Excerpts of Remarks by Dr. David Kessler, former head of the U.S. Food and Drug Administration, now Dean of the Yale Medical School, speaking on September 8, 1998, to the National Press Club.

What Congress has done this year on tobacco legislation is a national disgrace. This Congress has abdicated its responsibility. And as a result, it has continued to expose tens of thousands of children to a lifelong burden of addiction and many to a premature death.

The last few months have not been a good time for the public health community. But more importantly, it is not has been good for the public health of this country.

The tobacco industry is winning more battles than it is losing. It seems that almost everyone in Washington has been on the tobacco industry's payroll of late -- lawyers, pollsters, lobbyists and advertisers. A minority of senators almost gleefully killed the McCain bill, which had a majority of members supporting it. And the recent round of judicial opinions have favored the tobacco industry.

Am I concerned? No, not really.

Let me tell you why not.

The basic fact is that nothing that has occurred over the past few months can change what we now know.
The scientific evidence today is incontrovertible.

• Where we once saw tobacco products as things that people smoked and chewed for pleasure, we now know that nicotine is an addictive drug.
• Where the industry was once able to argue that smoking is a matter of choice for adults to make, we now know, as the industry has known, that smoking begins in childhood.
• Where we once saw tobacco products as natural agricultural products, we now know that the levels of nicotine in those products have been manipulated to deliver optimal doses of an addictive drug.
• And we now know that for years the tobacco industry has targeted young people.

That's the record. No amount of money, lawyers or lobbyists or advertisers can change that record.

The industry gets indignant at comparisons of nicotine to morphine, cocaine or heroin.

But the science doesn't lie.

• Nicotine's effect on the brain is like any other addictive drug.
• And it's not just that the product is addictive.
  It also kills.

That is why the day of reckoning for the tobacco industry will come -- maybe not this year, maybe not even next, but it will come.

Nicotine is an addictive drug and a deadly product. It is a fact with which we as a country will ultimately confront. And because it is children who are becoming addicted as children, I am convinced that we as a country will deal with this deadly product.

The problem with the settlement was just that: it was a settlement.

• The industry has for years wanted to achieve one thing: to make cigarettes less controversial.
• The industry wanted peace.
• It is wrong to reach a settlement with someone who is selling an addictive drug and a deadly product.

I am actually optimistic.
The way the Congress killed the McCain bill was so blatant that it is hard to believe that they can live with the consequences of their actions.

• One day -- maybe in this Congress, maybe in a future Congress -- a majority leader or speaker of the House will wake up one morning and look himself in the mirror and say that enough is enough.
  
  We have seen it happen with industry whistle-blowers; they live in a world shaped by denial.
  
• One day a leader in Congress will say to himself that it is no longer right for the Congress to come down on the side of the tobacco industry.
  
  I am not holding my breath, but it will happen.
  
  It will happen because a majority leader or a speaker is not going to want to admit that he has fronted, consciously or not, for an industry that has addicted so many.
  
• I am confident that the Fourth Circuit will be reversed.
  
  Respectfully, they got it wrong.
  
  They got it wrong because they didn't recognize one major fact: nicotine is an addictive drug.
  
  The two judges who voted against FDA argued that tobacco products fit the definition of "drug" only mechanistically.
  
  They are wrong -- seriously wrong.
  
  It is as if the decision were written years ago when our knowledge about nicotine's pharmacological activities were kept as top secrets with in the companies, when all the public knew was that cigarettes were smoked for pleasure, or what the cigarette companies called "satisfaction."
  
  Cigarettes are smoked to satisfy an addiction.

The two judges in the Fourth Circuit didn't understand the science.

• They didn't understand the record.
• The record today is there for everyone to see.

The Fourth Circuit also made certain other fatal errors.

• They misconstrued the rules of statutory construction.
• They misinterpreted the holdings of the Supreme Court in the Chevron case.
• Would anyone seriously take the position that each time a new product is synthesized or a new medical device is invented, Congress needs to enact specific legislation governing the regulation of those products? Of course not.

Agencies are assigned general regulatory responsibilities over types of products.

• NISTA has authority over motorized vehicles.
• The FAA has responsibility over any mechanical object that carries people into flight.
• OSHA regulates everything that might pose a threat to workers.
• FDA has responsibility over drugs. No amount of tortured legal reasoning can get around that fact.

As Judge Hall said in the dissent, the administrative record in this case is a perfect illustration of why an agency's opportunity to adopt a new position should remain open.

• The crux of the panel's majority's ruling is that Congress has made it clear that the FDA has no authority over tobacco products.
• Nothing -- nothing in the federal Food, Drug and Cosmetic Act says that.
• Under no rule of statutory construction that I know of can you reach that opinion from the words of the statute.

There is also one other interesting problem with the Fourth Circuit's opinion:
If Congress were unequivocal in saying that FDA doesn't have the authority to regulate tobacco products, why did Congress appropriate millions of dollars to the agency to do so?

To quote Judge Hall:

"Under the facts found by the FDA during the rule-making process, it is now a scientific certainty that nicotine is extremely addictive, and that a large majority of tobacco users use the product to satisfy that addiction."

He went on, and I quote:

"Even more important to my mind is the new evidence that the manufacturers design their products to sustain such addiction."

Our scientific understanding today of nicotine addiction makes it imperative for the FDA to regulate tobacco products.
With absolute certainty I can predict that there will come a time when the Congress finally comes to grips with the terrible toll that nicotine and the deadly carcinogens in cigarettes have had on millions of families.

The tobacco companies may be able to buy vast amounts of influence here in Washington and state capitals around the country. They've proven that they're willing to spend millions of dollars to get what they want. But they can't buy the facts or the science.

• And the science on cigarette carcinogens and nicotine's devastating effect on the brain is incontrovertible fact.
• Science does not wait on politicians or campaign ads or judicial fights or public policy skirmishes.
• And the science on cigarettes and nicotine is unfolding at a pace never seen in this country.

These are facts that the tobacco companies have fought for years -- for decades -- to obscure.

Some in the Congress and the courts have yet to recognize it.

Nicotine is a drug of abuse.

• It is delivered to the body very effectively by the cigarette.
• All that remains to be seen is whether Congress and the courts will let FDA do its job.

With every ounce of energy, Dr. Koop and I are committed to seeing to it, that in the end, the public health will prevail.