Blow Tests FDA’s, Industry’s Patience For Illicit Drug-Related Product Brands
This article was originally published in The Tan Sheet
Executive SummaryThree months after FDA acted on a trade group's complaint and took enforcement action against an energy beverage firm for marketing its product as an alternative to an illicit street drug, the dietary supplement industry has another opportunity to judge how well the agency responds to a firm using drug jargon to market a product
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The agency warns Arco Globus Trading LLC to immediately stop marketing purported dietary supplements that it promotes as alternatives to illicit street drugs, including one with an active pharmaceutical antihistamine. The firm's Legal Lean Syrup and Coco Loko are unapproved and misbranded new drugs, the agency says.
FDA inspects Belmora's website and product labeling in March and issues a warning letter that firm’s Elavil OTC Sleep Aid is an unapproved new drug with inadequate directions for its intended use.
The firm launches Ionamin as its second weight loss supplement using a brand name once used for a drug as it contests FTC allegations of failing to comply with a settlement not to make unsubstantiated claims.