# FDA WARNING_LETTER - Beyond Vape Boston LLC d/b/a Beyond Vape - July 28, 2020

Source: https://www.keypedia.com/records/warning_letter/beyond-vape-boston-llc-dba-beyond-vape/e538877f-64f5-4b33-a4da-143acc4be9f3

> FDA WARNING_LETTER for Beyond Vape Boston LLC d/b/a Beyond Vape on July 28, 2020. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Beyond Vape Boston LLC d/b/a Beyond Vape
- Inspection Date: 2020-07-28
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA Center for Tobacco Products issued a Warning Letter to Wen Wei of Beyond Vape on March 27, 2020, following a review of their website, https://beyondvape.com. The review determined that the company was offering Electronic Nicotine Delivery System (ENDS) products for sale or distribution in the United States without the required premarket authorization.

The identified violations pertain to specific ENDS products: Blue Razz Caesar Juice Pods, Mango Iced Caesar Juice Pods, Passion Fruit Guava Caesar Juice Pods, and Strawberry Watermelon Iced Caesar Juice Pods. These products are classified as "new tobacco products" under section 910(a) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007.

The FDA states that these products lack the necessary marketing authorization orders under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt. Consequently, these ENDS products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required notice or information was not provided under section 905(j).

Beyond Vape is required to ensure all tobacco products and associated labeling/advertising comply with the FD&C Act and FDA regulations. Failure to correct

## Related Officers

- [Director](https://www.keypedia.com/people/ann-simoneau/155ef03c-6b60-4063-b35d-75522fa67d2b)
- [Trina Rozen](https://www.keypedia.com/people/trina-rozen/27eecff2-7656-45b1-946e-de913f3e8912)
- [Wen Wei](https://www.keypedia.com/people/wen-wei/3506e74e-5380-41ea-8c5e-fb17f40d852f)

Company: https://www.keypedia.com/companies/beyond-vape-boston-llc-dba-beyond-vape/590516fb-1a3a-40c0-90e8-885b9e9f2554

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