# FDA WARNING_LETTER - 10057223 canada inc.  - November 09, 2021

Source: https://www.keypedia.com/records/warning_letter/10057223-canada-inc/5439f916-b49e-4421-9f26-3d31e27e7b1c

> FDA WARNING_LETTER for 10057223 canada inc.  on November 09, 2021. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: 10057223 canada inc. 
- Inspection Date: 2021-11-09
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA Center for Tobacco Products issued a Warning Letter to David Di Lallo of Maddog Juice on November 5, 2021, following a review of their website, maddogjuice.com. The review determined that e-liquid products, specifically "Big Boy – Big Burst" and "Big Boy – Big Crunch," are manufactured and sold in the U.S. and are considered tobacco products under the FD&C Act.

These products are deemed "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007. The primary violation is that these e-liquid products are being marketed without the required premarket authorization order from the FDA, as mandated by section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the products are considered adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

Although a Premarket Tobacco Product Application (PMTA) (STN PM0003717) was submitted on September 4, 2020, it received a Marketing Denial Order on September 15, 2021, covering 94 products. The FDA emphasizes that all new tobacco products on the market without statutory premarket authorization are unlawful and subject to enforcement action, including civil

## Related Officers

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

Company: https://www.keypedia.com/companies/10057223-canada-inc/3c5003f0-fd99-49d3-9fc2-53e1bfb10425

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