FDA Warns Companies for Promoting Street Drug Substitutes

On Dec. 12, 2017, FDA posted a warning letter to distributors and marketers of Legal Lean Syrup, a drink, and Coco Loko, a “snortable” chocolate powder, for selling unapproved new and misbranded drugs. The warning letter details how the claims made in the promotional materials for Coco Loko and Legal Lean Syrup prove that the products are intended to be used as substitutes for illegal street drugs, and that the products may pose safety concerns.

Street drug substitutes are products that claim to mimic the effects of recreational drugs and are intended to be used for recreational purposes to affect psychological states. FDA has expressed concern that products like Legal Lean Syrup and Coco Loko encourage drug abuse.

“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, MD, in an agency press release. “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 is marketed a “snuff” and to be “snorted” (inhaled intranasally), which poses potential health risks including speaking/breathing difficulty, vocal cord spasms, and asthma induction or aggravation. Additionally, the ingredients listed on the product label for Coco Loko include taurine and guarana, which have not been evaluated by FDA for intranasal administration.

Legal Lean Syrup was found to contain the API doxylamine, which was not included in the product labeling, in an agency laboratory analysis. Approved products containing doxylamine warn against its use with alcoholic beverages and instruct people with certain medical conditions to consult a physician before use. The undocumented inclusion of doxylamine in Legal Lean Syrup poses a potential risk to those who have already had adverse reactions to this ingredient, and whose physicians have advised them to avoid the ingredient.

Companies included in the warning letter, Arco Globus International and Legal Lean, have been prompted to respond to the warning letter within 15 working days and include a statement of how the issues noted by the agency will be corrected. The warning letter also states that failure to correct violations may result in regulatory action such as seizure or injunction.

Adverse events related to these products should be reported to FDA’s MedWatch program.

Source: FDA