Newton Everett/WR Group Inc. FDA Warning (2017)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on September 07, 2017
Executive Summary
The FDA issued a warning letter to Newton Everett/WR Group Inc. on September 07, 2017 citing regulatory violations. Consumers who have purchased products from this company should exercise caution. The letter was issued by Denver District Office.
Detailed Analysis
False Claims and Regulatory Violations
“Alpha-lipoic acid … provide protection to the brain under conditions of damage or injury . . . . [M]ight also be helpful in certain liver diseases”
“Manages blood sugar – ALA can help remove glucose from the blood more quickly, benefitting diabetics by regulating blood sugar levels. This can also benefit people with heart disease or battling obesity.”
“Removes toxins – ALA aids the liver in ridding the body of toxins that cause liver scarring or failure. It can also protect brain and nerve tissue, preventing stroke.”
Potential Health Risks
“Omega-3 fatty acids are believed to have health benefits ranging from reducing the risk of heart attack … to combating depression, bipolar disorder and schizophrenia”
Regulatory Context
“Guggal extract … can dramatically lower blood cholesterol levels in people for … cholesterol-lowering drugs have failed … used in the management of arthritis, rheumatism … cardiovascular problems, dermatitis, eczema, high cholesterol, obesity and psoriasis.”
“[A]ntibacterial and antifungal properties … help to reduce inflammation of the gums and can help to fight infections of Candida albicans.”
On June 28, 2016: “#DMannose: For the elimination of bladder and Urinary Tract Infection”
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with Newton Everett/WR Group Inc.?
- The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
- Are Newton Everett/WR Group 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 Newton Everett/WR Group Inc. products?
- If you have used products from Newton Everett/WR Group 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