Friday, December 28, 2007

N-9 contraceptives must carry warning label... but not condoms

[LifeLube tip - check that condom before you buy it or use it. If it contains nonoxynol-9, N-9, as many Trojan and Lifestyle brand condoms do... don't use it! Instead, use a condom that doesn't have this dangerous ingredient! Buy and use Durex, Kimono and Johnson and Johnson brand condoms - none of which have N-9.]

The federal Food and Drug Administration is adopting a new rule that will require warning labels on contraceptive products that contain the spermicide nonoxynol-9 but the federal agency is delaying the establishment of a similar rule on condoms containing N-9.

"It's still not sufficient," said Judy Auerbach, the deputy executive director of science and public policy for the San Francisco AIDS Foundation.

Echoed Anna Forbes, the deputy director for Global Campaign for Microbicides, "It seems to me that they are completely stalling about this."

The FDA is considering labeling requirements for N-9 condoms separately because it classifies condoms as "medical devices." The two major manufacturers of N-9 condoms, Church and Dwight, the makers of the Trojan brand, and Ansell, the maker of the LifeStyles brand, wrote to the FDA suggesting that warning consumers about N-9 condoms could be confusing and could cause fewer consumers to use condoms at all.

That objection was the major factor in causing the FDA to delay N-9 labeling rules.

Citing that objection, the FDA opted to study the issue further. The first phase of the study will be completed by February and the second phase, which will take about 17 weeks, will begin after the FDA analyzes the first study, according to FDA spokeswoman Peper Long.

A number of organizations, including the Global Campaign for Microbicides and SFAF, have called for the removal of N-9 from condoms.

Read the rest in the Bay Area Reporter.

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