Alter the Manner In Which the Agency Reviews Drug Approval Applications for & Regulates Nicotine Replacement Therapy Medications-CLOSED
CDER tobacco medications regulates nicotine replacement therapy CLOSED
2010-04-14 2010-03-10 2010-03-15 2010-03-10 2010-03-15 2010-03-15 2010-04-14
FDA-2010-P-0089-0011 FDA-2010-P-0089-0007 FDA-2010-P-0089-0009 FDA-2010-P-0089-0006 FDA-2010-P-0089-0008 FDA-2010-P-0089-0010 FDA-2010-P-0089-0012
04:00:00 05:00:00 04:00:00 05:00:00 04:00:00 04:00:00 04:00:00
https://api.regulations.gov/v4/comments/FDA-2010-P-0089-0011 https://api.regulations.gov/v4/comments/FDA-2010-P-0089-0007 https://api.regulations.gov/v4/comments/FDA-2010-P-0089-0009 https://api.regulations.gov/v4/comments/FDA-2010-P-0089-0006 https://api.regulations.gov/v4/comments/FDA-2010-P-0089-0008 https://api.regulations.gov/v4/comments/FDA-2010-P-0089-0010 https://api.regulations.gov/v4/comments/FDA-2010-P-0089-0012
Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous
Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous
As a nurse who has specialized in Tobacco Cessation Treatment for over 25 years, I implore the FDA to adopt all the provisions as stated in this petition.   All tobacco products contain nicotine which is unquestionably the most powerful of all addictions to overcome.   It is more difficult to control nicotine addiction than alcohol, heroin or cocaine.  The majority of tobacco users wish they could stop but do not have the tools to do so.   It is long overdue that the treatment of tobacco dependence and that the labeling on the NRT products reflect evidence based findings and recommendations. The use of medications such as nicotine replacement products is vital to helping millions of smokers quit.  As a primary care physician, I see the horrible consequences of smoking each and every day.  The proportion of smokers who use these medications to quit is woefully low.  There is a great deal of misinformation and misperception regarding them, and these are needless barriers.  Smokers should certainly have better access to life-saving medications (i.e. those that help people quit smoking) than the products that are killing them (tobacco).  Right now, you can buy a pack of Marlboros that carries minimal warnings as to how harmful it is in any convenience store, gas station, etc.  In order to get NRT, you need to usually go to a pharmacy, ask for them as they are often behind the counter, overpriced, and have warnings that are vastly out of proportion to the actual harms (consult your doctor if you have diabetes or ulcers for the gum/lozenge??? - who thought of that?).  Tobacco smoke contains HIGH levels of nictoine along with 4000 known txoins.  NRT contains low-dose nicotine in its safest form - with all products tested and available for 20 years in the general public.  Yet, it is harder to obrain these medications than cigarettes.  Something has to change.  Please meet your agencys mission and keep our citizens safe. To whom it may concern:As a member of ATTUD and a clinician who has been working in the trenches to help tobacco dependent patients quit, I would strongly urge you to follow through on the ATTUD/SNRT Citizen Petition, to lower barriers on NRT, so we can help more tobacco users successfully quit.Chris Kotsen, PsyD, CTTSProgram Manager, Tobacco QuitcenterSteeplechase Cancer CenterSomerset Medical CenterSomerville, NJ I  think the  nicotine  replacment therapy should  be  readily  avaliable in all  convient store  that  sell  tobacco  and I  support  the  efforts in getting this  done. Please do as New York State Health Commissioner Richard Daines asked through a petition to the FDA two years ago and make nicotine replacement therapy more readily available and encourage more quit attempts. Recently the Association for the Treatment of Tobacco Use and Dependence (ATTUD) and the Society for Research on Nicotine and Tobacco (SRNT) submitted similar petitions. This petition allows FDA-approved over-the-counter NRT products (i.e. nicotine gums, patches and lozenges) to be sold in all stores that sell cigarettes. This petition also allows NRT products to be competitively priced with cigarettes and/or sold in less expensive daily dose units. It changes the labeling on NRT products to inform consumers of the health benefits of NRT compared to cigarettes/other tobacco products. When these changes are made the FDA will increase the percentage of tobacco users who successfully quit as well as move users beyond contemplation of quitting to their first real quit attempt. I agree with all statements of the ATTUD-SRNT petition.  Access to these products will be greatly increased with smaller trial size packages.  And combination therapy with muliple NRT therapies should be promoted, as it has been shown to be one of the mosst effective means to quit. I disagree with the section listed below:Availability of NRT at Retail Stores: NRT should be available as widely as possible . The FDA should explicitly remove any restrictions that discourage the sale of NRT at non-pharmacy retail locations ; NRT should be widely available at retail establishments, including all stores wherecigarettes are sold .I am a pharmacist and I treat many patients with tobbaco dependence. One of the reasons for treatment failure is improper use of NRT products. By removing the education compopnent from the use of the medication, will increase failure rates with NRT. By allowing NRT to be sold with tobacco products, smokers will no longer believe that these products are medictions to treat tobacco dependence and assume that it is just another form of tobacco. I would like to suggest that pharmacies continue to have NRT products with the option of the pharmacy keeping the products behind the counter, to encourage counseling of the product and discourage misuse by adolescents.Ideally, pharmacies should not sell tobacco products.