FDA: XXXX condom carries "extremely misleading" label. Federal agency allows distribution for public health's sake.

@entity1 @entity2953 @entity645 @entity2144 @entity2636
The labeling of the Avanti @entity2636 condom selling in 10 Western states makes misleading claims about protection from pregnancy and @entity2953 ( @entity2953 ) according to officials at the US Food and Drug Administration (FDA). Avanti is sold in a foil package printed with the claim that it is effective against pregnancy, @entity645 , and @entity2953 . However, @entity2636 condoms have not undergone clinical efficacy testing for contraception or @entity2953 , according to officials. The manufacturer of the condom refuted this allegation, stating that latex condoms have the same claims on them. In early 1995 the FDA met with the manufacturer and other companies developing plastic condoms, and concluded that these condoms could not make such claims, nor any claims about slippage and breakage rates. Despite warnings in 1993 to the manufacturer of Avanti about labeling restrictions, the company printed pregnancy and STD efficacy claims on the boxes and individual packages. The FDA later worked out a compromise with the firm in which only the boxes had to be reprinted with the generic label. The FDA had to weigh the risk of the public health cost of delaying sale of the condom, which is the first impermeable condom proven safe for @entity1 with @entity2144 . In 1991 the FDA was defining standards for clinical testing and labeling of @entity2636 condoms under congressional mandate, but the manufacturer of Avanti began mass production based on a preliminary approval determining that the condom was equivalent to latex condoms already on the market. 7000 Avanti condoms were subsequently tested in five countries, but these user tests did not compare Avanti to latex condoms and did not test for pregnancy and STD protection. Test results submitted to the FDA by the company indicated that, although Avanti is more than 1/3 less elastic than latex condoms, it did not break more frequently in an in-use study involving 187 couples.
