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FDA Proposals Would Not Reduce Youth Smoking

FDA proposals would not reduce youth smoking A look beyond the headlines... recent trends in youth smoking The FDA has used misleading claims of a dramatic rise in youth smoking to win favor for its proposal to regulate tobacco. In particular, the FDA focused. on data from a "Monitoring the Future" study sponsored by the National Institirte on Drug Abuse (NIDA) that reported a 30 percent rise between 1991-1994 in the number of 8th graders who had experimented with one or more cigarettes in the previous 30 days. NIDA notes that 18.6 percent of eighth graders tried at least one cigarette within a 30 day period in 1994, compared to 14.3 percent in 1991. This uptick is cause for concern, but is it really the beginning of an upward spiral? Doubtfiil. With these figures, FDA alarmists provide only a small snapshat of the overall situation. And since NIDA has only tracked 8th grade use since 1991, it is unclear what the long- term trends are for the group. Long-term trends show decreased smoking NIDA has tracked a more significant group for an extended period of time: 12th graders. For twenty years NIDA has surveyed 12th graders on smoking use and attitudes about smoking. The long term is promising. Since 1975, when N][DA began surveying high school seniors, the percentage of dai)y smoking among that group has plunged 39 percent. Heavy smoking among high school seniors - defined as at least a half-pack a day - has dropped even more significantly - 60 percent since, 1975. Not only have the rates of smoking fallen sharply, but 12th graders' attitudes about smoking have changed dramatically. In 1994, 32 percent more 12th graders described smoking as a "great risk" than did in 1975. And 70 percent of high school seniors in 1994 disapproved of adults smoking a pack of cigarettes or more per day. NIDA survey shows startling rise in illicit drug use Lost during the attack on tobacco is the fact that the NIDA survey reported an explosion in the use of marijuana and other illicit drugs among teenagers. The percentage of 8th graders using marijuana at least once in the last 30 days jumped 144 percent between

1991-1994. Moreover, only 58 percent percent of high school seniors disapproved of marijuana use in 1994; only 19.5 percent perceived it to be a "great risk." And while the NIDA study's chief investigator has been quick to accuse tobacco advertising of driving up the prevalence of youth smoking and changing attitudes about smoking, that argument looks specious in light of the illicit drug; data. Clearly there are no billboards, print ads, or event sponsorships provided by illegal drug purveyors. Yet the growth in the use and acceptability of illegal drugs among high school students dwarfs that of tobacco. Broad social issues are involved The results of these surveys raise broad social issues that go fa; beyond tobacco, as the data on illegal drugs illustrate. When Secretary of Health and Human Services Donna Shalala released the data on illegal drug use and attitudes in December 1994, she also issued a call to action: "The real work has to be done in our communities and in our homes - with parents leadin tg_he way °" That call to action sh:)uld also apply to teenage tobacco use. In discussing the incredibly low smoking rates and unpopularity of cigarettes among black youths, Michael Ericksen, director of the Office on Smoking and Health at the U.S. Centers for Disease Control and Prevention, echoes Secretary Shalala's words. Trying to explain the source of the "success story," Ericksen does not &,te a federal regulation, but states, "It evolved out of the black communitv." (Washington Post, 8/20/95) The idea that attitudes about smoking are strongly affected by those around us is nothing new. For years behavior experts and most anti-tobacco advo:ates have understood that it is not advertising and vending machines that get kids to start smoking, but the influence of friends and family. As Mortimer B. Lipsett, M.D., Director of the National Institute of Child Health and Human Development testified before Congress in 1983, "The most forceful determinants of smoking [by young people] are parents, peers, and older siblin s." There is general agreement that families and local communilies are the places best equipped to address youth smoking. So why drag in the FD A and the regulatory baggage it brings? The statistics are clear. As the NIDA surveys have shown over their 20 year history, youth smoking rates have declined significantly over time - without FDA regulation. Let's not get into the business of trampling First Amendment rights, economically injuring retailers, advertisers, and publishers, or infringing the ability of 50 million Americans to use a legal product, by giving unelected bureaucrats a job that is better accomplished by parents and friends within their own communities.

hn Daily Smoking Prevalence Among 12th Graders Over the past 20 years, daily smoking prevalence among 12th graders has dropped 39%. 29% 27% 25% 23% ld' 19% 17% 15% V4ee4zs9 Source: The Monitoring the Future Study, the University of MI. Sponsored by the National Institute on Drug Abuse.

Rise in Substance Use By 8th Graders Between 1991-1994* While much has been made about the 1991-1994 uptick in teenage smoking rates, it is illustrative to note that the same survey shows dramatic increases in illicit drug use. Allllticit Marijuarra Dnigs Smoking ao N ~ *Percentage increase in number of 8th graders who experimented with illicit drugs, ~ marijuana, or cigarettes within the last 30 days. For cigarettes, use is defined as at least I one cigarette in the previous 30 clays. Source: The Monitoring the Future Study, the University of MI. Sponsored by the National Institute on Drug Abuse.

FDA advertising restrictions wi ll not affect youth smoking rates The advertising provisions of the FDA's proposal, based on the false premise that tobacco advertising causes youth smoking, will not affect youth smokinl; rates. Why kids begin smoking is a complex issue that involves a variety of cultural and sociological factors. The overwhelming evidence suggests the influence of parents and peers - not advertising - is the most important determinant in the decision to begin sm oking. Nearly three- quarters of respondents to a 1993 Gallup survey cited peer pressure and family influences as the major factors affecting the decision to smoke. Advertising was not listed at all. Tobacco critics have acknowledged the lack of a connection be,tween tobacco advertising and smoking initiation. Former U.S. Surgeon General C. Ever,tt Koop, in the 1989 Surgeon General's Report explained, "There is no scientifically rigorous study available to the public that provides a definitive answer to the basic question whether advertising and promotion #ncrease the level of tobacco consumption." And former U.S. Federal Trade Commission Chairman and to!)acco foe Michael Pertschuck, at a 1983 Harvard University seminar, stated, "[n]o one really pretends that advertising is a major determinant of smoking in this country or any other." The international experience bears this out. While tobacco acls are restricted or banned in several countries, these controls have Pad little or no effect on youth smoking rates. In fact, in 1987, University of Helsinki (Finland) researchers discovered that smoking rates among juveniles increased after a complete ban on tobacco advertising was implemented in 1978. Interestingly, the smoking rates for this age group h?,d been declining before the ban was adopted. Sweden saw similar reversals in the early a980's after severe tobacco advertising restrictions were imposed in 1979. Norway, which completely banned tobacco advertising in 1975, has a higher percentage of youth smokers than the United States. A 1987 study publi.shed in the Journal of the Norwegian Medical Association indicates that the ban has had little noticeable effect on incidence of smoking in that country. And a 1986 study by 1he Children's Research Unit found that Hong Kong and Spain - countries with only minor advertising restrictions -- had a significantly smaller proportion of regular smokers between the ages of 11-15 thanm Norway. W N .1 The evidence is clear: there is simply no significant connection between advertising CJ and the decision to start smoking. Q~

Cigarette manufacturers have long addressed concerns about youth :smoking and cigarette advertising and promotion Cigarette manufacturers oppose youth smoking. The industry has a long history of efforts to discourage youth smoking and to address related concerns about cigarette advertising and promotion. As early as 1963, cigarette manufacturers ended advertising and promotion in college publications and on campuses. The code was revised in 1964 to include restrictions on advertising and promotion in publications directed primarily to persons under 21. The code also forbids the use of testimonials by sports or celebrity figures and requires models in ads to be, or to appear to be, at least 25 years old. In 1981, the tobacco industry adopted a code of cigarette sampling practices. It included provisions to refuse to give samples to anyone known to be wider 21 years of age or who, without reasonable identification, appears to be less than 21 years old. No sampling was -done in any public place within two blocks of centers of youth activities such as playgrounds or schools. In 1990, the cigarette manufacturers strengthened the adverti:;ing and promotion code to include provisions to strictly limit the distribution of product samples; prohibit billboards advertising cigarettes within 500 feet of schools and playgroimds; eliminate paid movie product or cigarette advertising placements in movies produc ed for the general public; and place strict limitations on the distribution of non-tobacco premium items. ~ Cigarette manufacturers and The Tobacco Institute, on the industry's behalf, have implemented since the early 1980s a range of voluntary programs with the goal to discourage youth smoking. The efforts include education arid awareness programs for retailers to bolster compliance with minimum age laws, as vrell as outreach to parents and educators to help young people develop skills to deal with peer pressure issues. To date, more than 2.4 million pieces of the industry's "It's the Law" retail compliance program materials have been distributed to retailers. Parents, teachers and other interested adults have requested more than 353,000 cor ies of "Tobacco: Helping Youth Say No," a parental guide on dealing with peer pressure. In 1990, the industry pledged support for raising the minimum age for the sale of cigarettes to 19 in those states with no minimum age or one; lower than 18. Today, those laws are on the books in every states and the District of Columbia. The tobacco industry supports rigorous enforcement of those laws.

The Department of Health and Human Services (HHS), however, has yet to finalize regulations dealing with youth access issues. The rules, implem,-.nting 1992 legislation passed by Congress, require the states to enforce laws prohibiting the sale of tobacco to minors. The draft rules included provisions addressing retail lic,.-nsing, vending machines and annual inspections of retail outlets. The Clinton Administration has now sat on these rules for more than two years. The foot-dragging comes from the White House and its bureaucrats. Meanwhile, the tobacco industry has worked at the state level to meet the HHS/Synar amendment goals in the states. j

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~ ~...,..~ gC,t~gS A-U, An FDA Smoke Screen By Roemrr Gouffec David Kessler is Washington's latest Comeback Kid. Less than a month ago. the Food and Drug Administration was backpedaling, pledBing to reinvent itself- to farm out activities that private agencies could do faster and more effectively, and to eliminate regulations that add nothing to the public health. Today, the FDA is back in business wtth more swagger and certainty of mission than ever because of its crusade against tobacco, particuiaFly as it relates to children's healtti. But protecting the health of children may not be the only consideration in the FDA's new campaign to regulate tobacco. Surely the FDA and its allies in Congress and the White House realize how effec- tively an imminent threat to the public can renew the leverage of an agency many Re- publicans are trying to eliminate. About 35 years ago, another "imminent crisis" helped the FDA solidity its power within Washington's politicized regulatory net- work. The now legendary 1962 FDA intercep- tion of thalidomide before it reached the U.S. market allowed the agency to assert increasingly broad control over every as- pect of medical progress. As is weU known. thalidomide was a sleeping pill that caused birth defects when taken by several thou- sand pregnant women in Europe. We now take for granted that but for the diligence of the FDA. American babies would have suffered the same horrible fate. In fact, ac- cording to an account written by econo- mist Joseph D. Cooper (which appeared as an essay in the book "Regulating New Drugs." University of Chicago Press, 1972): "thalidomide had been blocked for non-relevant reasons Isimply because of bureaucratic slothl. and was actually mov- ing toward approval when the drug com- pany itself reported the terrible news." It took the FDA more than four months to realize that many, many people were still at risk. But even that comprehension was provided from the outside by Dr. He- len Taussig of Johns Hopkins University. More months. passed before the FDA moved with dispatch, this time with the aid and insistence of President Kennedy. Months after the en- tire matter had been reported. Sen. Estes Kefauver and his staff, along with the FDA, contrived to dramatize the cata- strophe through the medium of the press as a means of secur- ing passage of legisla- tion eivin¢ the FDA Damd Kessler pharmaceutical in- dustry. The tactic worked. The world was at last shocked into action, the legislation passed, new heroes were manufactured. Ironically, the powers Congress gave the agency in 1962 had nothing to do with drug safety. Instead, the Kefauver amend- ments totoe FDA's charter allowed the agency to hold up drugs it thought could not do what companies claimed. And since that time, the FDA has undermined the public health with capricious decisions and arbitrary delays without any offsetting safety benefits. For 30 years, by invoking its legendary defense of public safety in the thalidomide case. the FDA has sat on or rejected drugs for depression, schizo- phrenia, kidney cancer and epilepsy- not because they were unsafe, but because in the final analysis the agency didn't think the drug was so important or effective. Tobacco is today's thalidomide, allow- ing the FDA to "reinvent" itself as the only thing standing between our children and certain danger. In fact, there was no need to expand the FDA's authority to protect pregnant women from taking thalidomide: alert consumerism and a community of re- searchers made the public aware of that danger. SimilaHy, the percentage of smok- ers has declined dramatically since 1971. Even if tobacco companies are spiking cig- arettes to keep people hooked, public in- formation on smoking's link to cancer and Its declining acceptability has changed public behavior. As with thalidomide, the FDA is riding to the rescue well after Americans found other means to protect their health. The tobacco issue has allowed the FDA to rise, thalidomide-like, from the ashes and regain its regulatory roost. Legisla- tive efforts to reform the agency are likely to stall. The FDA's reputation is enhanced enough that President Clinton thinks his re-election chances will be helped by iden- tifying himself with the agency's initiative to regulate a whole new industry. No doubt we would save more lives by reducing the FDA's control over medical progress than we will by getting the agency into the reg- ulation of cigarettes. When the FDA has to choose between sustaining its political power or protecting the public health. it will invariably invoke the latter to protect the fotmer. not the other way around. .tifr. Goldberg is a senior research telfou• at Brandeis Gnit'erstty's Gordon Public Pol- icy Center.