Posted March 10, 2015

Maker of Magnesium, Calcium, Zinc, B Vitamins and More Warned for Manufacturing Violations, Drug Claims

On January 8, 2015, the FDA issued a warning letter to Complete H2O Minerals, following a facility inspection which found the company's products, including Sulfur Concentrate, Copper, Extra Strength Copper, Extra Strength Magnesium, Extra Strength Zinc, Platinum, Gold, Indium, Molybdenum, Sodium, Chromium, Extra Strength Calcium Concentrate and B6 & B12 Folic Acid 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 of finished batches of dietary supplements, and failure to establish written procedures for the responsibilities of the quality control operations, as required by federal regulations.

In addition, statements made on product labels were found to be drug claims. For example, Extra Strength Magnesium was promoted with statements such as "[W]as shown to reduce the risk of diabetes. It was also shown to lower the risk of osteoporosis," and Extra Strength Calcium Concentrate was promoted with statements such as "Calcium is essential for the prevention of osteoporosis in post-menopausal women."

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

Extra Strength Zinc was promoted with statements such as "[V]ital for wound healing from surgery and tissue repair following radiation/chemotherapy," and Chromium was promoted with statements such as "[C]hromium may also be effective in alleviating elevated blood sugar levels (hyperglycemia)."

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

B6 & B12 Folic Acid was promoted with statements such as "Vitamin B-6 ...has a role in preventing heart disease."

See ConsumerLab.com's Review of B Vitamin 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.