FDA Announces Destruction, Recall of Kratom-Containing Supplements

FDA has encouraged all companies selling kratom to humans to remove their products from the market amid continuing concerns over the botanical.

Josh Long, Associate editorial director, Natural Products Insider

February 21, 2018

2 Min Read
FDA Announces Destruction, Recall of Kratom-Containing Supplements

FDA on Wednesday announced the voluntary destruction and recall of dietary supplements containing kratom, the latest action against a botanical the public health agency said poses safety concerns.

In cooperation with FDA, Missouri-based Divinity Products Distribution has agreed to stop selling products containing kratom. FDA said the company manufactured and distributed the kratom-containing supplements nationwide under various brand names, including Botany Bay, Divinity and Enhance Your Life.

Divinity Products Distribution could not be reached for comment.

FDA’s announcement comes in the wake of a multi-state outbreak of Salmonella, likely tied to kratom, under investigation by local, state and federal authorities.

FDA said it considers kratom to be a new dietary ingredient (NDI) when intended for use as a supplement, and generally a kratom-containing supplement would be subject to a NDI notification establishing “the product will reasonably be expected to be safe.” But the agency revealed it is unaware of any evidence establishing kratom as a dietary ingredient that meets the safety standard above.

Although FDA has received three separate notifications in recent years to lawfully market kratom in dietary supplements, the agency has objected to each submission based on determinations the notices failed to provide sufficient evidence of safety.

“The extensive scientific data we’ve evaluated about kratom provides conclusive evidence that compounds contained in kratom are opioids and are expected to have similar addictive effects as well as risks of abuse, overdose and, in some cases, death,” FDA Commissioner Scott Gottlieb, M.D., said in a statement. “At the same time, there’s no evidence to indicate that kratom is safe or effective for any medical use. To protect the public health, we’ll continue to affirm the risks associated with kratom, warn consumers against its use and take aggressive enforcement action against kratom-containing products.”

FDA has encouraged all companies selling kratom to humans to remove their products from the market and submit evidence to the agency based on the applicable regulatory path.

“We appreciate the cooperation of companies currently marketing any kratom product for human consumption to take swift action to remove these products from circulation to protect the public,” Gottlieb said.

About the Author(s)

Josh Long

Associate editorial director, Natural Products Insider, Informa Markets Health and Nutrition

Josh Long directs the online news, feature and op-ed coverage at Natural Products Insider, which targets the health and wellness industry. He has been reporting on developments in the dietary supplement industry for over a decade, with a focus on regulatory issues, including at the Food and Drug Administration.

He has moderated and/or presented at industry trade shows, including SupplySide East, SupplySide West, Natural Products Expo West, NBJ Summit and the annual Dietary Supplement Regulatory Summit.

Connect with Josh on LinkedIn and ping him with story ideas at [email protected]

Education and previous experience

Josh majored in journalism and graduated from Arizona State University the same year "Jake the Snake" Plummer led the Sun Devils to the Rose Bowl against the Ohio State Buckeyes. He also holds a J.D. from the University of Wyoming College of Law, was admitted in 2008 to practice law in the state of Colorado and spent a year clerking for a state district court judge.

Over more than a quarter century, he’s written on various topics for newspapers and business-to-business publications – from the Yavapai in Arizona and a controversial plan for a nuclear-waste incinerator in Idaho to nuanced issues, including FDA enforcement of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

Since the late 1990s, his articles have been published in a variety of media, including but not limited to, the Cape Cod Times (in Massachusetts), Sedona Red Rock News (in Arizona), Denver Post (in Colorado), Casper Star-Tribune (in Wyoming), now-defunct Jackson Hole Guide (in Wyoming), Colorado Lawyer (published by the Colorado Bar Association) and Nutrition Business Journal.

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