I am pleased to join you to discuss the implementation of the Family Smoking Prevention and Tobacco Control Act.
It is perhaps fitting that you hear about this historic legislation in a setting like historic Williamsburg.
Let me start by telling you something about myself. Then let’s talk about your products and FDA regulation.
As you heard in my introduction, I have spent the last 30 years working to improve the health of Americans through my work as a physician and through the field of public health.
I trained in and worked in public health well before I became a physician and a researcher.
In graduate public health school, I studied the impact of diseases and behaviors on populations such as tuberculosis in inner cities, schistosmiasis in the Nile delta and lead exposure in infants, as well as tobacco use in the United States.
After receiving my public health degree, I initially worked on Capitol Hill and then continued my work in public health as a member of the Surgeon Generals’ staff in the Ford and then Carter Administrations. I was privileged to work on important public health issues of the day, including clean air, clean water, the health effects of poverty, health manpower issues. Back in 1978, I helped set up the original Office on Smoking and Health in what was then the Department of Health, Education and Welfare.
Later in life, I decided I wanted to become a doctor and went to medical school and completed my internship and residency right at the time when HIV/AIDS was discovered and became a major public health challenge. So in 1987, my medical training started to combine with my public health experience and I went to NIH to train in Infectious Diseases and to conduct AIDS research. I stayed at NIH for about 11 years, during which time I was able to contribute to much of the basic and clinical research that defined HIV and helped test the drugs which we use today to treat people with HIV infection. During this time, I also continued to be an active clinician both at the NIH and Johns Hopkins.
I left NIH in 1998 to join the leadership team of the largest health care system in the country — the one that delivers care to our nation’s Veterans. I became the head of VA’s HIV/AIDS programs at a time when not many people recognized that VA was and is the largest provider of patient care to people with HIV infection. That was a time when VA began its transformation into a modern integrated health care system which has been proven to deliver the highest quality of care in the Nation. Over time I was asked to take on more responsibility and I became VA’s Chief Public Health Officer in 2006. Among my many responsibilities for our nation’s Veterans was to revitalize the VA’s tobacco cessation programs.
On my watch, Veteran’s tobacco use dropped from 33 to 22 percent.
Again, during this time I continued to practice medicine and became a primary care provider to about 100 Veterans at the Washington, D.C. VA Medical Center.
I love helping deliver medical care to Veterans — there is no group of patients more deserving of the best care we can provide. Let me tell you about one of my patients. I’ll call him Mr. Smith*. I met Mr. Smith in about 1999 and I was his primary care provider. Mr. Smith proudly served in the infantry in Vietnam. He was injured on his 2nd tour of duty, nearly died on the battlefield but was medivac-ed out, and after a long recovery from his wounds, he returned to civilian life.
Vietnam scarred Mr. Smith both physically and mentally. He suffered from PTSD from the horrors of war and his injuries. He began to use drugs and became infected with HIV. His years using drugs also scarred his kidneys so when we first met, Mr. Smith had AIDS, kidney failure — and he was on dialysis.
Mr. Smith entered VA’s drug recovery programs and, because of his determination and the good care he got from VA, he was successfully able to quit using drugs. His HIV infection had hurt his immune system but fortunately, with effective drug treatment, his immune system recovered and his overall health improved.
Despite needing to go to dialysis three times a week Mr. Smith held a job and cared for his family. He was so clinically stable that we began preparing Mr. Smith for a kidney transplant. One of the important criteria to be eligible for transplant is to be drug and tobacco free. He was drug free and although I had encouraged him to quit smoking for many years, the prospect of being free of dialysis gave him even more motivation — so we had been working on helping him quit smoking.
While we prepared to get him on the transplant waiting list, we tried many approaches to help him quit smoking. Mr. Smith was really having a hard time. But he was determined. He told me many times something I have heard over the years from many patients — how much harder it was to quit smoking than it was to quit shooting heroin.
Then around Thanksgiving, he began to lose weight, he developed a cough and a chest X ray showed a mass in his right lung which on biopsy was lung cancer. Other X-rays showed the lung cancer had spread to his bones.
So, the battlefields of Vietnam didn’t kill him. He came home.
His drug use didn’t kill him - he recovered from that.
His HIV didn’t kill him - his treatments restored his immune system.
His kidney failure didn’t kill him and was being treated.
And Mr. Smith had the possibility of a transplant and a normal life without dialysis.
But for this tough, resilient, determined infantry soldier NONE of that took him out.
Mr. Smith died in January — it was his battle with smoking that finally took out this brave soldier.
So after Commissioner Hamburg asked me to take this job and during the first months I’ve been on the job, I’ve often thought about Mr. Smith and other patients like him. I recognized that this was an opportunity to serve my country by helping to prevent our men, women and children from suffering and dying from tobacco-related disease.
I took this job so there are fewer kids who start to use tobacco. I took this job so fewer families devastated by the early death of a loved one. And I took this job because the public health mandate of the Family Smoking Prevention and Tobacco Control Act is so promising with respect to helping reduce the toll of disease, disability and death caused by tobacco use in this country.
I have been on the job nine months now. I have had a chance to take stock of the status of tobacco use in the United States, and let me give you a quick glimpse of what I see.
I see that more than 400,000 Americans still die unnecessarily each year from diseases related to using tobacco products.
I see that another 8.6 million Americans have at least one serious illness due to smoking.
I see the 50,000 non-smokers who die each year from exposures attributed to second-hand smoke.
I see that between 20 to 25 percent of American high school students still use tobacco.
I see that 4,000 kids start smoking every single day — and 1,000 of them become regular users.
I see that many of these kids will become addicted before they are old enough to understand the risks and will ultimately die too young from diseases directly linked to their tobacco use — lung disease, heart disease and stroke and cancers of the lung, mouth, larynx, esophagus and bladder.
I also see that these kids who are smokers aren’t rummaging around through mom’s purse looking for a stray cigarette. Many are addicted and have product loyalties as pronounced as any adult.
You’re in the tobacco business — you know these choices don’t happen by accident. Recent data show that 43 percent of youth smokers actually prefer one brand of cigarette, Marlboro. In fact, according to CDC, 81 percent of underage smokers preferred the three most heavily advertised brands: Marlboro, Newport, and Camel.
I also see that even today, many smokers falsely believe that terms like “Light” or “Low Tar” mean that those products are less harmful than full flavored cigarettes. Of course, we know that is not true because no data exists that prove the decades of engineering and marketing of products called ‘light’ ‘low’ and ‘mild’ are safer than any other cigarettes. In fact, it has actually been shown because of smokers’ now-proven misperceptions that those products actually reduce motivation to quit tobacco use and keep people smoking longer.
I also see that as states and communities are enacting more indoor clean air laws and increase taxes particularly on cigarettes, new types of tobacco products are being developed. Some of these new products appear, taste like and may be confused for candy by kids.
I see my job at FDA is to address this enormous toll of confusion, suffering, and death caused by the current state of tobacco use in this country.
And frankly, we have a long way to go.
And if we can’t make significant progress, I have failed in my job.
So now let me turn to what we intend to do with this new law at FDA to protect public health.
As I recently wrote in the New England Journal of Medicine with the FDA’s Commissioner and Principal Deputy, the FDA’s public health approach to tobacco regulation has four key elements:
- reducing the rate of initiation of tobacco use,
- educating the public,
- applying regulatory science to the control of tobacco products, and
- engaging actively with public health partners and industry.
Reducing Initiation: The most effective way to reduce the harm is to deter use altogether. Stopping addiction before it starts is a key initial priority for FDA. FDA’s first efforts will focus on restricting the marketing and illegal sales of tobacco products to youth and setting initial standards for additives that facilitate youth use.
We will do so by implementing requirements of the law which places restrictions on marketing and promotion to kids such as setting a national minimum age of 18 for purchases and a minimum pack size of 20 cigarettes, banning free cigarette samples and restricting free smokeless samples, eliminating the brand-name sponsorship of sporting events and concerts and establishing a national enforcement system with States and Territories to deter underage tobacco purchases.
We will do so by regulation of tobacco products themselves. Effective September 22, 2009, FDA banned cigarettes with fruit, candy, and other characterizing flavors. Congress authorized this ban because of clear evidence that these flavors act to encourage youth experimentation, regular use, and addiction.
FDA is also examining the role of menthol flavoring in tobacco use by young people and its specific impact on racial and ethnic minorities. And FDA also has the authority to act on tobacco products other than cigarettes or smokeless tobacco that may lead to addiction and tobacco use by young people.
Educating the Public: Most Americans know generally that tobacco is harmful, l but few know the key facts of how damaging tobacco is to their own health and the health of those around them. In the Tobacco Control Act, Congress gave FDA the tools to educate the public about the actual ingredients and constituents in tobacco products and the profound consequences of exposure to them.
The law also requires FDA to enforce truth in advertising. As I said before, even today, many smokers falsely believe that terms like “Light” or “Low Tar” indicate that those products are less harmful than other cigarettes. To correct false impressions about the safety of these and other tobacco products, the law requires that tobacco products that use the terms “light,” “low,” and “mild,” on labels or in advertising can no longer be manufactured after June 22nd without FDA approval.
In addition, under the new law tobacco manufacturers must submit detailed lists of ingredients and constituents to FDA as well as documents and data regarding their safety. This material will enable FDA to publish lists of potentially harmful constituents in tobacco products and their smoke, as required by the new law.
The law also requires FDA to propose new graphic pack warning labels comprising 50 percent of the front and back of each cigarette pack and box and start a new system of health warnings for smokeless tobacco products.
FDA also has the authority to request information and studies conducted by tobacco manufacturers on any topic.
Applying Regulatory Science: There exists a substantial scientific base for each of the areas in which the FDA has been empowered to act. FDA will build on this base to guide key decisions in tobacco regulation.
A major area of focus is in the approval of “modified risk” products. We expect companies to seek approval for products that have “fewer carcinogens” or are “less toxic.” In setting standards for approval of these products, FDA is well aware of the public health calamity of “light” and “low” cigarettes that I have mentioned.
The law says that in reviewing applications regarding “modified risk” products, the FDA must be presented with sufficient data to understand the health impact on users and non-users as well as the appeal to young people, who might begin a lifetime of tobacco use. To assist, FDA may request and tobacco companies must provide this data with their applications as well as conduct strict post-market surveillance to verify that the products are reducing tobacco-related morbidity and mortality.
Importantly, the new law sets new public health product standard for FDA’s tobacco product regulations which is more appropriate than FDA’s traditional, ‘safe and effective’ standard. One of FDA’s most powerful tools is the setting of product standards across a class of tobacco products to reduce addictiveness or harm.
Let me end with a few words about the relationship between FDA and industry.
We at FDA understand that it is never easy for an industry to submit to new regulation. The tobacco industry poses special challenges, and speaking frankly, the industry has a long history of resistance to government action.
And, you may realistically perceive the Tobacco Control Act as a serious threat to the tobacco industry’s long-term interests.
Yet I realize that successful implementation of this law will require engaging the various components of the tobacco industry directly, fairly, and transparently. The design of effective regulatory measures must be based on an understanding of the industry to be regulated. For example, input from a wide variety of tobacco companies helped us in establishing a system for industry registration and listing of tobacco products and industry feedback is important to improvements we intend to make in those systems.
While we are a new part of FDA, we have already established a Small Business Assistance Office, a Call Center to field questions and a Web site which adds new information almost every day. We’ve held listening sessions with industry representatives, distributors and others and we are organizing a series of moderated discussions throughout the country over the next 18 months.
And I want you to know that understanding and engaging with the tobacco industry is important. That is why I am here today.
That’s also why I asked Les Weinstein to join me at this meeting. Les is the Center for Tobacco Products Ombudsman. His job is to help resolve regulatory confusion and problems so that this law can be implemented fairly.
I also asked some other members of my staff to come here, too. Perhaps they could stand up. Unlike me, they didn’t come here to give a speech — they came to listen.
When I was preparing for this meeting, I realized that as representatives of different parts of the tobacco industry, you each face a choice of walking one of two paths with FDA.
One path is confrontational, to try to block FDA at every turn in implementing this law.
To those on such a path, I can only point out that FDA regulation of tobacco products is the result of a law which passed overwhelmingly by Congress and signed by the President. It is the law and the FDA has the authority to bring advisory, administrative,or judicial actions, including, for those who ignore the law issuing warning letters, seizures, injunctions, civil money penalties and criminal prosecutions.
And FDA will not hesitate to take these steps when warranted by the facts.
But there is the other path too. And that path is based on the recognition that the people of the United States expect us to use this law to protect their families and the public health.
I hope you will see value of helping FDA to understand the tobacco industry, and that you will participate in the regulatory process and then comply with the FDA’s policies to reduce the devastating harm that tobacco causes for millions of American families.
In my career, I have witnessed what happens when we apply science to public health challenges. In the case of HIV, through the application of science, what was once a uniformly fatal infectious disease is now largely a manageable chronic condition.
It is my hope that tobacco will become another example of how the application of excellence in science will have a major impact on the public health.
Thank you for your attention.
Dr. Lawrence Deyton, Fda.go