Ozark Country Herbs FDA Warning (2018)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on March 30, 2018
Executive Summary
The FDA issued a warning letter to Ozark Country Herbs on March 30, 2018 citing cgmp violations, labeling violations. Consumers who have purchased products from this company should exercise caution. The letter was issued by Dallas District Office.
Detailed Analysis
False Claims and Regulatory Violations
“[R]elieve and prevent migraine headaches”
“[C]lean the arteries, preventingheart attacks and strokes.”
“It contains herbs that will prevent miscarriage . . . .”
Potential Health Risks
Your Sinus & Hayfever, Eldermint, Anti-Yeast, and Insure Herbal product labels declare the ingredient Echinacea, your Natural Calcium product label declares the ingredient shavegrass, your Bowel Cleanser product label declares the ingredient turkey rhubarb, your Hormone Health, Lactation Aid, and Ladies Formula product labels declare the ingredient vitex, and your Joint Support and Arthritis Relief product labels declare the ingredient Brigham tea, but these are not the standardized common names noted in the referenceHerbs of Commerce;
Regulatory Context
“May be beneficial for all viral infections, stomach disorders, inflammation, and skin disorders. It activates white blood cells that help destroy bacteria, fungus, and virus.”
“This formula is extremely valuable in strengthening and healing the entire respiratory tract, and relieves irritation in the lungs and bronchials. Use forasthma and other lung conditions.”
“When the liver does not function properly the bile does not excrete freely into the intestinal tract and so it passes off into the bloodstream causing . . . reflux and irritable bowel syndrome, headache . . . . High blood pressure, heart attack, stroke, diabetes, gallstones . . . are directly related to poor liver function. This combination of herbs was formulated to cleanse [,] nourish and support your liver . . . .”
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with Ozark Country Herbs?
- The FDA issued a warning letter citing cgmp violations, labeling violations related to their products or manufacturing practices.
- Are Ozark Country Herbs products safe to use?
- Based on the FDA's findings, consumers should exercise caution. The company was found to have cgmp violations that may affect product safety.
- What should I do if I've used Ozark Country Herbs products?
- If you have used products from Ozark Country 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