FDA WARNING_LETTER - JUSTFOG USA YB Sales, Inc. - September 24, 2019

The FDA's Center for Tobacco Products issued a Warning Letter to Justfogusa.com on September 24, 2019, following a review of their website. The FDA determined that several e-liquid products advertised and offered for sale, such as ROYAL 13 – Lords of Pineapples, GEMINI – Adam & Eve, and Spaceship Jam – Starship 1, are tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified is that the labeling and/or advertising for these e-liquid products on the website fails to include the required nicotine warning statement: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." This omission renders the products misbranded under sections 903(a)(7)(B), 903(a)(1), and/or 903(a)(7)(A) of the FD&C Act, and in violation of 21 C.F.R. § 1143.3(b). The FDA considers the failure to reveal material facts, such as the addictive nature of nicotine, as misleading.

Justfogusa.com is required to immediately correct these violations and ensure all tobacco products and related advertising comply with the FD&C Act and FDA regulations. Failure to comply may result in further FDA action, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure