Requesting Expansion of Availability of Nicotine Replacement Therapy to Consumers Who Use Tobacco - CLOSED
NRT CDER nicotine tobacco replacement therapy CLOSED
2008-08-24 2008-04-20 2008-08-18 2008-09-01 2008-08-24 2008-08-15 2008-09-03 2008-08-24 2008-08-16
FDA-2008-P-0116-0036 FDA-2008-P-0116-0020 FDA-2008-P-0116-0035 FDA-2008-P-0116-0043 FDA-2008-P-0116-0038 FDA-2008-P-0116-0029 FDA-2008-P-0116-0044 FDA-2008-P-0116-0040 FDA-2008-P-0116-0031
04:00:00 04:00:00 04:00:00 04:00:00 04:00:00 04:00:00 04:00:00 04:00:00 04:00:00
https://api.regulations.gov/v4/comments/FDA-2008-P-0116-0036 https://api.regulations.gov/v4/comments/FDA-2008-P-0116-0020 https://api.regulations.gov/v4/comments/FDA-2008-P-0116-0035 https://api.regulations.gov/v4/comments/FDA-2008-P-0116-0043 https://api.regulations.gov/v4/comments/FDA-2008-P-0116-0038 https://api.regulations.gov/v4/comments/FDA-2008-P-0116-0029 https://api.regulations.gov/v4/comments/FDA-2008-P-0116-0044 https://api.regulations.gov/v4/comments/FDA-2008-P-0116-0040 https://api.regulations.gov/v4/comments/FDA-2008-P-0116-0031
Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous
Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous
 As someone who works with tobacco users young and old every day I am very muchin favor of the proposed changes in NRT labeling. People who smoke and want toquit need to have it be easier to get medication than it is to buy another packof cigarettes. Being over the counter is not sufficient.Individuals should be able to buy treatment as readily as they can buycigarettes, in convenience stores and any store that sells tobacco. I dontthink this should be optional. I think that stores that sell tobacco should berequired to sell nicotine replacement products as well. In addition a personshould not be faced with having to pay $40.00 for 2 weeks worth of nicotinepatch or $5 for a pack of cigarettes. If dailly doses of patches were availablethey would only have to pay $3 for a single patch. It makes no sense to make iteasier to buy cigarettes than it is to buy treatment when the treatment isactuallly cheaper but costs more due to being packaged as a pack of 14 insteadof a single days allotment. It is also important to  label the products so thatpatients will not be frightened by a patch that could save their lives thinkingit will cause them to have a heart attack if they smoke a cigarette while on thepatch since this is not true. Products need to be labeled so that it is clearthat they are so much safer than cigarettes there is really no comparison. Allof these recommendations have particular benefit for those who have low incomewho are of course the ones most likely to continue to smoke. These changesshould help them in their efforts to quit tobacco by making it more financiallyfeasible for those who dont have medical coverage for tobacco treatment.Although there are many states that provide free nicotine patches there arestill at least half of the states that do not provide free patches through thetelephone helpline. California , where I live and work is one state that doesnot provide free patches and regulation changes like those proposed will help tooffset this problem.I am extremely hopeful that these bold recommendations will be followed soon sowe can continue to stem the tide of deaths due to smoking.Cathy McDonald, MD  Medicinal nicotine products should be widely available to consumers.  They should be available wherever cigarettes are sold, in package sizes that can be competitively priced with cigarettes, and with package information that accurately informs smokers about the risks and benefits of medicinal nicotine relative to continued cigarette use.  Widespread availability of medicinal nicotine likely will increase smokers access to and use of the products, as well as smokers familiarity and experience with the products.  As smokers become more experienced using these products, their chances of quitting smoking successfully will likely increase.  Jim As a Nurse Pracititoner I have seen the harm caused by primary and secondhand smoke, such as in Chornic Obstructive Pulmonary Disease, Lung Cancer, and asthma exacerbations.  One of the actions that may/will help people quit and thus expose fewer people to secondhand smoke is to make nicotine replacement more accessable.  Please allow broader availability of nicotine replacement for example that it be sold in the same places that cigarettes are sold ie liquor stores and gas stations.  These same locations sell aspirin and Tylenol, why not nicotine replacement?  Thank you for your attention to this matter.Susan H. Ward, MSN, APNP As a coordinator for a tobacco cessation program, I urge the FDA to adopt the recommendations in Dr. Daines petition.  Not only would these recommendations help people quit tobacco, they would also help people who slip and start using tobacco again after quitting.  If we really want to help people end tobacco use, this is a good way to do so! When providing cessation counseling you find that many people want to quit and they actually go through the process.   Unless a program is providing free Nicotine Replacement Therapy (NRT), cessation is difficult for those who need to maintain their quit status and want to use NRTs.   Not having access or resources available tends to create a barrier to treatment with no true accountability.  From a treatment perspective, if the FDA makes the products more consumer friendly, more individuals, especially those in underserved communities, will notice that the pharmaceutical industry is interested in their well being by bringing the prices and units to a level that is considered affordable.  The tobacco industry knew exactly what to do when they began to market, package and price their products.  They made it look appealing to the consumer.  Now its time for treatment to look just as appealing. There is no reason why those who choose to quit cigarette smoking shouldnt have readily available access to over the counter nicotine replacement therapy at affordable for all prices.  For the good of the public health, and the cost burden of smoking tobacco products, help make NRT readily available to all who desire it and need it!!thank you, Margaret Murphy, RN MS The detrimental effects of cigarette smoking are well documented, and nicotine clearly is not the worst constituent.I highly support suggested labeling changes, and cost/pricing alterations to make these products more widely accessible.  Cold Turkey has always been the best way to quit smoking.  NRT is very ineffective.  The American Cancer Societys 2003 Cancer Facts and Figures report asserts that 91.4% of all successful long-term quitters quit entirely on their own.  A 2006 Australian study found that 88% of all successful quitters quit smoking cold turkey and that cold turkey quitters were twice as likely to succeed as those using the nicotine patch, nicotine gum, nicotine inhaler or Zyban (bupropion). http://whyquit.com/whyquit/LinksCAids.htmlThe loosening of regulations on the places and means in which NRT is sold is just an excuse for the pharmaceutical companies to expand their market share of an ineffective and costly product.Jeremy Richards, Ph.D. Roswell Park Cancer Institute strongly supports the State of New York Department of Health - Citizen Petition that requests the FDA to increase access to over-the-counter nicotine replacement medications.  