FDA seizes $2m worth of confusing cosmetics
product, one of a new breed of beauty goods that fall into
regulatory no-man's land between drugs and cosmetics.
The Food and Drug Administration (FDA) ordered the seizure of 12,682 applicator tubes of Age Intervention Eyelash after declaring it to be an unapproved and misbranded drug. Age Intervention Eyelash contains ingredients present in prescription medicines and is therefore one of growing number of products that blur the boundary between drugs and cosmetics. The FDA said that manufacturer Jan Marini Skin Research (JMSR) had promoted the product as a means to increase eyelash growth, a claim that caught the FDA's regulatory radar. The regulator was also concerned that the product contains bimatoprost, an active ingredient present in an FDA-approved drug used to treat fluid pressure inside the eye. The regulator warned that patients using the approved drug along with the Age Intervention Eyelash product would be at risk of damaging their optic nerves because of the extra dose of bimatoprost. In addition, the FDA warned that the presence of bimatropost in Age Intervention Eyelash could be hazardous for certain people during normal use. The regulator said swelling of the retina, inflammation and reduced vision are among the possible side effects of using bimatropost. Age Intervention Eyelash contains ingredients present in prescription medicines and is therefore one of growing number of products that blur the boundary between drugs and a cosmetics. The issue raised by the seizure relates to the split responsibly of the FDA, which is finding the lines between drugs, cosmetics and foods becoming increasingly unclear as new product concepts hit the market. Unlike cosmetics, drugs are reviewed and approved by the FDA before reaching the market, which makes classification an important issue for manufacturers of boundary defying cosmeceuticals. FDA policy distinguishes between drugs and cosmetics on the basis of their intended use and so Jan Marini's claim that Age Intervention Eyelash increased eyelash growth meant that the regulator labeled it a drug. Given that the eyelash lengthening product had not been shown to be safe and effective the FDA decided to order the seizure. In response, manufacturer JMSR said the safety concerns were not substantiated by any studies offered by the FDA and insisted that the company had carried out tests that went way beyond those ordinarily carried out for a cosmetic product. Nonetheless, JMSR said it had stopped manufacturing and marketing Age Intervention Eyelash in September last year after the FDA ordered that it be embargoed. The discontinued product was stored in JMSR's warehouse in San Jose, California, until the seizure on Friday. "JMSR offered to destroy the product voluntarily, but the FDA recently informed JMSR that it preferred to seize the product so that it could issue a press release announcing the statement," said the company in a statement. After the FDA made its judgment last year, JMSR removed bimatropost, changed its marketing and released the reformulated product in February 2007.