The agency has already concluded that the active ingredients in marketed spermicides generally are safe, but their effectiveness in final product formulations is highly variable. Therefore, the agency is proposing that manufacturers submit new drug applications for all individual spermicide products. The following can be used to answer questions.
Spermicide contraceptives are available in foam, gel, cream, film and suppository formulations.
They work by forming a physical and chemical barrier to sperm in the vagina. There is evidence that some formulations of spermicide products can lose effectiveness during use. Vaginal contraceptives also are sometimes associated with vaginal irritation, which may play a role in transmission of sexually transmitted diseases. While none of these products currently has an approved indication for prevention of STDs, FDA is aware of literature reports and other data suggesting they may play a role. Separate clinical trials need to be conducted before such claims could be made for the products.