What happened
Original notice title
Thang Botanicals, Inc. d/b/a 7ΩHMZ, 7-OHMZ, or 7OHMZ MARCS-CMS 710190, June 25, 2025
From the archived source record
Moreover, some of the available data raise serious concerns about potential harm associated with 7-OH and kratom extract. Our review of published scientific literature and adverse event reports related to consumption of kratom and kratom-derived products raise a number of safety concerns, including liver toxicity, cardiovascular toxicity, seizures, gastrointestinal distress, respiratory depression, addiction, withdrawal symptoms, and death. Because of this, products containing 7-OH as an ingredient or otherwise containing enhanced levels of 7-OH are of particular concern because we anticipate an increased risk of adverse effects as the dose of 7-OH increases. Under section 409, a food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing. 7-OH and kratom extract are not approved for use in any conventional food. Food containing an unsafe food additive within the meaning of section 409 is adulterated within the meaning of section 402(a)(2)(C)(i) of the Act. Therefore, your 7OHMZ 7-Hydroxymitragynine Gummies product, in Strawberry Acai flavor, is adulterated within the meaning of section 402(a)(2)(C)(i) of the Act because it bears or contains an unsafe food additive. The introduction or delivery for introduction of an adulterated food into interstate commerce is prohibited under section 301(a) of the Act. We note that we are concerned that your 7OHMZ 7-Hydroxymitragynine Gummies product may be appealing to children given the form of the products and the associated packaging. Although your 7OHMZ 7-Hydroxymitragynine Gummies product is labeled with the statement “Keep Out of Reach of Children,” we are concerned that this statement may not be sufficient to prevent children from consuming this product. Adulterated Dietary Supplements The labeling of your 7OHMZ Tropic Thunder Kratom Shot and 7OHMZ 14 mg 7-Hydroxymitragynine Tablets declares 7-OH as a dietary ingredient.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- bd79ca33ce82
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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