What did the FDA find wrong with Biomin Industries, Inc.?

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

Are Biomin Industries, Inc. 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 Biomin Industries, Inc. products?

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

Biomin Industries, Inc. FDA Warning (2017)

Name: Biomin Industries, Inc. FDA Warning (2017)
Creator: Supplement Safety Data Team
Published: 2026-03-27T01:44:23.130442

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on October 13, 2017

MODERATE SEVERITY Denver 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 Biomin Industries, Inc. on October 13, 2017 citing labeling violations. The letter was issued by Denver District Office.

Labeling Violations

Detailed Analysis

False Claims and Regulatory Violations

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

Potential Health Risks

Consumers should be aware of potential risks associated with products from Biomin Industries, Inc..

Regulatory Context

Identity specifications for each component that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b)(1);

Components specifications, for each component that you use in the manufacture of a dietary supplement, that are necessary to ensure that specifications for the purity, strength, and composition of dietary supplements manufactured using the components are met, as required by 21 CFR 111.70(b)(2); and

Establishing limits on those types of contamination that may adulterate, or may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(b)(3).

Key Entities Identified

21 CFR 111.70 21 CFR 111.70 21 CFR 111.70 Lead

Frequently Asked Questions

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