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Is Grandma's Herbs Safe? FDA Warning Letter Review (2017)

Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on September 15, 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 Grandma's Herbs on September 15, 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

"This tincture is effective at preventing and eliminating the common cold and the flu viruses."

“I am very excited with the results I have received from herbs. I have been a Diabetic for 28 years and was diagnosed with Amyotrophic Lateral Sclerosis, ALS, or Lou Gehrigs Disease about a year and a half ago. Diabetic Neuropathy was very advanced in my feet….My brother, Bert S Leany, suggested that I use Cayenne (http://www.grandmasherbs.com/daily-herbal-vitamins-minerals/cayenne.html) to stop the bleeding in my eye when I was losing the sight in it due to complication of surgery following a detached retina...I have partially regained the feeling in my feet”.

"Deliverance is one of the most potent antiviral, antibacterial, antifungal combinations available. Its many uses include respiratory infections, sore throats, strep throats, dental diseases and infections, cold sores, canker sores, cuts, general infections, athlete's foot and toe nail fungus and infection from slivers."

Potential Health Risks

"In this day and age, we seem to encounter a lot of stress…some signs and symptoms of an unhealthy or failing nervous system are: [...] physical symptoms like hives, rashes, shingles; insomnia... "

“I knew prostate problems happened to older men, but I was only 34 years old. I thought I was in pretty good shape until I started having pain and trouble urinating. Someone said it was because I didn’t drink enough water, so I drank more water. That helped but my prostate still bothered me and my back hurt. A friend suggested Grandma’s herbal PROSTATE formula. I took two capsules morning and evening an hour before meals. I also drank more water. Right away, like just two days later, I noticed a difference, but the pain didn’t leave altogether. The man at the health food store said if the pain was still there it could be an infection and that I should use some Grandma’s NATURE’S BIOTIC along with the PROSTATE formula. The day after I started using the NATURE’S BIOTIC with the PROSTATE, it

Regulatory Context

"Helps to avoid issues such as kidney stones and kidney or urinary tract infections."

"Millenia essential oil is effective in working with ADHD and hyperactivity."

Key Entities Identified

Grandma's Herbs FDA Warning Letter

Frequently Asked Questions

What did the FDA find wrong with Grandma's Herbs?
The FDA issued a warning letter citing regulatory violations related to their products or manufacturing practices.
Are Grandma's Herbs 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 Grandma's Herbs products?
If you have used products from Grandma's Herbs 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.