# FDA WARNING_LETTER - Turkish Trade LLC d/b/a Tarblock, Inc. - March 31, 2020

Source: https://www.keypedia.com/records/warning_letter/turkish-trade-llc-dba-tarblock-inc/3824bcc0-6be6-4ec2-8947-1c248716fec9

> FDA WARNING_LETTER for Turkish Trade LLC d/b/a Tarblock, Inc. on March 31, 2020. Product: Tobacco. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Turkish Trade LLC d/b/a Tarblock, Inc.
- Inspection Date: 2020-03-31
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: On January 14, 2020, the FDA's Center for Tobacco Products issued a Warning Letter to Cem Cigir regarding products sold on https://www.tarblockshop.com. The FDA determined that disposable cigarette filters, specifically "Tarblock Cigarette Filters," are tobacco products under section 201(rr) of the FD&C Act. These products were found to be adulterated under section 902(8) of the FD&C Act because they are modified risk tobacco products (MRTPs) sold or distributed without an FDA order in effect. The website made claims such as "Tarblock Cigarette Filters reduce Tar & Chemicals," "minimizes the bad effects of smoking," "Get rid of morning cough," and "Easier breathing," which explicitly or implicitly represent the product as presenting a lower risk or reduced exposure to substances, thus classifying them as MRTPs under section 911(b)(2)(A)(i). Section 911(a) prohibits the introduction of MRTPs into interstate commerce without an FDA order. The company is required to immediately correct the violation, discontinue all violative labeling, advertising, sale, and distribution of these products. A written response detailing corrective actions 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)

Company: https://www.keypedia.com/companies/turkish-trade-llc-dba-tarblock-inc/7e4a974d-0406-451d-a1b1-7e5ed43a359f

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