From: SMOKEFREE@compuserve.com
Date: Wed, 08/27/08
Please urge the FDA to approve Dr. Daines' petition to make smokefree
nicotine products (i.e. patches/gum/lozenges/inhalers) smoker friendly.
Roswell Park Cancer Institute's supportive comment is below the following
news article.
To submit a comment, go to:
http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=FD
A-2008-P-0116
Then click on the "Add Comments" icon to the right of the first document
titled "State of New York Department of Health - Citizen Petition" with ID
number
FDA-2008-P-0116-0001
Bill Godshall
- - -
State pushes nicotine therapy
Health commissioner wants products available at stores where cigarettes are
sold
By Cathleen F. Crowley
Times-Union (Albany, NY)
Saturday, August 23, 2008
http://timesunion.com/ASPStories/Story.asp?StoryID=714535&LinkFrom=RSS
ALBANY -- What would happen if nicotine replacement lozenges were as easy
to buy as Tic Tac mints?
State Health Commissioner Richard Daines believes more smokers would
purchase them instead of cigarettes.
Daines petitioned the U.S. Food and Drug Administration in January to relax
the regulations on nicotine replacement therapy. Right now, so-called "safe
nicotine" products are kept behind drugstore counters and sold only in
large quantities.
The FDA responded to Daines' request earlier this month and said the agency
needs more time to study the issue.
"We were disappointed, but we were not surprised by the FDA reaction," said
Ursula Bauer, director of chronic disease prevention and adult health at
the state Department of Health. "As they said in their letter, it is a
complicated issue."
Bauer predicted the FDA wouldn't rule on the nicotine issue until after the
presidential elections, when a new administration is in place.
The Department of Health wants nicotine replacements to be sold everywhere
cigarettes are sold and to be packaged in small units, instead of making
smokers buy a week's supply for $30 to $50.
"So a smoker can go into a convenience store and they see their pack of
Marlboros behind the counter, but on the counter is a 10-pack of nicotine
gum that is selling for $4.99," Bauer said. "And they can decide, 'Do I
want to spend $6 on my Marlboros or $4.99 on a pack of gum?' "
Convenience stores, which derive 10 percent to 25 percent of their revenue
from tobacco sales, are prohibited from selling nicotine replacement
therapy, said Jim Calvin, president of the New York Association of
Convenience Stores. Calvin supports changing FDA regulations to allow
stores to sell the drug.
The Health Department effort to change the FDA rules is part of a larger
campaign to get New York's 2.7 million smokers to quit. The state has
already raised the cigarette tax and is looking at increasing the licensing
fee for businesses that sell cigarettes, Bauer said. There is one tobacco
retailer for every 100 smokers in New York, she noted, and the annual
licensing fee they pay is just $100.
In 2009, the agency will launch an education campaign to teach smokers
about nicotine.
"Nicotine is the thing in cigarettes that makes you feel good," Bauer said.
"It's also the addictive component of the cigarette. We know that 70
percent of smokers say they want to quit, but they can't because they are
addicted to nicotine."
But how safe is "safe" nicotine?
"It's certainly far safer to use the safe-nicotine products than the
combustible nicotine," she said. "There are people in the tobacco-control
community that say we should think about nicotine the same way we think
about caffeine."
Bauer said it's the side effects of combustion -- the burning of the
cigarette -- that create carcinogens and toxins. The mantra in public
health is people "smoke for the nicotine, but die from the smoke." Cathleen
F. Crowley can be reached at 454-5348 or by e-mail at
ccrowley@timesunion.com.
What do you think?To read and comment on Health Commissioner Richard
Daines' FDA petition, go to http://www.regulations.gov and search for
Docket ID: FDA-2008-P-0116
- - -
Roswell Park Cancer Institute
Elm & Carlton Streets
Buffalo, NY 14263
716-845-2300
www.roswellpark.org
August 16, 2008
Division of Dockets Management
Food and Drug Administration
Department of Health and Human Services
5630 Fishers Lane, Room 1061
Rockville, Maryland 20852
Re: Docket number FDA-2008-P0116
I am writing this letter on behalf of the Roswell Park Cancer Institute, in
support of the petition submitted by Richard F. Daines, MD, Commissioner of
the New York State Department of Health (NYSDOH) requesting that the Food
and Drug Administration (FDA):
1. Allow the sale of over-the-counter (OTC) nicotine replacement therapy
(NRT) in all retail locations where cigarettes and other tobacco products
are sold;
2. Allow OTC NRT to be packaged in units of a size that can be
competitively priced with cigarettes and/or in units containing an amount
of OTC NRT product that would typically be consumed during a 24-hour
period;
3. Allow OTC NRT to be advantageously positioned relative to cigarettes and
tobacco products in order to promote the sale of OTC NRT; and
4. Modify labeling requirements to fully disclose to smokers that a) OTC
NRT is safe for use by smokers and safer for use than continued cigarette
use; b) OTC NRT is appropriate for use in situations of temporary
abstinence from cigarettes in order to moderate symptoms of nicotine
withdrawal associated with periods of smoking restriction; and c) grave
risks are not associated with the use of OTC NRT for those who do not
completely abstain from tobacco use.
We strongly agree with the statement of grounds and evidence described by
Commissioner Daines that: 1) OTC NRT needs to be made more widely
accessible to smokers in order to increase use, increase quit attempts and,
eventually, increase success at quitting; 2) increased availability of OTC
NRT will not lead to increased abuse by adolescents; 3) OTC NRT is safe and
safer than cigarettes for all smokers; and 4) use of OTC NRT for situations
of temporary smoking restriction in order to moderate transient withdrawal,
as a substitute for smoking, and concomitantly with cigarette use in order
to reduce consumption (and eventually quit) is safe and needed to advance
public health.
The argument in support of Dr. Daines' petition to the FDA is advanced by
recent studies showing that pre-cessation treatment with NRT can increase
the odds of odds of quitting smoking. Allowing smokers the opportunity to
learn how to obtain nicotine from NRT while they are still using tobacco
should enhance their ability to subsequently quit and remain abstinent.
We are dismayed and perplexed by the recent statement by the FDA (see
letter from Jane Axelrad, dated 8-7-08) that the agency are unable to reach
a decision on the petition because it raises complex issues requiring more
extensive review. The issues are hardly complex, tobacco use kills over
400,000 American's annually, and NRT is a proven to be a safe and effective
treatment for tobacco dependence. The FDA has over 14 years of experience
with OTC NRT treatments and can look to the experience of other countries,
such as Finland and the United Kingdom where NRT is more widely available
to citizens.
We believe that there will be a substantial positive impact on the public's
health of increasing the availability of OTC NRT by expanding the types of
retail outlets that may offer OTC NRT for sale, permitting a "daily"
package size, and modify labeling requirements to accurately address
smokers' misperceptions about the relative risks and benefits of OTC NRT
use. We also believe that failure to approve of the NYSDOH petition will
continue the status quo, resulting in millions of avoidable deaths from
tobacco-attributable diseases. We ask you to approve of the NYSDOH
petition.
Sincerely,
K. Michael Cummings, PhD, MPH
Chairman, Department of Health Behavior
Roswell Park Cancer Institute
(716) 845-8456;
e-mail: michael.cummings@roswellpark,org
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