Food and Drug Administration assessment of Kratom
The FDA's assessment of kratom has been characterized by a series of concerns and regulatory actions aimed at addressing potential health risks associated with this botanical substance. In April 2019, the FDA issued a statement emphasizing that kratom had not received approval for any medical use. The agency raised concerns about the safety of kratom products available in the United States and continued to enforce an import alert, which allowed the confiscation of imported kratom supplies. This move underscored the FDA's commitment to ensuring the safety of products containing kratom that enter the U.S. market.
FDA’s regulation on Kratom
One significant development in this regulatory landscape occurred on April 4, 2018, when the FDA issued its first-ever mandatory recall due to concerns of salmonella contamination in various kratom-containing products. These products, manufactured by Triangle Pharmanaturals and marketed under the brand name 'Raw Form Organics,' tested positive for contamination, and the manufacturer did not comply with federal requests for voluntary recall. The FDA's Commissioner at the time, Scott Gottlieb, stressed that the recall was primarily driven by the imminent health risk posed by salmonella contamination, rather than other regulatory concerns. Consumers were strongly advised to discard such products promptly to mitigate potential serious health risks.
FDA's scrutiny of kratom
In February 2018, Commissioner Gottlieb further highlighted the opioid-like properties of kratom and reiterated that it should not be used for medical treatment or recreational purposes. The FDA's scrutiny of kratom extended to overseeing the voluntary destruction of kratom dietary supplements by a distributor in Missouri, signaling a proactive approach to regulating the substance. The agency encouraged all companies involved in kratom commerce to remove their products from the market, emphasizing the need for vigilance in addressing potential safety issues.
Food and Drug Administration evidence
In November 2017, the FDA voiced serious concerns over the marketing and effects of kratom use in the United States, including instances of death associated with its consumption. The agency emphasized that there was no reliable evidence to support the use of kratom as a treatment for opioid use disorder and highlighted the absence of FDA-approved therapeutic uses for the substance. These concerns underscored the significant safety issues linked to kratom use, further reinforcing the FDA's cautious stance on this botanical product.
Food and Drug Administration Public health
Overall, the FDA's assessments and actions regarding kratom reflect its commitment to protecting public health by addressing potential risks and safety concerns associated with this substance. These regulatory measures aim to ensure that consumers are informed and protected when it comes to the use of kratom-containing products.
Sources
C. Michael White. (2018). Pharmacologic and clinical assessment of kratom. American Journal of Health-System Pharmacy. Available at: https://academic.oup.com/ajhp/article-abstract/75/5/261/5102317?login=false
Papadis, A., et al. (2022). Assessment of the possible health risks associated with the consumption of botanical preparations of Mitragyna speciosa (kratom). EFSA Journal. Available at: https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2022.e200415
Scott Gottlieb, M.D. (2018). Statement from FDA Commissioner on the agency’s scientific evidence on the presence of opioid compounds in kratom, underscoring its potential for abuse. Available at: https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-agencys-scientific-evidence-presence-opioid-compounds
Eastlack, S.C., et al. (2020). Kratom-Pharmacology, Clinical Implications, and Outlook: A Comprehensive Review. Pain Ther. Available at: https://link.springer.com/article/10.1007/s40429-023-00478-3
Singh, D., et al. (2017). Changing trends in the use of kratom (Mitragyna speciosa) in Southeast Asia. Hum Psychopharmacol. Available at: https://www.ncbi.nlm.nih.gov/books/NBK585120/
Gerlach, K.K., & Henningfield, J.E. (2019). Kratom as a substitute for opioids: Results from an online survey. Drug and Alcohol Dependence. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10243221/
Eggleston, W., et al. (2019). Kratom use and toxicities in the United States. Pharmacotherapy. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10243221/
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