What did the FDA find wrong with Biotek, Inc.?

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

Are Biotek, 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 Biotek, Inc. products?

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

Is Biotek, Inc. Safe? FDA Warning Letter Review (2018)

Name: Is Biotek, Inc. Safe? FDA Warning Letter Review (2018)
Creator: Supplement Safety Data Team
Published: 2026-03-27T01:44:25.792100

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on March 13, 2018

MODERATE SEVERITY Denver District Office 2018

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 Biotek, Inc. on March 13, 2018 citing labeling violations. The letter was issued by Denver District Office.

Labeling Violations

Detailed Analysis

False Claims and Regulatory Violations

“Immune system is improved helping to combat stress and disease”

“Stress…the cause of all degenerative diseases.” ~ Stress of Life, Hans Selye, M.D.

“Increases Resistance to Disease”

Potential Health Risks

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

Regulatory Context

“They also protect against toxic reaction and heavy metal poisoning.”

The label on your Bio-35 Softgel capsule bottle does not state your product contains soy. However, contract manufacturer batch records for your Bio- 35 Softgel capsules, manufacturer lot # S17D055, manufacture date of 6/28/17, indicate this product contains soy lecithin.

The ingredients Magnesium Trisilicate and Titanium Dioxide were listed as ingredients on the Certificate of Analysis for the bulk finished Lipotropic Formula, but were not present on your finished product label for your Lipotropic Formula received from a contract manufacturer in bulk for packaging, labeling, and distribution by your firm, manufacturing lot # 0727601, with manufacture date of 09/2016.

Key Entities Identified

21 CFR 101.2 21 CFR 101.93 section 403(w) section 403(w)

Frequently Asked Questions

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