Is Bio TE Medical Safe? FDA Warning Letter Review (2017)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on May 22, 2017
Executive Summary
The FDA issued a warning letter to Bio TE Medical on May 22, 2017 citing regulatory violations. The letter was issued by Dallas District Office.
Detailed Analysis
False Claims and Regulatory Violations
“Probiotics aide in the prevention of tooth decay and other oral health problems.”
“Adequate Iodine supplementation can control and reduce: ●ADD/ADHD ●Atherosclerosis ●Breast Diseases…●Fibrocystic Breast ●Goiter ●Ovarian Disease ●Parotid Duct Stone ●Peyronie’s ●Prostate Disorders…●Thyroid Disorders ●Vaginal Infections ●Hemorrhoids ●Headache/Migraines ●Hypertension ●Infections …●Liver Diseases”
“[B]lood clotting prevention…”
Potential Health Risks
“Therefore, DIM can help to further reduce the risk of atherosclerosis…help guard against prostate enlargement, a condition known asbenign prostatic hypertrophy”
Regulatory Context
This warning letter is part of the FDA's enforcement of federal regulations.
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with Bio TE Medical?
- The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
- Are Bio TE Medical 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 Bio TE Medical products?
- If you have used products from Bio TE Medical 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