FDA issues warning letter to promoters of Coco Loko and Legal Lean Syrup

The US Food and Drug Administration (FDA) has posted a warning letter to companies marketing and distributing Legal Lean Syrup (a drink) and Coco Loko (a ‘snortable’ chocolate powder), which have been found to be unapproved and misbranded drugs.

The warning letter goes into details about the claims made in the promotional materials for Legal Lean Syrup and Coco Loko, which, it explains, are promoted as alternatives to illicit street drugs. Additionally, it is noted that these products, as currently labelled and marketed, may pose safety concerns.

“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 Dr Scott Gottlieb. “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.”

Coco Loko — described as a ‘snuff’ and promoted on labelling to be ‘snorted’ — includes the ingredients taurine and guarana, neither of which have been evaluated for intranasal administration.

A laboratory analysis of Legal Lean Syrup by the FDA found that the drink included the ingredient doxylamine, which was not specified on the product labelling. According to the agency, approved products that contain this ingredient should not be taken with alcoholic beverages and those with certain medical conditions should consult a physician before use. Therefore, the inclusion of this undeclared ingredient poses a potentially serious risk to those who have already had adverse reactions to this ingredient and whose physicians have advised them to avoid it.

In general, the FDA reports that products containing undeclared drug ingredients pose a serious health risk, because consumers with underlying medical issues may take the products without knowing the potential side effects or interactions.

The FDA has requested that Arco Globus Trading LLC (dba Arco Globus International), Legal Lean LLC and LegalLeanStore.com respond within 15 working days and include a statement of how the issues noted in the warning letter will be corrected. The warning letter also states that failure to correct violations may result in regulatory action such as seizure or injunction.