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Latest From Eileen Francis
FDA and the Federal Trade Commission should bring immediate enforcement action against marketers of non-kratom dietary supplements promoted as opioid-withdrawal aids, says the Center for Science in the Public Interest in letters to the agency and commission Dec. 8. The nonprofit identified eight supplement products making opioid-withdrawal claims without sufficient science to support the statements.
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.
Nonprofit Harm Reduction Therapeutics targets an OTC switch of naloxone, an opioid antagonist used to reverse an opioid overdose. It aims to make the product available at low cost in 110,000 retail locations nationwide.
FDA’s NDI notification draft guidance should be rewritten and its Nutrition Facts and Supplement Facts Final Rule delayed, the Natural Products Association says in comments submitted to the agency in response to President Trump’s executive order aimed at cutting down on burdensome regulations.
Post-market surveillance system for dietary supplements should contain a process for identifying sentinel events, or low-incidence and unusual adverse events that can indicate big problems, says a toxicologist speaking during a recent Council for Responsible Nutrition webinar.
A JAMA study finds SARMs in 23 of 44 products marketed online as containing the steroid-like ingredient while the rest contained other unapproved drugs and substances. Sports medicine and doping researchers say e-commerce provides cover for firms to sell the risky bodybuilding drugs without consequence.