couple of months, people could start to see that this was a very different type of product and it skyrocketed,” said Marini, who wouldn’t discuss sales figures.

The same month two years later, the FDA targeted Age Intervention Eyelash Conditioner as an “unapproved and misbranded drug,” and seized nearly 12,700 applicator tubes valued at approximately $2 million retail. In a statement, the FDA said Jan Marini Skin Research had promoted the product by claiming it could “increase eyelash growth.”

The FDA listed possible side effects in its statement, as well, but Marini insisted it wasn’t the possible side effects or bimatoprost, per se, that was the direct rationale for the FDA action. Instead, she said it was her description of the ingredient as “an eyelash growth factor,” a term modeled upon “growth factors” frequently seen on skin care labels, that the FDA viewed as breaching cosmetic regulations. She removed the term from the product.

“Bimatoprost is on a drug label. That technically shouldn’t make a difference. The FDA states an ingredient can either become a drug or a cosmetic depending on the claims. An ingredient is not a drug unless you use it as a drug,” explained Marini. “We are not making claims, and we do have excellent safety studies, so there really shouldn’t be an issue.”

Responding to the FDA, Marini opted to reformulate Age Intervention Eyelash Conditioner and released a second-generation product in February 2007 with a customized prostaglandin analogue that she stressed “had never been on a drug label.”

Athena Cosmetics, maker of RevitaLash, took the same course and suspended its initial RevitaLash product from the market for a matter of weeks to switch over to a different prostaglandin.

“The FDA had taken an action that was causing consumers to be concerned about safety. Athena Cosmetics made a significant financial decision to withdraw a product that was by all accounts safe to restore public confidence in their product,” said Carol Pratt, an attorney for RevitaLash-maker Athena with Kirkpatrick & Lockhart Preston Gates Ellis in Portland, Ore. “The original formula had bimatoprost in it. The current formula has a compound that is in the general family of prostaglandin.”

Marini ultimately pulled Age Intervention Eyelash Conditioner from the U.S. market entirely last month due to the complications of selling here, although she continues to distribute the product abroad.

“It takes on the average about 24 months to get a patent infringement lawsuit into the court. It can take $3 million to $8 million. You can spend all that money and effort and during that time, and you don’t know what the FDA is going to do,” explained Marini of her decision to discontinue U.S. sales.

Another defendant in the Allergan lawsuit, Civic Center Pharmacy, followed the Marini route by ending the sale of its Luxette product.

“We settled with Allergan,” said Jeffrey Kaufman, an attorney for Civic Center Pharmacy owner Ari Schafer. “He frankly didn’t do enough business in this area to make it worthwhile for him to fight it one way or the other. He just agreed to stop using the allegedly counterfeit product.”

Peter Barton Hutt, an attorney specializing in food and drug law at Covington & Burling in Washington, said that, despite Allergan’s suit and FDA action, eyelash products with prostaglandins would continue to proliferate. “There are at least four other eyelash conditioner products with prostaglandins out on the market today. All of them went to a prostaglandin other than the one that was in Jan Marini’s original product. They did that just to avoid any kind of an FDA issue,” he said. “I think we are going to see more because the FDA has taken no action against them.”

Products that fortify the look of eyelashes — regardless of their shape and form — are in high demand at retail. Sephora’s customers are asking for them, said Betsy Olum, senior vice president of marketing for Sephora. Sephora currently sells Talika’s Lipocils Eyelash Conditioning Gel, ModelCo Lash & Brow Growth Stimulator and Anastasia GoBrow (formerly NuBrow). Olum said she sees lots of opportunity in the eyelash enhancement category.

“In general, eye looks have been the most popular trends season to season,” said Olum. “Consider the smoky eye, for example, which is now a year-round staple. Long lashes are universally flattering and give a more youthful look, which is why new products to accentuate them are constantly hitting the market.”

Henri Bendel plans to add a Laura Mercier eyelash bar to its beauty floor later this month. The five-foot counter has a pull-out desk, where clients can sit opposite a beauty associate to have false lashes applied, and a pull-down mirror for lessons on how to apply them.

“In the Sixties, false eyelashes were absolutely prolific,” said Claudia Lucas, senior vice president and general merchandise manager at Henri Bendel. Today, “lots of women are interested in applying lashes, but have no idea how to do it. We can provide them a service where they can get their lashes done, and learn how to apply them.”

Lucas said the boutique had begun selling RevitaLash about a year ago, but six months ago, Athena Cosmetics, the maker of the eyelash conditioner, decided to pull the product from retail stores and exclusively distribute to spas. Lucas said she assumed that the firm felt the product — designed to be applied to the base of the upper lashes at bedtime — wanted an environment where associates could provide education on how to properly use it. “But we’re a high-service, high-touch store,” she said. “RevitaLash was certainly well received. We all tried the product and everyone was raving about it.”

Meanwhile, several companies that market products without prostaglandins report that retailers are searching for alternative eyelash enhancers to satiate mounting customer demand.

“People definitely have called because they are concerned about the [Age Intervention Eyelash Conditioner] side effects. It has helped us because they find out that our product is natural. We don’t use those [prostaglandin] ingredients, and we never have,” said Mary Ershadi, president of Rozge Cosmeceutical. The company’s Renew Eyelash Revitalizer, which retails for $80 to $130 is carried in about 300 doctors’ offices, spas and salons.

French company Talika launched in the U.S. two years ago with its Lipocils Eyelash Conditioning Gel, and recently has notched 40 percent month-over-month sales increases in this country, according to Talika president Alexis de Brosses. The Lipocils product, which is based on natural ingredients and sells for $40, is in about 400 doors, including Sephora and HSN.

Swiss company Mavala’s product, Double Lash, has been available in the U.S. for about 24 years, but Richard Nelson, president of Mavala’s U.S. distributor, hadn’t noticed much competition in the eyelash treatment arena until two years ago. “We had always had increases in that product, but for two years it has been phenomenal,” said Nelson. He reported sales of Double Lash, which costs around $16.50 at 500 stores nationwide and is formulated with natural compounds, have doubled in the last two years. Nelson doesn’t see interest in the lash category ebbing anytime soon. “Once the door or the eyes have been opened, I see it as a continuing situation,” he concluded.

Lucas of Bendel’s observed, “Isn’t it so funny that we work so hard to get rid of hair in certain places by zapping and tweezing, and yet want to grow it in other places?”

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