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Posted February 24, 2015

Seller of Antioxidant Water, Energy Drops Warned for Manufacturing Violations and Drug Claims

On February 18, 2015, the FDA issued a warning letter to Better Health Lab, Inc., following a facility inspection which found the company's ALKAZONE Alkaline Booster with Antioxidant water to be adulterated because it was 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 of finished batches of dietary supplements, and failure to establish written procedures for the review and investigation of product complaints, as required by federal regulations.

In addition, statements made on product labels and Better Health's website about ALKAZONE Alkaline Booster with Antioxidant water, and other products -- ALKAZONE Gout Reliever drops and ALKAZONE Premium Energy Booster drops -- were found were found to be drug claims.

ALKAZONE Alkaline Booster with Antioxidant water contains selenium and potassium. It was promoted for a variety of conditions with statements such as "Selenium can prevent cancer growth or reduces the growth rate of certain cancers. Additionally the occurrence of heart disease and severe arthritis was greater in diets that were low in selenium" and "Help regulate blood pressure."

ALKAZONE Gout Reliever drops were promoted to treat gout and kidney stones with statements such as "Decrease Uric Acid Level" and "Reduce the side effects of alcohol."

ALKAZONE Premium Energy Booster drops contain zinc and selenium. It was promoted for a variety of conditions with statements such as "Reduces the risk of heart disease" and "Decreases blood pressure ."

See ConsumerLab.com's Reviews of Selenium Supplements, Potassium Supplements and Zinc 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.