April 19, 2018

FDA Warns Companies That Make Coco Loko and Legal Lean as Unapproved New Drugs

The FDA is warning makers and manufacturers of two products, Legal Lean Syrup, a drink, and Coco Loko, a “snortable” chocolate powder, for selling unapproved new drugs and misbranded drugs. These products are promoted as alternatives to street drugs. The government has sent a warning letter to one company about this problem.

FDA

Claims made in the promotional materials for the products demonstrate they are intended to be used as alternatives to street drugs. These products, as labeled and marketed, “may pose safety concerns,” according to the press release. The FDA is concerned that these products encourage drug abuse in individuals, including minors.

These street drug alternatives are used for recreational purposes to affect psychological states. FDA Commissioner Scott Gottlieb said in a statement, “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.”

Intranasal administration (snorting) of a powder can trigger spasms of the vocal cords and the muscles that line the airways in the lungs. This action may also induce or exacerbate asthma. The ingredients in Coco Loko include taurine and guarana, neither of which have been evaluated for intranasal administration.

FDA lab analysis found that Legal Lean Syrup contains the active pharmaceutical ingredient doxylamine, which is not listed on the label. FDA-approved products that contain this compound warn against its use with alcoholic beverages, and tell people with certain medical conditions to consult a doctor before use. And the inclusion of undeclared doxylamine in the product poses a potentially serious risk to anyone who have already had adverse reactions to this ingredient.

The FDA has requested that Arco Globus Trading LLC, Legal Lean LLC, and LegalLeanStore respond to the FDA to indicate how these issues will be corrected. They have 15 days to correct violations.

Anyone who has had an adverse experience while using these products can contact the FDA’s MedWatch Adverse Event Reporting Program. You can fill out the form online, or submit it via fax.

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