FDA warns companies for promoting alternatives to street drugs

FDA has issued a warning letter to the marketers and distributors of Legal Lean Syrup and Coco Loko for selling unapproved new drugs and misbranded drugs.

FDA has issued a warning letter to the marketers and distributors of Legal Lean Syrup and Coco Loko for selling unapproved new drugs and misbranded drugs. The warning letter details how the claims made in the products' promotional materials indicate they are intended to be used as alternatives to illicit street drugs and that the products could pose safety concerns. Coco Loko is described as a snortable chocolate powder. The product label also includes taurine and guarana, neither of which have been evaluated for intranasal administration. Meanwhile, an FDA analysis found that Legal Lean Syrup, a drink, contained the active pharmaceutical ingredient doxylamine, which was not listed on the product label. FDA-approved products that include doxylamine caution against its use with alcoholic beverages and instruct individuals with certain medical conditions to consult a physician prior to use. The companies involved have 15 working days to respond to FDA, including a statement of how the issues listed in the warning letter will be corrected. Failure to correct the violations could result in regulatory action, such as seizure or injunction, the letter noted.