Condom Regulations, Standards and Rules
Until the 1980s, there weren't many rules governing condoms and their quality, and the rules that did exist weren't always enforced. All that changed with the AIDS epidemic, when using poor-quality condoms could lead to death.
Current regulations start with manufacturing. Good manufacturing practices (GMP) rules are standards for factories that make drugs, including products like condoms and hand sanitizers that play a role in preventing disease. In the United States, GMP rules fall under the jurisdiction of the Food and Drug Administration (FDA). Internationally, the International Organization for Standardization has created a standard called ISO 9000. Another ISO standard, ISO13485, covers medical devices and is used in many areas to regulate condom production. These sets of rules cover everything from manufacturing methods to record keeping in ways that can apply to all drugs. What they don't do is govern the specifications of the condoms that leave the factory. That's where specific condom standards come in.
While many countries have their own standards, a couple of international standards set guidelines for everything from how condoms are tested to what color they are. The primary international standard is ISO 4074:2002. The World Health Organization (WHO) Male Latex Condom Specification uses ISO standards as a foundation for its guidelines on purchasing condoms for health promotion.
The ISO and WHO specifications for condoms include parameters for:
- Acceptable quality levels (AQLs), or the maximum number of condoms that can be defective in each batch
- Accreditation for laboratories that test condoms
- Procedures for the tests
- Materials, shelf life and stability
The ISO and WHO standards also outline passing and failing grades for the tests described in Zapping, Popping, Rolling and Other Condom Testing Tools.
Finally, there are rules about how, where and when condoms can be distributed and sold, and these vary from place to place. The purchase and sale of condoms is often a clandestine affair because of cultural or religious taboos. Catholicism and Orthodox Judaism prohibit contraceptive use, including condoms. Islam allows the use of contraception within the context of married heterosexuals who have a reason to prevent pregnancy. Some conservative Christian groups also promote abstinence rather than the use of condoms [source: Allen]. On the other side of the coin are laws requiring condom use -- for example, they have been mandatory in brothels in Nevada since 1988 [source: Grudzen].