Tuesday, December 4, 2012

Call to Awareness - FDA Public Hearing on Nicotine Reduction Therapy Products

The Food and Drug Administration (FDA) has announced a 1-day public hearing to obtain input on certain questions related to the implementation of the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act (FSPTCA.)

Background:
CASAA endorses the use of low-risk, smoke-free alternatives; in an effort to reduce harm and risks associated with smoking. Currently, no products are approved by the FDA for use as "harm reduction." The FDA currently classifies nicotine products in just two ways: (1) as an approved treatment for nicotine addiction called "nicotine replacement therapy (NRT,)" which is better described as "nicotine reduction therapy;" intended to end nicotine and/or tobacco use (ie., pharmaceutical nicotine gums, patches and lozenges) and (2) as a "tobacco or tobacco product," which encompasses all tobacco and nicotine products not intended to treat nicotine addiction, including but not limited to cigarettes, cigars, snus, snuff, chewing ("spit") tobacco, tobacco lozenges, strips, sticks and electronic cigarettes.

With the passage of  the FSPTCA, Congress required the FDA to submit a report examining "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 the following three goals: (1) total abstinence from tobacco use, (2) reductions in consumption of tobacco, and (3) reductions in the harm associated with continued tobacco use."

What this means for CASAA members:
This particular hearing is related only to NRT products and is NOT seeking comments on the regulation of electronic cigarettes or smoke-free tobacco. However, the FDA is interested in receiving any new or additional information that might be relevant to the extended use of NRTs for tobacco dependence:

    "What evidence is available to support the approval of NRTs for extended use to maintain abstinence in individuals who have quit?" and  "What evidence is available to support the approval of NRTs for extended use to achieve cessation (quitting)?"

To put it very simply, the FDA is considering allowing the promotion and use of products such as nicotine gums, patches and lozenges not only as NRT to achieve complete nicotine abstinence, but also as "harm reduction" products for those who cannot or will not remain nicotine and/or tobacco abstinent. By doing so, the FDA will finally be approving nicotine products for a third category for which CASAA has campaigned: smoking-related "harm reduction" products. This would open the door for harm-reduction products such as electronic cigarettes and low-risk tobacco products for consideration. It is CASAA's understanding that the FDA still insists upon an "end date" for use, rather than using products as a permanent replacement for smoking. It is our intention to ask the FDA to consider removing such restrictions, since there is no scientific evidence that such restrictions are either beneficial or necessary.

What you can do:
CASAA directors will be in attendance at this hearing and will speak on key points on behalf of its membership. If members would like to add their own written comments, we have included "talking points" below for you to follow. It is very important that we focus on the harm reduction aspect of this hearing and not on e-cigarette or smoke-free issues. Our time for those points will come later. 

Regardless of attendance at the public hearing, interested persons may submit written comments in one of two ways. Printed comments can be mailed to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the docket number [Docket No. FDA-2012-N-1148].

To submit a comment electronically, on the page http://www.regulations.gov/#!documentDetail;D=FDA-2012-N-1148-0001, click the “Comment Now” button. Electronic or written comments will be accepted after the public hearing until January 2, 2013. NOTE: The FDA has extended the deadline for written comments until January 16, 2013.

If members plan to attend in person, CASAA requests that you first email your proposed presentation to board@casaa.org, so we may assist in the talking points and avoid duplication of our efforts. Once the FDA notifies registered presenters of their scheduled times, the FDA will require an electronic copy of your presentation be submitted by December 10, 2012.

The public hearing will be held on December 17, 2012, 8 a.m. to 5 p.m. Individuals who wish to present at the public hearing must register by December 6, 2012 and provide complete contact information, including name, title, affiliation, address, email, and phone number  Section III of this link has more information on registering to comment at the hearing: http://www.gpo.gov/fdsys/pkg/FR-2012-11-28/html/2012-28835.htm The hearing will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, rm. 1503, Silver Spring, MD 20993.

What you can say:
1) Write about what you know:
  • Did you ever try the nicotine patch, gum, lozenges, or inhalers?
  • How did they work for you? Were you able to completely quit smoking, just to reduce how much you smoke, or did they not help at all?
  • What do you see as some of the shortcomings of the products and how do you think the NRT products could be improved?
  • What other ways did you try to control your smoking in the past?
  • If you have quit smoking, what product made this possible? (Perhaps e-cigarettes?) What does this product (or the combination of products that you use) provide that NRTs did not?
2) Tell the FDA:
  • Providing smokers with low-risk alternative sources of nicotine works much better than requiring nicotine abstinence.
  • Recommend removing barriers to using the products such as time limits on how long to use them, warnings about using more than one product at a time, and warnings against smoking while using an NRT.
  • Point out that reducing the number of cigarettes smoked each day can be a stepping stone to quitting altogether.
  • Point out that achieving freedom from inhaling smoke is much more important for health than concerns about addiction to nicotine.
  • Recommend that the FDA educate the public about the relative safety of nicotine that comes from sources other than smoking.
  • Recommend that the FDA consider promoting other innovative products that have helped smokers reduce their consumption of cigarettes and eventually stop smoking altogether.

2 comments:

  1. This comment has been removed by the author.

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  2. i been smoking cigarettes for 16 years i tryed patches i broke out in sores had a massive rash on my arm i tryed the gum it made me very ill and i tryed the tablets witch hosptalised me i been useing the electronic cigarette for a month now and i havent touched a tobacco cigerette since i also managed to drop down my nicatine levels now down to 8mg from 16mg thy have returned mt sence of smell taste my fitness level i havent felt this helthy in many years thay been the best form of quiteing my smoke addicting in a long time in my opinion thay should be avalble as a alternatiove to smoking tobacco cigetettes i was a 2 packs a 40 a day i havent tuched a cigarette since i started useing a elctronic cigarette

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