Citizens’ Petition To FDA on Regulation of Tobacco Treatment Medicines.

On Friday February 12th 2010 two of the leading organizations concerned with reducing the harm to health from tobacco submitted a petition to the US Food and Drug Administration, requesting changes in the way tobacco treatment medicines are regulated. The Association for the Treatment of Tobacco Use and Dependence (ATTUD) and the Society for Research on Nicotine and Tobacco (SRNT) were co-petitioners, with the final petition being reviewed and approved by the relevant committees within these organizations. At SRNT this included review by a sub-committee consisting entirely of members who have no links with pharmaceutical companies. The petition was accompanied and supported by a review paper, entitled “Barriers to Use of FDA-Approved Smoking Cessation Medications: Implications for Policy Action”, which was funded by the Robert Wood Johnson Foundation.

The review paper sought to identify barriers to consumer demand for effective FDA-approved tobacco treatment medications, and to suggest potential policy solutions. It identified widespread misconceptions about the harms and benefits of nicotine replacement therapy, characterized by an exaggerated concern about the safety of NRT and skepticism about the effectiveness of NRT. Many of the recommended solutions are consistent with those that have previously been recommended to reduce tobacco consumption generally. In addition, broadening indications and access conditions, and altering labeling on tobacco treatment products may enable these products to help more tobacco users to become tobacco-free. There is an urgent need for this policy action, because every additional year that hundreds of billions of cigarettes are smoked in this country results in hundreds of thousands of premature deaths and millions of cases of avoidable illness.

The mission statement of the FDA states that:
?The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nations food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health?.

The Citizens Petition from ATTUD and SRNT requests that FDA regulate tobacco treatment medicines in a manner that is consistent with this mission. Specifically, it requests that the following actions be taken. Support for these actions and further explanation is provided in the body of the Petition and in the Barriers Report.

1) Comparison of Health Risks: The FDA must recognize and use as a guiding principle that tobacco dependence is a chronic disease, one that causes other grave illness and often death in smokers. The magnitude of the risk of continued smoking should be considered at all phases of review of NRT products. On NRT products approved as safe and effective, product labeling should reflect the potential health risks associated with use of NRT as compared to the significant negative health risks caused by smoking. This comparison is the appropriate measure, as it should be assumed that the consumer considering NRT is currently smoking and plans to reduce or quit smoking by using NRT.

2) Combined Use: Package labeling should allow for combined use of NRT products. Current labeling strongly warns against the combined use of NRT products yet sound research shows that combined use is safe and highly effective. Labeling should reflect that certain NRT products may be used safely and effectively in combination rather than that such use is prohibited or discouraged.

3) Term of Treatment: NRT users should not be discouraged from using the product beyond the currently recommended 10 to 12 weeks. Research supports that use well beyond 12 weeks is safe and may be more effective in achieving full and permanent smoking cessation for some individuals than the standard shorter course of treatment. Current labeling instructing that NRT
use stop at 10 or 12 weeks should be amended.

4) Package Size: To enhance accessibility, the FDA should permit the sale of NRT in one-day packages that can be priced affordably. Currently the FDA prohibits such packaging. The high price of NRT under current packaging standards, particularly as compared to the much lower price of a package of cigarettes, discourages quit attempts and smoking cessation.

5) Continued Smoking and NRT: Package labeling strongly warning against continued smoking and use of NRT should be amended such that consumers are encouraged to use NRT to treat the symptoms of nicotine withdrawal during temporary smoking abstinence or to assist consumers

You can access the Citizens Petition and the report on barriers to the use of FDA-approved smoking cessation medicines on the ATTUD website at:

and on the SRNT website at:

I believe these documents will shortly be posted on the FDA website and at that point will be available for comment.
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About the Author

MA, MAppSci, PhD

Dr. Jonathan Foulds is an expert in the field of tobacco addiction.