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 (202)

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 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 Anti-Nicotine Herbal Patches Smoker’s vitamins Aroma therapies Cigarette “alternatives” Herbal lozenges Hypnosis Oral sprays Filter blockers Etc... Brand Names of Some Products: 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 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 FDA- approved 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 Qui tting and Reducing T obacco Use I nventory of P roducts (QuiTIP) database at - 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?

Source - What about this product? Cigarette? Drug?

And next in line??? 1.NicoShot: Nicotine Beer. 2.Blue Whale: Non-Tobacco Chew WITH Nicotine. Source – and

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.

Ariva Tobacco Lozenge: Not FDA- Approved FDA- Approved NRT 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.