FDA WARNING_LETTER - Royal Diamond Imports, Inc. - July 15, 2025

**FDA Warning Letter Summary**

**Company:** Roxy Instamix

**Inspection Dates:** Not specified in the document.

**Main Violations/Issues:** 1. **Adulterated Human Foods:** The Roxy Instamix Complex Alkaloid Drink Mix, containing 7-hydroxymitragynine (7-OH) derived from kratom extract, is considered an unsafe food additive. The FDA has not approved kratom extract for use in conventional foods, and it does not meet the Generally Recognized as Safe (GRAS) criteria. The introduction of such adulterated food into interstate commerce is prohibited.

2. **Unapproved New Drugs:** The 7-OH tablets, including ROXY 7-OH and ROXY XL 7-OH, are marketed with claims suggesting they can diagnose, cure, mitigate, treat, or prevent disease, classifying them as drugs under the Federal Food, Drug, and Cosmetic Act. These products have not received FDA approval as drugs, making their marketing illegal.

**Regulatory Framework:** - The Federal Food, Drug, and Cosmetic Act prohibits the introduction of adulterated foods and unapproved new drugs into interstate commerce. - Section 201(s) and 409 of the Act address food additives, requiring FDA approval for safety. - Section 201(g)(1) of the Act defines drugs and requires FDA approval for marketing.

**Required Actions:** - Cease the distribution and sale of the adulterated food products and unapproved new drugs. - Remove any claims from marketing materials that suggest the products have drug-like effects. - Ensure compliance with FDA regulations before reintroducing any products into the market.

The FDA emphasizes the need for immediate corrective actions to avoid further regulatory actions, including potential seizure or injunction.