Sherman's 1400 Broadway, N.Y.C. LLC. FDA Warning (2018)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on February 23, 2018
Executive Summary
The FDA issued a warning letter to Sherman's 1400 Broadway, N.Y.C. LLC. on February 23, 2018 citing labeling violations. The letter was issued by the FDA.
Detailed Analysis
False Claims and Regulatory Violations
The FDA identified regulatory violations in Sherman's 1400 Broadway, N.Y.C. LLC.'s operations or product claims.
Potential Health Risks
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."
Regulatory Context
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.
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with Sherman's 1400 Broadway, N.Y.C. LLC.?
- The FDA issued a warning letter citing labeling violations related to their products or manufacturing practices.
- Are Sherman's 1400 Broadway, N.Y.C. LLC. products safe to use?
- Based on the FDA's findings, consumers should exercise caution. The company was found to have labeling violations that may affect product safety.
- What should I do if I've used Sherman's 1400 Broadway, N.Y.C. LLC. products?
- If you have used products from Sherman's 1400 Broadway, N.Y.C. LLC. and experience any adverse effects, contact your healthcare provider immediately. You can also report adverse events to the FDA's MedWatch program.
Source Document
This report is based on an official FDA warning letter. The original document is a public record.
View Original FDA Warning Letter