# FDA WARNING_LETTER - ShiVish International LTD. d/b/a Evapstore - March 10, 2020

Source: https://www.keypedia.com/records/warning_letter/shivish-international-ltd-dba-evapstore/f72b0f09-cc9b-457e-ab2b-aa079ff5c52b

> FDA WARNING_LETTER for ShiVish International LTD. d/b/a Evapstore on March 10, 2020. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: ShiVish International LTD. d/b/a Evapstore
- Inspection Date: 2020-03-10
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: The FDA Center for Tobacco Products issued a Warning Letter to evapstore.com on February 28, 2020, following a review of their website. The FDA determined that e-liquid products advertised and sold to U.S. customers are tobacco products under the FD&C Act.

The primary violation is that several e-liquid products, including "Whoop E Liquids Mango Sexy Multipack," "King Cloudz Green Apple," and "Golden Cream E Liquids Strawberry Milkshake Multipack," are misbranded. This is because their website advertising fails to include the required nicotine warning statement: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." This violates 21 C.F.R. § 1143.3(b) and consequently misbrands the products under sections 903(a)(7)(B) and 903(a)(7)(A) of the FD&C Act. The absence of this material fact also renders the advertising misleading.

The letter requires immediate corrective actions, including discontinuing violative advertising, labeling, sale, and distribution. A written response detailing corrective actions and a plan for maintaining compliance must be submitted within 15 working days. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, or injunction, and products may be detained upon import.

## Related Officers

- [Director](https://www.keypedia.com/people/ann-simoneau/155ef03c-6b60-4063-b35d-75522fa67d2b)
- [Marian Marinov](https://www.keypedia.com/people/marian-marinov/d400e6e6-d9e2-48d7-9003-9606e7cc033a)

Company: https://www.keypedia.com/companies/shivish-international-ltd-dba-evapstore/115a45af-4b46-4c2c-8f1f-1d9a3611da97

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