(RxWiki News) The US Food and Drug Administration (FDA) is warning consumers about a drink and a “snortable” chocolate powder that claim to be alternatives to illicit street drugs.
The FDA has sent warning letters to the companies that are marketing and distributing Legal Lean Syrup and Coco Loko. The letters accuse the companies of selling unapproved new drugs and misbranded drugs.
The FDA's warning explains how the companies have marketed these products to be used as alternatives to illicit street drugs and that the products may pose safety concerns to those who use them. The agency is concerned that Legal Lean Syrup, Coco Loko and similar products encourage drug abuse, especially in minors.
Products marketed as alternatives to street drugs claim to mimic the effects of recreational drugs and, as a result, appear to be intended for recreational and mind-altering use. These products are easily accessible to the masses, including minors, which the FDA said is concerning.
"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,”’ said Dr. Scott Gottlieb, FDA commissioner, in a press release.
Coco Loko, listed as a “snuff," is being promoted to be “snorted” and claims to provide users with an endorphin and serotonin rush similar to ecstasy, euphoric energy and a calm focus. Inhaling powder into the nose can trigger vocal cord spasms that make it difficult to speak or breathe, tighten the muscles that line the airways in the lungs, and induce or exacerbate asthma.
In addition, Coco Loko's ingredients include taurine and guarana. Researchers have not studied the effects of inhaling either of these ingredients into the nose.
An FDA analysis found doxylamine in Legal Lean Syrup. This ingredient was not listed on the product labeling. This becomes a problem for certain people who are not supposed to take doxylamine. If the consumer does not know doxylamine is in the product, he or she may face serious health risks when using Legal Lean Syrup.
The FDA has given Arco Globus Trading LLC (dba Arco Globus International), Legal Lean LLC and LegalLeanStore.com 15 working days to respond to the FDA with a statement on how they will correct these issues.
Speak with your health care provider before taking any new product that makes health claims, particularly if you purchased it online.
Written By Anyssa Garza, PharmD, BCMAS