рив KF

26

227

985€

2

ments available to States, local governments, school systems, and other entities. The Secretary is also directed to conduct and support research on the effects of smokeless tobacco on human health and to collect, analyze, and disseminate information and studies on smokeless tobacco and health.

The Secretary would be authorized to provide technical assistance to States to assist them in developing educatioanal programs and materials and public service announcements on the dangers to human health from the use of smokeless tobacco.

The bill would direct the Secretary to transmit a report to the Congress not later than January 1, 1987, and biennially thereafter. The report would contain: (1) a description of the effects oif health education efforts on the use of smokeless tobacco products; (2) a description of the public use of smokeless tobacco products; (3) an evaluation of the health effects of smokeless tobacco products and an identification of areas for further research; and (4) recommendations for appropriate legislation and administrative action.

S. 1574 would require the display of one of three warning statements on smokeless tobacco product packages and smokeless tobacco advertising:

WARNING: THIS PRODUCT MAY CAUSE MOUTH
CANCER:

WARNING: THIS PRODUCT MAY CAUSE GUM DIS-
EASE AND TOOTH LOSS; AND

WARNING: THIS PRODUCT IS NOT A SAFE ALTERNATIVE TO CIGARETTES.

The statements would be randomly displayed on each package of smokeless tobacco product by a manufacturer, packager, or importer of a smokeless tobacco product in each twelve-month period in as equal number of times as possible and would be randomly distributed in all parts of the United States in which the product is marketed. The labels would be displayed and distributed in accordance with the regulations and guidelines issued by the FTC pursuant to a plan submitted to and approved by the FTC.

Each of the three warning statements would be rotated every four months in advertisements for each brand of smokeless tobacco products, in accordance with the regulations and guidelines issued by the FTC pursuant to a play submitted to and approved by the FTC. In the case of a radio or television advertisement for a smokeless tobacco product, one of the statements would have to be read once during the advertisement in compliance with FTC guidelines. The bill would require the FTC to promulgate and periodically revise regulations and guidelines to implement the warning statement and advertising provisions of the bill. Within 180 days of the enactment of the bill, the FTC would be required to promulgate guidelines regarding the display, format and distribution of the statements required on smokeless tobacco packages and the rotation, display, format, and distribution of the statements on each advertisement.

The bill would establish a smokeless tobacco "additive" reporting system. Each person who manufactures, packages, or imports smokeless tobacco products would have to provide the Secretary of HHS annually with a list of ingredients added to tobacco in the

UNIVERSITY OF MICHIGAN LIBRARIES

manufacture of the product and a specification of the quantity of nicotine contained in each product. The ingredient list would not the FTC, recommend to the Congress appropriate revisions to the warning statements contained in this legislation.

II. BACKGROUND AND NEED FOR LEGISLATION

Over the past twenty years, the Congress and the Federal Government have taken a strong stand on the hazards to human health of cigarette smoking. Nearly neglected in this history of concern and action has been the use of smokeless tobacco products, such as snuff and chewing tobacco, and the hazards of such use to health. The smokeless tobacco industry, once almost the forgotten factor in tobacco production and sales, has staged a resurgence in recent years. Estimated from the National Institutes of Health indicate that some 22 million Americans currently use smokeless tobacco products regularly.

The evidence has steadily mounted on the health risks of smokeless tobacco use. Gains in production and sales of such products over the past ten years have made it essential that Congress and the Federal Government take action to broaden our knowledge on effects of smokeless tobacco use and to make such knowledge readily available to the public. The apparent popularity of smokeless tobacco among our children and youth make such legislative action particularly crucial.

The various types of smokeless tobacco, such as chewing tobacco and snuff, contain, like tobacco that is smoked, significant levels of nicotine. Nicotine use in the levels found in smokeless tobacco has been associated with a rise in blood pressure, and may increase the risk of addiction. In addition, the use of smokeless tobacco products has been strongly associated with certain alterations in the tissues of the mouth, such as gingival recession (recession of the gums), periodontal bone destruction, and tooth abrasion. Most importantly, perhaps, smokeless tobacco use has been linked to the development of precancerous lesions, such as leukoplakia. Approximately 7 percent of leukoplakia lesions convert to squamous cell carcinomas accounting for roughly 90 percent of all oral cancers.

One study indicates that the risk of developing cancer is four times greater for users of snuff than for nonusers, and approaches 50 times greater for chronic long-term users. Another group has reported research that there may be as many as 700 deaths per year from oral cancer caused by smokeless tobacco use. The Surgeon General of the United States has reported that smokeless tobacco contains the highest amount of certain cancer-causing toxins in a consumer product for oral consumption, and, in a letter to the Federal Trade Commission in December of 1984, stated that "Smokeless tobacco including snuff does indeed pose a cancer threat and is associated as well with certain other pathologic oral conditions."

Until fairly recently, the use of smokeless tobacco in the U.S. had been restricted to a relatively small percentage of the population and had declined in volume of sale and use from the early years of this century. The 1964 Surgeon General's report on smoking and health, which barely mentions smokeless tobacco products, includes a table (page 45) showing consumption of tobacco products

for selected years between 1900 and 1962. The table shows the insignificance of smokeless tobacco use in the early 1960s compared with earlier days. While cigarette consumption had risen from 49 cigarettes per person in 1900 to 3,958 per person in 1962, consumption of chewing tobacco had fallen from 4.10 pounds per person to 0.50 pounds per person during the same period. Consumption of snuff declined slightly from 0.32 pounds per person in 1900 to 0.26 pounds per person in 1962. The decline continued into the 1970s. By 1974 the annual per capita consumption of snuff had dropped to .18 pounds per person.

There has been resurgence in recent years, in the popularity of smokeless tobacco products, particularly snuff. According to Standard and Poor's Industry Survey of April 1985, moist snuff is the fastest-growing product in the entire tobacco industry, with poundage gains of 7 percent in 1984. Annual per capita consumption is back up to .26 pounds for 1983.

One of the sources of concern about the increase in the use of smokeless tobacco products and a major reason for the development of a legislative proposal is the alarming incidence of use by children. Studies have shown that almost 10 percent of high school students regularly use smokeless tobacco products. A recent study of persons who regularly use such products indicated that 88 percent started using smokeless tobacco before the age of 15 and 55 percent started before the age of 13.

Apparently many of these young people are under the mistaken impression that the use of smokeless tobacco carries no significant risk to health. The 1964 Surgeon General's report on cigarettes and health with the subsequent legislation to require warning labels and limit advertising have established a public awareness of the dangers of cigarette smoking. There has been no parallel development of public information on the dangers of smokeless tobacco use. Young people starting to use such products, perhaps as hopeful symbols of maturity, seem to view smokeless tobacco as a safe and healthful alternative to cigarettes. Current packaging and promotional practices, including endorsement by professional athletes, further this mistaken impression.

The significant health risks associated with smokeless tobacco use, the public's seeming lack of awareness about such risks, and the popularity of the product among children and adolescents have led to concern and action on various fronts. A number of national health and professional organizations, such as the American Cancer Society, the American Lung Association, the American Heart Association, the American Dental Association, the American Academy of Otolaryngology, the American Association of Pediatrics, and the American Medical Association, have called for the enactment of legislation to require warning labels on smokeless tobacco products and in advertisements. Massachusetts has required, by executive order, that every package of moist snuff sold in the State after December 1, 1985, carry a warning label. Other States are considering similar action.

Early in 1985, the Health Research Group petitioned the Federal Trade Commission seeking warning label requirements for smokeless tobacco products. To assist in its considerations of the petition, the FTC requested information from the Surgeon General of the