The agency warned people about the possible dangers of Coco Loko, an "infused raw cacao snuff."
When we first told you about Coco Loko, it was having a bit of a moment, thanks to a Washington Post story suggesting that the "infused raw cacao snuff" was, if not provably popular, at least “a thing.” Now the Food and Drug Administration has warned the company behind Coco Loko and Legal Lean Syrup—a “relaxation drink” pitched as a legal equivalent to mixing cough syrup with soft drinks and a Jolly Rancher—that it’s peddling “unapproved new drugs.”
The FDA letter, dated December 11, lays out the agency’s case. It argues that, despite the company labeling its products as dietary supplements (which are not regulated by the FDA), what they’ve really done is introduce unapproved new drugs into the marketplace and promote the products as alternatives to recreational drugs.
For example, the Legal Lean website claims that Coco Loko produces feelings similar to morphine and ecstasy and compares its syrup to promethazine and codeine, ingredients found in cough syrup, but brags that its “legal” formula doesn’t require a prescription. (Codeine is a narcotic, while promethazine is an antihistamine.) The agency says this marketing is evidence that the company intends people to use the products as drugs, and that will not fly.
At the same time, FDA testing of Lean Lean Syrup found it did contain an antihistamine and sedative called doxylamine, which isn’t mentioned on the label. That’s an especially egregious problem if you figure people drinking the syrup could also be drinking alcohol: combining the two can leave users feeling dizzy and disoriented. Anyone who has an adverse reaction to the drug wouldn’t know it’s in the drink, either. That’s why the FDA wants it to be labeled, with specific instructions for use, just like other FDA-approved products that include the active ingredient.
Coco Loko contains familiar energy-drink substances, guarana and taurine, and combines them with cacao powder into a “snuff” that’s supposed to be snorted. First of all, the FDA says you shouldn’t snort powders since doing so could trigger spasms of the vocal cords that make it hard to talk or breathe, tighten the muscles that line the lungs’ airways, and bring on asthma or make it worse. Plus “intranasal administration” of guarana or taurine hasn’t been evaluated for safety, the agency says.
FDA Commissioner Scott Gottlieb said the agency is also concerned that the products encourage drug abuse. “Encouraging the use of snortable chocolate as an alternative to illegal street drugs is not acceptable—there are very real consequences to snorting any powder, not to mention the societal dangers of promoting drug abuse,” Gottlieb said in a statement.
Back in July, when Coco Loko was having its moment, New York Senator Chuck Schumer called on the FDA to regulate it, saying it has no recognized medical value. He also took issue with the company comparing it to ecstasy for its stimulating effects. “Cocaine on training wheels,” he called it—a not totally clear comparison, but we take it that he’s saying it’s bad.
The FDA seems to agree with his larger point, if not his choice of analogies. The letter sent this week gives the people marketing Coco Loko and Legal Lean Syrup 15 business days to respond to the agency, detailing how they intend to fix the problems outlined in the letter. As of this writing, the two websites cited by the FDA are all down, and the sellers didn’t respond to Tonic’s requests for comment by phone and email.