FDA on Tuesday announced warning letters were sent to Cali Botanicals of Folsom, California and Kratom NC of Wilmington, North Carolina because the companies claimed without proof to cure or treat opioid addiction and withdrawal symptoms.

Josh Long, Associate editorial director, Natural Products Insider

June 25, 2019

2 Min Read
FDA targets marketers of kratom for unproven drug claims

Two distributors and marketers of kratom have been flagged by FDA for selling unapproved, misbranded drugs.

FDA on Tuesday announced warning letters were sent to Cali Botanicals of Folsom, California, and Kratom NC of Wilmington, North Carolina, because the companies claimed without proof to cure or treat opioid addiction and withdrawal symptoms.

The companies also make claims regarding the treatment of pain and other medical conditions such as anxiety, cancer and depression, according to an FDA news release.

Among some of the claims identified by FDA in the recent warning letters:

  • "Kratom acts as a μ-opioid receptor-like morphine."

  • "In fact many people use kratom to overcome opiate addiction."

  • "Of course, people who are using kratom to overcome a preexisting opiate addiction may need to use kratom daily to avoid opiate withdrawal."

  • Usage: It is for the management of chronic pain, as well as recreationally."

Cali Botanicals and Kratom NC did not immediately respond to emailed requests for comment.

FDA requested both companies respond to the letters within 15 working days, explaining their actions to address the agency’s concerns. Failure to correct the violations, FDA cautioned the firms, may result in a law enforcement action, such as a seizure or injunction, without further notice.

In several warnings in recent years, FDA has cautioned the public about certain risks related to the use of kratom, such as unapproved claims of treating diseases and the detection of heavy metals, including lead and nickel, in some kratom products at levels unsafe for human consumption.

“Despite our warnings, companies continue to sell this dangerous product and make deceptive medical claims that are not backed by science or any reliable scientific evidence," Acting FDA Commissioner Ned Sharpless, M.D., said in a statement. "As we work to combat the opioid crisis, we cannot allow unscrupulous vendors to take advantage of consumers by selling products with unsubstantiated claims that they can treat opioid addiction or alleviate other medical conditions."








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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