What happened
Original notice title
Royal Diamond Imports, Inc. MARCS-CMS 709540, June 25, 2025
From the archived source record
Moreover, some of the available data raise serious concerns about potential harm associated with 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 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. 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 Roxy Instamix Complex Alakaloid Drink Mix (in passion fruit 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 (21 U.S.C. 331(a)). Unapproved New Drugs Based on our review of your website, www.roxytabs.com, your 7-OH Tablets are drugs under section 201(g)(1) of the Act (21 U.S.C. 321(g)(1)), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Accordingly, these products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the Act (21 U.S.C 355(a) and 331(d)). Conclusion This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products.
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
- 955a1ebcc893
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.
Sources, dates, and coverage →