# FDA WARNING_LETTER - Wholesome Wholesales d/b/a Wholesome Vapes - Unknown Date

Source: https://www.keypedia.com/records/warning_letter/wholesome-wholesales-dba-wholesome-vapes/31fe4bec-52f0-4f8f-9d47-cc884ff5c918

> FDA WARNING_LETTER for Wholesome Wholesales d/b/a Wholesome Vapes on Unknown Date. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Wholesome Wholesales d/b/a Wholesome Vapes
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: 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

## Related Officers

- [Director](https://www.keypedia.com/people/ann-simoneau/155ef03c-6b60-4063-b35d-75522fa67d2b)
- [Anita Fiouris](https://www.keypedia.com/people/anita-fiouris/aab103b6-588b-4a38-9b08-35a4556a6d16)

Company: https://www.keypedia.com/companies/wholesome-wholesales-dba-wholesome-vapes/0732d122-b9c5-434a-b673-0cf690d3f434

Office: https://www.keypedia.com/offices/center-for-tobacco-products/65f73cae-ef6f-4e9f-a311-a111daa67374