Dietary supplements contaminated, may cause blindness

August 1, 2005

Minneapolis, MN—Two "all natural" dietary supplements sold as a possible treatment for cataracts and allergy symptoms are not sterile and could be contaminated with bacteria that can cause serious injury when applied to the eyes—including blindness— warn the FDA and manufacturer.

Minneapolis, MN-Two "all natural" dietary supplements sold as a possible treatment for cataracts and allergy symptoms are not sterile and could be contaminated with bacteria that can cause serious injury when applied to the eyes-including blindness- warn the FDA and manufacturer.

The supplements, called Fortified Mineral Neutralizer and Ultra Fortified Mineral Neutralizer, are manufactured and marketed by The Master's Miracle. The 3-year-old "network marketing" company said it produces "natural, toxin-free products [that] can produce dramatic, life-changing results by cleansing your body and mind-simply and naturally."

However, the FDA said the neutralizer, which has been distributed throughout the United States in 8- and 20-ounce and 1-gallon sizes, may be contaminated with Pseudomonas aeruginosa, P fluorescens/putida, and Enterobacter cloacae.

"A patent-pending process energizes the neutralizer to make its minerals more readily available for the cells in the body to absorb," the site states. Testimonials from product users, posted on different independent distributors' Web sites, claim the neutralizer can remove moles, cure infertility, clear cataracts, reduce headaches and earaches, and eliminate colic in babies, among other ailments.

Steve Manske, general manager, said the bacteria were discovered after a December visit by FDA inspectors. No adverse effects have been reported, he said.

The products are sold by independent distributors, which have been ordered to stop using, eliminate, and destroy all marketing materials that make claims for ophthalmic use of the products. The company said it is working with an independent laboratory to identify and eliminate the source of bacterial contamination.

"The product was never designed for that use [in the eyes]," Manske said. "We did have in our marketing materials testimonials where individuals in a verbal testimonial said, 'I use this for my eyes and had a benefit,' so we have eliminated those testimonials. That was a product use that we never should have promoted."

Meanwhile, Health Canada issued a warning May 12 urging consumers not to use the company's Fortified Mineral Neutralizer or Miracle II Miracle Neutralizer, which is manufactured by a competing company, because samples proved to contain bacteria that could cause "serious adverse reactions"-including nausea, severe diarrhea, body rash and fever-or death. The Miracle II Miracle Neutralizer was found to contain Escherichia coli, the agency reported.

Neither product was authorized for sale in Canada, but consumers could make purchases via the Internet and in some retail stores in Canada. The agency is blocking future products from being imported into Canada.

Contact the company at 763/493-3200 for more information.