The promotional materials for Coco Loko purport the products are intended as “alternatives to illicit street drugs,” said the FDA.
“Street drug alternatives are products that claim to mimic the effects of recreational drugs and are intended to be used for recreational purposes to affect psychological states," it said.
FDA commissioner Scott Gottlieb said: “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,” he added.
Senator warning
The warning came five months after US senator Charles Schumer called on the government agency to regulate the company for its energy drink ingredients.
Legal Lean originally claimed Coco Loko could give consumers increased energy, elevated mood and a sense of calm focus, according to ConfectioneryNews’ previous report.
Despite the website shutdown, the infused raw cacao snuff products, which has a two-star rating out of five, are still available on Amazon.com for $18.47 per 0.125-ounce container as the article is being written.
“Coco Loko is described as a ‘snuff’ and promoted to be ‘snorted’,” said the FDA. “Intranasal administration of a powder substance can trigger spasms of the vocal cords making it difficult to speak or breathe or tightening of the muscles that line the airways in the lungs and may also induce or exacerbate asthma.”
“The ingredients listed on the product label for Coco Loko also include taurine and guarana, neither of which have been evaluated for intranasal administration,” it added.
The FDA has requested Legal Lean to respond with a statement of how the issues noted in the warning letter will be corrected within 15 days. It also stated that failure to correct violations might result in regulatory action such as seizure or injunction.
Coco Loko could not be reached for comment.