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FDA Continues its Enforcement Efforts Aimed at Companies Marketing Kratom Products

  • On May 22, 2018 FDA announced that it had issued warning letters to three companies marketing kratom products with medical claims.  FDA’s letter asserts that the claims that the products could be used as pain killers, to reduce opioid dependence, to treat diabetes, to lower blood pressure, and to treat other ailments; are medical claims that have not been reviewed by the Agency.  Such claims, when not approved by FDA, render the products unapproved new drugs.
  • FDA Commissioner Gottlieb indicated that these warning letters are part of a concerted effort to fight the opioid epidemic.  The effort by FDA includes a commitment to “make the approval process more efficient for novel, safe and effective medical treatments aimed at the treatment of addiction; and to help more people suffering from addiction get access to approved therapies.”  Commissioner Gottlieb encouraged kratom manufacturers to provide FDA a new drug submission if the manufacturers have data that can substantiate medical claims.  Commissioner Gottlieb’s call for submissions specifically noted pain treatment or opioid addiction claims.
  • These warning letters come on the heels of widespread salmonella contamination of kratom containing products, resulting in multiple recalls, a 2016 seizure of kratom products promoted with unapproved drug claims, and FDA’s general emphasis on addressing the opioid crisis.  The actions are also consistent with FDA’s recent crackdown on youth tobacco use, another FDA strategic priority.  It is clear that FDA is taking, and will continue to, take, aggressive steps to pursue its strategic priorities.  For manufacturers, distributors, and retailers of products that might be impacted, increased vigilance to ensure compliance with all regulations and laws impacting the your products is in order.  Those wishing to make medical claims on products will need to determine if such claims will render their product a new drug and take actions (potentially including submitting new drug application to FDA) consistent with this assessment.
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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...

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