What did the FDA find wrong with New Capstone, Inc?

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

Are New Capstone, 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 New Capstone, Inc products?

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

Is New Capstone, Inc Safe? FDA Warning Letter Review (2017)

Name: Is New Capstone, Inc Safe? FDA Warning Letter Review (2017)
Creator: Supplement Safety Data Team
Published: 2026-03-27T01:44:19.545199

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on June 27, 2017

CRITICAL SEVERITY Los Angeles 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 New Capstone, Inc on June 27, 2017 citing regulatory violations. Consumers who have purchased products from this company should exercise caution. The letter was issued by Los Angeles District Office.

Regulatory Violations

Detailed Analysis

False Claims and Regulatory Violations

“Boron [an ingredient in ReMyte] is being investigated as a treatment for the following conditions: congestive heart failure, high cholesterol, arthritis, gout, [and] osteoporosis . . .. Some people claim that it’s a near miraculous treatment for arthritis.”

“A zinc to copper imbalance, with too much copper and not enough zinc, can be a factor in postpartum-depression, . . .ADHD, psychosis, and paranoia . . .. ReMyte contains 15 times more zinc than copper, which will help treat excess copper in the body.”

“[C]opper deficiency and copper toxicity can both block copper function, resulting in hypothyroidism, decreased muscle function, and a sluggish brain. That’s why a small amount of bioavailable copper, found in ReMyte, is the treatment of choice for both copper deficiency and copper excess.”

Potential Health Risks

“[F]or local injury, arthritis, muscle pain or joint pain . . . for painful injuries”

“[F]or injury, pain, and arthritis”

“May reduce the risk of Macular Degeneration by lowering blood sugar and inflammation”

Regulatory Context

“One customer, after being on ReMag and ReMyte for several months, lowered her blood pressure from 180/95 to 110/60. Also, her ejection fraction improved to 60%, and her last ultrasound of her carotid artery showed a 30% to 40% lessening of calcified occlusions.”

Key Entities Identified

Lead Mercury

Frequently Asked Questions

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