May 19, 2022

Volume XII, Number 139

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FDA Continues Enforcement Action Against Kratom

  • FDA has warned consumers for years against using products containing Mitragyna speciosa, a plant from Southeast Asia that is commonly known as kratom, or its psychoactive compounds, mitragynine and 7-hydroxymitragynine, which affect the same opioid brain receptors as morphine.  Since identifying kratom on an import alert for unapproved drugs in 2012 and on a second import alert for kratom-containing dietary supplements and bulk dietary ingredients in February 2014, FDA has taken numerous enforcement actions.

  • Most recently, on May 21, 2021, FDA announced the seizure of approximately $1.3 million worth of products including over 34,000 kilograms of bulk kratom and more than 207,000 units of dietary supplements containing kratom with the brand names Boosted Kratom, The Devil’s Kratom, Terra Kratom, Sembuh, Bio Botanical, and El Diablo manufactured by Atofil, LLC located in Fort Myers, Florida.

  • The latest activity shows that FDA remains ready to initiate enforcement action against supplements that are believed to pose safety risks. 

© 2022 Keller and Heckman LLPNational Law Review, Volume XI, Number 144
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About this Author

Lisa P. Alsobrook Attorney Keller Heckman DC Office
Associate

Lisa Alsobrook practices in the area of food and drug law. She advises domestic and foreign clients on regulatory requirements for foods, dietary supplements, cosmetics, and food and drug packaging in jurisdictions around the world. Her main focus is regulatory and compliance matters of the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture relating to human food, food packaging material, animal feed, food additives and ingredients, and dietary supplements.

Prior to attending law school, Lisa earned a master’s degree in Food Science. She worked as a...

202-434-4237
Melvin S. Drozen, FDA, regulatory lawyer, Keller Heckman, law firm
Partner

Melvin S. Drozen joined Keller and Heckman in 1987.

Mr. Drozen advises clients on a broad spectrum of FDA, FTC, USDA and EPA (pesticides) regulatory matters, ranging from premarket approval requirements for food additives, dietary supplement ingredients, drugs, and medical devices to advertising and labeling provisions applicable to all of these products. Prior to joining Keller and Heckman, he was an Assistant District Attorney in Brooklyn, N.Y., and then an attorney in the General Counsel's Office of the Food and Drug Administration for seven...

202-434-4222
Jill M Mahoney Associate Attorney Keller Heckman
Associate

Jill Mahoney advises clients on regulatory requirements for food, animal feed, food additives, dietary supplements, and cosmetics. She counsels clients on labeling and advertising compliance and claims substantiation issues, including nutrition labeling, ingredient declarations, nutrient content claims, structure function claims, and Country of Origin labeling. She assists food, animal feed, and dietary supplement manufacturers in preparing self-determined GRAS positions, GRAS Notifications for Food and Drug Administration (FDA) submissions, New Dietary Ingredient Notification submissions...

202-434-4184
Richard Mann Partner Keller Heckman DC
Partner

Richard (Rick) Mann represents his clients in business and trade association disputes relating to food advertising, promotional and labeling claims, food safety and compliance issues, and general business and corporate law matters.

Rick works extensively with clients in the development of compliant advertising, promotional, and labeling claims and campaigns, and the development of appropriate support for such claims. His regulatory experience allows him to represent his clients in proceedings at the Food and Drug Administration (FDA), the Federal Trade Commission (FTC), the National...

202-434-4229
Evangelia C. Pelonis, food and drug regulatory lawyer, Keller Heckman law firm
Partner

Evangelia C. Pelonis joined Keller and Heckman in 2003 as a Food and Drug Associate. Ms. Pelonis' practice focuses on all regulatory and compliance matters of the U.S. Food and Drug Administration and the U.S. Department of Agriculture relating to human food, animal feed, food additives and ingredients, and dietary supplements. Ms. Pelonis' works with clients to achieve their marketing goals within the applicable legal frameworks. She counsels clients in all aspects of food development and marketing, from product formulation and manufacturing considerations to food...

202-434-4106
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