United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2000_register executive 2010-09-24 article Rules and Regulations D09002ee1c81ed9cb D09002ee1c81eda3b United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency 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". 65 FR 62282 https://www.govinfo.gov/app/details/FR-2000-10-18/00-26248 00-26248 fr18oc00-5 4160-01-F Docket No. 98N-0970 https://www.govinfo.gov/app/details/FR-2000-10-18/00-26248 https://www.govinfo.gov/content/pkg/FR-2000-10-18/html/00-26248.htm https://www.govinfo.gov/content/pkg/FR-2000-10-18/pdf/00-26248.pdf Labeling Medical Devices Reporting and Recordkeeping Requirements 4 p. 62282 62285 65 FR 62282 Title 21 Part 801 21 CFR Part 801 Medical Devices; Labeling for Menstrual Tampon for the “Ultra” Absorbency; Federal Register Vol. 65, Issue RULE 00-26248 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2001-01-16 Docket No. 98N-0970 4160-01-F 00-26248 Final rule.

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".

This rule is effective January 16, 2001. Colin M. Pollard, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1180. Labeling Medical Devices Reporting and Recordkeeping Requirements Medical devices: Clinical chemistry and toxicology devices Menstrual tampons labeling; ultra absorbency, Vol. 65, no. 202 Office of the Federal Register, National Archives and Records Administration 2000-10-18 continuing daily deposited born digital 311 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2000-10-18 P0b002ee1809fbc96 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr18oc00 https://www.govinfo.gov/app/details/FR-2000-10-18 https://www.govinfo.gov/content/pkg/FR-2000-10-18/pdf/FR-2000-10-18.pdf https://www.govinfo.gov/content/pkg/FR-2000-10-18/xml/FR-2000-10-18.xml fdlp 62275 62575 DGPO 2010-09-24 2024-06-08 FR-2000-10-18 machine generated eng FR FR-2000-10-18 65 202