FDA WARNING_LETTER - www.primewholesale.com

The FDA Center for Tobacco Products issued a Warning Letter to Prime Wholesale (primewholesale.com) after reviewing their website and determining they distribute cigarette and roll-your-own (RYO) tobacco products to U.S. customers. The FDA found that Prime Wholesale sells loose tobacco products, labeled as "pipe tobacco," but promotes them as "multi-use" or "dual purpose" tobacco, intended for cigarettes, including brands like Golden Harvest and OHM. This marketing causes them to meet the definition of "cigarette tobacco" and/or "roll-your-own tobacco" under the FD&C Act.

The products are deemed adulterated under section 902(8) of the FD&C Act because they are modified risk tobacco products (MRTPs) sold without an FDA order. Specifically, products like OHM Mild, Golden Harvest Silver, OHM Blue, OHM Blue (OHM Mild), OHM Gold Mint, and OHM Silver are marketed using descriptors like "Light" or "Mild," which classify them as MRTPs requiring premarket authorization.

Additionally, products such as OHM Mint, OHM Mild Mint, Golden Harvest Mint, and OHM Gold Mint are offered with purported artificial or natural characterizing flavors. This violates section 907(a)(1)(A) of the FD&C Act, which prohibits characterizing flavors (other than tobacco or menthol) in cigarettes, cigarette tobacco, and RYO tobacco