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

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

Are Sunstone, 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 Sunstone, Inc. products?

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

Is Sunstone, Inc. Safe? FDA Warning Letter Review (2017)

Name: Is Sunstone, Inc. Safe? FDA Warning Letter Review (2017)
Creator: Supplement Safety Data Team
Published: 2026-03-27T01:44:17.329980

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on April 17, 2017

CRITICAL 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 Sunstone, Inc. on April 17, 2017 citing regulatory violations. Consumers who have purchased products from this company should exercise caution. The letter was issued by Denver District Office.

Regulatory Violations

Detailed Analysis

False Claims and Regulatory Violations

“it has been used for cancer, cancer prevention, AIDS, diabetes . . .”

“Traditionally used for cancer, and as a broad-spectrum internal and external antimicrobial to treat bacterial and fungal infections.”

“tumor-preventing activity.”

Potential Health Risks

“if we’re interested in doing something proactive about eliminating the overabundance of Candida and other dangerous yeasts and fungi from our bodies, we need to start taking Candida-X Tablets . . .”

“People . . . who take FYC daily report staying healthy while others around them readily fall victim to colds and flus."

“Excellent for killing infections without harming beneficial bacteria in the intestines.”

Regulatory Context

“Traditionally used for liver congestion, arthritis, malignant growths, respiratory and urinary tract infection.”

“Boron as a Radioactive contaminant Detoxifier . . .”

“boron is commonly recognized as a viable antidote, when taken internally, against severe, acute radioactive poisoning.”

Key Entities Identified

Sunstone Inc. FDA Warning Letter

Frequently Asked Questions

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