The Food and Drug Administration (FDA) is taking action against Arco Globus Trading, Legal Lean LLC and LegalLeanStore.com, the marketers and distributors of Legal Lean Syrup and Coco Loko. Both of these products may pose safety concerns as they are being promoted as alternatives to illicit street drugs.
Coco Loko is described as a snortable chocolate powder that contains taurine and guarana, neither of which have been evaluated for intranasal use. The FDA notes that snorting of the powder could lead to laryngospasm or bronchospasm and may induce or exacerbate asthma.
An analysis of Legal Lean Syrup, which is labeled as a dietary supplement, found that the product contains undeclared doxylamine, an antihistamine found in over-the-counter sleep aids and cough and cold medications. Unknown ingestion of doxylamine may pose a health risk to patients who have been advised to avoid the drug due to underlying medical conditions (ie, glaucoma, asthma, emphysema, chronic bronchitis, GI or GU obstruction).
In a press release, FDA Commissioner Scott Gottlieb said “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.”
Arco Globus Trading, Legal Lean LLC, and LegalLeanStore.com have been given 15 days to respond to the FDA on how they intend to correct the issues noted in the warning letter. Failure to correct the violations can results in regulatory action such as seizure or injunction.
Healthcare professionals are encouraged to report any adverse events related to the use of these products to FDA’s MedWatch Adverse Event Reporting program.
For more information visit FDA.gov.