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Saturday, May 22, 2021
FDA Announces Seizure of Adulterated Dietary Supplements Containing Kratom
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
Tuesday, May 18, 2021
| 05/18/2021 | 05/07/2021 | Nicotine Nirvana | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||
| 05/12/2021 | 05/04/2021 | Baltimore Beauty Security Square Mall | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 05/18/2021 | 04/21/2021 | North American Hirudin Biotech Products Inc. | Office of Regulatory Affairs | New Drug/Misbranded | ||
| 05/18/2021 | 04/27/2021 | NeuroHydrate LLC | Office of Human and Animal Food Operations East – Division 1 | New Drug/Misbranded | ||
| 05/18/2021 | 04/29/2021 | Wismettac Asian Foods, Inc. | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) | ||
| 05/18/2021 | 05/05/2021 | Bio-Botanica, Inc./Nature’s Answer, Inc. | Office of Human and Animal Food Operations East – Division 1 | Dietary Supplement/Adulterated/Cesium Chloride | ||
| 05/18/2021 | 05/07/2021 | High Voltage Vaporz LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||
| 05/18/2021 | 05/07/2021 | Central Iowa Electronic Cigarettes Inc | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||
| 05/18/2021 | 05/07/2021 | Sema International Inc. | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||
| 05/18/2021 | 05/07/2021 | The Iron Crow LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||
| 05/18/2021 | 05/07/2021 | JP & SN Enterprises Inc. d/b/a eCigs International | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||
| 05/18/2021 | 05/07/2021 | FF Vapors, LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
N.Y. bill to limit mandatory mail-order pharmacy services for specialty drugs advances |
Although independent pharmacists in New York lauded the development, pharmacy benefit managers said the bill would increase costs for employers and patients and compromise patient safety. |
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