Re: Comments on 16 CFR Part 307

Dear Sir/Madam,

The Society for Research on Nicotine and Tobacco (SRNT) would like to respond to several of the questions posed in the above referenced call for comments on warning labels for smokeless tobacco. SRNT is composed of over 600 of the leading scientists in tobacco and nicotine research in the US and 34 other countries. Our society often informs agencies of scientific findings of nicotine/tobacco studies that bear on a proposed policy. We will be brief and refer you to the citations for more detailed information documenting our points.

The first question posed is "Is there a continuing need for the regulations as currently promulgated?" Since the original Smokeless Tobacco Act was promulgated by Congress in 1986, substantially more scientific evidence has accrued that use of smokeless tobacco is harmful and addictive 1,2. In addition, the prevalence of use of smokeless tobacco has declined little in recent years.3 In 1999, 12% of high school boys reported use of smokeless tobacco in the last 30 days.4 Thus, we see no diminution in the need for effective warnings.

The second question is "What effects, if any, have the regulations had on smokeless tobacco purchasers, potential purchasers or the general public?" Recent reports of the Surgeon General,5 the World Bank 6 and Health Canada 7 document the several studies that indicate labels that are large and explicit do influence motivation to not begin or to stop smoking cigarettes. We see no reason not to expect similar results from ads on smokeless tobacco. .

The fifth question is "What significant burdens or costs, including costs of compliance, have the regulations imposed on small firms subject to their requirements?" and the twelfth question is "What is the likely effect of any changes in the regulations suggested to questions 6 through 11 on costs, profitability, competitiveness, or employment in small business entities?" We believe evaluation of any such negative effects should only be considered in the context of the savings in health care costs from label-induced reductions in smokeless tobacco use. Although we are unaware of quantitative data to make a precise calculation, even a reduction in the prevalence of smokeless tobacco use of 1-2% is likely to eventuate in a large saving in health care costs 1,2.

The eleventh question is "Are there other provisions of the regulations that need to be amended?" Research 6,7 and clinical opinion 8 indicates that warning labels emphasizing addiction are especially effective. If the prior legislation does not explicitly prohibit the use of other labels besides the three stated, we would suggest adding a label that states "smokeless tobacco use can be addicting."

Thank you for the opportunity to comment,

John R. Hughes, M.D
Chair, Policy Committee
SRNT

CC: SRNT Policy Committee
SRNT Executive Committee

Reference List

1. National Cancer Institute 1992 Smokeless Tobacco or Health, An International Perspective. Smoking and Tobacco Control Monograph 2 .1992 NIH Publication No. 93-3461

2. Hatsukami D, Severson HH, 1999. Oral spit tobacco: addiction, prevention and treatment. Nicotine and Tobacco Research 1:21-44

3. Everett SA, Husten CG, Warren CW, Crossett L, Sharp D, 1998. Trends in tobacco use among high school students in the United States, 1991-1995. Journal of School Health 68:137-140

4. US Center for Disease Control, 2000. Tobacco use among middle and high school students - United States, 1999. Morbidity and Mortality Weekly Report 49:49-53

5. US Dept Health and Human Services. 1989. Smoking Control Policies. In: Davis RM, Hawk S, Novotny TE, (ed) Reducing the Health Consequences of Smoking: 25 Years of Progress. A Report of the Surgeon General. Rockville, MD: DHHS Publication No. (CDC) 89-8411, pp.461-636

6. The World Bank 1999 Curbing the Epidemic: Governments and the Economics of Tobacco Control. 1999 (www1.worldbank.org/tobacco/book/html/cover2.html) The World Bank, Washington DC

7. Health Canada 2000 Research on Labeling. 2000 (www.hc-sc.gc.ca/hppb/tobacco/bureau/current_research/index.html)

8. Brecher EM. 1972. Nicotine as an addicting drug. Licit and Illicit Drugs. Boston: Little, Brown and Company, pp.220-228