# FDA WARNING_LETTER - Vapewear, LLC - April 27, 2020

Source: https://www.keypedia.com/records/warning_letter/vapewear-llc/c5db91b4-f2be-4c37-95d9-c565374bf492

> FDA WARNING_LETTER for Vapewear, LLC on April 27, 2020. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Vapewear, LLC
- Inspection Date: 2020-04-27
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA's Center for Tobacco Products issued a Warning Letter to Scott Arnel after reviewing vapewearlabs.com and identifying the Vapewear vWaTch Starter Kit ENDS product as a tobacco product offered for sale without required marketing authorization. This product is considered a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the product is adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required notice or information under section 905(j). The failure to provide such a report is also a prohibited act under section 301(p). FDA expressed significant concern that the product's smartwatch-like design is likely to appeal to children and conceal tobacco use. The firm must promptly correct all violations, discontinue violative labeling, advertising, sale, and distribution, and submit a written response within 15 working days detailing corrective actions and a compliance plan. Non-compliance may lead to civil money penalties, seizure, injunction, and import refusal.

## Related Officers

- [Director](https://www.keypedia.com/people/ann-simoneau/155ef03c-6b60-4063-b35d-75522fa67d2b)

Company: https://www.keypedia.com/companies/vapewear-llc/d2a21528-4005-4ac3-9fa6-af58ae9ad8b1

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