Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.
Violations2
Issue DateJun 29, 2023
Product TypeFood & Beverages
StatusOpen
Letter Details
Firm
Nikte’s Wholesale, LLC
Location
Efrain Villalobos
Nikte’s Wholesale, LLC
7408 Spring Flower Rd. SW
Albuquerque , NM 87121-6402
United States
FEI Number
N/A
Country
United States
Issue Date
June 29, 2023
Issuing Office
Center for Food Safety and Applied Nutrition (CFSAN)
Product Type
Food & Beverages
Status
Open
Summary
Nikte's Wholesale, LLC was warned for selling Delta-8 THC-infused food products (including gummies, lemonade, and snacks) through websites agrodine.com and cbdwarehouseusa.com that the FDA determined were adulterated under the Federal Food, Drug, and Cosmetic Act because they contained unsafe food additives. The company violated federal law by introducing these unapproved Delta-8 THC products into interstate commerce without FDA evaluation or authorization. The FDA cited serious public health concerns including the lack of safety evaluation for Delta-8 THC products, receipt of adverse event reports, the psychoactive and intoxicating effects of Delta-8 THC, and concerns about the manufacturing processes used to produce these cannabinoid products.
Nikte’s Wholesale, LLC FDA Warning Letter, June 29, 2023