Distributor refuses to comply with Health
Canada order to pull virility pill
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
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
"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
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
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
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
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.