The Food and Drug Administration is warning a pair of Florida companies to stop distributing a snortable chocolate powder, claiming it's being sold as an unapproved new drug and as a “street drug alternative.”
The FDA warned Legal Lean LLC and distributor Arco Globus Trading LLC they have 15 business days to respond with steps to come into compliance. Neither company immediately responded to requests for comment.
Legal Lean's website was offline Wednesday morning.
Unless the companies challenge the FDA, they likely will have to discontinue sales or dramatically change promotional materials discussing nasal use and experiential effects.
FDA Commissioner Scott Gottlieb said in a statement that “[a]s 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,”’ Gottlieb said.
Although creator Nick Anderson made waves with the product, Coco Loko’s price inhibited sales. Containers with 10 servings sold for $24.99, and initially only a few head shops and convenience stores carried the product.
After an initial gush of media attention, the small Orlando company was sued in July by the maker of alcoholic energy drink Four Loko, which alleged trademark infringement.
Snorting chocolate first received significant attention in 2007, when Belgian chocolatier Dominique Persoone created a device called the Chocolate Shooter to snort cocoa (not cacao) powder.
In 2016, spokespeople for the Drug Enforcement Administration and the FDA said they appeared powerless to regulate snortable chocolate. An FDA spokeswoman described an apparent "Catch-22" created by legal definitions for food and drugs, with "drug" defined as "a product other than food” and food defined as "articles used for food or drink.”
In its letters, dated Monday, the FDA focused on the method of consumption, and company claims such as “Euphoric energy. ... Raw cacao will give you a steady rush of euphoric energy” and “Raw cacao ... is also known to help with anxiety and to reduce stress.”
Coco Loko uses cacao, which is processed at a lower heat than cocoa, retaining more beneficial nutrients. Raw cacao contains mood-lifting anandamide and phenylethylamine, cognition-assisting flavonoids and muscle-relaxing magnesium.
Ordinary cacao powder can be purchased on Amazon or at Walmart, but Coco Loko is cut to enhance its effects. The label lists B vitamins, ginkgo biloba, blood flow-improving amino acid L-Arginine and the energy drink stimulants guarana and taurine.
Although not common, there are some other examples of FDA action against alleged "street drug alternatives," including 2013 action against a product called Hemp Garden Tea, which was promoted using the phrase "Chill your head with the good stuff!"
The FDA warns in a statement about Coco Loko that snorting powders "can trigger spasms of the vocal cords making it difficult to speak or breathe (laryngospasm) or tightening of the muscles that line the airways in the lungs (bronchospasm) 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.”
Dr. Andrew Lane, director of rhinology and sinus surgery at the Johns Hopkins School of Medicine, said earlier this year he was “not aware of any studies showing harm from inhaling any of these ingredients, nor any scientific evidence that there is a benefit,” specifically addressing inhalation of cacao, taurine and guarana.
The FDA also is taking action against another Legal Lean product, a so-called "sipping syrup" that allegedly contains an undisclosed ingredient.
Gottlieb presented the FDA's action against Coco Loko as about more than stomping out a novelty product.
"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," he said. "We’ll continue to vigorously target bad actors that sell unapproved products, including products that contain undeclared drug ingredients.”