What did the FDA find wrong with ITG Brands, LLC?

The FDA issued a warning letter citing labeling violations related to their products or manufacturing practices.

Are ITG Brands, 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 ITG Brands, LLC products?

If you have used products from ITG Brands, LLC and experience any adverse effects, contact your healthcare provider immediately. You can also report adverse events to the FDA's MedWatch program.

Is ITG Brands, LLC Safe? FDA Warning Letter Review (2017)

Name: Is ITG Brands, LLC Safe? FDA Warning Letter Review (2017)
Creator: Supplement Safety Data Team
Published: 2026-03-27T01:44:24.955557

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on September 05, 2017

MODERATE SEVERITY 2017

Disclaimer: This report is an analysis of a public FDA warning letter. It is not medical advice. If you have consumed these products and feel unwell, contact a healthcare professional immediately.

Executive Summary

The FDA issued a warning letter to ITG Brands, LLC on September 05, 2017 citing labeling violations. The letter was issued by the FDA.

Labeling Violations

Detailed Analysis

False Claims and Regulatory Violations

The FDA identified regulatory violations in ITG Brands, 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. Specifically, you sold or distributed Winston cigarettes described in product labeling as "Additive Free."

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 for your products pursuant to section 905(i) of the Federal Food, Drug, and Cosmetic Act (FD&C 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

section 905(i) FD&C Act FD&C Act

Frequently Asked Questions

What did the FDA find wrong with ITG Brands, LLC?: The FDA issued a warning letter citing labeling violations related to their products or manufacturing practices.
Are ITG Brands, 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 ITG Brands, LLC products?: If you have used products from ITG Brands, 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

Medical Disclaimer: This report is an analysis of public FDA warning letters. It is not medical advice. If you have consumed these products and feel unwell, contact a healthcare professional immediately. You can report adverse events to the FDA MedWatch program.