What did the FDA find wrong with The Herbalist, Inc.?

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

Are The Herbalist, Inc. products safe to use?

Based on the FDA's findings, consumers should exercise caution. The company was found to have regulatory issues that may affect product safety.

What should I do if I've used The Herbalist, Inc. products?

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

The Herbalist, Inc. FDA Warning (2017)

Name: The Herbalist, Inc. FDA Warning (2017)
Creator: Supplement Safety Data Team
Published: 2026-03-27T01:44:18.774975

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on May 25, 2017

MODERATE SEVERITY Seattle District Office 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 The Herbalist, Inc. on May 25, 2017 citing regulatory violations. The letter was issued by Seattle District Office.

Regulatory Violations

Detailed Analysis

False Claims and Regulatory Violations

The FDA identified regulatory violations in The Herbalist, Inc.'s operations or product claims.

Potential Health Risks

Consumers should be aware of potential risks associated with products from The Herbalist, Inc..

Regulatory Context

Your finished product specification provides for organoleptic testing for establishing the identity of the dietary supplement. However, organoleptic analysis may not be an appropriate method of testing for certain substances. This is particularly true when the nature of the substance decreases the reliability of organoleptic analysis. For example, while organoleptic analysis may be an appropriate identity test for whole or coarsely-cut botanical parts, it may not be an appropriate identity test for powdered or extracted botanicals because of decreased reliability, or in those instances where misidentification of botanicals is known to occur [72 FR 34852 (Jun. 25, 2007)].

Key Entities Identified

The Herbalist Inc. FDA Warning Letter

Frequently Asked Questions

What did the FDA find wrong with The Herbalist, Inc.?: The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
Are The Herbalist, Inc. products safe to use?: Based on the FDA's findings, consumers should exercise caution. The company was found to have regulatory issues that may affect product safety.
What should I do if I've used The Herbalist, Inc. products?: If you have used products from The Herbalist, Inc. 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.