FDA WARNING_LETTER - Shake Hemp - October 01, 2024

The FDA's Center for Tobacco Products issued a Warning Letter to shakehemp.co after reviewing their website and identifying electronic nicotine delivery system (ENDS) products offered for sale in the United States. These products, including those containing nicotine from any source, are regulated as tobacco products under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The inspection revealed two primary violations. First, the firm is marketing "new tobacco products," specifically Shake Bar 15000 Puffs Disposable Vapes (Gummy Bear, Blue Slushie) and Shake Bar 9000 Puffs (Energy Drink), without the required premarket authorization orders. This renders these products adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. Second, the firm sold an ENDS product (Shake Bar 15000 Puffs Disposable Vape – Gummy Bear) to an individual under the age of 21, violating section 906(d)(5) and consequently misbranding the product under section 903(a)(7)(B) of the FD&C Act. The FDA requires the firm to submit a written response within 15 working days, detailing corrective actions, including discontinuing violative sales and a plan for sustained compliance. Failure to address these violations may lead to significant regulatory actions, such as civil money penalties, product seizure, or injunctions.