Is Antioch Smoke Shop Safe? FDA Warning Letter Review (2017)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on March 21, 2017
Executive Summary
The FDA issued a warning letter to Antioch Smoke Shop on March 21, 2017 citing misbranding, labeling violations. The letter was issued by the FDA.
Detailed Analysis
False Claims and Regulatory Violations
The FDA identified regulatory violations in Antioch Smoke Shop's operations or product claims.
Potential Health Risks
We remind you that you are also required to follow all other applicable federal laws and regulations. For example, section 3(b)(3) of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. ยง 4402) requires the quarterly rotation of warning label statements on advertising for each brand of smokeless tobacco. Quarterly rotation must be done in accordance with a plan submitted by the tobacco product manufacturer, importer, distributor, or retailer and approved by FDA.
Regulatory Context
The United States Food and Drug Administration's (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions included in your email dated August 5, 2016, in response to our Warning Letter dated July 28, 2016. Based on our evaluation, it appears that you have addressed the violation contained in the Warning Letter by no longer advertising misbranded smokeless tobacco products on your website http://www.antiochsmokeshop.com.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with 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/Bryan HillsBranch ChiefDivision of Promotion, Advertising, and LabelingOffice of Compliance and EnforcementCenter for Tobacco Products
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with Antioch Smoke Shop?
- The FDA issued a warning letter citing misbranding, labeling violations related to their products or manufacturing practices.
- Are Antioch Smoke Shop products safe to use?
- Based on the FDA's findings, consumers should exercise caution. The company was found to have misbranding that may affect product safety.
- What should I do if I've used Antioch Smoke Shop products?
- If you have used products from Antioch Smoke Shop 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