In July, U.S. Senate Minority Leader Charles Schumer held a press conference to denounce Coco Loko, a chocolate-flavored energy powder intended for sniffing. He called it “cocaine on training wheels” and called on the Food and Drug Administration to investigate.
The agency did, it turns out. And while regulators didn’t come up with a description as catchy as Schumer’s, their assessment of Coco Loko was even more damning.
Regulators determined that the powder was an unapproved new drug and that its maker, Legal Lean, was unlawfully marketing it, according to an announcement Tuesday. In addition, the agency also looked at another of the company’s products, Legal Lean Syrup. The agency found that it was also an unapproved drug. The syrup contained an undisclosed sedative, doxylamine, found in the over-the-counter sleep aid Unisom.
In a December 11 warning letter, the FDA requested that Legal Lean “immediately stop marketing conflicting drugs to U.S. consumers.” Legal Lean has 15 working days after receipt of the letter to respond.
Legal Lean did not immediately respond to Ars’ request for comment, but the store has stopped working on the website.
In its warning letter, the FDA explained that Coco Loko and Legal Lean Syrup are unapproved drugs because they are marketed as being used to “affect the structure or function of the mind.”
Coco Loco contains cocoa powder as well as ingredients commonly found in energy drinks, including taurine, guarana and ginkgo biloba. Legal Lean advertised Coco Loko as a “steady stream of euphoric energy”, plus positive feelings akin to ecstasy and morphine. The company markets it as a nutritional and dietary supplement. But the FDA said that because the powder is meant to be snorted — thus entering the body through mucosal tissue in the nasal cavity, not swallowed — it’s neither a conventional food nor a supplement. The FDA also expressed concern that sniffing could be dangerous and could potentially trigger asthma attacks or spasms that could make breathing difficult.
In addition, the agency said Legal Lean’s marketing made it clear that Coco Loko is intended as an alternative “to illegal street drugs,” a big no-no. Such a drug violates federal regulations, the agency said in a previous policy guidance.
In a statement Tuesday, FDA Commissioner Scott Gottlieb condemned Legal Lean’s products.
“As a physician and parent, I am deeply concerned by the unlawful marketing of these potentially dangerous products, especially because they are so easily accessible to minors. Encouraging the use of sniffed chocolate as an alternative to illegal street drugs is unacceptable – sniffing powder has very real consequences, not to mention the societal dangers of promoting drug abuse… At a time when drug addiction threatens the fabric of the American society, we need to take action when we see efforts to fuel illicit drug use. We will continue to vigorously target bad actors selling unapproved products, including those containing undeclared drug ingredients.”
The FDA found similar problems with the marketing of Legal Lean Syrup, which was also found to contain a hidden sedative. The grape-flavored syrup based on herbal extracts is supposed to mimic a concoction developed in Houston, Texas called Lean, using cough syrup (with promethazine and codeine), Sprite soda, and Jolly Rancher candy. The result is also referred to as ‘purple drink’.