FDA WARNING_LETTER - Wholesome Wholesales d/b/a Wholesome Vapes

The FDA's Center for Tobacco Products issued a Warning Letter to Wholesome Vapes after reviewing their website, wholesomevapes.com, and determining that their e-liquid products are offered for sale in the U.S. These e-liquids are classified as tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified was the sale of Coolport e-liquid to a person younger than 18 years of age, which constitutes misbranding under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)). This violates 21 C.F.R. § 1140.14(b), which prohibits retailers from selling covered tobacco products, including e-liquids, to individuals under 18.

Wholesome Vapes is required to immediately correct this violation and any similar issues to ensure compliance with the FD&C Act and FDA's implementing regulations. Failure to comply may result in further FDA actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Adulterated and misbranded tobacco products imported into the U.S. are subject to detention.

A written response detailing corrective actions, including dates of discontinued violative sales and a plan for maintaining compliance, must be submitted