FDA cracks down on snortable chocolate powder

pharmafile | December 13, 2017 | News story | Medical Communications, Research and Development FDA, biotech, drugs, pharma, pharmaceutical 

The FDA has taken action on Coco Loko and Legal Lean Syrup, both made by Arco Globus Trading LLC, after the former was brought to US nationwide attention by Senate Minority Leader, Charles Schumer, back in July.

The senator referred to the product as “cocaine on training wheels” and the FDA has taken action by sending a warning letter to the company for selling unapproved new drug and misbranded drugs.

The active ingredients of Coco Loko are raw cacao powder, as well as taurine, guarana and ginkgo biloba – commonly found in energy drinks. The company fell foul of the FDA by advertising the product as producing ‘euphoria’ and by comparing the product to ecstasy, an illegal drug. As well as this, the product was marketed as a food or supplement, when instructions tell users to ingest the product nasally – something that FDA highlighted as a potential health risk.

While Legal Lean Syrup was found to contains active pharmaceutical ingredient doxylamine, despite this not featuring on the label. This drug is an antihistamine, but can also be used as a short-term sedative.

“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,” said FDA Commissioner Scott Gottlieb.

He continued, “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.”

The latter is an indirect reference to the opioid crisis that has swept North America in recent years. In fact, Gottlieb has made tackling this crisis one of the major objectives of the FDA since he was appointed to the position of commissioner earlier in the year.

After the warning letter was delivered, the website for the company is now displaying the message, “Legal Lean Store is down for Maintenance.”

This comes after it was previously reported that the retail store of the website had been taken down, suggesting that the company may have taken the decision to back away from its product after the FDA chose to get involved.

Ben Hargreaves

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