SELLING HELP OR FALSE HOPE

1
SELLING HELP OR FALSE HOPE? A COMPARISON OF
CLAIMS BY TRADITIONAL AND NON-TRADITIONAL
CESSATION PRODUCTS Matt Barry Director of Policy
Research Campaign for Tobacco Free Kids 1400 I
Street, NW - Suite 1200 Washington, DC
20005 [phone] mbarry_at_tobaccofreekids.org
2

• 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?

3

• 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

4

• 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)

5
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).
6

• 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)

7

• 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 users 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.

8

• 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.

9

• Examples of Alternative Products on the Market
• Anti-Nicotine Herbal Patches
• Smokers vitamins
• Aroma therapies
• Cigarette alternatives
• Herbal lozenges
• Hypnosis
• Oral sprays
• Filter blockers
• Etc...

• Brand Names of Some Products
• CigSation
• SmokeLess
• Smokers Control
• Smokers Health
• Smokers Vitamin
• Smokers Herbal Formula
• Final Smoke
• HerbaQuit
• Kikit
• Endit
• The Breather
• Citrol
• Curb Your Cravings
• 7 Day Smoke Away
• NicoStop
• NicoBloc
• NicoLite

10
What is in these products? Ingredients listed
include
Lobelia Ginger Root Peppermint Lemon
Grass Cayenne Pepper Alfalfa Licorice
Root Myrhh Eucalyptus Slippery Elm Skullcap Benalk
onium Chloride Citric Acid Fennel Seed Black
Walnut Husk Kava Kava Root Bayberry
Fruit Coconut Malitol Syrup Vinegar Beef Salt Chic
ken 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 Pr
ickly-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?
11

• 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?
12
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 FDA-approved smoking-cessation
products.
13
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.
14
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.
15

• 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.

16
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?

17
What about this product? Cigarette? Drug?
Source - http//www.nicstic.com/engl/index.php.
18

• And next in line???
• NicoShot Nicotine Beer.
• Blue Whale Non-Tobacco Chew WITH Nicotine.

Source www.nicoshot.com and http//www.bluewhale
smokeless.com/. .
19
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.
20
FDA-Approved NRT
Ariva Tobacco LozengeNot FDA-Approved
CVS, Washington, DC, Spring 2002
21
(No Transcript)
22
(No Transcript)
23

• 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 wheres 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.