Business ProfileforLegal Lean

December 12, 2017 FDA NEWS RELEASE FDA warns companies for promoting alternatives to street drugs The U.S. Food and Drug Administration today posted a warning letter (/ucm588493) to the marketers and distributors of Legal Lean Syrup, a drink, and Coco Loko, a "snortable" chocolate powder, for selling unapproved new drugs and misbranded drugs. The warning letter explains how the claims made in the promotional materials for Legal Lean Syrup and Coco Loko demonstrate that the products are intended to be used as alternatives to illicit street drugs and that the products, as labeled and marketed, may pose safety concerns. Drug abuse is a serious public health issue, and the FDA is concerned that products like Legal Lean Syrup and Coco Loko encourage drug abuse in individuals, including minors. 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. "As 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,"' said FDA Commissioner Scott Gottlieb, M.D. "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." Coco Loko is described as a "snuff" and promoted to be "snorted" (inhaled intranasally). Intranasal administration of a powder substance 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 5/20/2019 FDA warns companies for promoting alternatives to street drugs FDA https://www.fda.gov/news-events/press-announcements/fda-warns-companies-promoting-alternatives-street-drugs 2/3 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. An FDA laboratory analysis found that Legal Lean Syrup contained the active pharmaceutical ingredient doxylamine, which was not included in the product labeling. FDA-approved products that contain doxylamine warn against its use with alcoholic beverages and instruct people with certain medical conditions to consult a physician before use. Furthermore, the inclusion of undeclared doxylamine in Legal Lean Syrup poses a potentially serious risk to those who have already had adverse reactions to this ingredient and whose physicians have advised them to avoid it. In general, products that contain undeclared drug ingredients pose a serious health risk, because consumers with underlying medical issues may take the products without knowing of any potential side effects or interactions. The FDA has requested that Arco Globus Trading LLC (dba Arco Globus International), Legal Lean LLC and LegalLeanStore.com respond to the FDA within 15 working days and include a statement of how the issues noted in the warning letter will be corrected. The warning letter also states that failure to correct violations may result in regulatory action such as seizure or injunction. Health care professionals and consumers should report any adverse events related to these products to the FDA's MedWatch (/medwatch-fda-safety-information-and-adverse-eventreporting-program) Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home). The completed form (/download-forms) can be submitted online or via fax to 1-800-FDA-0178. The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. Related Information Warning Letter: Arco Globus Trading LLC 12/11/17 (/ucm588493) Coco Loko and Legal Lean Syrup found to be unapproved drugs