FDA WARNING_LETTER - Einstein Vapes LLC - February 09, 2022

The FDA issued a Warning Letter to Einstein Vapes LLC on February 9, 2022, following a review of submissions and inspection records. The FDA determined that Einstein Vapes LLC manufactures and distributes e-liquid products, which are classified as tobacco products under the FD&C Act and subject to FDA jurisdiction.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the products Chemistry Sweet Georgia Peach 3MG, Chemistry Theory of Relativity 3MG, and Chemistry Pink Passion 3MG were found to be new tobacco products not commercially marketed before February 15, 2007, and lacking FDA marketing authorization orders or exemptions. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The failure to provide required reports under section 905(j) is also cited as a prohibited act.

Einstein Vapes LLC is a registered manufacturer with over 500 listed products. A Premarket Tobacco Product Application (PMTA), STN PM0001200, submitted on September 7, 2020, received a Marketing Denial Order on September 10, 2021, covering 317 products. The FDA emphasizes that all new tobacco products on the market without premarket authorization are unlawful and subject to enforcement