CLOSEOUT LETTER
Sherman's 1400 Broadway, N.Y.C. LLC. MARCS-CMS 475207 —
- Recipient:
- Sherman's 1400 Broadway, N.Y.C. LLC.
United States
- Issuing Office:
United States
|
|
|
|
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993
|
FEB 23, 2018
VIA UPS
William M. Sherman
Executive Vice President
Sherman's 1400 Broadway N.Y.C., Ltd.
10 Sterling Blvd.
3rd Floor
Englewood, NJ 07631
RE: Warning Letter issued to Sherman's 1400 Broadway N.Y.C. LLC (Nat Sherman) (RW1500346)
Dear Mr. Sherman:
On August 27, 2015, 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). Specifically, you sold or distributed Nat Sherman cigarette products described in product labeling as "Natural."
In response to the Warning Letter, you stated that you implemented corrective actions to address the violations identified in the Warning Letter. You also submitted revised labeling and advertising for your products pursuant to section 905(i) of the Federal Food, Drug, and Cosmetic Act.
FDA conducted an inspection of your manufacturing facility to confirm your corrective actions. After reviewing the results of this inspection, it appears that you have addressed 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.
Sincerely,
/S/
Ele Ibarra-Pratt
Director
Division of Promotion, Advertising and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products