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Domestic Tobacco Company, LLC MARCS-CMS 510912 —

Recipient Name
Lois B. Ranck
Recipient Title
Domestic Tobacco Company, LLC

830 N. Prince Street
Lancaster, PA 17603
United States

Issuing Office:
Center for Tobacco Products

United States

Dear Ms. Ranck:

The Center for Tobacco Products (CTP) of the United States Food and Drug Administration (FDA) has completed an evaluation of your corrective actions following the issuance of our Warning Letter dated January 19, 2017. Based on our evaluation, it appears you have addressed the violations contained in the Warning Letter. You have submitted the following to CTP:

• Establishment registration and finished tobacco product listing as required by sections 905(b) and (i) of the Federal Food, Drug , and Cosmetic Act (FD&C Act);
• A listing of all ingredients added to your finished tobacco products, as required by section 904(a)(1) of the FD&C Act; and
• A reporting of harmful and potentially harmful constituents (HPHC) in your finished tobacco products, as required by section 904(a)(3) of the FD&C Act.

Additionally, CTP has reviewed the establishment inspection report (EIR) for a routine inspection of your establishment performed on January 23, 2018. Based on our evaluation of the EIR, it appears that you have addressed CTP's additional observation regarding section 903(a)(2)(D) of the FD&C Act noted in the January 19, 2017, Warning Letter. Specifically, FDA investigators observed during the inspection that your smokeless tobacco product labels, packaging, and shipping containers bear the statement, "Sale only allowed in the United States," as required by section 920(a) of the FD&C Act.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the FD&C Act and its implementing regulations or with other relevant legal authority. This letter also will not preclude any regulatory action should FDA become aware of any failure to comply with any other violations in the future.

If you have any questions concerning this matter, please contact David Keith at 301-796-2722 or via email at David.Keith@fda.hhs.gov.

David Keith
Division of Enforcement and Manufacturing
Office of Compliance and Enforcement
Center for Tobacco Products

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