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  1. Guidance, Compliance, & Regulatory Information

Nicotine-Containing Products

FDA has issued a citizen petition response and a Notice of Findings related to over-the-counter (OTC) nicotine replacement therapy (NRT) products, which are currently approved as aids to smoking cessation. In addition, HHS has submitted a report to Congress that discusses the regulation and promotion of innovative products and treatments targeting tobacco dependence. This report discusses a variety of products and treatments, including NRTs.

Citizen Petition Response
In January 2008, The State of New York’s Commissioner of Health submitted a citizen petition to the Agency asking FDA to take various actions regarding the regulation of OTC NRT drug products. In February 2010, the University of Maryland School of Law submitted a petition raising similar issues on behalf of the Association for the Treatment of Tobacco Use and Dependence and the Society for Research on Nicotine and Tobacco. We received a third petition in August 2010, from four not-for-profit public health organizations: the American Cancer Society Cancer Action Network, the American Lung Association, the Campaign for Tobacco-Free Kids, and the American Legacy Foundation. These three petitions raise many common issues, so FDA issued a combined response granting and denying the various requests made in the petitions. 
Notice of Findings
Each of the citizen petitions described above requested changes to approved drug product labeling for OTC NRT products. Because changes to the labeling of OTC NRT products must be supported by submissions from product sponsors to the appropriate New Drug Applications, FDA was unable to make the requested labeling changes through the citizen petition process. The Agency has, however, conducted its own review of the available literature and data on the safety of OTC NRT products. Based on that review, we have concluded that certain statements set forth in the approved labeling of OTC NRT products, including statements related to duration of use and concomitant use with other nicotine-containing products, can be modified. FDA intends to allow the modification of these statements based on sponsor submissions as set forth in a Notice of Findings.
Report to Congress
Section 918 of the Food, Drug & Cosmetic Act requires the Secretary to submit a report to Congress, after consultation with recognized scientific, medical, and public health experts, that “examines how best to regulate, promote, and encourage the development of innovative products and treatments (including nicotine-based and non-nicotine based products and treatments) to better achieve, in a manner that best protects and promotes the public health – (A) total abstinence from tobacco use; (B) reductions in consumption of tobacco; and (C) reductions in the harm associated with continued tobacco use.” 
The Section 918 report was submitted to Congress on April 22nd, 2013. The report discusses FDA’s actions and current policies relating to fast track processes and new indications for NRT products, in addition to the regulation of “innovative products and treatments” for achieving abstinence, reductions in consumption, and reductions in harm. On December 17, 2012, FDA held a public hearing under 21 CFR Part 15 to gather input from all interested stakeholders on the full range of issues raised by Section 918, and the input received at that hearing (including comments submitted to the associated docket) has been taken into account in the development of the report to Congress. 
A copy of the report is available here: Section 918 Report to Congress (PDF - 221KB)
Product sponsors may contact CDER’s Division of Nonprescription Clinical Evaluation for samples of what the new labeling would look like with the changes supported by the Notice of Findings.
Doris J. Bates, Ph.D.
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave.
Bldg. 22, Room 4417
Silver Spring, MD 20993
TEL: 301-796-1040
FAX: 301-796-9721

EMAIL: doris.bates@fda.hhs.gov

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