FDA: polyurethane condom carries 'extremely misleading' label. Food and Drug Administration. Clearinghouse, P.O. Box 6003, Rockville, MD 20849-6003. 800-458-5231 ext. 5023.

Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.

FDA: polyurethane condom carries 'extremely misleading' label. Food and Drug Administration. Clearinghouse, P.O. Box 6003, Rockville, MD 20849-6003. 800-458-5231 ext. 5023.

AIDS Alert. 1995 Jan;10(1):1-4. Unique Identifier : AIDSLINE AIDS/95700020

Abstract: The Avanti polyurethane condom was placed on the market bearing a misleading claim that it is effective against pregnancy, HIV (AIDS) and STDs. While the Food and Drug Administration (FDA) knew that the condoms were being marketed with a label that breaches regulations prohibiting the use of such language until fully proven by clinical trials, it did not stop the product from going to market. Instead, for the public health's sake, it agreed that the condom packages could be sold as is, if the condom boxes were reprinted bearing a generic label which states that, the risks of pregnancy, and STDs, including AIDS (HIV infection), are not known for this condom....A study of the effectiveness of this condom for prevention of pregnancy and STDs is now under way. Individual condom packages alrady produced, still bear the original claim, but that will be changed with new production.

Keywords: Acquired Immunodeficiency Syndrome/*PREVENTION & CONTROL/ TRANSMISSION Condoms/SUPPLY & DISTRIBUTION/*STANDARDS Female Human HIV Infections/*PREVENTION & CONTROL/TRANSMISSION Male Materials Testing Polyurethanes Pregnancy Pregnancy Complications, Infectious/*PREVENTION & CONTROL Product Labeling/*STANDARDS Sexually Transmitted Diseases/*PREVENTION & CONTROL/TRANSMISSION United States United States Food and Drug Administration NEWSLETTER ARTICLE
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