Oxygen Health Systems, LLC FDA Warning (2017)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on April 17, 2017
Executive Summary
The FDA issued a warning letter to Oxygen Health Systems, LLC on April 17, 2017 citing regulatory violations. Consumers who have purchased products from this company should exercise caution. The letter was issued by Chicago District Office.
Detailed Analysis
False Claims and Regulatory Violations
“Herbs like these can also be used in conjunction with modern medicine when treating diseases like cancer . . .”
“Liposomes can be filled with drugs, and used to deliver drugs for cancer and other diseases.”
“Laetrile (i.e. Vitamin B17) therapy is one of the most popular and best known alternative cancer treatments.”
Potential Health Risks
“It fights inflammation . . . with effects ‘comparable’ to statinsbut without the recognized dangers.”
“It fights cancer cells in multiple ways, and makes certain chemotherapy drugs more effective while protecting healthy cells . . .”
“Graviola is still used extensively by native Indians in South America . . . who use Graviola as a natural herbal remedy for health problems such as high blood pressure, digestive issues and infections.”
Regulatory Context
“Flax Seed Oil contains lignans, which are naturally antibacterial and are currently being studied for their ability to bind to estrogen receptors and interfere with potentially cancer causing affects [sic] on tissue, especially breast tissue.”
“Rerum® is Macrophage Activing Factor (MAF) . . .”
“studies around the world by many researchers have demonstrated . . . that the activation of macrophages produces pro-immunogenic . . . and even anti-cancer/anti-angiogenetic effects.”
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with Oxygen Health Systems, LLC?
- The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
- Are Oxygen Health Systems, LLC 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 Oxygen Health Systems, LLC products?
- If you have used products from Oxygen Health Systems, LLC 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