FDA Warns Consumers Against Unapproved, Contaminated 'Miracle II Neutralizer'

December 8, 2005
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

FDA Warns Consumers Against Unapproved, Contaminated 'Miracle II Neutralizer'

On Dec. 6, the US Food and Drug Administration warned consumers to avoid two unapproved, bacteria-contaminated products manufactured by Tedco, Inc. (West Monroe, LA, www.miracleii.biz): "Miracle II Neutralizer" (promoted as an eyewash for the treatment of cataracts and pink eye)  and "Miracle II Neutralizer Gel" ("an incredible hygiene product used externally or for cleaning your teeth," according to the company’s Web site).

In its press statement, FDA warned that "use of these products could pose a risk of serious adverse events such as infections, particularly in children, the elderly, and individuals with weakened immune systems who are particularly susceptible to illness."

The statement quoted  Margaret O'K. Glavin, FDA's associate commissioner for regulatory affairs, who said, "We will not tolerate the marketing of products that use deceptive and untruthful claims to lure consumers into potentially dangerous situations. We consider it a significant public health hazard when consumers are deliberately deceived into using potentially dangerous products that promise health benefits but deliver only risk of harm."

According to FDA, Tedco markets Miracle II Neutralizer for a raft of unapproved uses, including the treatment of AIDS, cancer, Crohn's Disease, dermatitis, diaper rash, diabetes, ear ache, hemorrhoids, hives, gout, herpes, mouth ulcers, psoriasis, skin cancer, and yeast infection, including claims like, "Supreme technology has made possible for a perfect soap cleaner, deodorizer, natural insecticide, and antibacterial product to be put on the market. This is the only product that is made in the world that can wash a newborn baby or clean up an oil spill and everything in between."

Tedco lists the ingredients as "energized stabilized oxygenated water, ash of Dedecyl solution, calcium, potassium, magnesium." It sells its products online (where they were still being sold as of Dec. 8) and through retail outlets.

In July 2003, FDA sent Tedco a

Warning Letter

, calling the product an unapproved drug.