Blackhawx – FDA Warning Letter, Apr 7, 2020

The FDA's Center for Tobacco Products issued a Warning Letter to Blackhawx.com after reviewing their website and determining that their Electronic Nicotine Delivery Systems (ENDS) products are tobacco products subject to FDA jurisdiction. The FDA found that the advertising for several ENDS products, including "Tobacco Flavored Disposable - 10 Pack," "Presidente" - Disposable Electronic Cigar," and "Menthol E-Cigarette Cartridges," failed to include the required nicotine warning statement, "WARNING: This product contains nicotine. Nicotine is an addictive chemical," as mandated by 21 C.F.R. § 1143.3(b). This omission renders the ENDS products misbranded under section 903(a)(7)(B) of the FD&C Act for violating regulations prescribed under section 906(d), and under section 903(a)(7)(A) of the FD&C Act because the advertising is considered false or misleading due to the failure to reveal material facts. The company must immediately correct these violations across all advertising platforms and submit a written response within 15 working days detailing corrective actions, including dates of discontinuance of violative advertising and a plan for sustained compliance. Failure to comply may result in further FDA actions, such as civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and detention of imported products.