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# FDA Warns 5 Kratom Distributors
- URL: https://www.fdaweb.com/fda-warns-5-kratom-distributors/
- Published: 2022-07-11T12:00:00.000Z
- Updated: 2026-09-14T17:51:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152231

FDA has sent Warning Letters to five distributors of kratom products, saying that claims made for the products on Web sites and social media establish them as unapproved new drugs that are being illegally delivered into interstate commerce. The 6/30 letters went to [Kratom Exchange](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kratom-exchange-633972-06302022?ref=fdaweb.com), [Herbsens Botanicals](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/herbsens-botanicals-634373-06302022?ref=fdaweb.com), [Klarity Kratom](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/klarity-kratom-634501-06302022?ref=fdaweb.com), [Omni Consumer Products](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/omni-consumer-products-llc-dba-yokratom-634184-06302022?ref=fdaweb.com) (doing business as YoKratom), and [MONO](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/monq-llc-613570-06302022?ref=fdaweb.com).

The letters list claims for the kratom products that establish that they are unapproved new drugs. The companies were told to respond with a list of specific actions they have taken to correct the violations and prevent their recurrence, with documentation for each action and a schedule for completing the corrections.

The letters also include a cease and desist demand from the Federal Trade Commission covering the claims made for the products in advertising.