If you buy makeup in the US, beware: It could very well contain the same chemicals as prescription drugs.
That’s because the vast majority of makeup products don’t have to go through the FDA drug-approval process. As long as cosmetics don’t make health claims on their labels or in advertisements, they can bypass the FDA entirely.
“Whether a product is a drug or cosmetic depends on the product’s intended use,” FDA press officer Theresa Eisenman told BuzzFeed News by email. By law, “intended use” is shown by how the cosmetic is sold, rather than by side effects or other uses of a drug it contains, she added. “The FDA makes this determination on a case by case basis.”
The question is particularly relevant for “eyelash enhancers,” the popular (and expensive) gels that promise to give you more beautiful eyelashes. One of the most popular products, Latisse, is a prescription drug, approved by the FDA in 2008 to treat “hypotrichosis” — a condition of too-small eyelashes, typically seen in a small number of patients after chemotherapy. The active ingredient in Latisse is a hormonelike prostaglandin originally intended to treat glaucoma. As it turns out, this drug and similar prostaglandins are found in about one-third of over-the-counter cosmetic eyelash serums, including the popular RevitaLash and NeuLash.
“All kinds of cosmetics have active ingredients,” drug law expert Peter Hutt of Covington & Burlington LLP in Washington, DC, told BuzzFeed News. “As long as they stick to a cosmetic claim and not a functional one, it is not a drug.”
And that is the crux of it. Eyelash enhancers with drug ingredients might promise more “luscious” lashes, “improved lash appearance,” or “stronger, healthier-looking lashes,” but as long as they stick to promising only appearance improvements, they are just cosmetics, exempt from the extensive and costly clinical trials needed to prove the safety of the same ingredients sold as a prescription drug. But if they cross the line into health claims — by promising the growth of lashes, for example — then they become “unapproved” drugs and draw the FDA’s ire.
In 2011, for example, FDA sent a warning letter to NeuLash’s owner, warning that sales claims that its prostaglandin ingredient would grow longer and thicker eyelashes made it an unapproved prescription drug. “Failure to promptly correct these violations may result in legal action,” warned the agency. The brand only makes appearance claims now.
The agency also watches for claims about injuries linked to cosmetics, Hutt said, and “a lack of action likely indicates they haven’t seen a problem.”
Prostaglandins in eyelash enhancers have been linked to discolored eyes in case reports, along with eye irritation and hair growing on cheeks. The FDA’s adverse event reporting system contains about 50 reports of such side effects from eyelash cosmetics over more than a decade. A few BuzzFeed reviewers tested eyelash enhancers, finding overall they made their lashes thicker (alongside complaints of eye gunk). Another BuzzFeed reviewer found castor oil just as effective as RevitaLash.
I tested over-the-counter RevitaLash on myself for three months. My eyelashes didn’t seem any longer, but my eyes did get itchy. (The maker of the product, Athena Cosmetics, did not respond to a request for comment.)
Occasionally, FDA has stepped in to warn people about dangerous cosmetic ingredients. For example, kohl (also known as al-kahal, kajal, or surma), often found in products used for eyeliner and mascara, has been linked to lead poisoning in children. And last year, after testing 400 brands of lipstick, the agency warned lipstick makers to limit lead in their products. (The agency found that 99% of lipsticks had safe levels of lead, below a 10-parts-per-million limit.)
Cosmetics with drugs in them are more widespread than people recognize, pharmacologist Adriane Fugh-Berman of Georgetown University School of Medicine told BuzzFeed News. Progesterone hormones found in cosmetic skin creams sold to menopausal women have triggered FDA warning letters, and a wax found in lipsticks and eyeliners called butylated hydroxyanisole (BHA) is also an ingredient in some over-the-counter medicines. A prostaglandin in an eyelash enhancer falls into this same in-between place in medicine.
“Yeah, it’s a drug, it has drug effects, and can cause inflammation,” Fugh-Berman said. “You get out of a lot of safety testing just by calling it a cosmetic,” she said. "It’s quite a loophole.”