Thursday, May 8, 2008

Many Antismoking Aids Are Being Banned by U.S.



No nonprescription smoking deterrent now available has been shown to be effective in helping people quit and new shipments of the products will be prohibited after Dec. 1, the Food and Drug Administration said today.

The agency said the action would affect more than two dozen smoking deterrents sold over the counter as pills, tablets, lozenges and chewing gum under names like Cigarrest, Bantron, Tabmint and Nikoban.

The action, published as a final rule in the June 1 Federal Register, does not affect smoking deterrents available only by a doctor's prescription, including Nicorette, a prescription chewing gum, and nicotine patches.

The agency said the nonprescription products did not present a safety hazard and could be sold until supplies were exhausted, but manufacturers would not be allowed to ship more stock after the deadline. 'Deterrents Have to Work'

"Smoking is one of the nation's leading public health risks, and we favor any safe and effective method for helping people kick the habit," said Dr. David A. Kessler, the head of the agency. "However, to reduce smoking-related illnesses and deaths, smoking deterrents have to work."

The antismoking products involved in the action contain ingredients that have not been proven to deter smoking in controlled tests. Mike Shaffer, an F.D.A. spokesman, said that the agency was unsure exactly how many of the products were on the market and what they contained.

An agency review identified about 20 ingredients that had been used, alone or in combination, in the products, he said, "and there are probably others we don't have on our list." Among the ingredients listed were licorice root extract, menthol, cloves, coriander, eucalyptus oil, ginger, lemon oil, methyl salicylate, lobeline sulfate and silver acetate, he said.

The agency said several manufacturers of nonprescription smoking deterrents had discussed conducting possible clinical trials on lobeline sulfate and silver acetate, two ingredients found in several products. Lobeline sulfate is claimed to help curb the urge for nicotine; silver acetate, taken before smoking, purportedly produces a foul taste in the month when it comes in contact with tobacco. Responses Vary

But the agency said, "Past studies with these and other ingredients have not proven their effectiveness in helping people stop or reduce their smoking."

Judy Berglass, an executive with the DEP Corporation, of Rancho Dominguez, Calif., maker of Bantron, said it was "not a major product for us, only making up one-half of one percent of our total sales." The agency's action "will not have a major effect on the company," she said, adding that it does not advertise or promote Bantron, which lists lobeline sulfate as its main ingredient.

James Stapleton, vice president of Advantage Life Products of Laguna Hills, Calif., maker of Cigarrest, said lobeline sulfate tablets were used as part of its smoking cessation program, which sold with a tape cassette and a manual. "Even if lobeline sulfate by itself may not be effective in making someone stop smoking, it is only a small part of our program, and we feel confident we will find another product to substitute for it."

17 States in Vanguard of War on Smoking (#2)

Prompted in part by the institute's effort, the Centers for Disease Control and Prevention, the Atlanta-based arm of the United States Public Health Service, has announced the award of seed grants for tobacco control to health departments in 20 states, plus the District of Columbia, that are not included in the Assist project. The agency plans to provide funds to the remaining states this year. Congress has awarded the agency $20 million for the fiscal year 1994, which began last month, for this effort, up from just $3 million in 1991.

Dr. Michael Eriksen, who heads the centers' technical assistance program, said, "By 1994, every state in the U.S. will have dedicated tobacco control activities."

In addition, the Robert Wood Johnson Foundation is soliciting applications from public and private organizations for $10 million in grants for tobacco control programs.

The enemy these organizations are battling is a particularly tough and tenacious one. Although for the first time ever there are now more American men who have quit smoking than who still smoke and though the overall smoking rate among adults is now just below 25 percent, more than 43 million American men and women still smoke. And there has been no decline in smoking by teen-agers, with 17 percent of high school seniors now smoking daily.

Dr. Samuel Broder, director of the National Cancer Institute, noted that more than 434,000 Americans die each year, almost 50 people every hour, from smoking-related diseases like cancer, heart and blood-vessel diseases and respiratory disorders. The victims are not just old people. Smoking accounts for more than on-quarter of all deaths among Americans 35 to 64 years old.

An further 50,000 nonsmokers a year are believed to die as a result of environmental exposure to tobacco smoke. A third of all cancer deaths are smoking-related. The North Carolina Assist project put it this way: "The loss of life from smoking in North Carolina equals the death toll if two fully loaded Boeing 737 passenger planes crashed each week in our state, with no survivors."

How, then, to contain the costs of smoking? The studies sponsored by the cancer institute have shown that community-wide approaches work together in keeping youngsters from starting to smoke and enabling adults to quit. These community efforts include everything from public information campaigns to school-based educational programs that "inoculate" youngsters against smoking to professionally run stop-smoking clinics with long-term programs to help people stay away from tobacco.

"If we can keep teen-agers from starting, chances are they will never become smokers." Dr. Marshall said. By 1998, the states participating in the Assist project expect to have research-proven smoking prevention curriculums for all children in kindergarten through 12th grade and to have all public schools designated as smoke-free environments.

Major emphasis will also be placed on stemming illegal sales of tobacco products to minors. In Assist communities, teen-age undercover agents will monitor compliance with the law by acting as buyers, and states that fail to enforce their laws will lose Federal funds.

To help the two-thirds of current adult smokers who want to quit, doctors and other health care professionals will be armed with stop-smoking expertise and sources of referrals to programs with good track records. High Relapse Rate

But quitting itself is not the hardest task. Relapse rates among smokers, especially the hard-core smokers who make up the bulk of adult smokers, are as high as 90 percent. One premise of the Assist project is that the rapidly expanding restrictions on smoking in public places and at work sites are a major key to preventing relapse. Community groups within each state in the Assist project will encourage employers to restrict or ban smoking at work.

Major lobbying efforts will be devoted to raising state tobacco taxes, with a portion of the revenue set aside for smoking control programs. The California experience showed that an increase in prices can produce an immediate decline in tobacco sales, but unless other tactics are then used, sales soon creep back up.

By JANE E. BRODY

17 States in Vanguard of War on Smoking (#1)

WHILE most funerals are somber events, in Portland, Me., residents cheered last Friday as a local funeral director laid to rest a life-size model of Joe Camel, the advertising symbol for Camel cigarettes. The event and others like it around the country marked the start of the largest, most comprehensive effort ever undertaken against smoking.

As the health and other costs related to smoking soar to a projected $68 billion this year and as the social acceptability of tobacco smoke sinks to an all-time low, the National Cancer Institute and the American Cancer Society have begun a five-year, 17-state project intended to attack smoking from every possible angle -- at work, at home and at play -- through schools, health-care settings, community groups, work sites and the mass media.

When the $150 million demonstration project draws to a close in 1998, its organizers expect that the percentage of smokers in participating states will be down at least to half that in the United States as a whole.

The statewide efforts will rely heavily on the cooperation of a variety of community groups and the cancer society's cadre of volunteers. The program, called Assist (for American Stop Smoking Intervention Study for Cancer Prevention), will reach 91 million people, or a third of the population, including about 20 million current smokers. Its ultimate objective, said Dr. John Seffrin, the society's executive vice president, "is to reduce adult smoking to 15 percent or less by the year 2000." The cancer institute expects 4.5 million smokers to quit and 2 million youngsters not to start as a result of the program. Success in California

Directors of the project base their optimism on the success California has had in reducing smoking after some of the money the state raised through a tax increase on cigarettes was used to finance a broad-based smoking control program. In just three years, said Dr. Robert Marshall, who is running the national project, there was a 15-to-20-percent drop in the number of tobacco users in California. In contrast, in the nation as a whole, the decline in smoking each year is usually only one-half of 1 percent to 1 percent.

"Opposition to smoking has gone beyond a trend to become a real movement," Dr. Marshall said in an interview. "Our job is to drive this thing home. Nothing could be more important to health care reform than doing something about the tobacco problem. For more than a decade, we've cut and pasted to try to control smoking. Now at last we've got a dedicated nationally based resource."

The project represents the first significant transfer of public funds for tobacco control to individual states. Thirty-seven states competed for the privilege of participating in the program. The 17 that were chosen include the major tobacco-producing states of North Carolina, Virginia and Indiana, where, agriculture and health officials note, tobacco farmers are getting an ever-shrinking share of what the consumer pays for tobacco.

The other states are Colorado, Maine, Massachusetts, Michigan, Minnesota, Missouri, New Jersey, New Mexico, New York, Rhode Island, South Carolina, Washington, West Virginia and Wisconsin.

Participating states have just completed two years of planning and organizing their resources and assembling antismoking coalitions and are now ready to meet the tobacco industry head on. Although the total monies available, $120 million from the cancer institute and $25 million to $30 million from the cancer society, represent a mere fraction of the $3.9 billion the industry spends each year to promote the use of tobacco, Dr. Marshall believes the project's focused efforts will make a major dent in smoking by Americans.

"Smoking control is an idea whose time has come," Dr. Marshall said in an interview. "We've known for a long time that smoking is the nation's leading preventable cause of premature death and disease. Now a critical mass has built up. There's tremendous public interest and concern over the rise in smoking-related diseases and we have a solid research base on tobacco control developed through about 100 smoking intervention studies that the National Cancer Institute has funded in the last five years, including a communitywide smoking cessation trial conducted in 11 cities throughout the country. Now we're ready to apply what we've learned."

Tips on How to Quit

Below, some tips to help you quit smoking are listed. First and foremost, set a quit date and quit COMPLETELY on that day. To prepare for that day:

  • Identify the times you are most likely to smoke. For example, do you tend to smoke when feeling stressed? When you are out at night with friends? While you are drinking coffee? When you are bored? While you are driving?
  • Keep a diary to help you determine such risky times. Record each time you have a cigarette, including time of day and what you are doing.
  • Make a plan about what you will do instead of smoking at those times that you are most likely to smoke. For example, drink tea instead of coffee -- tea may not trigger the desire for a cigarette. Or, take a walk when feeling stressed. Remove ashtrays and cigarettes from the car. Place pretzels or hard candies there instead. Pretend-smoke with a straw.
  • Let all of your friends, family, and co-workers know of your plan to stop smoking and your quit date. Just being aware that they know can be a helpful reminder and motivator.
  • Prior to your quit date, start reducing your cigarette use, including decreasing the number and strength of the cigarettes. However, DON'T do this simply to make your diary "look good!" Get rid of all of your cigarettes just prior to the quit date and clean out anything that smells like smoke, such as clothes and furniture.

Other tips that can help you quit and stay quit include:

  • Enroll in a smoking cessation program (hospitals, health departments, community centers, and work sites frequently offer programs).
  • Ask your health care provider for advice, including whether prescription medications (such as bupropion -- Zyban or Wellbutrin) are safe and appropriate for you.
  • Find out about nicotine patches, gum, and sprays.
  • Try hypnosis -- it works for some people.
  • Avoid smoke-filled settings and situations in which you are more likely to smoke.
  • Exercise to relieve urges to smoke.

The American Cancer Society is an excellent resource for smokers who are trying to quit, and the Great American Smokeout can serve as a useful catalyst for some smokers.