New Tobacco Products: Harm Reduction or Harm Induction?

Herbert H. Severson

Senior Research Scientist

Oregon Research Institute

Eugene, Oregon

Harm Reduction Definition

Harm reduction refers to minimizing harms and decreasing total morbidity and mortality, without completely eliminating tobacco and nicotine use

Institute of Medicine study, 2001

New Products

Lower tobacco-specific nitrosaminesSpitlessIn neat packetsDifferent flavorsSnus products produced by American

Tobacco Companies

New Smokeless Products

Urgency for Research

Increased advertising directed at smokers and influx of new products

Controversy over the use of smokeless tobacco as a harm reduction agent

Little data to determine the impact of these products and to support it’s use as a harm reduction agent

State of affairs

Scientific consensus on lower risks to individual users of ST

and at the same timeAdamant dissension, sometimes bitter

& personal, on whether ST can help to reduce population tobacco harm

What We Know - Point #1

Wide variability in tobacco-specific nitrosamines (TSNAs) in non-combustible oral products

Considerable levels of carcinogenic tobacco-specific nitrosamines even in newer oral tobacco products

Tobacco-Specific Nitrosamines Across Products

Product µg/g product (wet weight)

NNN NNK NAT NAB Total

Copenhagen Snuff 2.20 0.75 1.80 0.12 4.80

General Snus 0.98 0.18 0.79 0.06 2.00

Camel Snus (frost) 0.83 0.16 0.14 0.01 1.12

Taboka 0.91 0.06 0.23 0.00 1.27

Revel 0.62 0.03 0.32 0.02 0.99

Ariva 0.02 0.04 0.12 0.01 0.19

Commit (lozenge, 2 mg nicotine)

nd nd nd nd nd

What We Know - Point #2

Significant reductions in toxicant uptake can occur when tobacco users switch from products with higher TSNAs to products with lower TSNAs

Urinary Total NNAL in Smokeless Tobacco Users Who Switched to Snus or Nicotine Patch

1.4

3.2

1.5

0.5

0.2

2.82.8

0.50.3

0

0.5

1

1.5

2

2.5

3

3.5

4

4.5

Baseline Week 2 Week 4

Visit

Mea

n t

ota

l NN

AL

(p

mo

l/m

g c

rea

tin

ine)

* P< 0.01

*

*Patch (verified, N=15)

Patch (N=22)89-90% reduction

Snus (N=19)49% reduction

What We Know - Point #3

Wide variability in levels of free nicotine in oral tobacco products

Considerable amounts of free nicotine in some of the newer tobacco products that may sustain addiction

What We Know: Wide Variability in Nicotine Levels Across Products

Product pHNicotine (mg/g dry weight)

Total Free

Copenhagen Long Cut 7.53 26.7 7.14

Skoal Long Cut 7.51 25.6 6.03

Marlboro Snus Rich 6.80 25.2* 1.42*

Camel Snus Original 7.46 28.2 6.09

General Snus 7.95 16.7 7.69

* increased in the past year: 2008 values; total 17.8, free 1.08I. Stepanov et al, Nicotine Tob. Res. 12: 1773 (2008)

What We Know

Products with lower TSNAs are not benignOral pathologies Pancreatic cancerMetabolic syndromeFetal toxicityCardiovascular disease?

Reasons for opposing use of ST for reducing population tobacco harm

“(a) . . . limited studies to show that the dual use of smokeless tobacco and cigarettes is not as harmful or more harmful than the single use of these products.”

1. “Main concern with marketing ST as cessation aid or substitute for cigarettes”

Sequential or Concurrent Dual Use?

Sequential “dual” use (moving completely off cigarettes to ST) will very likely show some reduction in smoking-caused diseases—as a function of duration of smoking & daily dose of smoking

As with dual use of NRT and cigarettes in smokers who do not want to quit smoking*, because nicotine intake is somewhat regulated, total intake of smoke toxins is unlikely to rise with dual use and will likely decrease* Fagerstrom, KO, Tejding R, Westin A, Lunell E. Aiding reduction of smoking with

nicotine replacement medications: hope for the recalcitrant smoker? Tob Control. 1997 Winter;6(4):311-6.

“(b) Aggressive marketing of smokeless tobacco as less risky than cigarettes may not necessarily lead to reduced total tobacco use but increased use, especially newly initiated use.”

2. “Main concerns with marketing ST as cessation aid or substitute for cigarettes”

“(c) Oral smokeless tobacco products are not harmless . . . .”[There is a need for a regulatory authority to set a] “lower standard for lower standard for toxinstoxins and require disclosure over these products” [to be able to] “assess true harm from oral tobacco use.”

New FDA Regulations may develop these standards

“Main concerns with marketing ST as cessation aid or substitute for cigarettes”

“Main concerns with marketing ST as cessation aid or substitute for cigarettes”

“. . . (d) smokeless tobacco use may be a gateway to using cigarettes. Whereas few smokers switch to smokeless tobacco, a greater number of smokeless tobacco users switch to cigarettes, a more deadly product

“No Consensus on Gateway”

In support for gateway Tomar SL. Is use of smokeless tobacco a risk factor for cigarette smoking?

The U.S. experience. Nicotine and Tobacco Research, 2003;5(4):561-70. Severson, H.H., Forester, K.A., & Biglan, A. (2007). Use of smokeless tobacco is

a risk factor for cigarette smoking. Nicotine & Tobacco Research 9(12); 1331-1337.

In opposition to gateway O’Connor RJ, Flaherty BP, Edwards BQ, et al. Regular smokeless tobacco use

is not a reliable predictor of smoking onset when psychosocial predictors are included in the model. Nicotine and Tobacco Research, 2003; 5(4), 535-44.

Ramstrom LM, Foulds J Role of snus in initiation and cessation of tobacco smoking in Sweden. Tob Control. 2006 Jun;15(3):210-4.

Arguments For ST Use for Cigarette Harm Reduction

Fewer negative health consequences associated with smokeless tobacco use compared to cigarettes

Swedish snus experience

Arguments Against ST Use for Cigarette Harm Reduction

ST use is harmful and less harmful products are available

ST use leads to nicotine addictionST may facilitate use of cigarettesQuitting ST is difficult

NIH State-of-the-Science Conference on Tobacco Use: Prevention, Cessation, and Control

Data about the effectiveness of ST in facilitating smoking cessation and associated harm reduction are very limited. High-quality comparisons of ST to proven pharmacologic and behavioral cessation interventions are needed

http://consensus.nih.gov/

What We Need to Learn

Level of toxicants in these newer products Addictive potential of these products Consumer perception of these products Use of these products by consumers Health impact of these newer products Effectiveness of products as a smoking

cessation aid What impact these products have on a

population level (e.g., rate of initiation, maintenance, or precipitation of relapse)

Harm Reduction StudyHatsukami and Severson

Randomized clinical trial comparing the efficacy of oral tobacco and pharmaceutical nicotine lozenges in smoking cessation

Acceptability of ST products for cessationAssess the toxicity of tobacco exposure

for participants in the RCT Funded by the National Cancer Institute

Product Preference of Six Oral Tobacco Products

Provide data on preference of ST products Subjective rating of product Withdrawal symptoms during ST use Optional: Can choose to quit smoking using ST

choice

ST Products Used in Study 1

Compared: Camel Snus – Mellow & Frost Marlboro Snus – Peppermint & Rich General Snus (Swedish) Stonewall – Java, Wintergreen, & Natural Ariva – Java & Wintergreen

ST Product Preference Study Design

Conclusion

Whether smokeless tobacco is a viable treatment method for smoking cessation is unknown

Developing more rapid and acceptable methods of nicotine delivery may be better alternative to using smokeless tobacco