What did the FDA find wrong with Pure Smoke LLC?

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

Are Pure Smoke 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 Pure Smoke LLC products?

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

Is Pure Smoke LLC Safe? FDA Warning Letter Review (2017)

Name: Is Pure Smoke LLC Safe? FDA Warning Letter Review (2017)
Creator: Supplement Safety Data Team
Published: 2026-03-27T01:44:17.711286

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on April 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 Pure Smoke LLC on April 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 Pure Smoke LLC's operations or product claims.

Potential Health Risks

Consumers should be aware of potential risks associated with products from Pure Smoke LLC.

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 letter dated January 3, 2017, in response to our Warning Letter dated December 13, 2016. 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.puresmokeonline.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.

Bryan HillsBranch ChiefDivision of Promotion, Advertising, and LabelingOffice of Compliance and EnforcementCenter for Tobacco Products

Key Entities Identified

Pure Smoke LLC FDA Warning Letter

Frequently Asked Questions

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