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Posted June 26, 2015

Seller of CoQ10, Anxiety Supplements and More Warned for Manufacturing Violations, Drug Claims

On June 6, 2015, the FDA issued a warning letter to Country Doctor Herbals, following a facility inspection which found the company's products, including  Herbal Flu Be-Gone, Herbal Multi-Bac, Herbal Nervine, Herbal Pain-A-Way, Herbal Pancreas, Herbal Parasite Cleanse, Herbal Perfect Heart, Herbal S.H.A., Herbal Virex, Pain-A-Trate and COUNTRY DOCTOR CoQ10 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 the identity, purity, strength, and composition for each finished batch of dietary supplements and failure to establish and follow written procedures for the responsibilities of quality control operations.

In addition, statements made on product labels and on the company's websites were found to be drug claims. For example, Herbal Flu Be-Gone was promoted with statements such as "All natural herbal formula that works to rid the body of flu."

(See ConsumerLab.com's Reviews of Echinacea Supplements for tests of related products.)

Herbal Nervine was promoted with statements such as "All natural herbal formula that works to relieve... insomnia and anxiety.

(See ConsumerLab.com's Reviews of Melatonin Supplements and Ashwagandha Supplements for tests of related products.)

Herbal Perfect Heart was promoted with statements such as " All natural herbal formula that works to treat the primary cause of heart disease and not just the symptoms." COUNTRY DOCTOR CoQ10 was promoted with statements such as "Helps to lower blood pressure... used extensively in treatment and prevention of heart disease. Helps reduce side effects of chemotherapy. Has the ability to counter histamines, benefiting those with allergies, asthma, or respiratory problems. Enhances treatment of periodontal disease, diabetes and muscular dystrophy. Used to treat mental conditions associated with schizophrenia and Alzheimer's. Has been found to be beneficial in the treatment of obesity, Candida, multiple sclerosis, diabetes, and chronic fatigue syndrome."

See ConsumerLab.com's Reviews of CoQ10 or Ubiquinol Supplements for tests of related products.

See Related Warnings:

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.