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FDA is not cuckoo for Coco Loko, a chocolatey alternative to snorting cocaine

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In July, US Senate Minority Leader Charles..

EnlargeLegal Lean

In July, US Senate Minority Leader Charles Schumer held a press conference to denounce a chocolate-flavored energy powder meant for snorting, called Coco Loko. He dubbed it “cocaine on training wheels” and called on the Food and Drug Administration to investigate.

The agency did, it turns out. And though regulators didn’t come up with a description quite 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 a Tuesday announcement. Moreover, the agency also looked into another product by the company, Legal Lean Syrup. The agency found that it, too, was an unapproved drug. The syrup contained an undisclosed sedative, doxylamine, which is found in the over-the-counter sleep-aid Unisom.

In a warning letter dated December 11, the FDA requested that Legal Lean “immediately cease marketing violative drug products to US consumers.” Legal Lean has 15 business days after the receipt of the letter to respond.

Legal Lean did not immediately respond to Ars’ request for comment, but its retail store was no longer working on its website.

In its warning letter, the FDA explained that Coco Loko and Legal Lean Syrup constituted unapproved drugs because they are marketed as being used to “affect the structure or function of the mind.”

Coco Loco contains cacao powder as well as ingredients often found in energy drinks, including taurine, guarana, and ginkgo biloba. Legal Lean advertised Coco Loko as offering a “steady rush of euphoric energy,” plus positive feelings similar to ecstasy and morphine. The company markets it as a food and dietary supplement. But the FDA said that because the powder is intended to be snorted—thus entering the body through mucosal tissue in the nasal passage, not ingestion—it is neither a conventional food nor a supplement. The FDA also expressed concern that snorting could be dangerous, possibly triggering asthma attacks or spasms that could make breathing difficult.

Additionally, the agency said that Legal Lean’s marketing made it clear that Coco Loko is intended to be an alternative “to illicit street drugs,” a big no-no. Any such drug is in violation of 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 a parent, I’m deeply troubled by the unlawful marketing of these potentially dangerous products, especially since they are so easily accessible by minors. 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… At a time where drug addiction is threatening the fabric of American society, we must take action when we see efforts that may further fuel illicit drug abuse. We’ll continue to vigorously target bad actors that sell unapproved products, including products that contain undeclared drug ingredients.”

The FDA found similar problems with the marketing of Legal Lean Syrup, which also was caught containing a hidden sedative. The grape-flavored syrup based on herbal extracts is supposed to mimic a concoction developed in Houston, Texas, called Lean, which involves cough syrup (containing promethazine and codeine), Sprite soda, and Jolly Rancher candy. The result is also sometimes referred to as “purple drank.”

Original Article

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Ars Technica

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