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Public Meeting on FDA Approach to Evaluating Nicotine Replacement Therapies

The Food and Drug Administration (FDA or the Agency) will hold a public hearing on FDA’s approach
to evaluating the safety and efficacy of nicotine replacement therapy (NRT) products, including how they should
be used and labeled.

A majority (roughly 70%) of adult smokers in the United States report that they want to quit, and nearly half
of them make a quit attempt each year. Many of those quit attempts involve the use of NRT products, which are designed to help people quit smoking by supplying controlled amounts of nicotine to ease their withdrawal symptoms. The Agency is committed to increasing access to and use of nicotine replacement therapy that which could help more smokers quit. FDA believes it is critical to obtain input from researchers, health care professionals, manufacturers, interested industry and professional organizations, the public health community, and the public regarding how evolving science could influence FDA’s approach to evaluating the safety and effectiveness of NRT products.


The public hearing will be held on Friday, January 26, 2018, from 9 a.m. to 5 p.m. The public hearing may be extended or may end early depending on the level of public participation.

Meeting Location

FDA White Oak Campus
10903 New Hampshire Avenue
Building 31 Conference Center
the Great Room A
Silver Spring, MD 20993-0002

The entrance for public meeting participants (non-FDA employees or contractors) is through Building 1,
where routine security check procedures will be performed.

For parking, security and other visitor information, please refer to Public Meetings at the FDA White Oak Campus.

Background Information

  • Federal Register notice
  • Agenda (an agenda and any other background materials will be made available 5 days before the meeting)


If you wish to attend the public meeting (either in person or via webcast) and/or present at the meeting,
please register by Tuesday, January 2, 2018.

If you need special accommodations due to a disability, please contact Allison Hoffman at 301-796-9203
or OMPTFeedback@fda.hhs.gov at least 7 days before the meeting.


FDA will provide instructions for viewing the live Webcast in advance of the public meeting. We will post a link
to the archived Webcast on this Website approximately one week after the meeting.

Submitting Comments

Regardless of attendance at the public meeting, you can submit electronic or written comments to the public
docket by February 15, 2018. Submit electronic comments to Regulations.gov. Submit written comments to the Division of Docket’s Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.
All comments must be identified with the docket number TBD. The FDA may post, without change, all comments received to Regulations.gov, including any personal information provided.


If you have questions about registering for the meeting, contact Allison Hoffman, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, phone: 301-796-9203, email: OMPTFeedback@fda.hhs.gov.