Posted October 30, 2014

Seller of Vitamin C, Iron and Detox Supplements Warned for Violations, Drug Claims

On October 16, 2014, the FDA issued a warning letter to Vitalab Co., Inc. (which manufactures and labels supplements for three distributors: V.E. Irons, Inc., Springreen Products, Inc., and Sonne's Organic Foods, Inc.) following a facility inspection which found the company's products, including Springreen No. 30 SPRINGREEN, Sonne's No. 17 NATURAL SOURCE VITAMIN C and V.E. Irons Whole Beet Plant Juice No. 48 to be adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.

These violations include failure to prepare and follow a written master manufacturing record for each unique formulation of dietary supplement manufactured, and failure to establish and follow written procedures for the responsibilities of the quality control operations.

In addition, statements made on labels and distributor websites about the company's "detoxification" products, Vit-Ra-Tox #16 Detoxificant and Vit-Ra-Tox #38 Calphonite were found to be drug claims.

Vit-Ra-Tox #16 Detoxificant contains sodium, iron and bentonite clay. It was promoted with statements such as "[B]entonite, the Detoxificant's main ingredient, has been used to rid the body of bacteria (such as ecoli and staph), viruses, parasites."

Vit-Ra-Tox #38 Calphonite contains calcium, iron, phosphorous, magnesium, sodium, montmorillonite (a component of clay) and manganese. It was promoted with statements such as "[A]ssists the body in ... helping repair broken bones!"

The company's Springreen No. 88 Whole Beet Plant Juice and Springreen No. 30 SPRINGREEN products were also found to be misbranded because the labels failed to provide information required by federal regulations, including this warning statement required for products containing iron, "WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, calf a doctor or poison control center immediately."

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

See Related Warnings:

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.