# FDA WARNING_LETTER - Bulk E-Juice Enterprise Inc d/b/a Bulk E-Juice - April 07, 2020

Source: https://www.keypedia.com/records/warning_letter/bulk-e-juice-enterprise-inc-dba-bulk-e-juice/400774ca-5533-4a55-b338-62a5c1118032

> FDA WARNING_LETTER for Bulk E-Juice Enterprise Inc d/b/a Bulk E-Juice on April 07, 2020. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Bulk E-Juice Enterprise Inc d/b/a Bulk E-Juice
- Inspection Date: 2020-04-07
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA Center for Tobacco Products issued a Warning Letter to Misty Shipp and Bryan Shipp concerning e-liquid tobacco products advertised and sold on bulkejuice.com. The FDA determined that several e-liquid products are misbranded under sections 903(a)(7)(B) and 903(a)(7)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The primary violation identified is the failure of the website advertising to include the required nicotine warning statement, "WARNING: This product contains nicotine. Nicotine is an addictive chemical," as mandated by 21 C.F.R. § 1143.3(b). This omission renders the advertising non-compliant and the products misbranded. The letter emphasizes that all tobacco products, including e-liquids, are subject to FDA jurisdiction and regulations. The company is required to immediately correct these violations and ensure all advertising across all platforms complies with the FD&C Act and implementing regulations. A written response detailing corrective actions, dates of discontinuation of violative activities, and a compliance plan must be submitted within 15 working days. Failure to comply could lead to severe enforcement actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and refusal of admission for imported products.

## Related Officers

- [Director](https://www.keypedia.com/people/ann-simoneau/155ef03c-6b60-4063-b35d-75522fa67d2b)
- [Bryan Shipp](https://www.keypedia.com/people/bryan-shipp/387966ca-b295-4524-9cc1-bddb4b2032a1)
- [Misty Shipp](https://www.keypedia.com/people/misty-shipp/adc981e9-ad9b-4fb3-9dbe-fded398e10c5)

Company: https://www.keypedia.com/companies/bulk-e-juice-enterprise-inc-dba-bulk-e-juice/71addf3c-7f01-4476-9ad6-d1c84e35b9ce

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