Is Gr8 E Vape Safe? FDA Warning Letter Review (2017)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on April 11, 2017
Executive Summary
The FDA issued a warning letter to Gr8 E Vape on April 11, 2017 citing labeling violations. The letter was issued by the FDA.
Detailed Analysis
False Claims and Regulatory Violations
The FDA identified regulatory violations in Gr8 E Vape's operations or product claims.
Potential Health Risks
Consumers should be aware of potential risks associated with products from Gr8 E Vape.
Regulatory Context
The United States Food and Drug Administration's (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions following the issuance of our Warning Letter dated August 31, 2016, and teleconference held on January 5, 2017. Based on our evaluation, it appears that you have taken steps to address the violation contained in the Warning Letter for the website http://www.gr8evape.com.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure compliance with the Federal Food, Drug, and Cosmetic 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 Gr8 E Vape?
- The FDA issued a warning letter citing labeling violations related to their products or manufacturing practices.
- Are Gr8 E Vape 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 Gr8 E Vape products?
- If you have used products from Gr8 E Vape 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