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CLOSEOUT LETTER

Nova Distributors, LLC MARCS-CMS 539670 — Feb 20, 2018

Nova Distributors, LLC - 539670 - 02/20/2018

Delivery Method:
VIA UPS and Electronic Mail
Product:
Tobacco

Recipient:
Recipient Name
Donald E. Bruch
Nova Distributors, LLC

One Nova Way
R.R. 1 Box 52
Golden Eagle, IL 62036
United States

info@tarbarfilter.com
Issuing Office:
Center for Tobacco Products

10903 New Hampshire Avenue
Silver Spring, MD 20993
United States


Dear Mr. Bruch:

On November 17, 2017, the United States Food and Drug Administration's (FDA) Center for Tobacco Products (CTP) issued you a Warning Letter for the sale or distribution of modified risk tobacco products without an FDA order in effect that permits such sale or distribution, in violation of section 911 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

On December 21 , 2017, you sent FDA a response to the Warning Letter, and we had a teleconference on January 17, 2018 to discuss the Warning Letter and your response. In response to the Warning Letter, you stated that you implemented corrective actions to address the violations identified in the Warning Letter.

Based on our evaluation, it appears that you have taken steps to address the violations identified in the Warning Letter. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure 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 violations be observed in the future.

Should you have any questions or concerns, please contact Ele Ibarra-Pratt at (301) 796-9235 or by email at elenita.ibarrapratt@fda.hhs.gov.

Sincerely,
/S/
Ann Simoneau, J.D.
Director
Office of Compliance and Enforcement

cc:

Azim Chowdhury
Keller and Heckman, LLP
1001 G Street, N.W.
Suite 500 West
Washington, D.C. 20001
chowdhury@khlaw.com