# FDA WARNING_LETTER - Yogi's Vape - March 15, 2022

Source: https://www.globalkeysolutions.net/records/warning_letter/yogis-vape/43cd0350-e57f-4fd3-9433-8ea1514e6c0c

> FDA WARNING_LETTER for Yogi's Vape on March 15, 2022. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Yogi's Vape
- Inspection Date: 2022-03-15
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: On March 15, 2022, the FDA issued a Warning Letter to Yogi’s Vape for manufacturing and distributing e-liquid products, specifically Yogi’s Legend Berry 3mg e-liquid, without required premarket authorization. The FDA determined these e-liquid products are "new tobacco products" under section 201(rr) of the FD&C Act, as they were not commercially marketed in the U.S. as of February 15, 2007.

The identified product, Yogi’s Legend Berry 3mg e-liquid, lacks an FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act, rendering it adulterated under section 902(6)(A) and misbranded under section 903(a)(6). The failure to provide a required report under section 905(j) is also a prohibited act under section 301(p).

Yogi’s Vape is a registered manufacturer with over 31,300 products listed. A Premarket Tobacco Product Application (PMTA), STN PM0003759, submitted on September 2, 2020, received a Marketing Denial Order on September 9, 2021, covering 24,760 products.

The FDA requires prompt action to address these

## Related Documents

- [WARNING_LETTER - 2022-08-02](https://www.globalkeysolutions.net/records/warning_letter/yogis-vape/615ea40a-0164-40d3-ae5d-25888300ea0e)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/yogis-vape/33d6c047-c81a-41b6-b43d-4feb2074ccf8

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