The FDA has seized $2 million worth of Age Intervention Eyelash Conditioner, an eyelash lengthener that may contain optic nerve-damaging ingredients.
At fault is a compound called bimatoprost, approved by the FDA for use in treating people with certain eye problems, but unapproved as a casual cosmetic. It can cause eye inflammation and retinal swelling, and — in people already taking the drug medically — nerve damage.
On Saturday, U.S. marshals, acting on FDA orders, confiscated the cosmetic from a warehouse in San Jose, where California health officials had ordered it held. The Associated Press reports that Jan Marini Skin Research, Age Intevention Eyelash Conditioner’s manufacturer, say they stopped using bimatoprost last year.
When I read this, some journalistic sixth sense perked up: why did the FDA do this now? And why this particular product? The more I think of it, the more it seems like a warning shot. This time, Jan Marini’s ticket got punched; next time it could be anyone who sells drugs for potentially risky, unapproved cosmetic purposes.
What remains to be seen is whether Jan Marini’s error was, in a sense, simply a matter of success. The FDA doesn’t allow companies to systematically develop drugs for unapproved purposes. It does, however, allow individual pharmacists to do this at the request of doctors. The loophole lets doctors prescribe custom formulations to patients who might be harmed by standard-issue drugs; however, it also lets plastic surgeons procure bimatoprost-containing compounds for the purpose of offering them cosmetically. The pharmacists and plastic surgeons just can’t be systematic about it. They have to stay, so to speak, on a mom-and-pop level.
The Age Intervention Eyelash seizure has particular resonance to injectable, allegedly fat-dissolving drugs that have been poorly studied and linked to numerous side effects. I’m currently writing an article on these; one company in particular, Fig, the makers of Advanced LipoDissolve, has pushed the commercialization boundary, administering shots to at least 20,000 people.
Steve Silverman, an official at the FDA’s Center for Drug Evaluation research, told me that, speaking broadly about the marketing and use of anti-fat injections, the agency is “aware of, concerned about, and paying attention to this practice.”
Silverman wouldn’t be more specific about Fig or the possibility of ongoing investigations. Decoding the precise meaning of his statement thus requires some reading between the lines, but the Age Intervention Eyelash seizure may provide an useful footnote.
Source: wired.com
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