The Food and Drug Administration (FDA) is warning marketers and distributors of “snortable” chocolate powder, calling the products misbranded, unapproved new drugs.
The warning letters targeted Legal Lean Syrup and Coco Loko, the safety labels of which the agency says “demonstrate that the products are intended to be used as alternatives to illicit street drugs.” The way the drugs are labeled and marketed raises safety concerns, the agency said, because they encourage drug abuse in individuals, including minors.
“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, M.D. “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 as a dietary supplement “snuff,” to be snorted, or inhaled through the nose. Snorting a powder substance can trigger spasms of the vocal cords making it difficult to speak or breathe, or tighten the muscles that line the airways to the lungs. It can also induce or exacerbate asthma. The product also contains taurine and guarana, neither of which have been evaluated for safety, the FDA added.
The FDA conducted a laboratory analysis of Legal Lean Syrup and found it to contain the pharmaceutical drug doxylamine, an antihistamine, which is not listed on the drug’s label. Doxylamine can interact with alcoholic beverages and may not be safe for people with certain medical conditions.
The FDA issued warning letters to Arco Globus Trading LLC (doing business as Arco Globus International), Legal Lean LLC and LegalLeanStore.com, giving the companies 15 working days to respond to the agency with a statement of how the issues noted in the warning letter will be resolved. Failure to correct the violations may result in regulator action, including seizures or injunction.
Anyone who has used these products and experienced any adverse effects should file a report with the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
FDA News Release