Miracle in a Bottle? Hardly, Says FDA

Clayton Tedeton claims to have awakened one July morning in the early 1980’s to find the formula for his product, Miracle II --- the “Anointed Miracle Soap,” as he describes it --- divinely inscribed on his bedroom wall.

In the years that followed, he claims to have received formulas for similar divinely conceived soap products, which he began bottling and selling in 1987.

Divinely inspired or not, Tedeton has managed to sell lots of Miracle II products within the last couple of decades via distributors and through the Internet.

Miracle II, according to one distributor’s description, is a “gentle, environmentally friendly, biodegradable soap with remarkable cleaning, cleansing, degreasing, neutralizing and detoxifying attributes” originally used in restaurants.

People eventually began using it as a cleaning and detoxifying agent for their hands and bodies and as a treatment for skin ailments ranging from acne to skin cancer.

Others began using it to whiten teeth and relieve gum problems. In time, the demand for a palatable version of the product prompted Tedeton’s company, Tedco, Inc., based in West Monroe, La., to develop an extracted version of the soap that was then marketed as a “neutralizer.” Eventually, this product was developed into a skin gel and lotion.

For its part, Tedco, Inc. describes Miracle II as a result of “supreme technology” --- the “perfect soap cleanser, deodorizer, natural insecticide and antibacterial product.”

“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,” the company maintains.

The FDA is not convinced --- nor, for that matter, is its Canadian counterpart, Health Canada.

On Dec. 6, the FDA issued a warning to consumers not to use Miracle II Neutralizer and Miracle II Neutralizer Gel products because the products are bacterially contaminated and have not been proven to be safe and effective.

According to the press release posted on the FDA Web site, 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 risks posed by nonsterile solutions, FDA warns consumers about the dangers of applying Miracle II products to the eyes.

Tedco, Inc., the FDA contends, also employs other unapproved claims, marketing Miracle II Neutralizer as a treatment for 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, according to FDA.

Although it has been advised by FDA of the contamination found in its Miracle II Neutralizer and Miracle II Neutralizer Gel products, Tedco, Inc., has not voluntarily removed these products from the market.

This is not the first time regulatory authorities have clashed with Tedco, Inc. In July 2003, FDA issued a warning letter to Tedco President Byron K. Tedeton and Director Clayton Tedeton contending that the products were in violation of several provisions of the Federal Food, Drug and Cosmetic Act.

In May, 2005, Health Canada recalled all Tedco, Inc. health products distributed in Canada due to concerns about bacterial contamination. Health Canada’s analysis of Miracle II Neutralizer revealed the product was contaminated with the harmful bacterial Escherichia coli, commonly known as E.coli.

FDA urges consumers, health care providers, and caregivers to cease using and dispose of these products and report any adverse events related to these products to MedWatch, the FDA's voluntary reporting program at (800) FDA-1088; by fax at (800) FDA-0178; by mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD, 20857-9787; or online at www.fda.gov/medwatch/report.htm.

Posted by Jim Langcuster at December 8, 2005 03:26 PM | TrackBack