Drug Dispute Rages On

When the owners of Manitoba-based NorthRegentRx decided to get into the nutraceutical health supply business in 2004, they had no idea that six years later they would be engaged in a deadlock with Health Canada that would cost them most of their business, their professional reputation and even their life savings.

Now they say they’re on the brink of taking the federal department to court in an effort to clear their name.

Health Canada, however, says it hasn’t done anything wrong and has offered to meet with company officials to resolve the dispute.

“We’ve used up virtually every cent of our savings and we’ve gotten ourselves even deeper in debt than when we started this business. We’re on the verge of losing it all,” said Cheryl Swarath, a partner in the business, based just south of Lockport in the hamlet of Gonor.

NorthRegentRx’s trouble stems from a little beige capsule called Libidus, a circulation improvement pill billed as a “natural sexual performance enhancer.” 

In 2006, Health Canada recalled Libidus after the U.S. Food and Drug Administration issued a statement warning that a sample of the product it obtained from a different company was tainted with Acetildenafil, an analogue of Sildenafil, which is an active ingredient in Viagra.

Swarath said NorthRegentRx complied with Health Canada, handing off all of its samples, which had been tested and deemed clean by a large and reputable private lab.

Meanwhile, the company was forbidden from selling the product, a situation that persists to this day.

After testing the samples Health Canada concluded NorthRegentRx’s pills were tainted with a form of the drug Vardenafil, an ingredient in prescription erectile dysfunction drugs like Levitra.

Swarath insists that isn’t the case and claims she’s not only got the testing to prove it, but also has a signed affidavit from a former Health Canada chemist who calls into question the department’s results.

Christelle Legault, a spokeswoman for Health Canada, said the department stands by its testing.

“Health Canada is confident these results are not false positives,” she said via e-mail. “Health Canada uses sound scientific testing methodolgies based on modern instrumental techniques to determine whether or not a product contains an undeclared ingredient and is confident in their test results.”

Regardless of whose science will ultimately prove right, Swarath said the damage has already been done.

“Once Health Canada accuses you of selling a tainted product, most stores won’t touch you with a 10-foot pole,” she said. “We were in over 700 stores and doctor’s clinics across the country, and if we’ve got 50 stores left that buy our other products, then we’re doing well.”

After more than three years of letters and phone calls — as well as the support of James Bezan, the Conservative MP for Selkirk-Interlake — the company no closer to being able to sell Libidus again.

Swarath said she and her partners are considering filing a lawsuit.

Legault said Health Canada has offered to meet with company officials “to provide further clarification as required and to assist them in complying with the product and site licensing requirements.”