Posted December 29, 2015

Maker of Vitamin K, Vitamin A & More Warned for Manufacturing Violations, Drug Claims

On December 10 2015, the FDA issued a warning letter to Dherbs Health Emporium, Inc., following a facility inspection which found the company's product, including  10 Day Kidney Cleanse, Anti-Viral Cleanse and Regimen, Athletic Package, Cardiovascular Extract, Cough Extract, Kidneys Extract, Vitamin K, Fibroid Cleanse and Regimen, Circulation Aid, Cerebrovascular Formula, Sex Organs Cleanser and Vitamin A to be adulterated because they prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.

These violations include failure to establish product specifications for each dietary supplement for the identity, purity, strength, and composition of finished batches of dietary supplements, and failure to establish and follow written procedures for the responsibilities of the quality control operations , as required by federal regulations.

In addition, statements made about these products on product labels and the company's website were found to be drug claims. For example, Vitamin K was promoted with statements such as "[P]revent harmful blood clots, arrest internal bleeding, help keep bones strong and healthy, and provide essential nutrients to pregnant women" and Vitamin A was promoted with statements such as "[F]ight infections." 

(See ConsumerLab.com's Reviews of Vitamin K Supplements and Vitamin A Supplements for tests of related products. 

See Related Warnings:

Seller of "Hangover" Supplement Warned for Manufacturing Violations & Drug Claims

Seller of "Natural" Cough Syrup Warned for Manufacturing Violations, Drug Claims

Seller of Aloe, Sexual Enhancement Supplements and More Warned for Manufacturing Violations, Drug Claims

Maker of Aloe, Weight Loss Supplements and More Warned for Manufacturing Violations, Drug Claims

Seller of Omega-3 "Syrup" Warned for Manufacturing Violations and Drug Claims

Seller of Diabetes, Prostate Supplements and More Warned for Manufacturing Violations, Drug Claims

Seller of "Cleanse," Allergy Supplements and More Warned for Manufacturing Violations, Drug Claims

Maker of Herbal Supplements Warned for Manufacturing Violations and Drug Claims

Seller of Mineral and Joint Supplements Warned for Manufacturing Violations and Drug Claims

Vita Springs Health Warned for Manufacturing Violations and Drug Claims

Seller of Flaxseed, Ginkgo and More Warned for Manufacturing Violations and Drug Claims

Seller of Aloe, Thyroid and Other Supplements Warned for Manufacturing Violations and Drug Claims

Herbal Supplement Company Warned For Drug Claims, Manufacturing Violations

Maker of Digestive Health Supplement Warned For Manufacturing Violations, Drug Claims

To read the FDA's warning letter, use the link below