May 27, 2020

May 26, 2020

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FDA oversees destruction and recall of kratom products

  • On February 21, FDA issued a press release announcing the voluntary destruction and recall of a large volume of kratom-containing dietary supplements manufactured and distributed nationwide under the brand names Botany Bay, Enhance Your Life and Divinity

  • The manufacturer of the products, Divinity Products Distribution, has also agreed to stop selling all products containing kratom

  • As discussed previously in this blog, FDA has used its administrative detention power followed by seizure against large volumes of kratom containing dietary supplements

  • In its current press release, FDA stressed the potential dangers of kratom as having opioid-like properties and indicated that there are no FDA-approved therapeutic uses of kratom

  • FDA urged all manufacturers of kratom containing supplements to cease marketing and to submit New Dietary Ingredient Notifications to FDA for kratom prior to marketing

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...