Submit Comments to FDA on 2 Tobacco Issues.

The FDA is accepting comments from the public on two tobacco control issues:

• Nicotine Replacement Therapy (NRT): Two years ago, New York State Health Commissioner Richard Daines submitted a petition to the FDA to make nicotine replacement therapy more readily available and encourage more quit attempts. Two groups, the Association for the Treatment of Tobacco Use and Dependence (ATTUD) and the Society for Research on Nicotine and Tobacco (SRNT), recently submitted a similar but more detailed petition. The ATTUD-SRNT petition seeks action on the following issues:

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

The full ATTUD-SRNT petition is available here:
http://www.regulations.gov/search/Regs/home.html#docketDetail?R=FDA-2010-P-0089.

To submit a comment to the FDA on this issue, go to
http://www.regulations.gov/search/Regs/home.html#submitComment?R=0900006480aa6675.


 
• E-Cigarettes: Since last year, the FDA has sought to regulate e-cigarettes as drug delivery devices, citing the lack of published studies on product safety. However, a federal judge recently ruled that the FDA cannot regulate e-cigarettes as such. An appeal is expected. Click here to read more. The American Association of Public Health Physicians recently submitted a petition to request that the FDA classify and regulate e-cigarettes as tobacco products instead of drug delivery devices, noting the potential for harm reduction. The petition can be found at http://www.regulations.gov/search/Regs/home.html#docketDetail?R=FDA-2010-P-0095.
To submit a comment on this petition, go to
http://www.regulations.gov/search/Regs/home.html#submitComment?R=0900006480aa84a7. 
 


Labels: Citizens Petition, e-cigarette, FDA, jonathan foulds, NRT, tobacco

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