Unapproved multipurpose wipes being circulated

Hey there, time traveller!
This article was published 15/05/2020 (1995 days ago), so information in it may no longer be current.

A product called Akwaton multipurpose wipes, which has not been approved by Health Canada, is in circulation in Westman.

The point of entry is Gambler First Nation.

Band member Darlene Labelle Gerula told The Brandon Sun that she became aware the product had resurfaced as part of COVID-19 cleaning supplies in the community, after first being introduced in 2018. A band member told her that Chief David LeDoux, his wife Rose LeDoux and counsellors Kellie LeDoux and Louis Tanner were handing the product out to staff and the community, said Gerula.

When Gerula learned the wipes surfaced again in April this year, she was shocked.

“I was in disbelief,” she said. 

“I couldn’t believe somebody could be so careless. Not even careless, just disregard for human life. I was scared that someone would get seriously ill or die.”

Gerula and her husband, Greg Wakin, were asked two years ago by LeDoux and his wife to investigate a possible business opportunity, Gerula said. 

Fosfaton Akwaton International Ltd. owner Izabela Jarocka was looking to sell her company, which makes the wipes, as part of her retirement plan. She was asking for $41 million.

The April 2018 business plan states: “The following schedule starting in May 2018, shows the funding required to complete the technology transfer and construction of the new manufacturing plant in Manitoba, either in Brandon or in the Gambler reserve. Sales can start immediately using current Polish plant.”

Gerula said she was never able to establish whether the Polish plant existed.

Jarocka wanted $500,000 immediately. Also according to the plan, Fosfaton Akwaton International Ltd. was
incorporated in Manitoba in 2005.

“It owns and produces a natural formulation of Poly Hexa Methylene Guanidine Hydrochloride (PHMGH-FAI), the active ingredient of Akwaton,” according to the plan.

The small wipe packages seemed innocuous enough.

“They look like wet naps you get at restaurants,” said Gerula.

But as she and Wakin researched, they learned the main ingredient is polyhexamenthylene guanidine phosphate (PHMG-P), and that a similar polymer antimicrobial compound had caused the deaths of approximately 100 people and left hundreds with permanent lung damage when used as a humidifier disinfectant in South Korea. The deaths, due to pulmonary fibrosis, led to a seven-year jail sentence for one company executive, according to news reports.

“We approached Rose LeDoux and Chief Dave LeDoux with our findings and research regarding the dangers of the product,” said Gerula, who added she believed at the time LeDoux dropped the idea of purchasing the company.

Polyhexamenthylene guanidine research shows great success as an antimicrobial. There are numerous studies published. One researcher linked with Jarocka, Université de Saint-Boniface’s Mathias Oulé, was written up in the Winnipeg Free Press in 2012. The product, Akwaton, showed promise as a “weapon in war on superbugs.”

That’s the year the company made an application to Health Canada for a drug identification number (DIN). They were turned down. To this day, Health Canada has never approved the use of the polymer, according to an email to Wakin dated April 7, 2020.

“Health Canada has never approved a disinfectant or antiseptic containing polyhexamenthylene guanidine as an ingredient,” the department stated.

The Brandon Sun has been trying to get answers to questions from the federal government since Monday. Gerula and Wakin had been told by Health Canada that the file had been punted over to Indigenous Services Canada. That department told the Sun to contact Health Canada.

“Thank you so much for your patients (sic). We continue to work diligently with our experts to provide a response to your request, given the complexity and volume of incoming requests we are doing our best to have something for you at the soonest,” Health Canada stated Tuesday.

LeDoux has not replied to questions The Brandon Sun sent him Wednesday about whether Gambler invested in the company, or whether he was aware Health Canada had not approved products containing polyhexamenthylene guanidine. The Sun also asked where the wipes have been distributed.

How the product came to be introduced at Gambler First Nation, with Oulé’s endorsement on the package, remains a strange matter. Oulé told the Sun he only found out his name was on the product endorsing it two weeks ago. As for Jarocka, she said she didn’t sell the wipes to Gambler First Nation. She said they were past their expiry date.

“Instead of throwing them out, I gave it to them. I didn’t charge them for anything. Those wipes are no longer existing,” she said.

She repeatedly told the Sun the wipes did not exist, that she had told Rose LeDoux to take them to the dump.

Yet, Gambler First Nation member Roxanne Brass, Chief LeDoux’s sister, said Rose LeDoux had tried to sell her a box of Akwaton wipes for $12 in 2018. She found them too expensive, so she never purchased them.

Delores Tanner, also a band member and at one time a band employee, said she was given Akwaton wipes in 2019 to use in the community’s recreation centre where Jordan’s Principle work was taking place.

“We were told to wipe all the toys down, counters, tables,” said Tanner.

Jarocka said she purchased the proprietary rights for the polyhexamenthylene guanidine formulation from the Polish government, and that it was in no way similar to the South Korean product used in humidifiers.

In the business plan presented to Gambler First Nation, she stated that two production machines came with that purchase, and that the company had trademark registrations in 49 countries. She told the Sun all that equipment was now in Manitoba.

The proposed plant would produce 2,000 litres per day of a product that would have “health care and medical benefits; and for water purification related to drinking and wastewater treatment.”

“I was unable to confirm if she actually had a plant in Poland with machines and the mass production of the product she kept talking about,” Gerula said.

“She also made these outlandish statements about how the product was being used in the Mayo Clinic in the United States and that the provincial government was going to pour her product in the Manitoba waterways to eradicate the zebra mussel infestation. We found this statement to be untrue as we discovered the product was not approved for use in Canada.”

Both Jarocka and Oulé told the Sun a new application for Health Canada approval is in the works. Health Canada, they said, wanted toxicity testing done on live animals. Oulé’s laboratory doesn’t have that capacity, so Jarocka turned to researchers in Brazil.

But, Oulé said, “The wipes are not usable.”

“We are waiting for Health Canada approval. I did not know how and when she gave them to the First Nation.”

Jarocka said Health Canada should be ashamed.

“The product has been tested for zebra mussel, has been tested for algae application, has been tested for all the infection diseases, has been tested for everything else, and now the product can be produced. I brought all the machines here to Winnipeg. Now I have to send them back to the U.S. and to different places because we can’t put the production in Canada,” she said.

“I don’t think (Premier Brian) Pallister is going to be happy when he’s going to find out.”

Jarocka’s business plan for Gambler First Nation states the target market for the product is Canadian First Nations.

 » mletourneau@brandonsun.com

» Michele LeTourneau covers Indigenous matters for The Brandon Sun under the Local Journalism Initiative, a federally funded program that supports the creation of original civic journalism.