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 2013_register executive 2013-04-02 article Notices D09002ee1c7fbac10 D09002ee1c7fbac76 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 announcing that we have concluded that certain statements set forth in the FDA-approved labels of over-the-counter nicotine replacement therapy products, related to concomitant use with other nicotine-containing products and duration of use, can be modified. In light of currently available evidence, these statements are no longer believed to be necessary in their current form to ensure the safe and effective use of over-the- counter nicotine replacement therapy products for their approved intended use as aids to smoking cessation. We encourage the submission of supplemental new drug applications (labeling supplements) to modify these statements as described in this notice. 78 FR 19718 https://www.govinfo.gov/app/details/FR-2013-04-02/2013-07528 2013-07528 fr02ap13-54 4160-01-P Docket No. FDA-2013-N-0341 https://www.govinfo.gov/app/details/FR-2013-04-02/2013-07528 https://www.govinfo.gov/content/pkg/FR-2013-04-02/html/2013-07528.htm https://www.govinfo.gov/content/pkg/FR-2013-04-02/pdf/2013-07528.pdf 4 p. 19718 19721 78 FR 19718 Modifications To Labeling of Nicotine Replacement Therapy Products for Over-the-Counter Human Use; Federal Register Vol. 78, Issue NOTICE 2013-07528 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2013-N-0341 4160-01-P 2013-07528 Notice.

The Food and Drug Administration (FDA) is announcing that we have concluded that certain statements set forth in the FDA-approved labels of over-the-counter nicotine replacement therapy products, related to concomitant use with other nicotine-containing products and duration of use, can be modified. In light of currently available evidence, these statements are no longer believed to be necessary in their current form to ensure the safe and effective use of over-the- counter nicotine replacement therapy products for their approved intended use as aids to smoking cessation. We encourage the submission of supplemental new drug applications (labeling supplements) to modify these statements as described in this notice.

Doris J. Bates, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4417, Silver Spring, MD 20993, 301-796- 1040, FAX: 301-796-9721, email: doris.bates@fda.hhs.gov. Modifications to Labeling: Nicotine Replacement Therapy Products for Over-the-Counter Human Use , doris.bates@fda.hhs.gov http://www.regulations.gov Vol. 78, no. 63 Office of the Federal Register, National Archives and Records Administration 2013-04-02 continuing daily deposited born digital 399 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2013-04-02 P0b002ee183fcf802 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr02ap13 https://www.govinfo.gov/app/details/FR-2013-04-02 https://www.govinfo.gov/content/pkg/FR-2013-04-02/pdf/FR-2013-04-02.pdf https://www.govinfo.gov/content/pkg/FR-2013-04-02/xml/FR-2013-04-02.xml fdlp 19585 19977 DGPO 2013-04-02 2024-06-03 FR-2013-04-02 machine generated eng FR FR-2013-04-02 78 63