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.
E. coli is a bacteria that is present in the human colon, and most strains are harmless. But as a food-borne pathogen, it can cause nausea, severe diarrhea, body rash, fever and even death. Children may be more sensitive to the effects than adults.
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.
Given the lack of substantial evidence that Miracle II products are generally recognized as safe and effective for their intended uses, the FDA said they were considered to be 'new drugs'. New drugs may not be legally marketed in the US without approved new drug applications.
According to the Centers for Disease Control and Prevention, 73,000 cases of E coli occur in the United States each year, and around 60 people die as a direct result of infection. Recently, the incidence of infection is believed to have declined by 36 percent.