Left: box of spermicide sold in the United States with corresponding warning on back of carton. Right: box of spermicide sold in Canada with corresponding warning on insert.

Health Canada says no warnings for spermicide chemical necessary

Nonoxynol-9, a chemical common in most spermicides carries visible warnings in the United States but requires none to be sold in Canada.

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Health Canada does not require manufacturers of spermicide to put warnings on their cartons stating that nonoxynol-9 can increase a person's risk of contracting HIV.

Nonoxynol-9, the active chemical ingredient found in most contraceptive foams or gels has been found to increase a person's risk of acquiring HIV or other STDs by causing lesions in the vagina or anus.

In the United States, Food and Drug Administration rules state that warnings must appear on the outside of the carton and must say that nonoxynol-9 does not protect against STDs and may increase a person's chances of contracting HIV. They also must state that the product cannot be for rectal use, may cause vaginal irritation and should not be used if you or your partner is HIV positive.

While most manufacturers do include warnings of some kind with nonoxynol-9 products, they are usually located on the information insert.

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Close-up of warnings required on packaging in USA

What this means for consumers is that they must buy the product, open it and seek out the information on the insert before discovering that the product should not be used if they or their partner are HIV positive or at risk of having an STD.

Deciding the danger

Gary Scott Holub, a media relations officer with Health Canada, explained that Health Canada does not require any warnings on products containing nonoxynol-9 because it falls under a minimal classification category.

"Medical devices are broken into various categories depending on the risks of the so-called side effects," Holub said. "The Medical Devices Regulations do not require specific labelling for devices containing nonoxynol-9, including condoms," Holub later added in an email.

As it stands, nonoxynol-9 is a Class I device, which means it represents the lowest risk. The highest classification level is a four.

This means that Health Canada does not consider the risks associated with using nonoxynol-9 serious enough to warrant a different classification and mandatory labeling requirements.

Kenneth Mews, a consultant with the Canadian AIDS Society, thinks that any risk at all is risk enough.

"Put it this way, let's not be arrogant about deciding what's too much and too little risk. Let's give people the information and let them make an informed choice," Mews said.

The numbers

In 2005, approximately 58,000 Canadians were living with HIV/AIDS. Those numbers have continued to steadily increase with women now making up a large part of infection rates, representing 24.9 per cent of new infections in 2007. In that year alone, almost 3,000 new HIV diagnoses were given.

While nonoxynol-9 is not considered a widely used form of contraception, only 2.7 per cent of women surveyed in a 2006 national contraceptive survey named it as their method of contraception, its risks still can present themselves.

Due to the intimate nature of products containing nonoxynol-9, returning products is not permitted; so once you buy it, it's yours. And with a cost varying between $10.00 to $20.00 dollars, it's not that cheap either.

While Health Canada and the Public Health Agency of Canada both have websites and documents detailing the dangers that nonoxynol-9 can pose to its users, it is information that must be located by curious consumers instead of readily available on packaging.

Mews noted that, while many people who use a sophisticated, chemical-based form of contraception like spermicide probably do try to educate themselves, that doesn't cover all the bases.

"Based on the information that we have it would be prudent [to have warnings]" Mews said.

 

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