Medical Devices; Labeling for Menstrual Tampon for the “Ultra” Absorbency

Information

Type

Rule

Regulated products

Medical Devices

Published

October 18, 2000

Last updated

October 18, 2000

Description

Document number 00-26248. The Food and Drug Administration (FDA) is issuing a final rule that amends its menstrual tampon labeling regulation to add the term "ultra" absorbency for tampons that absorb 15 to 18 grams (g) of fluid with the syngyna test. At present, FDA requires standardized terms to be used for the labeling of a menstrual tampon to indicate its particular absorbency. This rule enables consumers to compare the absorbency of one brand and style of tampon with the absorbency of other brands and styles. FDA is issuing this final rule under the Federal Food, Drug, and Cosmetic Act (the act) to ensure that labeling of menstrual tampons is not misleading. Elsewhere in this issue of the Federal Register, FDA is proposing to change the standardized menstrual tampon term "junior" to "light".

Organization

Country / Region

United States

License

Other (Public Domain)

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