Thursday, December 08, 2005

FDA protection: pray for a miracle

"Miracle II: Not everyone who believes in God uses Miracle II,
but everyone who uses Miracle II believes in God."

Yes, it really does say that. And if you believed in Miracle II it might be right, because you'd believe in anything. And if you used Miracle II, you might be slated for some face time with Saint Peter. What's Miracle II?
Miracle II is a gentle, environmentally friendly, biodegradable soap with remarkable cleaning, cleansing, degreasing, neutralizing, and detoxifying attributes and contains no animal fats, harmful chemicals or preservatives. Although some information is given as to its ingredients, its composition is a proprietary trade secret. The company manufacturing Miracle II, Tedco, Inc., is privately held and its CEO is the inspired inventor of Miracle II. It began over 24 years ago as basically an industrial cleaner used primarily in local restaurants as a degreaser. But because it is such a powerful cleansing agent and yet an extremely pleasant, environmentally friendly, and human friendly substance, people began to experiment with it. Before long people were washing their hands and their bodies with it and soaking in it in bath tubs. Tedco began receiving reports that Miracle II did wonders for the skin, with several claims that it cleared up skin ailments, even skin cancers. It is so gentle that people began washing their kids and babies in it in bubble baths. Used in bubble baths, it is not irritating to children’s eyes and will not cause bladder or vaginal infections like many commercial bubble baths. People were pouring their used bath water on plants and the plants were thriving.

As personal human uses of Miracle II expanded, some began to brush their teeth with it and to ingest small quantities of the soap with reports of whiter teeth, gum problems clearing up, and parasites leaving. Demand developed for extracting the non-suds part of the soap to make it more tolerable to the human pallet. This extracted substance from the soap was labeled “neutralizer” and it became very popular with Miracle II users. Tedco began receiving several reports of the health benefits experienced by those ingesting the neutralizer (usually an ounce or two daily). Reports were received of neutralizer being poured into murky ponds that then cleared up, and that growers of crawfish doubled the size of the crawfish with neutralizer. Later the neutralizer was made into a gel and lotion for use on the skin, which resulted in more testimonials on the beneficial effect of Miracle II on the skin, including clearing up acne. Claims were being made that insects such as ants were repulsed by the soap. Moisturizers were put in the original soap for those with dry skin. Etc., etc.
Here are some other things about Miracle II, according to the US FDA:
December 6. 2005. The Food and Drug Administration (FDA) is advising consumers not to use Miracle II Neutralizer and Miracle II Neutralizer Gel products manufactured by Tedco, Inc., in West Monroe, Louisiana because the products are bacterially contaminated and have not been proven to be safe and effective. 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.

"We will not tolerate the marketing of products that use deceptive and untruthful claims to lure consumers into potentially dangerous situations," said Margaret O'K. Glavin, FDA's Associate Commissioner for Regulatory Affairs. "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."

Tedco, Inc., promotes Miracle II Neutralizer for ophthalmic use (in the eyes), including treatment of cataracts and pink eye, and as an eyewash. FDA requires that all ophthalmic products be sterile. Due to the substantial risk posed by non-sterility, Miracle II Neutralizer should never be applied to the eyes.

Tedco, Inc., also markets Miracle II Neutralizer for other unapproved uses, including 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. The firm sells Miracle II Neutralizer Gel for many of the same unapproved uses, including diaper rash, diabetes, gout, psoriasis, and skin cancer.

Tedco, Inc., promotes its Miracle II products with claims such as, "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." Contrary to such claims, recent FDA testing of Miracle II Neutralizer and Miracle II Neutralizer Gel revealed bacterial contamination and poor manufacturing conditions.

Although Tedco, Inc., has been advised by FDA of the contamination found in its Miracle II Neutralizer and Miracle II Neutralizer Gel products, the firm has declined to voluntarily remove the products from the market. [my emphasis]

A number of stores sell Miracle II Neutralizer and Miracle II Neutralizer Gel, and the products are distributed and sold worldwide and sold via the Internet. The products are packaged in 8 oz, 22 oz, and one-gallon size containers.
That was yesterday. But this notice from Health Canada from last May references a previous notice from the FDA 18 months ago:
5/31/2005 - Health Canada is warning consumers not to use any natural products exported or sold by Tedco Inc, after the Louisiana company failed to provide proof that its Miracle II Neutralizer is not contaminated with the harmful bacteria Escherichia coli (E. coli).

Earlier this month the government agency said that laboratory tests had shown up the presence of E. coli in the product which, when taken orally, is said to help relieve the symptoms of heartburn.


According to the federal department, Tedco has “refused to cooperate” with its requests. “As a result, Health Canada cannot be sure that other products by Tedco do not contain the harmful bacteria,” it said.

Tedco is known to sell seven products, all variants of the Miracle II Neutralizer in gel or powder form, through the internet or individual distribution channels. Health Canada has emphasized that these products are not authorized for sale in Canada. It is working with the Canada Border Services Agency to prevent them from being imported into Canada.

In June 2003, Tedco had its knuckles rapped by the FDA in the United States, which sent the company a warning letter over claims that Miracle II could cure certain diseases, including Alzheimer's disease, Crohn's disease, lymphoma-follicular cancer and Lyme disease. [my emphasis]
Miracle II is still being sold, with the FDA standing on the sidelines gnashing its teeth. How come the FDA hasn't been able to stop Tedco from fraudulently purveying a potentially dangerous product? Tedco must have God on its side. Unless you godless atheists have a better explanation.