other · Food and Drug Administration · Rule · Published 1997-09-26 · Effective 1998-03-25 · 62 FR 50497
Document
Document number
97-25587
Federal Register citation
62 FR 50497
CFR reference
21 CFR 801
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1997-09-26
Effective date
1998-03-25
HHS docket
Docket No. 95N-0374
Abstract
The Food and Drug Administration (FDA) is issuing a final rule that requires the labeling of latex condoms to contain an expiration date based upon physical and mechanical testing performed after exposing the product to varying conditions that age latex. Studies show that latex condoms degrade over time. Such degradation has a significant effect on the product's ability to provide a barrier to sexually transmitted diseases (STD's), including human immunodeficiency virus (HIV). This requirement is established in order to provide consumers with essential information regarding the safe use of these products.