If you’re at all tapped into the world of indie makeup brands, you’re probably familiar with Lime Crime — and, if you’re familiar with Lime Crime, you probably know that Velvetines, its line of liquid matte lip stains, are cult favorites. But, if you’re a Velvetines devotee, you might want to look for a temporary alternative: Last month, on July 29, the FDA issued an official warning letter to Lime Crime stating that the use of ferric ferrocyanide and ultramarines listed as ingredients in the Red Velvet Velvetines Lip Stain constitutes a violation of the Federal Food, Drug, and Cosmetic Act.
The cult brand, known for its products’ unconventional colors (and somewhat controversial founder Xenia Vorotova, a.k.a. Doe Deere), didn’t respond to our request for comment. On the brand’s social media pages, Lime Crime has told concerned customers that the violation was due to a misprint on the product’s packaging, and it added a formal response on its website stating that the ingredients in question aren’t in its products.
According to FDA press officer Megan McSeveney, the FDA has not tested the product for the presence of these color additives. “However,” she says, “they were listed as ingredients in product labeling. If they do not contain these ingredients, the products are misbranded and therefore also prohibited in interstate commerce.” In other words, whether the company was utilizing unapproved ingredients or someone on their packaging team just made a very unfortunate typo, Lime Crime is still in violation of FDA regulation. The FD&C Act prevents "the adulteration or misbranding of any food, drug, device, or cosmetic in interstate commerce," meaning companies can be in violation either by using unapproved or unsafe ingredients (“adulteration”) or having false or misleading labeling (“misbranding”). McSeveney adds that the FDA investigation was launched after receiving six consumer complaints in two months.
Either way, it raises the question: How can this kind of mistake happen in the first place? Doesn’t every commercially sold cosmetic undergo extensive safety testing and analysis before hitting shelves? Surprisingly, the answer is…“not really.” Unlike the way the FDA exercises its authority over drugs and medical devices, the administration doesn’t require specific testing or approvals before a cosmetic product goes to market (with the exception of color additives as well as sunscreen, which is considered a drug by the FDA). “Cosmetic products and ingredients, other than color additives, are not subject to pre-market approval by the FDA,” McSeveney says. “But, once on the market, the FDA can take action on cosmetics that do not comply with the laws and regulations we enforce. If we become aware of a specific health concern, we will take additional steps to inform the public.”
In short, the expectation is that the cosmetics company will play by the rules, only use approved materials, and ensure that the product is safe for consumers — and the FDA is simply tasked with enforcing them after the fact. So, in theory, anyone could whip up some homemade makeup and sell it without having to meet FDA standards — at least until they’re caught. We asked the founder of indie start-up brand Hello Waffle, who goes by Christine, how, exactly, this works (or doesn’t). “Unfortunately, making sure products are within FDA regulations is largely based on honor,” says Christine. “As such, there are many companies out there who skirt the laws.” While online resources do exist for consumers to educate themselves and each other about makeup-ingredient safety, at the end of the day, “it is up to the consumer to take it upon themselves to do their research and make sure that what they're putting on their face is legit and safe,” Christine says.
"Cosmetic products and ingredients, other than color additives, are not subject to pre-market approval by the FDA. But, once on the market, the FDA can take action on cosmetics that do not comply with the laws and regulations we enforce."
While giant cosmetics corporations like L'Oréal can employ teams of toxicologists and physicians to test products and enforce regulatory standards internally, most smaller start-up brands are in a different situation. Caitlin Johnstone, founder of Shiro Cosmetics, explains that her company’s approach to safety involves a good deal of research, legwork, and due diligence: “We buy all of our base pigments and other ingredients from reputable sources in the United States whose products are fully labeled with complete ingredient lists and notes on eye/lip/face safety as recognized by U.S. FDA guidelines,” says Johnstone. “When we blend these ingredients to make our makeup, we use distinct equipment for colors with differing ingredient lists so that there is no cross-contamination: Lip-safe eyeshadows do not touch the same equipment as non-lip-safe ones. We're always careful to ensure our labels are comprehensive as well as our ingredient listings on the website.” Hello Waffle’s Christine adds that while this kind of legwork is a lot for a small business to manage, it’s crucial. “Being irresponsible with ingredients does a disservice to your customers and will damage your reputation in the long run,” says Christine. “It's not worth the risk for a pretty color.”
Additionally, Lime Crime isn’t really a mom-and-pop operation or a one-woman Etsy makeup shop: The brand has been carried by major retailers like ModCloth, Nasty Gal, Urban Outfitters, and, for a hot second, Sephora, though that relationship ended quickly and without much explanation from either party last November. (We reached out to Sephora for comment and will update the post when we hear back.) The fact that a makeup brand of Lime Crime's size could accidentally let potentially unsafe additives slip into their lipstick formulas (or, at the very least, onto their labels) is a little unsettling. According to some customers, the ingredients have been on the products’ labels for at least a couple of months.
"Being irresponsible with ingredients does a disservice to your customers and will damage your reputation in the long run. It's not worth the risk for a pretty color."
It should be noted that Lime Crime's additives in question are approved for external cosmetic use in the U.S., meaning they can be used in products like eyeshadow, but not in products meant to be applied to the lip area or anywhere near mucus membranes, where it could be ingested or absorbed into skin. This is not necessarily because they’ve been proven to cause harm: rather, it’s the lack of information about the ingredients that’s problematic. “Consumers should be aware that if color additives are not approved by the FDA for use on the lips, the FDA has not received, evaluated, and approved information supporting the safety of these color additives when used in this way,” explains McSeveney. Both ingredients are considered lip-safe in Europe and Japan, but the FDA couldn’t give much detail on why that differs from country to country: “We cannot comment on why certain color additives are permitted in other countries, as their legal frameworks are different from ours," she says.
Upon issuance of a warning letter, cosmetics companies have 15 business days to file a formal response, detailing “an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur,” as stated in the FDA’s warning letter. In a response to comments on her Instagram account, Doe Deere wrote that “the FDA has already accepted our response proving that it is, in fact, a mislabeling issue.” At the time we spoke with McSeveney, the FDA couldn’t confirm or deny that this was the case, and couldn’t comment on the Lime Crime case specifically. When we asked what the next steps were in the investigation, McSeveney said that the FDA will typically follow up with a warning letter to recipients “to determine the adequacy of any corrective action taken.” In the meantime, Nasty Gal has removed Lime Crime from its inventory entirely, according to PR associate Devan Pucci. The products are still available for purchase on Lime Crime’s website, which, according to McSeveney, is legal. The FDA doesn’t have the legal authority to force a recall on a brand, she explains.
In the meantime, Sephora’s Cream Lip Stains, NYX Soft Matte Lip Creams, and Jeffree Star’s liquid lipsticks all make for excellent Velvetine substitutions, minus the scandal.