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Distributor refuses to comply with Health Canada order to pull virility pill
Canadian Press

TORONTO (CP) - The distributor of an unregulated supplement that contains the active ingredient of the drug Viagra has refused to comply with a Health Canada request to remove it from the market.

Health Canada issued a warning to consumers Wednesday, urging them not to purchase or take the pill, marketed under the name Bell Magicc Bullet. A spokeswoman for the department said further action will be taken.

The department said the product, which is styled as an herbal supplement, contains the unauthorized chemical ingredient sildenafil, a prescription drug most consumers know by the name Viagra. Nothing on the product's labelling indicates that it contains sildenafil.

As seen on the company's website, the packaging does make the claim the pills are an "all natural herbal supplement to restore male virility," that helps "prevent premature ejaculation" and "works on the first dose."

Health Canada spokeswoman Krista Apse said an unapproved supplement cannot contain a prescription drug. Further, companies selling supplements cannot make unsubstantiated health claims about their products.

"When there's a therapeutic claim . . . the product has to be approved by Health Canada," Apse said from Ottawa.

She was emphatic when asked if the product would eventually be pulled from Canadian store shelves.

"Yes. Yes. But in the meantime our responsibility is to inform Canadians."

Bell Magicc Bullet is distributed by Bell Distributors Ltd. of Mississauga, Ont. The company referred media calls to the company's legal representative, Trueman Tuck, a self-described non-lawyer legal consultant.

He insisted the product does not contain sildenafil, but rather butea superba, "an unpatentable, naturally occurring herb" which has "marker molecules" similar to those of sildenafil.

"It does not contain the drug," Tuck said.

Health Canada insists it does.

"Our tests do show it was sildenafil so as such it does require approval from Health Canada before it can be marketed," Apse said.

Bell Distributors has launched a lawsuit against Health Canada, arguing it discriminates against the natural health industry, Tuck revealed, adding the lawsuit names three Health Canada employees who have been involved in the file, claiming they have worked "in a premeditated, malicious manner to destroy my client's financial business."

An initial court date has been set for Dec. 3 in Ontario Superior Court in Belleville, Ont., where Tuck's business is based.

Tuck said Bell Distributors has temporarily stopped shipping the product, but will not comply with the Health Canada order. "We will not implement a recall until the science is conclusively proven that their allegation is true, which our science indicates it is not true."

The Health Canada warning notes that inappropriate use of sildenafil can cause severe adverse reactions.

It should not be taken by people who are taking any nitrate medication or products, which are commonly used for some types of heart disease. The combination of the drugs could lead to life-threatening low blood pressure, it says.

In extremely rare cases, use of the drug could result in penile tissue damage and permanent loss of potency, it notes.

When Health Canada tested the product and found that it contained sildenafil, it approached the company and asked it to withdraw the pills from the market. Voluntary compliance is Health Canada's preferred method of operation, said Apse, who added that refusal to comply is "rare."

In the face of the company's position, the department is taking further "compliance and enforcement actions" to protect consumers, the statement said. Apse said regulations give the department a range of options, including import refusal and product seizure.

Consumers who have used Bell Magicc and have concerns should contact their physicians or health-care providers, the department said, noting there have been no reports of adverse events from use of the product.

 Copyright  2003 The Canadian Press

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