Jan Marini finally bats an eye at FDA, Allergan

We've discussed in July and November 2007 about cosmetics companies taking advantage of the observation of an interesting side effect of certain anti-glaucoma eyedrops - they increase eyelash number and thickness. In the cosmetics industry, this is a big deal such that consumers are willing to pay US$149-160 per unit of Revitalash or Age Intervention Eyelash Conditioner.

Here's the pharmacological backstory as I wrote back in July:

The background on this "breakthrough" relates to the side effect profile of prostamides, drugs that treat glaucoma by reducing intraocular pressure. These compounds mimic the effect of prostaglandin PGF2α to promote outflow of aqueous humor from the eye through the trabecular meshwork by acting as a local hypotensive. In the US, there are two such drugs: bimatoprost (Lumigan®) and latanoprost (Xalatan®).

Where am I going with this? Well, deep within the prescribing information for Lumigan (PDF here) one finds:

Lumigan® may gradually change eyelashes and vellus hair in the treated eye; these changes include increased length, thickness, and number of lashes. Eyelash changes are usually reversible upon discontinuation of treatment.

Hmmm...a side effect. Might this be used for cosmetic purposes?

Well, the Wall Street Journal reported this morning that one manufacturer has withdrawn from the cosmeceutical race:

Jan Marini Skin Research, the maker of Age Intervention Eyelash Conditioner, has suspended U.S. sales to avoid trouble with FDA and with Allergan, the WSJ reports.

The product, applied using a mascara-like wand, blurred the line between cosmetic and drug because it contained an ingredient similar to one found in Allergan's glaucoma drug Lumigan.

We noted back in November that the FDA seems to be focusing their eyes, as it were, on Jan Marini and not the manufacturer of Revitalash®. But to my eye (pun intended), there appears to be little difference between the products marketed by both companies. Both appear to contain chemicals or chemical relatives of prescription pharmaceuticals covered by US and international patents.

i-2bbcb1b9a93ff9c06b5f1d68203e27cb-FDCAct.jpgAlthough the US FDA is the "Food and Drug Administration," their regulatory authority is in part ordered by the Federal Food, Drug, and Cosmetic Act of 1938 (and subsequent legislation). That is, the FDA has regulatory latitude to intervene in the marketing of cosmetic products, particularly if the products overlap with prescription pharmaceuticals also regulated by the agency. In fact, the FDA's old photo accompanying their verbiage on the FD&C Act specifically shows a case of an eyelash dye that caused blindness (see right).

Anyway, despite today's WSJ article there were no changes or notices when I dialed up the Jan Marini site just before posting this. But, according to the WSJ Health Blog:

Chief executive Jan Marini told the WSJ that she doesn't know what the FDA will do about products that lie in the gray area between cosmetics and drugs, but "I don't think this issue is going away."

Well, my guess is that the FDA has the authority to regulate either, regardless of how the product is promoted.

That. . . and the fact that, "Allergan is thought to be pursuing its own version of an eyelash enhancer and on Nov. 7, filed a suit alleging patent infringement from seven eyelash-product companies."

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From your link:
Chief executive Jan Marini told the WSJ that she doesnt know what the FDA will do about products that lie in the gray area between cosmetics and drugs, but I dont think this issue is going away.

I don't think this issue is going to go away either. If people see a benefit they want they won't care where it originally came from.
Dave Briggs :~)