What did the FDA find wrong with Cape Fear Naturals?

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

Are Cape Fear Naturals 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 Cape Fear Naturals products?

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

Is Cape Fear Naturals Safe? FDA Warning Letter Review (2017)

Name: Is Cape Fear Naturals Safe? FDA Warning Letter Review (2017)
Creator: Supplement Safety Data Team
Published: 2026-03-27T01:44:16.610269

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on March 02, 2017

CRITICAL SEVERITY Atlanta 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 Cape Fear Naturals on March 02, 2017 citing regulatory violations. Consumers who have purchased products from this company should exercise caution. The letter was issued by Atlanta District Office.

Regulatory Violations

Detailed Analysis

False Claims and Regulatory Violations

“Prevent and treat diarrhea”

“Relieve irritable Bowel Syndrome, Crohn’s disease, and gut dysbiosis.”

“Treat respiratory infections”

Potential Health Risks

The Supplement Facts Panels do not list a symbol that links to the statement “Daily Value not established” on your Quercetin and Beta Glucan product labels. Other dietary ingredients shall bear a symbol (e.g., an asterisk) in the column under the heading of “% Daily Value” that refers to the same symbol placed at the bottom of the nutrition label and followed by the statement “Daily Value not established,” except that when the heading %Daily Value” is not used, the symbol shall follow the quantitative amount by weight for each dietary ingredient, per 21 CFR 101.36(b)(3)(iv).

Regulatory Context

“Decrease frequency of vaginal yeast infections and urinary tract infections”

Key Entities Identified

21 CFR 101.36

Frequently Asked Questions

What did the FDA find wrong with Cape Fear Naturals?: The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
Are Cape Fear Naturals 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 Cape Fear Naturals products?: If you have used products from Cape Fear Naturals 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.