Forty lashes for a cosmeceutical company

I wrote about the general issue of eyelash-enriching "cosmeceuticals" on my Terra Sigillata back in July. Increasing the number and thickness of eyelashes is not some hokey magical wish - it is a known side effect buried in the prescribing information for the prescription glaucoma drugs, bimatoprost (Lumigan®) and latanoprost (Xalatan®).

Last Friday, the US FDA seized a product called Age Intervention Eyelash at the San Jose facility of Jan Marini Skin Research, Inc., citing that the product contained an unapproved drug and could be harmful to the user's vision.

When composing my post in July, I understood that products like Age Intervention and Revitalash contained active compounds that were similar, but not identical, to the Rx drugs that cause the eyelash-enhancing side effect. However, the FDA has clearly acted on other companies attempting to skirt the law by putting Rx drug analogs in their supplement products, especially erectile dysfunction supplements. FDA now claims that Age Intervention Eyelash contained the actual drug, bimatoprost.

Cosmeceuticals are an unusual area for FDA regulation as the products straddle the lines between drugs, supplements, and cosmetics. For the record, FDA does not officially acknowledge the cosmeceutical product class:

The FD&C [Food Drug and Cosmetic] Act does not recognize any such category as "cosmeceuticals." A product can be a drug, a cosmetic, or a combination of both, but the term "cosmeceutical" has no meaning under the law.

So, the FDA acted on the maker of Age Intervention using the power of its drug enforcement policy.

Makers of eyelash-enhancing products may have perhaps reasoned they could stay on the right side of the FDA by offsetting their claims with the usual disclaimer for supplement products required under the 1994 Dietary Supplement Health and Education Act. As I noted previously, I had to hunt for this disclaimer on the Revitalash® site whereas the target of the current FDA action at least had the disclaimer right on their front page. Apparently this disclaimer was not adequate.

But, as noted in a press release from Jan Marini Skin Research, it is interesting that the FDA acted only on this manufacturer and not others with a greater market share. Interestingly, the maker of Revitalash, Athena Cosmetics, issued a press release yesterday distancing themselves from the Age Intervention seizure.

There is yet more to this story. According to a report yesterday in the Wall Street Journal (and as posted on the free-access, WSJ Health Blog), the company that makes Lumigan, Allergan, recently filed lawsuits against several companies selling these eyelash-enhancing products, claiming a violation of their Lumigan patent. The WSJ also cites a doctor whose patients working at Allergan claim the company is currently conducting clinical trials to gain approval for the eyelash-enhancing drug indication.

Using today's side effects to create tomorrow's therapies is nothing new. The prescription vasodilator, minoxidil, that was found to cause inappropriate hair growth; when formulated in a topical product, voilà, Rogaine!