# FDA WARNING_LETTER - HiggyCigs LLC d/b/a Viral Vapes - November 30, 2023

Source: https://www.keypedia.com/records/warning_letter/higgycigs-llc-dba-viral-vapes/ce90132f-27d4-40e5-9185-4156343ee9eb

> FDA WARNING_LETTER for HiggyCigs LLC d/b/a Viral Vapes on November 30, 2023. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: HiggyCigs LLC d/b/a Viral Vapes
- Inspection Date: 2023-11-30
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA issued a Warning Letter to HiggyCigs LLC d/b/a Viral Vapes on November 30, 2023, based on an inspection. The company manufactures and distributes e-liquid products, including "Hula Fruits," which are considered tobacco products under the FD&C Act, specifically section 201(rr) (21 U.S.C. § 321(rr)), due to containing nicotine.

The primary violation is the marketing of "new tobacco products" without the required premarket authorization. The FDA determined that "Hula Fruits" and other e-liquid products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. § 387j(c)(1)(A)(i)).

Consequently, these products are deemed adulterated under section 902(6)(A) (21 U.S.C. § 387b(6)(A)) and misbranded under section 903(a)(6) (21 U.S.C. § 387c(a)(6)) because required notices or information under section 905(j) (21 U.S.

## Related Officers

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

Company: https://www.keypedia.com/companies/higgycigs-llc-dba-viral-vapes/b75a9656-1bd2-4a30-88fb-ccf0f304d72e

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