FDA Warning - FYI

Something new is advertised or appears on the shelves, and if you are like
me, you are curious. Will it do what it claims? Is it safe, or does it have
any negative properties? What's in it? And so on.

Here is one that you need to keep your eye out for, and definitely avoid.

Annette

http://www.medscape.com/viewarticle/518620
FDA Warns Against Use of Miracle II Neutralizer Products
Yael Waknine
Medscape 2005. © 2005 WebMD Inc.

Dec. 7, 2005 - The US Food and Drug Administration (FDA) has advised
consumers against the use of Miracle II Neutralizer and Neutralizer Gel
products manufactured by Tedco, Inc, due to safety and efficacy concerns,
according to an alert sent yesterday from MedWatch, the FDA's safety
information and adverse event reporting program.

The FDA warned that the company's promotional health claims for the products
were deceptive and untruthful, and their use may lead to serious adverse
events such as infections. Susceptible populations such as children, the
elderly, and individuals with weakened immune systems may be at increased
risk for these events.

Although Miracle II Neutralizer has been promoted by the manufacturer for
the treatment of cataracts and pink eye, and for use as an eyewash, it does
not meet FDA sterility requirements for ophthalmic products. Because of the
substantial risk for bacterial infection, the solution should never be
applied to the eyes.

Other unapproved indications promoted by the company have included treatment
of AIDS, cancer, Crohn's disease, dermatitis, diaper rash, diabetes,
earache, hemorrhoids, hives, gout, herpes, mouth ulcers, psoriasis, skin
cancer, and yeast infection. Miracle II Neutralizer Gel has also been
marketed for many of these indications, including diaper rash, diabetes,
gout, psoriasis, and skin cancer.

Moreover, the company's promotional material claims that superior technology
renders the product useful as a cleaner, deodorizer, natural insecticide,
and antibacterial agent.

In contrast, FDA investigations have revealed bacterial contamination and
poor manufacturing conditions. The company has declined to voluntarily
remove the products from the market despite notification of these findings.

Miracle II Neutralizer and Miracle II Neutralizer Gel are sold in 8-oz,
22-oz, and one-gallon containers. They are marketed by a number of stores
and achieve worldwide distribution via Internet sales.

Consumers, healthcare providers, and caregivers are advised to cease using
and dispose of these products.

Adverse events related to the use of Miracle II products should be reported
to the FDA's MedWatch program by phone at 1-800-FDA-1088, by fax at
1-800-FDA-0178, online at http://www.fda.gov/medwatch/report.htm, or by mail
to 5600 Fishers Lane, Rockville, MD 20852-9787.

Reviewed by Gary D. Vogin, MD





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