[U.S. Food and Drug
Administration]

SPEECH 10/21/1994

Remarks

by

David A. Kessler, M.D.

Commissioner of Food and Drugs

National Association for the

Advancement of Colored People

Solomon's Island, Maryland

October 21, 1994

NOTE: THIS TEXT IS THE BASIS OF COMMISSIONER KESSLER'S ORAL REMARKS. IT SHOULD BE USED WITH THE UNDERSTANDING THAT SOME MATERIAL MAY HAVE BEEN ADDED OR OMITTED DURING THE PRESENTATION

Good evening.

I'm here tonight to thank you, and to acknowledge an obligation to the NAACP that extends back in time as far as my childhood.

All young people need heroes, and they either arise naturally in our lives, or we are forced to invent them, manufacturing them out of whole cloth to satisfy the need. The lucky ones are those who have the heroic example set before them in real life without the need of invention.

There is no substitute in a young man's eyes for the real, the quiet, and the enduring accomplishments of men and women who are dedicated to a cause.

Reading newspapers and watching television during the 1960s, I observed a nation in conflict with itself, and I quickly learned to identify myself with those who dared to challenge the status quo ante.

I watched the workings of the NAACP, and of other organizations and individuals -- men and women out on the firing line fighting the battles that convulsed our nation at that time, and I learned.

I learned about belief in a goal. I learned about endurance, and the need to sustain one's belief past the glamour stage of ideals and into the prosaic world of day-to-day living. I learned about defeat, how to live with it and how to build. I learned about hope deferred, and about the downward spiral of despair. I learned about anger, just anger in a just cause. I learned about trust, about holding hands with your brothers and sisters, and never letting go.

I learned about evil and the need to confront it, and I learned about the friendly faces that evil can assume at the drop of a hat. I learned to question, always question. I learned to trust my own feelings, and to live with them. I learned to judge other people on merit. I learned to look past a victory to the battles still to come.

I learned that there was more to becoming a man than simply growing up. All this, I learned from you and people like you, and I would like to thank you for it. This, of course, is idealism unrefined, but the word --call it a label if you wish --does not frighten me.

By the time that a man reaches my age he is supposed to have lost the urgency of ideals. Reality is supposed to have dulled the sharp edge of his resolution. He is supposed to be ready to accept second best. For whatever the reason, it hasn't worked that way with me.

I remain an unabashed, but realistic, idealist, and I see nothing contradictory in that combination, and nothing impractical.

By definition, an ideal situation is the best one there is, and an idealist is someone who works to achieve that condition. A practical idealist is someone who goes through life with a dream in one hand, and a compass in the other. Just in case the dream drifts off course. Much of this I learned from you, and I have not forgotten where I learned it.

Aristotle said that man is by nature a social animal whose desire is to live in the company of others, and we know how true this is from our own experiences. We go to schools, we marry, have families, join churches, and club together in discrete bundles that are stabilized, for the most part, only by a morality of our own making.

This morality, this moral glue that binds us together, comes from several sources. It comes from within us, it comes from family teaching, it comes from our religious institutions and our centers of learning, and to a great degree it comes from the governments that we choose to conduct our affairs. The morality that the best of governments has to offer is what defines us as a nation, what makes us different, for better or for worse, from our neighbors on this planet.

And in the United States, the ultimate force of government is not coercion, or the fear of penalty, but the moral persuasion that good government produces. Take away that moral persuasion, that binding glue, and all that is left are the bare bones of the law. And the law, by itself, is never enough. It must always be supported by the conscience of the people, and by a sense of personal responsibility on the part of us all.

We Americans are distinguished by our inventiveness. We are the makers of both tools and toys, weapons and medicines, space ships and snowshoes. We love to tinker, to grapple with nature, to twist its tail and bend it to our will. We are proud of what our hands and our minds create. But all too often we confuse creativity with morality, and we forget that true human progress depends not so much on inventive ingenuity as on how we respond to our personal responsibilities.

I strongly feel that part of my own personal responsibility as the Commissioner of the Food and Drug Administration is to sound the warning about the addictive nature of nicotine in tobacco.

And make no mistake about it....nicotine is addictive. This was carefully documented in the 1988 Surgeon General's report, and you can find nicotine's addictive properties described in numerous scientific papers. The cigarette manufacturers say otherwise. They say that no addiction is involved, and that smokers smoke out of casual choice and a desire for pleasure.

They couch nicotine's effects in euphemisms such as "satisfaction" or "impact" or "strength." But these terms only sidestep the fact that the companies are marketing a powerfully addictive agent. Despite the buzzwords used by industry, what smokers are addicted to is not "rich aroma" or "pleasure" or "satisfaction." They are addicted to nicotine, pure and simple.

Let's define an addictive substance. Definitions vary, but they all embody some key criteria. First, a compulsive use, often despite knowing that the substance is harmful. Second, a psychoactive effect....that is, a direct chemical effect on the brain. Third, what researchers call "reinforcing behavior" that conditions continued use.

In addition, withdrawal symptoms that occur with many drugs also occur with many cigarette smokers who try to quit. These are hallmarks of an addictive substance, and nicotine meets them all. And if you still have any doubts, consider this: Two-thirds of adults who smoke say they wish they could quit. 17 million try to quit each year, but fewer than one out of ten succeed. 3 out of 4 adult smokers say that they are addicted. 8 out of 10 smokers say that they wish they had never started smoking. To smokers who know they are addicted, to those who have buried a loved one who was addicted, it is simply no longer credible to deny the highly addictive nature of nicotine.

Yes, as with any addictive substance, some people can break their addiction to nicotine. But I doubt if there is a person in this room who hasn't either gone to great pains to quit smoking, or watched a friend or relative struggle to extricate himself or herself from a dependence on cigarettes.

Remarkably, we see the grip of nicotine even among patients for whom the dangers of smoking could not be starker. After surgery for lung cancer, almost half of smokers resume smoking. Among smokers who suffer a heart attack, 38 percent resume smoking while they are still in the hospital. Even when a smoker has had his or her larynx removed, 40 percent try smoking again.

Can anyone truly doubt the addictive nature of nicotine? But what about freedom of choice? What about the individual's right to decide? Yes, it is fair to argue that the decision to start smoking should be a matter of free choice, but how long does that choice remain free? Once they have started smoking regularly, most smokers are deprived by their addiction of the choice to stop.

And the saddest part of the addiction is that it starts with our young people, whose decision-making ability is impaired by their youth and inexperience... for a majority of adult smokers begin smoking as teenagers.

Of young people ages 12 - 18 who smoke say, 70 percent that they believe that they are already dependent on cigarettes, while 40 percent of high school seniors who smoke regularly say that they have tried to quit and have failed.

My concern is that the choice that these young people are making quickly becomes no choice at all, and eventually becomes something very difficult to undo for the rest of their lives.

But having said that, I must now point to the marked difference between teenage smoking in the African-American community and teenage smoking in white America.

I promise I'll only show one slide tonight, but I think the results shown on this slide are so dramatic, and so important, that it's worth showing. [slide]

According to the Centers for Disease Control, a survey of high school seniors in 1993 showed that while almost 30 percent of white students were daily smokers, the figure for African-American students was only 5 percent. And this gap is nothing new. Going back to 1976, when the figures for each group were about the same - - between 25 and 30 percent -- the number of white students smoking has shown only a limited yearly decline, while the number of black students smoking has steadily dropped to the present figure. Why has this happened? Frankly, we do not know.

What we do know is that the difference cannot be explained by smoking patterns among high school dropouts, or the substitution of other drug use for cigarettes, or a later initiation of smoking by African Americans, or an under-reporting of smoking status.

It cannot be explained by parental education, by school performance, by personal income, or by geographic region of the country. But even if it cannot be explained, it can certainly be applauded.

This difference in smoking patterns between the two communities becomes even more striking when considered against the background of cigarette advertising that is targeted on African- American neighborhoods.

Ethnic markets for cigarettes today are reached primarily through advertising on billboards, taxi tops, bus shelters, and other "street" media. Traditionally black neighborhoods have a particularly high density of billboards, and a large percentage of these are devoted to tobacco and alcohol ads, significantly higher than for billboards in general.

This intense targeting of African-American neighborhoods has not gone unchallenged. One clergyman in Chicago was motivated to paint over the brand names on many of the 118 billboards within 10 blocks of his school, and similar protests have taken place in New York City. There are even handbooks now available with plans of action to fight against billboards and racial targeting. But there is still much to be done, and for the FDA the question is whether nicotine-containing cigarettes should be regulated as drugs.

Although FDA has long recognized that the nicotine in tobacco produces drug-like effects, we have never stepped in to regulate most tobacco products as drugs because, in the past, we did not have sufficient evidence to show that the cigarette manufacturers intended their product to have a specific effect on the functions of the body. And without that evidence, we were unable to counter the widely-held assumption that the nicotine in cigarettes is present solely because it is a natural and unavoidable component of tobacco.

But we now have cause to reconsider this historical view, for accumulating evidence suggests that the cigarette manufacturers are controlling the choice that smokers make by controlling the levels of nicotine in their product.

If this is so, then it must be the function of the FDA to regulate the use of nicotine in tobacco as a drug. To do anything less would be contrary to the laws under which the FDA operates, and, equally important, to do any less would be a betrayal of my responsibility.

My responsibility also extends to the foods that we eat, to the need for a balanced and nutritious diet. The ability to attain that diet has recently been made easier by the new food labelling regulations that have been promulgated by the FDA. Before those regulations went into effect, purchasing nutritious food for the family was part of a high-stakes guessing game that produced more losers than winners.

Few, if any of us....and I include myself in this category....knew enough about nutrition to decide what properly belonged on the family dinner table. We knew a few facts, some generational wisdom along the lines of an apple a day keeping the doctor away, a mass of questionable folk myths.

But the "Nutrition Facts" label that you now see on products in the grocery store has changed all that. An informed consumer can now shop with confidence, reading the label to determine the calories, the carbohydrates, the fiber, the protein, the vitamins, the fats, the cholesterol, and the salt that he or she is about to toss into the shopping cart.

This is of particular importance to the African-American population, in which diseases, such as hypertension and diabetes run above the national norm. There is no longer a reason for any American to eat poorly because of a lack of information. No reason for any American to put himself or herself at risk because of a self-indulgent diet. No reason for any American to swim outside the mainstream of good nutrition.

Also gone are the extravagant health claims that used to make a stroll down the aisles of a supermarket seem like a tour of the local drugstore. Most of the food producers seem to be acting with a new responsibility, and with our nutrition labels and stringent regulations in place, I can say with confidence that for the first time in the history of this country the consumer holds in his or her own hands the ability to shape the nutritional fate of the family.

But if eternal vigilance is the price of liberty, it is also the price that we must pay to protect the nutritional health of ourselves and our children. For the consumer, that means reading and using the "Nutrition Facts" label as a basis for planning meals. It means cutting down on fats to eat more carbohydrates. It means eating more fiber (my grandmother called it "roughage") in fruits, vegetables, and whole-grain foods. It means keeping your sodium intake low, less than 3,000 mg a day. It means all of that, and more than that.

It means being constantly concerned with what appears on the family table, and it means being constantly aware of what foods give us benefits and what foods pose unacceptable risks. For those of us at FDA, this vigilance takes on an added dimension, for we are responsible for the safety and purity of much of what appears on your supermarket shelves. Our job is to regulate, and 25 cents out of every dollar spent by the American consumer goes for products that are regulated by our agency.

Our regulations touch upon every aspect of American lives, jobs, businesses, and professions, and it is not surprising that we are at times accused of being intrusive, invasive, and even obstructive. And because of this, we are constantly faced with the question: How much do you regulate, and when? The question traces itself back to the days of the Founding Fathers of our country.

The men who gathered in Philadelphia in 1787 to write the Constitution had two purposes in mind. One was to establish a strong central authority, and the other was to prevent that authority from being abused. If men were angels, no government would be necessary, said the 51st Federalist Paper. But government was necessary, then as now, because angels are always in short supply. No one questions the basic premise that, although government can be obstructive and costly, it is also essential.

Yet Americans have always regarded their government with a mixture of reliance and mistrust. It could almost be called the American way. When pollsters ask Americans large and generalized questions...."Do you think that government is too involved in your life?"...."Do you think that government should stop regulating business?" a majority of the people will always vote to get the government off our backs.

But when specific questions are asked...."Are you in favor of Social Security?" ...."How do you feel about Medicare?"...."What about the safety of your food and drugs?"....the same majority will vote for government intervention.

In fact, Americans do not want less government. What they want is a government that can solve problems, is more efficient and more capable of innovation. They want a government whose laws are bound together with the glue of moral persuasion. They want a government on the side of the angels, and it is part of my personal responsibility to see that we do our part.

Thank you.

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