Its ruling that no men who acknowledged having had homosexual sex within the past five years should be able to become anonymous donors sparked outrage among gay advocacy groups, which said the new rules were based on prejudice rather than fact.
"It's one thing to base these rules on legitimate scientific concerns, but it's another to reinforce baseless stereotypes," Matt Foreman, the executive director the National Gay and Lesbian Task Force told the New York Times. He said HIV tests were now fast and very effective.
Gay men will still be able to donate to friends and family members. Moreover, most sperm banks already freeze and quarantine donations for six months and test the donor at the beginning and the end of that period.
The new rules are part of an overall push to tighten the screening and testing of potential donors in all areas.
Giving the FDA the flexibility to respond to new diseases could also lead to the exclusion of different nationalities who come from high-risk areas. Examples of such diseases, the FDA says, include Sars and the west Nile virus.
According to the new regulations, all donors will now have to be tested for HIV, hepatitis B and C, syphilis and Creutzfeld-Jakob disease, the human form of mad cow disease. Sperm donors must also be screened for sexually transmitted diseases, including chlamydia and gonorrhoea. Besides the tests, donors must be asked a series of questions about their social lives.
People who use drugs intravenously will be barred from donations because they are at a higher risk of contracting HIV.
"This new rule was developed with input from many concerned consumers, associations and tissue establishments," said the FDA's acting commissioner, Lester Crawford. But an FDA spokeswoman could not confirm yesterday whether gay groups had been consulted.
The FDA claims that the behavioural risk factors used to screen donors are consistent with 1994 guidelines from the centres for disease control and Prevention for preventing the transmission of HIV through organ and tissue transplantation.