From: SMOKEFREE@compuserve.com
Date: Fri, 08/15/08
There are just two days left (of the 180 day public comment period) to
submit comments to the FDA regarding NY State Health Commissioner Richard
Daines' petition urging the FDA to make nicotine products (that are
marketed as smoking cessation aids) more consumer friendly and to increase
their usage by smokers.
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
Below is the supportive comment submitted by Smokefree Pennsylvania.
Bill Godshall
- - - -
Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
August 15, 2008
Dr. Andrew von Eschenbach
Commissioner
U.S. Food and Drug Administration
Division of Dockets Management
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Re: Docket No. FDA-2008-P-0116
Dear Commissioner von Eschenbach:
Smokefree Pennsylvania strongly urges the Food and Drug Administration
(FDA) to approve New York State Health Commissioner Richard Daines'
petition to expand consumer access to over-the-counter nicotine replacement
products by relaxing restrictions on how these products can be packaged and
sold.
The petition specifically requests the FDA to:
1. Allow the sale of over-the-counter (OTC) nicotine replacement therapy
(NRT) in all retail locations where cigarettes are sold, including in
convenience stores, gas stations, tobacco specialty stores, grocery stores,
and other retail businesses that sell tobacco;
2. Allow OTC NRT to be sold in "daily" units (containing an amount of NRT
that would typically be consumed in a 24-hour period) at prices competitive
with one 20-count pack of cigarettes and allow OTC NRT to be advantageously
positioned relative to cigarettes and other tobacco products in order to
promote the sale of OTC NRT products; and
3. Modify labeling requirements in order to fully disclose to smokers the
benefits of OTC NRT use relative to continued cigarette use, with risks
associated with OTC NRT compared to risks associated with continued
cigarette use.
As typically used in the U.S., cigarettes are about 100 times deadlier than
smokeless tobacco products, while NRT products (marketed as smoking
cessation aids) pose even fewer health risks. This huge difference in
mortality risk alone should compel the FDA to allow nicotine gums,
lozenges, patches and inhalers to be marketed in the same retail locations
and in similar daily dose packages as are tobacco products, and for the FDA
to modify labeling requirements to adequately inform consumers of the
comparable health risks of NRT products versus cigarettes.
Due to nicotine compensation, every dose of nicotine that a smoker obtains
from a smokefree tobacco or NRT product is a dose of nicotine that
otherwise would be obtained by inhaling smoke from a cigarette. As a
public health and consumer protection agency, the FDA has an ethical duty
to allow and encourage NRT manufacturers to truthfully inform consumers
about the comparable risks of different nicotine products, and to encourage
smokers to substitute far less hazardous NRT products for cigarettes for
both temporary and long term usage (in addition to using NRT as a smoking
cessation aid).
About 80% of nicotine now consumed by Americans is from cigarettes (down
from about 90% a decade ago), while nearly 20% of nicotine consumed is from
less hazardous smokefree tobacco/nicotine products (up from about 10% a
decade ago). Smokefree tobacco products and NRT provide about 18% and 2%
respectively of the nicotine consumed in the U.S. The health of Americans
who continue consuming nicotine daily can and will significantly improve as
the percentage of nicotine obtained from smokefree tobacco/nicotine
products continues to increase (due to the corresponding decline in the
percentage of nicotine obtained from cigarettes), and the FDA should
embrace this goal.
Although a meta-analysis (1) found that just 7% of smokers who used NRT
products remained cigarette free after six months (i.e. 93% of users
relapsed back to cigarettes), it is very likely that FDA approval of this
petition would result in millions (perhaps tens of millions) of additional
smokers beginning or resuming the use of NRT products instead of (or
concurrently with) cigarettes, with many of those smokers quitting.
An estimated 36.6% of current nicotine gum users have consumed the product
for longer than six months (2), which is far longer than the 12 weeks of
use currently recommended by NRT manufacturers and approved by the FDA,
indicating that NRT products also are effective for long-term nicotine
maintenance. Long-term use of NRT products has not been associated with
any known medical risks and is far less hazardous than relapsing to smoking
cigarettes (3, 4).
Many smokers are grossly misinformed about the risks of nicotine and NRT
products. A 2001 survey of 1,046 adult U.S. smokers found that 53%
incorrectly believed nicotine causes cancer and 14% didn't know (5).
Another survey found that 49% of U.S. smokers are concerned about negative
side effects of using NRT (6).
Some of this misinformation about nicotine and NRT products is due to
misleading warning labels currently on NRT packages, that tell consumers to
NOT use the product if they continue using tobacco products, and to ask a
doctor before using the product if they have hypertension, heart disease,
diabetes, or if they are pregnant, breastfeeding or under age 18. Current
warnings on NRT products also urge consumers to stop using the product and
consult a doctor if they experience relatively uncommon side effects that
pose lower health risks than continued smoking.
Despite the warning on NRT packages telling consumers to NOT use the
product if they are using any tobacco product, the overwhelming majority of
NRT product users concurrently smoke cigarettes. While NRT products are
most effective as smoking cessation aids when users refrain from smoking,
if/when an NRT user smokes just one cigarette, he/she must stop using the
NRT product (i.e. resume smoking) to remain compliant with that
counterproductive warning. Instead, NRT users should be informed to
continue using NRT products even if they concurrently smoke cigarettes.
Similarly, the use of NRT products by smokers who have hypertension, heart
disease, diabetes, or are pregnant, breastfeeding or under age 18 poses far
fewer health risks than does the continued smoking of cigarettes. The FDA
should allow and encourage NRT manufacturers to inform consumers of this
vital fact.
The high cost of NRT products (compared to cigarettes and especially
compared to smokeless tobacco products) is another deterrent for smokers to
try the product. In 2002, 60% of U.S. smokers surveyed thought that NRT
products were too expensive (6). The lowest retail cost for any NRT
product in Pittsburgh, PA is $25 for a discount brand of 48 nicotine
lozenges. Allowing the retail marketing of NRT products in daily dose
packages costing $5-$10 almost certainly will encourage more smokers to
purchase and use NRT products, which can reduce the per unit price of NRT,
which in turn can further increase use of NRT products by smokers.
A recent study estimated that over-the-counter NRT use results in 114,000
to 304,000 new former smokers annually in the U.S., including both men and
women (7). While this estimate may be considered good news for some, many
more of the 45 million smokers in the U.S. could benefit from NRT products
if the FDA approves this petition.
To encourage greater usage of NRT products, the United Kingdom recently
liberalized its NRT regulations. The new guidelines allow NRT use by
patients with cardiovascular disease, by confirmed smokers ages 12 to 17,
by pregnant smokers, by those who concurrently use other NRT products, and
by those who continue to smoke. NRT can now also be prescribed for up to
nine months if patients need it beyond the initial eight to twelve weeks
(8).
Regardless of the vastly different product advertising claims,
manufacturers of cigarettes, smokeless tobacco and NRT products compete
against each other to market nicotine to addicted consumers. Unfortunately
for public health and nicotine consumers, federal policies for cigarettes,
smokeless tobacco and NRT products favor the deadliest tobacco product
(cigarettes) at the expense of the least hazardous smokefree
tobacco/nicotine products.
This petition would allow NRT products to more effectively compete against
cigarettes and smokeless tobacco products, would better inform consumers of
NRT risks and benefits, and would improve public health.
For disclosure, neither I nor Smokefree Pennsylvania have received any
funding from any tobacco or drug company.
Sincerely,
William T. Godshall, MPH
Executive Director
1. Hughes JR, Shiffman S, Callas P, Zhang Z, A meta-analysis of the
efficacy of over-the-counter nicotine replacement, Tobacco Control, 2003,
Vol. 12, 21-27.
http://tc.bmjjournals.com/cgi/content/full/12/1/21?ijkey=5.ko5/Oz4yutl
2. Shiffman S, Hughes JR, Pillitteri JL, Burton SL, Persistent use of
nicotine replacement therapy: analysis of actual purchase patterns in a
population based sample, Tobacco Control, Vol. 12, 310-316, 2003.
http://tc.bmjjournals.com/cgi/content/full/12/3/310
3. Murray RP, Bailey WC, Daniels K, et al. Safety of nicotine polacriliex
gum used by 3,094 participants in the Lung Health Study. Chest, 1996, Vol..
109: 438-445.
4. Hubbard R, Lewis S, Smith C, et al. Use of nicotine replacement therapy
and the risk of acute myocardial infarction, stroke, and death. Tobacco
Control, 2005, Vol. 14, 416-421.
http://tc.bmjjournals.com/cgi/content/abstract/14/6/416
5. Cummings KM, Hyland A, Giovino G, et al. Are smokers adequately informed
about the health risks of smoking and medicinal nicotine? Nicotine &
Tobacco Research, 2004.
6. The Cigarette Market U.S. consumer intelligence, Mintel International
Group Ltd., September, 2002.
7. Henningfield JE, Fant RV, BuchhalterAR, Stitzer MS, Pharmacotherapy for
Nicotine Dependence, CA: A Cancer Journal for Clinicians, 2005, Vol. 55,
No. 5, 281-299.
8. Nicotine Replacement Therapy, Guidance for Health Professionals on
changes in the Licensing Arrangements for Nicotine Replacement Therapy,
ASH, London, December 2005.
http://www.ash.org.uk/html/cessation/Smoking%20reduction/NRT051229.pdf
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