Hot Juice LTD – FDA Warning Letter, Sep 15, 2020

On July 8, 2020, the FDA issued a Warning Letter to Hot Juice, LLC, following a review of their website, https://hotjuice.com. The FDA determined that several e-liquid products manufactured and sold by Hot Juice are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)).

The core violation is the failure to include the required nicotine warning statement in the advertising for e-liquid products, such as "Hot Juice – Bananaberry Tropicburst Vape Juice" and "Hot Juice – Bacon Bits Vape Juice." Under 21 C.F.R. § 1143.3(b), advertising for covered tobacco products, including e-liquids, must bear the warning: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." This omission renders the products misbranded.

Hot Juice is required to immediately correct this violation and any similar issues across all advertising platforms. A written response detailing corrective actions, including dates of discontinued violative advertising/sales and a compliance plan, must be submitted within 15 working days. Failure to comply may result in regulatory action, including detention and refusal of admission for imported products.