FDA WARNING_LETTER - bearlylegalhemp.com

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to bearlylegalhemp.com on September 18, 2025, following a recent review of their website. The FDA determined that the company is manufacturing and selling "Nicotine Infused Hemp Cigarettes," specifically naming "Nicotine Infused Hemp Cigarettes | 100% Tobacco Fee [sic] Nicotine (Pack)" and (Carton).

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), these products are considered "tobacco products" due to containing nicotine from any source, aligning with the FDA"s expanded jurisdiction since March 15, 2022. The primary violation is that bearlylegalhemp.com has marketed these as "new tobacco products" without obtaining the required premarket authorization from the FDA. New tobacco products not commercially available before February 15, 2007, generally require such authorization. Consequently, the FDA deems these products unlawfully marketed, classifying them as both adulterated and misbranded due to the absence of proper regulatory submission and approval.

bearlylegalhemp.com is required to submit a written response within 15 working days. This response must detail actions taken to correct the violations, including the dates when the sale and distribution of the unauthorized products were discontinued, and a comprehensive plan for maintaining future compliance with the FD&C Act. Failure to address these issues may lead to significant enforcement actions, such as civil money penalties, product seizure, or injunctions.