Medical Devices; Labeling for Menstrual Tampons; Ranges of Absorbency, Change From “Junior” to “Light”
Information
Type
Proposed Rule
Regulated products
Medical Devices
Published
October 18, 2000
Last updated
October 18, 2000
Description
Document number 00-26249. The Food and Drug Administration (FDA) is proposing to amend its menstrual tampon labeling regulation to change the current term for tampons that absorb 6 grams (g) and under of fluid. A tampon with 6 g or less absorbency is currently required to be labeled as "junior". FDA is proposing to change the term to "light". The term "junior" implies that it is only for younger, teenage women, while in fact, women of any age with light menstrual flow may find this tampon useful. FDA wishes to encourage women to use the lowest absorbency tampon appropriate for their flow to help minimize the risk of toxic shock syndrome (TSS). At present, FDA requires standardized terms to be used for the labeling of a menstrual tampon to indicate its particular absorbency. This enables consumers to compare the absorbency of one brand and style of tampons with the absorbency of other brands and styles. FDA is issuing this proposed rule under the Federal Food, Drug, and Cosmetic Act (the act).
Tags
Organization
Country / Region
United States
License
Other (Public Domain)