FDA Warns of Misbranding and Undeclared Drugs in Products That are Used as Street Drug Alternatives

The FDA has issued a warning letter to marketers and distributors of Legal Lean Syrup, a drink; and Coco Loko, a “snortable” chocolate powder; for selling unapproved new drugs and misbranded drugs.  These products are being promoted as alternatives to illicit street drugs, claiming to mimic the effects of recreational drugs and affect a patient’s psychological state (e.g., to get high, to promote euphoria, or to induce hallucinations).

Coco Loko is described as a “snuff” to be snorted.  Intranasal administration of a powder substance can trigger laryngospasm or bronchospasm and may also induce or exacerbate asthma. Coco Loko also includes taurine and guarana, neither of which have been evaluated for intranasal administration.

The FDA determined that Legal Lean Syrup contains doxylamine, which was not included in the product labeling, placing those who have been advised not to use or who have had adverse reactions at risk. 

During the preanesthesia assessment, anesthesia professionals ask the patient about their current medication history, which includes but is not limited to street drug alternatives, recreational drugs, and herbal supplements in addition to prescribed medications.  Awareness of new medications, over the counter and street drugs, that a patient may be taking allows anesthesia and healthcare professionals to develop the unique patient specific plan of care to address all considerations necessary for patient safety and optimal outcome.