Transcript No Slide Title

SELLING HELP OR FALSE HOPE?
A COMPARISON OF CLAIMS BY
“TRADITIONAL” AND “NONTRADITIONAL” CESSATION
PRODUCTS
Matt Barry
Director of Policy Research
Campaign for Tobacco Free Kids
1400 I Street, NW - Suite 1200
Washington, DC 20005
(202) 296-5469
[email protected]
Overview
•
Compare and contrast health claims made (on product labeling and
websites) for “traditional” (e.g., FDA-approved) and “non-traditional”
(e.g., not FDA-approved) tobacco use cessation products.
•
Highlight enormous number of products that do not fall under FDA
oversight and the claims being made about these products in terms
of their ability to help consumers quit, reduce smoking, or
temporarily suppress withdrawal symptoms.
•
The lack of peer-reviewed, scientific data about the safety and
effectiveness of these products (do they work and are they safe?),
and the potential for these products to have a negative impact on
public health if they do not do what they claim.
•
If these unregulated products do not work or are not safe, will they
discourage tobacco users who are concerned about their health or
who are interested in quitting from making further quit attempts with
products and techniques that are evidence-based and are proven to
be safe and effective?
Different lenses to look at cessation products:
• FDA approved and not FDA approved
• Prescription and Over-the-Counter
• Nicotine-based and not nicotine-based
• Long-term abstinence and short-term
withdrawal suppressant
• Smoking versus smokeless
• Homeopathic, nutritional and dietary
supplements
• Tobacco-based and non-tobacco-based
FDA approved:
•
Nicotine Gum (sold as Nicorette 4mg and 2mg by
GlaxoSmithKline (GSK), also sold as generic nicotine
polacrilex - available OTC)
•
Nicotine Patch (sold as NicoDerm/NicoDerm CQ by GSK
and as Nicotrol by Pfizer/Pharmacia, also sold as generic
nicotine transdermal patch - available OTC)
•
Nicotine Lozenge (sold as Commit by GSK - available
OTC)
•
Nicotine Inhaler (sold as Nicotrol Cartridge Inhaler by
Pfizer/Pharmacia - available prescription only)
•
Nicotine Nasal Spray (sold as Nicotrol NS by
Pfizer/Pharmacia - available prescription only)
•
Bupropion SR (sold as Zyban by GSK - available
prescription only; also sold as anti-depressant Wellbutrin)
Not FDA Approved …
EVERYTHING ELSE.*
* Legal issues stemming from compounding pharmacies, homeopathic
medicines, and herbal and dietary supplements raise unique issues that
create classes of products, such as nicotine lollipops, nicotine wafers,
nicotine lip balm and nicotine water, that, depending on how they are
manufactured and sold (marketed and advertised), they could avoid FDA
scrutiny of more “traditional” cessation products (but not FTC jurisdiction
regarding “false” and “misleading”).
Nicotine versus non-Nicotine Based FDA approved products
Nicotine-based:
• Gum
• Patch
• Lozenge
• Nasal spray
• Inhaler
Non-nicotine-based:
• Bupropion SR
• Clonidine (seldom used, primarily an anti-hypertensive, sold
as Catapres)
•
Nortriptyline (seldom used, primarily used as anti-depressant,
sold as Pamelor or Aventyl)
Long-term abstinence and short-term
withdrawal suppression
• FDA-approved drugs intended for “long-term abstinence”,
even though only labeled for 10-12 week courses of
treatment.
• “Other” products are targeting short-term (e.g., a few minutes
to a few hours) withdrawal suppression - products like
NicoWater and the Nicotine Wafer. These products appear
to be a response to (1) the desire to capitalize on tobacco
user’s concerns about their health and (2) an increase in the
number of jurisdictions covered by smokefree workplace
laws (a marketing opportunity has been created).
• More recently, in UK, approval for “reduce to quit” labeling for
NRT such as nicotine gum.
Smoking versus Smokeless Cessation Products
•
All the FDA approved drugs are approved as smoking
cessation products, not smokeless cessation products.
•
Most evidence to date does not suggest that FDA-approved
NRTs are effective for smokeless users in helping them quit
(although clinical guidelines do recommend their use).
•
There are an increasing number of non-tobacco smokeless
“substitutes” being sold - shredded mint, beef jerky,
coconut, tea, shredded bubble gum, other herbal/food
grade ingredients.
Examples of Alternative Products on the Market
Brand Names of Some Products:
•
Anti-Nicotine Herbal Patches
•
Smoker’s vitamins
•
Aroma therapies
•
Cigarette “alternatives”
•
Herbal lozenges
•
Hypnosis
•
Oral sprays
•
Filter blockers
•
Etc...
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
CigSation
SmokeLess
Smoker’s Control
Smoker’s Health
Smoker’s Vitamin
Smoker’s Herbal Formula
Final Smoke
HerbaQuit
Kikit
Endit
The Breather
Citrol
Curb Your Cravings
7 Day Smoke Away
NicoStop
NicoBloc
NicoLite
NicoRx
NicoWater
Smokers Edge
Herbal Nicotine Buster
NicoDrops
What is in these products? Ingredients listed include:
Lobelia
Ginger Root
Peppermint
Lemon Grass
Cayenne Pepper
Alfalfa
Licorice Root
Myrhh
Eucalyptus
Slippery Elm
Skullcap
Benalkonium Chloride
Citric Acid
Fennel Seed
Black Walnut Husk
Kava Kava Root
Bayberry Fruit
Coconut
Malitol Syrup
Vinegar
Beef
Salt
Chicken Stock
Arsenicum Album
Nicotinum
Nux Vomica
Monosodium glutamate
Sodium Nitrite
Red Clover
Barbados Molasses
Ginseng
Ylang Ylang
Rosemary
Virgin Olive Oil
Cinnamon Bark
Areca Nut
Pseudoginseng
Prickly-ash
Passion Flower
Mannitol
Sorbitol
2 Acetylpyridine
Plaintain Major 3X
Caladium Seguinum 6X
Daphne Indica 6X
Dextrose
Are these ingredients safe? Are these ingredients effective?
A lot of claims but is there evidence to support them?
•
“Helps diminish cravings for smoking.”
•
“Reduces tobacco cravings.”
•
“Quit smoking the easy and natural way.”
•
“Satisfy your cravings!”
•
“… aids in quitting or reducing smoking.”
•
“Reduces your desire to smoke!”
•
“... to help stop the smoking and reduce nicotine cravings.”
•
“Helps reduce and overcome smoking at your own pace.”
•
“Reduces withdrawal symptoms, including nicotine craving,
associated with quitting smoking.”
WHICH CLAIM IS FOR AN APPROVED
FDA CESSATION AID?
“The FTC alleged the defendants
did not have a reasonable basis
for the claims they made about
Smoke Away or for their claims
that it is more effective than FDAapproved smoking-cessation
products.”
“Based on several factors, including statements
contained in the labeling of the product, and
other evidence of intended use, FDA has
determined that this product should be regarded
as an unapproved new drug and cannot be
legally marketed as a dietary supplement.”
The letters inform the pharmacies that FDA has
found their nicotine lollipops and lip balm to be
illegal. Based on statements from the pharmacies'
Internet sites, the products are promoted as aids for
smoking cessation or to treat nicotine addiction.
For more information on cessation products, go to:
The Quitting and Reducing Tobacco Use Inventory of
Products (QuiTIP) database at https://secure.tobaccofreekids.org/Cessation/
Find information on over 110 products sold as tobacco use
cessation aids. Searchable information on:
• the manufacturer,
•
•
•
directions for product use,
product ingredients,
product claims,
•
•
product warnings and disclaimers,
evidence of product effectiveness.
And What About This Product? Is it a cigarette
or smokeless tobacco? Neither? Both?
•
Is it a cessation aid? If so, is it an unregulated drug?
•
Is it a cigarette? If so, where are the Surgeon General
warnings and are Federal and State cigarette excise
taxes being collected on it?
What about this product? Cigarette? Drug?
Source - http://www.nicstic.com/engl/index.php.
And next in
line???
1. NicoShot:
Nicotine Beer.
2. Blue Whale:
Non-Tobacco
Chew WITH
Nicotine.
Source – www.nicoshot.com and http://www.bluewhalesmokeless.com/. .
THE “MEATCAKE”
SYNDROME
There is a blurring of
the lines taking place
between smokeless
tobacco products
(being sold as harm
reduction products)
and so-called smoking
reduction and
cessation products.
FDAApproved
NRT
Ariva
Tobacco
Lozenge:
Not FDAApproved
CVS,
Washington,
DC, Spring
2002
Conclusions/Questions
• The universe of smoking/tobacco cessation aids that have been
tested for safety and effectiveness is VERY small in comparison
to all the products available on the market.
• Are consumers able to distinguish among products that have
been proven safe and effective and those that have not (e.g.,
need for seal of approval)?
• Virtually all of the non-FDA approved cessation products make
claims about their product and its effectiveness. But where’s
the evidence [and government approval] to back those claims?
• Growing competition in cessation arena, particularly short-term
withdrawal suppression, from smokeless tobacco products and
novel nicotine-based and non-nicotine based products that
claim they do not require FDA approval.
• Constantly evolving marketplace of products requires the
attention of state and federal law makers, along with the
scientific community, to determine if so many untested and
unproven cessation products is good or bad for public health.