FDA News Release
FDA Announces Seizure of Adulterated Dietary Supplements Containing Kratom
- For Immediate Release:
UPDATE: On October 26, 2021, Judge Sheri Polster Chappell of the United States District Court for the Middle District of Florida entered a consent decree of condemnation and destruction against the articles seized in May 2021. The consent decree declares that the claimants, BioBotanical LLC and MT Brands LLC, will be required to pay a penal bond and destroy all seized articles under the supervision of the FDA.
The U.S. Food and Drug Administration announced today that U.S. Marshals, at the agency’s request, seized more than 207,000 units of dietary supplements and bulk dietary ingredients that are or contain kratom, including over 34,000 kilograms of bulk kratom. The dietary supplements are manufactured by Atofil, LLC, which is located in Fort Myers, Florida, and is a subsidiary of Premier Manufacturing Products. The dietary supplements are marketed under the brand names Boosted Kratom, The Devil’s Kratom, Terra Kratom, Sembuh, Bio Botanical, and El Diablo. The seized products are worth approximately $1.3 million.
“There is substantial concern regarding the safety of kratom, the risk it may pose to public health and its potential for abuse,” said Judy McMeekin, Pharm.D., the FDA’s Associate Commissioner for Regulatory Affairs. “The FDA will continue to exercise our full authority under the law to take action against these adulterated dietary supplements as part of our ongoing commitment to protect the health of the American people. Further, there are currently no FDA-approved uses for kratom.”
Mitragyna speciosa, commonly known as kratom, is a plant that grows naturally in Thailand, Malaysia, Indonesia and Papua New Guinea. Serious concerns exist regarding the toxicity of kratom in multiple organ systems. Consumption of kratom can lead to a number of health impacts, including, among others, respiratory depression, vomiting, nervousness, weight loss and constipation. Kratom has been indicated to have both narcotic and stimulant-like effects, and withdrawal symptoms may include hostility, aggression, excessive tearing, aching of muscles and bones, and jerky limb movements.
In February 2014, the FDA issued an import alert that provides information to FDA field staff about detaining without physical examination imported dietary supplements and bulk dietary ingredients that are or contain kratom.
The U.S. Department of Justice, on behalf of the FDA, filed a complaint in the U.S. District Court for the Middle District of Florida alleging, among other things, that kratom is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that it does not present a significant or unreasonable risk of illness or injury; therefore, dietary supplements and bulk dietary ingredients that are or contain kratom are adulterated under the Federal Food, Drug, and Cosmetic Act.
The FDA continues to warn consumers not to use any products labeled as containing kratom. The FDA encourages health care professionals and consumers to report any adverse events related to products containing kratom to the FDA’s MedWatch program by:
- completing and submitting the report online at www.fda.gov/medwatch; or
- downloading the form, completing it and then faxing it to 1-800-FDA-0178.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
- Lauren-Jei McCarthy