FDA WARNING_LETTER - Access Vapor LLC d/b/a Cali Pods - September 14, 2023

The FDA issued a Warning Letter to Access Vapor LLC d/b/a Cali Pods, specifically addressing their website, https://www.calivapepods.com, and the redirected online retailer, https://calipodsonline.com. The review determined that electronic nicotine delivery system (ENDS) products offered for sale are tobacco products under section 201(rr) of the FD&C Act, as amended to include nicotine from any source.

The primary violation is the marketing of "new tobacco products" without required premarket authorization. The specific products identified as lacking marketing authorization are Cali Bars Disposable – Watermelon and Cali Bars V2 Disposable – Blueberry. These products are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack an FDA marketing authorization order or exemption. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The FDA requires the firm to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale and distribution of the non-compliant products and outlining a plan for future compliance. Failure to comply may result in regulatory or legal actions, such as civil money penalties, seizure, and/or injunction.