[Congressional Record Volume 148, Number 79 (Friday, June 14, 2002)]
[Senate]
[Pages S5597-S5613]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. KENNEDY (for himself, Mr. DeWine, Mr. Harkin, Mr. McCain, 
        Mr. Durbin, Mr.

[[Page S5598]]

        Graham, Mr. Wellstone, Ms. Collins, Mrs. Feinstein, and Mr. 
        Reed):
  S. 2626. A bill to protect the public health by providing the Food 
and Drug Administration with certain authority to regulate tobacco 
products; to the Committee on Health, Education, Labor, and Pensions.
  Mr. DeWINE. Madam President, today Senator Kennedy, my colleague from 
Massachusetts, and I, Senator Durbin, and others are introducing a bill 
designed to help protect children from the dangers of tobacco. Quite 
simply, our bill would finally give the Food and Drug Administration 
the authority it needs to effectively regulate both the manufacture and 
the sale of tobacco products.
  My colleagues will all remember that we visited this issue a few 
years ago, in 1998, when our colleague from Arizona, Senator McCain, 
and others introduced the Universal Tobacco Settlement Act, which 
included a major section that provided the FDA with the authority to 
regulate tobacco products. Also, of course, during 1998, 46 States 
entered into an agreement known as the Master Settlement Agreement, 
MSA. They entered into that agreement with the major tobacco companies 
to settle all State lawsuits seeking to recover the Medicaid costs of 
treating smokers.
  Fast forward from 1998 until today. Tobacco proponents would have you 
believe this master settlement resolved the issue of tobacco use by 
imposing all these restrictions. But the truth is, it did not. Smoking 
among young people remains a huge national problem.
  Every day in this country, nearly 5,000 young people under the age of 
18 try their first cigarette. In my own home State of Ohio, 33 
percent--one-third--of children 18 and under smoke. These kids in Ohio, 
by themselves, go through 45 million packs of cigarettes each year.
  If that is not bad enough, look at it another way: 90 percent of 
smokers start smoking before the age of 19. More than 6.4 million 
children across this country will die prematurely because of a decision 
they will make as children, as adolescents--a decision to start smoking 
cigarettes.
  In my home State of Ohio, as I indicated, one-third of the children 
smoke. We know the statistics are that one-third of people who smoke in 
this country will die prematurely because of an alcohol-related 
illness. One-third of the one-third, therefore, in the State of Ohio 
will die prematurely.
  While States have limited options available for tobacco advertising 
under this 1998 Master Settlement Agreement, the reality is that the 
tobacco companies still are able to choose the contents of their 
advertisements. They are still able to get around this settlement. They 
are still able to run ads like this: ``Skol, A Pinch Better.'' Guess 
where that ad ran? In Sports Illustrated.
  How many young people in this country every week wait for that Sports 
Illustrated to come in the mail, or buy it when it comes to the store?
  The companies are savvy. They have really changed their marketing 
strategies. They have concentrated more money into different 
advertising markets. As a result, more than 3 years after the major 
tobacco companies agreed to stop marketing to children as part of this 
tobacco settlement, children are still twice as likely as adults to be 
exposed to tobacco advertising.
  Let me repeat that. Children are still twice as likely as adults to 
be exposed to tobacco advertising.
  This chart shows and represents a poll which was done. The question 
asked was: Have you seen any advertising for cigarettes or tobacco in 
the last 2 weeks? Among teens, 64 percent said yes; adults, only 27 
percent.
  In spite of the claim that tobacco companies are not targeting 
children, for whatever reason that is the market that is hearing it; 
that is who is seeing the message; that is who is hearing the message; 
that is whom the message is affecting.
  According to the Federal Trade Commission's annual report on 
cigarette sales and advertising, the year 2000 represented the largest 
increase ever in tobacco companies' spending on ``promotional 
allowances''; that is, the money tobacco companies pay retailers to 
promote their products in prominent locations in stores, or for high 
visible shelf space. We know that is one of the greatest marketing 
techniques--put it somewhere I can see it when I walk in the store. It 
is right at eye level for kids near the cash register, in an aisle 
where the customer must walk by to pay the cashier.
  That same year--the year 2000--cigarette manufacturers spent a record 
$9.5 billion on advertising and promotion. That is an increase of 16 
percent from the year 1999.
  Tobacco companies also spend billions of dollars advertising through 
enticing promotional items--lighters, hats, and other products--they 
give away for free at the ``point of sale,'' or, in other words, at the 
cash register or the place of checkout in the grocery store or the 
convenience store.
  In fact, spending on such promotional or value-added items increased 
by 37 percent between 1999 and the year 2000.
  Let us not fool ourselves. These promotional strategies and 
advertisements reach our children. Statistics show that 75 percent of 
our children visit a convenience store at least once a week.
  I ask my colleagues. The next time you walk into a convenience store, 
look at how many different times you see an advertisement for tobacco 
products. They are everywhere. You walk in the store, and it may be on 
the clock--a little promotional clock that says when the store is open 
and when the store is closed. They will be at eye level. They will be 
by the cashier when you check out. They will be everywhere--image after 
image after image. It is calculated, and it works. Convenience stores 
are a place--right or wrong--where kids go. Seventy-five percent of 
kids visit convenience stores, as I said, at least once a week. That is 
a target area.

  This isn't just about advertising and marketing schemes. It is also 
about to be manufacturers' failure to disclose the specific ingredients 
in their products.
  I realize full well that tobacco users and nonusers alike recognize 
and understand that tobacco products are hazardous to their health. 
Everybody knows that. That is not what I am talking about. I am talking 
about requiring the tobacco companies to list the ingredients in their 
products. They do not have to do that today. Tobacco is an unregulated 
product. I believe it makes common sense that tobacco companies should 
be required to list when they put arsenic--and they do--or put 
formaldehyde or ammonia in the cigarettes. They should have to at least 
list it. It just makes common sense. Yet the law today does not require 
them to do that.
  While simply listing the ingredients, toxic as they may be, might not 
seem like much, think about it this way. Current law makes sure that we 
know what is in products designed to help people quit smoking--products 
such as the patch or the Nicorette gum, which are regulated, but not 
the very product that gets people addicted in the first place, the 
cigarettes. Doesn't that seem absurd?
  Think about it this way: Right now, the Food and Drug Administration 
requires Philip Morris to print the ingredients in its Kraft Macaroni 
and Cheese. They have to print all of the ingredients. Pick up a box. 
Every single ingredient that is in there they have to print but not the 
ingredients in cigarettes, a product, by the way, that contributes to 
the deaths of more than 440,000 people a year.
  Right now the FDA requires Philip Morris, which owns Nabisco, to 
print the ingredients contained in Oreo cookies and Ritz crackers but 
not the ingredients in Camel or Winston cigarettes, even though 
cigarettes cause one-third of all cancer deaths and 90 percent of lung 
cancer deaths. It is unfathomable to me--and I think it is unfathomable 
to everybody--that we would require the listing of ingredients on these 
products. We even require the listing of the ingredients on bottled 
water. Yet we do not require the listing of ingredients for one of the 
leading causes of death and disease in this country.
  Right now, the FDA requires printed ingredients for chewing gum, 
lipstick, bottled water, and ice cream, but not for cigarettes--a 
product that causes 20 percent of all heart disease deaths, 90 percent 
of lung cancer, which is the leading cause of cancer deaths among 
women, and the leading cause of preventable death in the United States.
  Another way to look at it is if a company wants to market a food 
product

[[Page S5599]]

as ``fat-free'' or ``reduced-fat'' or ``lite,'' that company is 
required to meet certain standards regarding the number of calories or 
the amount of fat grams in that product. You can look right on that 
package and find it. Yet cigarette companies can call a cigarette a 
``Camel Light'' or a ``Marlboro Light'' and not reveal a thing about 
the amount of tar or nicotine or arsenic in that supposedly ``light'' 
cigarette.
  Not having access to all of the information about this deadly product 
just makes no sense. It is something we need to change. With the bill 
we are introducing, we can change it.
  It is time we finally give the FDA the authority it needs to fix 
these problems. The legislation that Senator Kennedy and Senator Durbin 
and I are introducing will do just that.
  First, the bill would make changes regarding tobacco advertising. It 
would give the FDA authority to restrict tobacco industry marketing--
consistent with the first amendment--that targets our children.
  Additionally, our bill would require advertisements to be in black 
and white text only, unless they are in adult publications, and would 
define adult publications in terms of readership.
  Next, our legislation would give consumers more information about the 
ingredients in tobacco products. Specifically, the bill would provide 
the FDA with the ability to publish the ingredients of tobacco 
products.
  It would require a listing of all ingredients, substances, and 
compounds added by the manufacturer to the tobacco, to the paper, or to 
the filter.
  It would require a description of the content, delivery, and form of 
nicotine in each tobacco product.
  It would require information on the health, behavioral, or 
physiologic effects of the tobacco products.
  Further, it would require tobacco companies to provide information on 
the reduction of risk to health available through technology.
  And finally, it would establish an approval process for all new 
tobacco products entering the market--new products such as advance with 
its ``trionic filter'', which claims to have--and I quote--``all of the 
taste . . . less of the toxins'' of other cigarettes.
  Obviously, we already know that smoking is a health risk. We all know 
that. But, what we don't know about is the harm caused by or what 
adverse health effects are created by the other ingredients in tobacco 
products or by how the tobacco is burned. We do not know all the 
details about that. Tobacco companies should share that. There are 
tobacco products on the market that are not conventional cigarettes. 
They have carbon filters running down the center of them. They are 
sophisticated products that burn tobacco differently, that affect the 
body differently, and that may cause people to smoke them differently. 
These are all things that should be examined, they should be reviewed, 
and they should be commented on by the Food and Drug Administration, so 
the public knows what they are choosing to consume.
  Here we have a pack of Eclipse cigarettes, which claims it will--and 
I quote--``Change the way you smoke.'' It also claims that it--and 
again I quote--``may present less risk of cancer, bronchitis, and 
possibly emphysema.'' This is what they say in the bold print. I don't 
know who ``they'' are, and I don't know where they got their 
information, but the public should know.
  Below the bold print in this same pack is the following, smaller 
print:

       Evidence suggests that smokers who already have 
     cardiovascular disease and who switch to Eclipse may further 
     increase their health risk.

  So in the bold print we have a statement that is not cited and not 
supported, and then in the fine print we have a statement that is 
supported by numerous studies. Which claim are you more likely to 
believe? And which statement should be broadcast in bold lettering to 
the consumer?
  By introducing this bill, we are finally saying we are not going to 
let tobacco manufacturers have free rein over markets and consumers 
anymore.
  Today, we are taking a step towards making sure the public gets 
adequate information about whether to continue to smoke or even to 
start smoking in the first place. We all know it is dangerous. But the 
tobacco companies no longer should be able to hide all the facts.
  With this bill, we are not just saying, ``Buyer beware''--we all know 
there are dangers--but what we are saying is, ``Tobacco companies, be 
honest.'' We are saying, ``Tobacco companies, stop marketing to our 
kids.'' We are saying, ``Tobacco companies, tell consumers about what 
they are really buying.''
  Madam President, it is time we hold these companies to the same 
standards we expect from other producers. It is time to give kids a 
fighting chance when it comes to resisting cigarettes. It is time to 
finally just do the right thing.
  I thank the Chair and yield the floor.
  The PRESIDING OFFICER. The Senator from Massachusetts is recognized.
  Mr. KENNEDY. Madam President, I join my friend and colleague from 
Ohio, Senator DeWine, in expressing our appreciation to all of our 
cosponsors for this legislation that we have introduced. And I commend 
him for the excellent presentation and description of the legislation 
that he has just given to the Senate this morning.
  We indicate to our friends and colleagues that this legislation is 
very similar to the legislation that was included in the larger tobacco 
legislation the Senate considered several years ago. It was not really 
subject to any amendments that I remember during that period of time. 
That overall legislation, I believe, gained 58 votes on the floor of 
the Senate. So we had broad support for the legislation. In many 
respects, I think there is even broader support for this particular 
legislation.
  So we are very hopeful we will be able to make progress in 
considering this legislation favorably in the Senate, and in the House, 
and have it become law. We have every intention of holding hearings 
and, hopefully a markup in July. I believe we will have very broad 
support from our colleagues for the reasons Senator DeWine has 
outlined.
  This legislation is focused on children and what we can do to 
discourage children from becoming addicted to tobacco in this country. 
I will just take a very few moments to review the highlights.
  Just very quickly, every day, 5,000 children try their first 
cigarette. More than 2,000 become new daily smokers. A third will die 
prematurely.
  If the current trend continues, 6.4 million children, who are under 
18 years of age, will die prematurely from smoking related illness. 
400,000 people a year die from smoke related illness. We are telling 
the youth of America their lives are going to be greatly shortened as a 
result of this kind of addiction.

  As I mentioned, 400,000 Americans die each year from smoke-caused 
disease, and tobacco costs $75 billion in annual health care costs. 
These are costs that are spent by Medicare, Medicaid, veterans 
hospitals, and expended privately.
  Again, to give the focus of where the advertising is going, this 
chart shows the number of teens between 12 and 17 who were reached five 
or more times by tobacco advertising in the year 1999.
  A March 2002 study asked teenagers and adults, ``have you seen any 
advertising for cigarettes or spit tobacco in the last 2 weeks?'' For 
the teenagers, 64 percent had seen advertising; while for adults, just 
27 percent.
  What we are maintaining is that the industry is targeting children. 
These are commercial surveys, and they substantiate our point.
  The money that is being expended for these extraordinary advertising 
budgets is targeted to teenagers, to effectively hook them and addict 
them.
  This chart shows the very substantial increase in promotional 
expenditures from 1997 to the year 2000. As the chart showed, 
expenditures totaled $5.660 billion in 1997 and increased to $9.5 
billion in the year 2000.
  Over the last 5 years, it has virtually doubled. Where is it being 
targeted? The children. Are the children seeing it? Yes. Are they 
becoming more addicted? Yes. Is this really a national problem? Yes. 
Can we do something about it? Yes. Will this legislation do something 
about it? Yes, because it incorporates many of the recommendations made 
by former heads of the FDA as well as from the many experts we have 
heard from at a range of hearings we have held.

[[Page S5600]]

  The bottom line: If smoking rates do not decline, over 6 million 
children who are alive today under the age of 18 will suffer premature 
death.
  This is a matter of enormous importance. It is of importance to 
families, to parents, to children, and to our country. We have 
targeted, responsible legislation to deal with this issue. We are 
serious about presenting it to the Senate, which we will do. We are 
looking for broad support from the American people.
  We are grateful for all of the public health agencies that support 
it: cancer, heart, lung, all of the various health-related agencies 
that support this legislation. They are going to be strong allies.
  Mr. Myers, who is with Tobacco Free Children, has done such an 
extraordinary job and has made this a high priority. We are serious 
about it, and we hope to be able to help the families in this country 
by doing something about children being addicted to cigarettes.
  This bill will give the Food and Drug Administration broad authority 
to regulate tobacco products for the protection of the public health. 
We cannot in good conscience allow the federal agency most responsible 
for protecting the public health to remain powerless to deal with the 
enormous risks of tobacco, the most deadly of all consumer products.
  The provisions in this bill closely track those in the bipartisan 
compromise reached during Senate consideration of comprehensive tobacco 
control legislation in 1998. Fifty-eight Senators supported it at that 
time. That legislation was never enacted because of disputes over 
tobacco taxation and litigation, not over FDA authority.
  This FDA provision is a fair and balanced approach to FDA regulation. 
It creates a new section in FDA jurisdiction for the regulation of 
tobacco products, with standards that allow for consideration of the 
unique issues raised by tobacco use. It is sensitive to the concerns of 
tobacco farmers, small businesses, and nicotine-dependent smokers. But, 
it clearly gives FDA the authority it needs in order to prevent youth 
smoking and to reduce addiction to this highly lethal product.
  I believe that any attempt to weaken the 1998 language would 
undermine the FDA's ability to deal effectively with the enormous 
health risks posed by smoking. This concern is shared by a number of 
independent public health experts. The bipartisan compromise agreed to 
in 1998 is still the best opportunity for Senators to come together and 
grant FDA the regulatory authority it needs to substantially reduce the 
number of children who start smoking and to help addicted smokers quit. 
Nothing less will do the job.
  The stakes are vast. Five thousand children have their first 
cigarette every day, and two thousand of them become daily smokers. 
Nearly a thousand of them will die prematurely from tobacco-induced 
diseases. Smoking is the number one preventable cause of death in the 
nation today. Cigarettes kill well over four hundred thousand Americans 
each year. That is more lives lost than from automobile accidents, 
alcohol abuse, illegal drugs, AIDS, murder, suicide, and fires 
combined. Our response to a public health problem of this magnitude 
must consist of more than half-way measures.
  We must deal firmly with tobacco company marketing practices that 
target children and mislead the public. The Food and Drug 
Administration needs broad authority to regulate the sale, 
distribution, and advertising of cigarettes and smokeless tobacco.
  The tobacco industry currently spends over nine billion dollars a 
year to promote its products. Much of that money is spent in ways 
designed to tempt children to start smoking, before they are mature 
enough to appreciate the enormity of the health risk. The industry 
knows that more than 90 percent of smokers begin as children and are 
addicted by the time they reach adulthood.
  Documents obtained from tobacco companies prove, in the companies' 
own words, the magnitude of the industry's efforts to trap children 
into dependency on their deadly product. Recent studies by the 
Institute of Medicine and the Centers for Disease Control show the 
substantial role of industry advertising in decisions by young people 
to use tobacco products. If we are serious about reducing youth 
smoking, FDA must have the power to prevent industry advertising 
designed to appeal to children wherever it will be seen by children. 
This legislation will give FDA the ability to stop tobacco advertising 
which glamorizes smoking from appearing where it will be seen by 
significant numbers of children.
  FDA authority must also extend to the sale of tobacco products. 
Nearly every state makes it illegal to sell cigarettes to children 
under 18, but surveys show that those laws are rarely enforced and 
frequently violated. FDA must have the power to limit the sale of 
cigarettes to face-to-face transactions in which the age of the 
purchaser can be verified by identification. This means an end to self-
service displays and vending machine sales. There must also be serious 
enforcement efforts with real penalties for those caught selling 
tobacco products to children. This is the only way to ensure that 
children under 18 are not able to buy cigarettes.
  The FDA conducted the longest rulemaking proceeding in its history, 
studying which regulations would most effectively reduce the number of 
children who smoke. Seven hundred thousand public comments were 
received in the course of that rulemaking. At the conclusion of its 
proceeding, the Agency promulgated rules on the manner in which 
cigarettes are advertised and sold. Due to litigation, most of those 
regulations were never implemented. If we are serious about curbing 
youth smoking as much as possible, as soon as possible; it makes no 
sense to require FDA to reinvent the wheel by conducting a new multi-
year rulemaking process on the same issues. This legislation will give 
the youth access and advertising restrictions already developed by FDA 
the immediate force of law, as if they had been issued under the new 
statute.
  The legislation also provides for stronger warnings on all cigarette 
and smokeless tobacco packages, and in all print advertisements. These 
warnings will be more explicit in their description of the medical 
problems which can result from tobacco use. The FDA is given the 
authority to change the text of these warning labels periodically, to 
keep their impact strong.
  Nicotine in cigarettes is highly addictive. Medical experts say that 
it is as addictive as heroin or cocaine. Yet for decades, tobacco 
companies have vehemently denied the addictiveness of their products. 
No one can forget the parade of tobacco executives who testified under 
oath before Congress as recently as 1994 that smoking cigarettes is not 
addictive. Overwhelming evidence in industry documents obtained through 
the discovery process proves that the companies not only knew of this 
addictiveness for decades, but actually relied on it as the basis for 
their marketing strategy. As we now know, cigarette manufacturers 
chemically manipulated the nicotine in their products to make it even 
more addictive.

  The tobacco industry has a long, dishonorable history of providing 
misleading information about the health consequences of smoking. These 
companies have repeatedly sought to characterize their products as far 
less hazardous than they are. They made minor innovations in product 
design seem far more significant for the health of the user than they 
actually were. It is essential that FDA have clear and unambiguous 
authority to prevent such misrepresentations in the future. The largest 
disinformation campaign in the history of the corporate world must end.
  Given the addictiveness of tobacco products, it is essential that the 
FDA regulate them for the protection of the public health. Over forty 
million Americans are currently addicted to cigarettes. No responsible 
public health official believes that cigarettes should be banned. A ban 
would leave forty million people without a way to satisfy their drug 
dependency. FDA should be able to take the necessary steps to help 
addicted smokers overcome their addiction, and to make the product less 
toxic for smokers who are unable or unwilling to stop. To do so, FDA 
must have the authority to reduce or remove hazardous ingredients from 
cigarettes, to the extent that it becomes scientifically feasible. The 
inherent risk in smoking should not be unnecessarily compounded.

[[Page S5601]]

  Recent statements by several tobacco companies make clear that they 
plan to develop what they characterize as ``reduced risk'' cigarettes. 
This legislation will require manufacturers to submit such ``reduced 
risk'' products to the FDA for analysis before they can be marketed. No 
health-related claims will be permitted until they have been verified 
to the FDA's satisfaction. These safeguards are essential to prevent 
deceptive industry marketing campaigns, which could lull the public 
into a false sense of health safety.
  Smoking is the number one preventable cause of death in America. 
Congress must vest FDA not only with the responsibility for regulating 
tobacco products, but with full authority to do the job effectively.
  This legislation will give the FDA the legal authority it needs: To 
reduce youth smoking by preventing tobacco advertising which targets 
children; to prevent the sale of tobacco products to minors; to help 
smokers overcome their addiction; to make tobacco products less toxic 
for those who continue to use them; and to prevent the tobacco industry 
from misleading the public about the dangers of smoking.
  We cannot allow the tobacco industry to stop us from doing what we 
know is right for America's children. I intend to do all I can to see 
that Congress enacts this legislation this year. The public health 
demands it.
  Mrs. FEINSTEIN. Mr. President, I rise today with Senators Kennedy and 
DeWine in support of legislation to empower the Food and Drug 
Administration, FDA, to regulate tobacco products.
  During my time in the Senate, I have become very involved with 
cancer. I am the Co-Chair of the Senate Cancer Caucus and the Vice-
Chair of the National Dialogue on Cancer, which is Chaired by former 
President and Barbara Bush.
  The cancer community is united in the belief that the single most 
important preventive measure is to place tobacco products under the 
regulatory control of the FDA. I stand behind the cancer community and 
express the same belief.
  Smoking causes one-third of all cancers, and is the cause of 
approximately 165,000 deaths annually.
  I firmly believe that cancer cannot be conquered without addressing 
smoking and the use of tobacco products.
  Smoking results in death or disability for over half of tobacco 
users, according to the Centers for Disease Control, CDC. Smoking costs 
the health care system over $70 billion annually.
  Over the past two decades, we have learned that tobacco companies 
have manipulated the level of nicotine in cigarettes to increase the 
number of people addicted to their product.
  There are more than 40 chemicals in tobacco smoke that cause cancer 
in humans and animals, according to the CDC. Tobacco smoke has toxic 
components, as well as tar, carbon monoxide and other dangerous 
additives.
  It is long past time to reduce the addictive nature of cigarettes and 
curtail the marketing of these products to young people. I believe that 
empowering the FDA to regulate tobacco will help do that.
  The U.S. Surgeon General and the Centers for Disease Control and 
Prevention have unequivocally demonstrated that, for example, anti-
smoking campaigns can reduce smoking, a major cause of cancer.
  California is a good example: My state started an aggressive tobacco 
control program in 1989 and throughout the 1990s, tobacco use dropped 
at two to three times faster than the rest of the country.
  Ninety percent of adult smokers begin before age 18 and every day, 
3,000 young people become smokers.
  This bill will provide meaningful regulation by the Food and Drug 
Administration of the content and marketing of tobacco products, 
especially the addicting and carcinogenic components.
  Dr. C. Everett Koop, former US Surgeon General, and Dr. David 
Kessler, former Commissioner of the Food and Drug Administration, in 
1997 report, cited FDA and other studies and said:

       Nicotine in cigarettes and smokeless tobacco has the same 
     pharmacological effects as other drugs that FDA has 
     traditionally regulated . . . nicotine is extremely addictive 
     . . . and the vast majority of people who use nicotine-
     containing cigarettes and smokeless tobacco do so to satisfy 
     their craving for the pharmacological effects of nicotine; 
     that is, to satisfy their drug-dependence or addiction.

  They go to recommend that the ``FDA should continue to have authority 
to regulate all areas of nicotine, as well as other constituents and 
ingredients, and that authority should be made completely explicit.''
  I am pleased that to note that even the Philip Morris Companies has 
acknowledged the need for FDA to regulate tobacco. On their website, 
they say:

       We believe federal legislation that includes granting FDA 
     authority to regulate tobacco products could effectively 
     address many of the complex tobacco issues that concern the 
     public, the public health community and us.

  It is long past time to reduce the addictive nature of cigarettes and 
curtail the marketing of these products to young people. This bill 
gives FDA the power to regulate tobacco products' content, design, 
sale, and marketing.
  I ask unanimous consent that the text of the bill be printed in the 
Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                S. 2626

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

       (a) Short Title.--This Act may be cited as the ``Youth 
     Smoking Prevention and Public Health Protection Act''.
       (b) Table of Contents.--The table of contents of this Act 
     is as follows:

Sec. 1. Short title.
Sec. 2. Findings.
Sec. 3. Purpose.
Sec. 4. Scope and effect.

         TITLE I--AUTHORITY OF THE FOOD AND DRUG ADMINISTRATION

Sec. 101. Amendment of Federal Food, Drug, and Cosmetic Act.

                     ``CHAPTER IX--TOBACCO PRODUCTS

``Sec. 900. Definitions.
``Sec. 901. FDA authority over tobacco products
``Sec. 902. Adulterated tobacco products.
``Sec. 903. Misbranded tobacco products.
``Sec. 904. Submission of health information to the Secretary.
``Sec. 905. Annual registration.
``Sec. 906. General provisions respecting control of tobacco products.
``Sec. 907. Performance standards.
``Sec. 908. Notification and other remedies
``Sec. 909. Records and reports on tobacco products.
``Sec. 910. Premarket review of certain tobacco products.
``Sec. 911. Judicial review.
``Sec. 912. Postmarket surveillance
``Sec. 913. Reduced risk tobacco products.
``Sec. 914. Equal treatment of retail outlets.
``Sec. 915. Jurisdiction of and coordination with the Federal Trade 
              Commission.
``Sec. 916. Congressional review provisions.
``Sec. 917. Regulation requirement.
``Sec. 918. Preservation of State and local authority.
``Sec. 919. Tobacco Products Scientific Advisory Committee.
Sec. 102. Construction of current regulations.
Sec. 103. Conforming and other amendments to general provisions.

  TITLE II--TOBACCO PRODUCT WARNINGS AND SMOKE CONSTITUENT DISCLOSURE

Sec. 201. Cigarette label and advertising warnings.
Sec. 202. Authority to revise cigarette warning label Statements.
Sec. 203. Smokeless tobacco labels and advertising warnings.
Sec. 204. Authority to revise smokeless tobacco product warning label 
              Statements.
Sec. 205. Tar, nicotine, and other smoke constituent disclosure to the 
              public.
Sec. 206. Unlawful advertisements.

     SEC. 2. FINDINGS.

       The Congress finds the following:
       (1) The use of tobacco products by the Nation's children is 
     a pediatric disease of epic and worsening proportions that 
     results in new generations of tobacco-dependent children and 
     adults.
       (2) A consensus exists within the scientific and medical 
     communities that tobacco products are inherently dangerous 
     and cause cancer, heart disease, and other serious adverse 
     health effects.
       (3) Nicotine is an addictive drug.
       (4) Virtually all new users of tobacco products are under 
     the minimum legal age to purchase such products.
       (5) Tobacco advertising and marketing contribute 
     significantly to the use of nicotine-containing tobacco 
     products by adolescents.
       (6) Because past efforts to restrict advertising and 
     marketing of tobacco products have failed adequately to curb 
     tobacco use

[[Page S5602]]

     by adolescents, comprehensive restrictions on the sale, 
     promotion, and distribution of such products are needed.
       (7) Federal and State governments have lacked the legal and 
     regulatory authority and resources they need to address 
     comprehensively the public health and societal problems 
     caused by the use of tobacco products.
       (8) Federal and State public health officials, the public 
     health community, and the public at large recognize that the 
     tobacco industry should be subject to ongoing oversight.
       (9) Under Article I, Section 8 of the Constitution, the 
     Congress is vested with the responsibility for regulating 
     interstate commerce and commerce with Indian tribes.
       (10) The sale, distribution, marketing, advertising, and 
     use of tobacco products are activities in and substantially 
     affecting interstate commerce because they are sold, 
     marketed, advertised, and distributed in interstate commerce 
     on a nationwide basis, and have a substantial effect on the 
     Nation's economy.
       (11) The sale, distribution, marketing, advertising, and 
     use of such products substantially affect interstate commerce 
     through the health care and other costs attributable to the 
     use of tobacco products.
       (12) It is in the public interest for Congress to enact 
     legislation that provides the Food and Drug Administration 
     with the authority to regulate tobacco products. The benefits 
     to the American people from enacting such legislation would 
     be significant in human and economic terms.
       (13) Tobacco use is the foremost preventable cause of 
     premature death in America. It causes over 400,000 deaths in 
     the United States each year.
       (14) Reducing the use of tobacco by minors by 50 percent 
     would prevent well over 10,000,000 of today's children from 
     becoming regular, daily smokers, saving over 3,000,000 of 
     them from premature death due to tobacco induced disease. 
     Such a reduction in youth smoking would also result in 
     approximately $110,000,000,000 in savings attributable to 
     reduced health care costs.
       (15) Advertising, marketing, and promotion of tobacco 
     products have been especially directed to attract young 
     persons to use tobacco products and these efforts have 
     resulted in increased use of such products by youth. Past 
     efforts to oversee these activities have not been successful 
     in adequately preventing such increased use.
       (16) In 1999, the tobacco industry spent close to 
     $8,240,000,000 to attract new users, retain current users, 
     increase current consumption, and generate favorable long-
     term attitudes toward smoking and tobacco use.
       (17) Tobacco product advertising often misleadingly 
     portrays the use of tobacco as socially acceptable and 
     healthful to minors.
       (18) Tobacco product advertising is regularly seen by 
     persons under the age of 18, and persons under the age of 18 
     are regularly exposed to tobacco product promotional efforts.
       (19) Through advertisements during and sponsorship of 
     sporting events, tobacco has become strongly associated with 
     sports and has become portrayed as an integral part of sports 
     and the healthy lifestyle associated with rigorous sporting 
     activity.
       (20) Children are exposed to substantial and unavoidable 
     tobacco advertising that leads to favorable beliefs about 
     tobacco use, plays a role in leading young people to 
     overestimate the prevalence of tobacco use, and increases the 
     number of young people who begin to use tobacco.
       (21) The use of tobacco products in motion pictures and 
     other mass media glamorizes its use for young people and 
     encourages them to use tobacco products.
       (22) Tobacco advertising expands the size of the tobacco 
     market by increasing consumption of tobacco products 
     including tobacco use by young people.
       (23) Children are more influenced by tobacco advertising 
     than adults, they smoke the most advertised brands, and 
     children as young as 3 to 6 years old can recognize a 
     character associated with smoking at the same rate as they 
     recognize cartoons and fast food characters.
       (24) Tobacco company documents indicate that young people 
     are an important and often crucial segment of the tobacco 
     market.
       (25) Comprehensive advertising restrictions will have a 
     positive effect on the smoking rates of young people.
       (26) Restrictions on advertising are necessary to prevent 
     unrestricted tobacco advertising from undermining legislation 
     prohibiting access to young people and providing for 
     education about tobacco use.
       (27) International experience shows that advertising 
     regulations that are stringent and comprehensive have a 
     greater impact on overall tobacco use and young people's use 
     than weaker or less comprehensive ones.
       (28) Text-only requirements, while not as stringent as a 
     ban, will help reduce underage use of tobacco products while 
     preserving the informational function of advertising.
       (29) It is in the public interest for Congress to adopt 
     legislation to address the public health crisis created by 
     actions of the tobacco industry.
       (30) The final regulations promulgated by the Secretary of 
     Health and Human Services in the August 28, 1996, issue of 
     the Federal Register (62 Fed. Reg. 44615-44618) for inclusion 
     as part 897 of title 21, Code of Federal Regulations, are 
     consistent with the standards set forth in the amendments 
     made by this Act for the regulation of tobacco products by 
     the Food and Drug Administration and the restriction on the 
     sale and distribution, including access to and the 
     advertising and promotion of, tobacco products contained in 
     such regulations are substantially related to accomplishing 
     the public health goals of this Act.
       (31) The regulations described in paragraph (30) will 
     directly and materially advance the Federal Government's 
     substantial interest in reducing the number of children and 
     adolescents who use cigarettes and smokeless tobacco and in 
     preventing the life-threatening health consequences 
     associated with tobacco use. An overwhelming majority of 
     Americans who use tobacco products begin using such products 
     while they are minors and become addicted to the nicotine in 
     those product before reaching the age of 18. Tobacco 
     advertising and promotion plays a crucial role in the 
     decision of these minors to begin using tobacco products. 
     Less restrictive and less comprehensive approaches have not 
     and will not be effective in reducing the problems addressed 
     by such regulations. The reasonable restrictions on the 
     advertising and promotion of tobacco products contained in 
     such regulations will lead to a significant decrease in the 
     number of minors using and becoming addicted to those 
     products.
       (32) The regulations described in paragraph (30) impose no 
     more extensive restrictions on communication by tobacco 
     manufacturers and sellers than are necessary to reduce the 
     number of children and adolescents who use cigarettes and 
     smokeless tobacco and to prevent the life-threatening health 
     consequences associated with tobacco use. Such regulations 
     are narrowly tailored to restrict those advertising and 
     promotional practices which are most likely to be seen or 
     heard by youth and most likely to entice them into tobacco 
     use, while affording tobacco manufacturers and sellers ample 
     opportunity to convey information about their products to 
     adult consumers.

     SEC. 3. PURPOSE.

       The purposes of this Act are--
       (1) to provide authority to the Food and Drug 
     Administration to regulate tobacco products under the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), by 
     recognizing it as the primary Federal regulatory authority 
     with respect to the manufacture, marketing, and distribution 
     of tobacco products;
       (2) to ensure that the Food and Drug Administration has the 
     authority to address issues of particular concern to public 
     health officials, especially the use of tobacco by young 
     people and dependence on tobacco;
       (3) to authorize the Food and Drug Administration to set 
     national standards controlling the manufacture of tobacco 
     products and the identity, public disclosure, and amount of 
     ingredients used in such products;
       (4) to provide new and flexible enforcement authority to 
     ensure that there is effective oversight of the tobacco 
     industry's efforts to develop and introduce less harmful 
     tobacco products;
       (5) to vest the Food and Drug Administration with the 
     authority to regulate the levels of tar, nicotine, and other 
     harmful components of tobacco products;
       (6) in order to ensure that adults are better informed, to 
     require tobacco product manufacturers to disclose research 
     which has not previously been made available, as well as 
     research generated in the future, relating to the health and 
     dependency effects or safety of tobacco products;
       (7) to continue to permit the sale of tobacco products to 
     adults in conjunction with measures to ensure that they are 
     not sold or accessible to underage purchasers; and
       (8) to impose appropriate regulatory controls on the 
     tobacco industry

     SEC. 4. SCOPE AND EFFECT.

       (a) Intended Effect.--Nothing in this Act (or an amendment 
     made by this Act) shall be construed to--
       (1) establish a precedent with regard to any other 
     industry, situation, circumstance, or legal action; or
       (2) affect any action pending in State, Tribal, or Federal 
     court, or any agreement, consent decree, or contract of any 
     kind.
       (b) Agricultural Activities.--The provisions of this Act 
     (or an amendment made by this Act) which authorize the 
     Secretary to take certain actions with regard to tobacco and 
     tobacco products shall not be construed to affect any 
     authority of the Secretary of Agriculture under existing law 
     regarding the growing, cultivation, or curing of raw tobacco.

         TITLE I--AUTHORITY OF THE FOOD AND DRUG ADMINISTRATION

     SEC. 101. AMENDMENT OF FEDERAL FOOD, DRUG, AND COSMETIC ACT.

       (a) Definition of Tobacco Products.--Section 201 of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is 
     amended by adding at the end the following:
       ``(kk) The term `tobacco product' means any product made or 
     derived from tobacco that is intended for human consumption, 
     including any component, part, or accessory of a tobacco 
     product (except for raw materials other than tobacco used in 
     manufacturing a component, part, or accessory of a tobacco 
     product).''.
       (b) FDA Authority Over Tobacco Products.--The Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is amended--
       (1) by redesignating chapter IX as chapter X;
       (2) by redesignating sections 901 through 907 as sections 
     1001 through 1007; and

[[Page S5603]]

       (3) by inserting after section 803 the following:

                     ``CHAPTER IX--TOBACCO PRODUCTS

     ``SEC. 900. DEFINITIONS.

       ``In this chapter:
       ``(1) Brand.--The term `brand' means a variety of tobacco 
     product distinguished by the tobacco used, tar content, 
     nicotine content, flavoring used, size, filtration, or 
     packaging, logo, registered trademark or brand name, 
     identifiable pattern of colors, or any combination of such 
     attributes.
       ``(2) Cigarette.--The term `cigarette' has the meaning 
     given that term by section 3(1) of the Federal Cigarette 
     Labeling and Advertising Act (15 U.S.C. 1332(1)), but also 
     includes tobacco, in any form, that is functional in the 
     product, which, because of its appearance, the type of 
     tobacco used in the filler, or its packaging and labeling, is 
     likely to be offered to, or purchased by, consumers as a 
     cigarette or as roll-your-own tobacco.
       ``(3) Cigarette tobacco.--The term `cigarette tobacco' 
     means any product that consists of loose tobacco that is 
     intended for use by consumers in a cigarette. Unless 
     otherwise stated, the requirements for cigarettes shall also 
     apply to cigarette tobacco.
       ``(4) Commerce.--The term `commerce' has the meaning given 
     that term by section 3(2) of the Federal Cigarette Labeling 
     and Advertising Act (15 U.S.C. 1332(2)).
       ``(5) Distributor.--The term `distributor' as regards a 
     tobacco product means any person who furthers the 
     distribution of cigarette or smokeless tobacco, whether 
     domestic or imported, at any point from the original place of 
     manufacture to the person who sells or distributes the 
     product to individuals for personal consumption. Common 
     carriers are not considered distributors for purposes of this 
     chapter.
       ``(6) Indian tribe.--The term `Indian tribe' has the 
     meaning given such term in section 4(e) of the Indian Self 
     Determination and Education Assistance Act (25 U.S.C. 
     450b(e)).
       ``(7) Little cigar.--The term `little cigar' has the 
     meaning given that term by section 3(7) of the Federal 
     Cigarette Labeling and Advertising Act (15 U.S.C. 1332(7)).
       ``(8) Nicotine.--The term `nicotine' means the chemical 
     substance named 3-(1-Methyl-2-pyrrolidinyl) pyridine or 
     C[10]H[14]N[2], including any salt or complex of nicotine.
       ``(9) Package.--The term `package' means a pack, box, 
     carton, or container of any kind or, if no other container, 
     any wrapping (including cellophane), in which cigarettes or 
     smokeless tobacco are offered for sale, sold, or otherwise 
     distributed to consumers.
       ``(10) Retailer.--The term `retailer' means any person who 
     sells cigarettes or smokeless tobacco to individuals for 
     personal consumption, or who operates a facility where self-
     service displays of tobacco products are permitted.
       ``(11) Roll-your-own tobacco.--The term `roll-your-own 
     tobacco' means any tobacco which, because of its appearance, 
     type, packaging, or labeling, is suitable for use and likely 
     to be offered to, or purchased by, consumers as tobacco for 
     making cigarettes.
       ``(12) Smokeless tobacco.--The term `smokeless tobacco' 
     means any product that consists of cut, ground, powdered, or 
     leaf tobacco and that is intended to be placed in the oral or 
     nasal cavity.
       ``(13) State.--The term `State' means any State of the 
     United States and, for purposes of this chapter, includes the 
     District of Columbia, the Commonwealth of Puerto Rico, Guam, 
     the Virgin Islands, American Samoa, Wake Island, Midway 
     Islands, Kingman Reef, Johnston Atoll, the Northern Mariana 
     Islands, and any other trust territory or possession of the 
     United States.
       ``(14) Tobacco product manufacturer.--Term `tobacco product 
     manufacturer' means any person, including any repacker or 
     relabeler, who--
       ``(A) manufactures, fabricates, assembles, processes, or 
     labels a finished cigarette or smokeless tobacco product; or
       ``(B) imports a finished cigarette or smokeless tobacco 
     product for sale or distribution in the United States.
       ``(15) United states.--The term `United States' means the 
     50 States of the United States of America and the District of 
     Columbia, the Commonwealth of Puerto Rico, Guam, the Virgin 
     Islands, American Samoa, Wake Island, Midway Islands, Kingman 
     Reef, Johnston Atoll, the Northern Mariana Islands, and any 
     other trust territory or possession of the United States.

     ``SEC. 901. FDA AUTHORITY OVER TOBACCO PRODUCTS.

        ``(a) In General.--Tobacco products shall be regulated by 
     the Secretary under this chapter and shall not be subject to 
     the provisions of chapter V, unless--
       ``(1) such products are intended for use in the diagnosis, 
     cure, mitigation, treatment, or prevention of disease (within 
     the meaning of section 201(g)(1)(B) or section 201(h)(2)); or
       ``(2) a health claim is made for such products under 
     section 201(g)(1)(C) or 201(h)(3).
       ``(b) Applicability.--This chapter shall apply to all 
     tobacco products subject to the regulations referred to in 
     section 102 of the Youth Smoking Prevention and Public Health 
     Protection Act, and to any other tobacco products that the 
     Secretary by regulation deems to be subject to this chapter.
       ``(c) Scope.--
       ``(1) In general.--Nothing in this chapter, or any policy 
     issued or regulation promulgated thereunder, or the Youth 
     Smoking Prevention and Public Health Protection Act, shall be 
     construed to affect the Secretary's authority over, or the 
     regulation of, products under this Act that are not tobacco 
     products under chapter V or any other chapter.
       ``(2) Tobacco leaf.--
       ``(A) In general.--The provisions of this chapter shall not 
     apply to tobacco leaf that is not in the possession of the 
     manufacturer, or to the producers of tobacco leaf, including 
     tobacco growers, tobacco warehouses, and tobacco grower 
     cooperatives, nor shall any employee of the Food and Drug 
     Administration have any authority to enter onto a farm owned 
     by a producer of tobacco leaf without the written consent of 
     such producer.
       ``(B) Exception.--Notwithstanding any other provision of 
     this subparagraph, if a producer of tobacco leaf is also a 
     tobacco product manufacturer or controlled by a tobacco 
     product manufacturer, the producer shall be subject to this 
     chapter in the producer's capacity as a manufacturer.
       ``(C) Rule of construction.--Nothing in this chapter shall 
     be construed to grant the Secretary authority to promulgate 
     regulations on any matter that involves the production of 
     tobacco leaf or a producer thereof, other than activities by 
     a manufacturer affecting production. For purposes of the 
     preceding sentence, the term `controlled by' means a member 
     of the same controlled group of corporations as that term is 
     used in section 52(a) of the Internal Revenue Code of 1986, 
     or under common control within the meaning of the regulations 
     promulgated under section 52(b) of such Code.

     ``SEC. 902. ADULTERATED TOBACCO PRODUCTS.

       ``A tobacco product shall be deemed to be adulterated if--
       ``(1) it consists in whole or in part of any filthy, 
     putrid, or decomposed substance, or is otherwise contaminated 
     by any poisonous or deleterious substance that may render the 
     product injurious to health;
       ``(2) it has been prepared, packed, or held under 
     insanitary conditions whereby it may have been contaminated 
     with filth, or whereby it may have been rendered injurious to 
     health;
       ``(3) its container is composed, in whole or in part, of 
     any poisonous or deleterious substance which may render the 
     contents injurious to health;
       ``(4) it is, or purports to be or is represented as, a 
     tobacco product which is subject to a performance standard 
     established under section 907 unless such tobacco product is 
     in all respects in conformity with such standard;
       ``(5) it is required by section 910(a) to have premarket 
     approval, is not exempt under section 906(f), and does not 
     have an approved application in effect;
       ``(6) the methods used in, or the facilities or controls 
     used for, its manufacture, packing or storage are not in 
     conformity with applicable requirements under section 
     906(e)(1) or an applicable condition prescribed by an order 
     under section 906(e)(2); or
       ``(7) it is a tobacco product for which an exemption has 
     been granted under section 906(f) for investigational use and 
     the person who was granted such exemption or any investigator 
     who uses such tobacco product under such exemption fails 
     to comply with a requirement prescribed by or under such 
     section.

     ``SEC. 903. MISBRANDED TOBACCO PRODUCTS.

       ``(a) In General.--A tobacco product shall be deemed to be 
     misbranded--
       ``(1) if its labeling is false or misleading in any 
     particular;
       ``(2) if in package form unless it bears a label 
     containing--
       ``(A) the name and place of business of the tobacco product 
     manufacturer, packer, or distributor;
       ``(B) an accurate statement of the quantity of the contents 
     in terms of weight, measure, or numerical count; and
       ``(C) an accurate statement of the percentage of the 
     tobacco used in the product that is domestically grown 
     tobacco and the percentage that is foreign grown tobacco,

     except that under subparagraph (B) reasonable variations 
     shall be permitted, and exemptions as to small packages shall 
     be established, by regulations prescribed by the Secretary;
       ``(3) if any word, statement, or other information required 
     by or under authority of this chapter to appear on the label 
     or labeling is not prominently placed thereon with such 
     conspicuousness (as compared with other words, statements or 
     designs in the labeling) and in such terms as to render it 
     likely to be read and understood by the ordinary individual 
     under customary conditions of purchase and use;
       ``(4) if it has an established name, unless its label 
     bears, to the exclusion of any other nonproprietary name, its 
     established name prominently printed in type as required by 
     the Secretary by regulation;
       ``(5) if the Secretary has issued regulations requiring 
     that its labeling bear adequate directions for use, or 
     adequate warnings against use by children, that are necessary 
     for the protection of users unless its labeling conforms in 
     all respects to such regulations;
       ``(6) if it was manufactured, prepared, propagated, 
     compounded, or processed in any State in an establishment not 
     duly registered under section 905(b), if it was not included 
     in a list required by section 905(i), if a notice or other 
     information respecting it was not provided as required by 
     such section or section 905(j), or if it does not bear such 
     symbols from the uniform system for identification of tobacco 
     products prescribed under section 905(e) as the Secretary by 
     regulation requires;

[[Page S5604]]

       ``(7) if, in the case of any tobacco product distributed or 
     offered for sale in any State--
       ``(A) its advertising is false or misleading in any 
     particular; or
       ``(B) it is sold or distributed in violation of regulations 
     prescribed under section 906(d);
       ``(8) unless, in the case of any tobacco product 
     distributed or offered for sale in any State, the 
     manufacturer, packer, or distributor thereof includes in all 
     advertisements and other descriptive printed matter issued or 
     caused to be issued by the manufacturer, packer, or 
     distributor with respect to that tobacco product--
       ``(A) a true statement of the tobacco product's established 
     name as defined in paragraph (4), printed prominently; and
       ``(B) a brief statement of--
       ``(i) the uses of the tobacco product and relevant 
     warnings, precautions, side effects, and contraindications; 
     and
       ``(ii) in the case of specific tobacco products made 
     subject to a finding by the Secretary after notice and 
     opportunity for comment that such action is necessary to 
     protect the public health, a full description of the 
     components of such tobacco product or the formula showing 
     quantitatively each ingredient of such tobacco product to the 
     extent required in regulations which shall be issued by the 
     Secretary after an opportunity for a hearing;
       ``(9) if it is a tobacco product subject to a performance 
     standard established under section 907, unless it bears such 
     labeling as may be prescribed in such performance standard; 
     or
       ``(10) if there was a failure or refusal--
       ``(A) to comply with any requirement prescribed under 
     section 904 or 908;
       ``(B) to furnish any material or information required by or 
     under section 909; or
       ``(C) to comply with a requirement under section 912.
       ``(b) Prior Approval of Label Statements.--The Secretary 
     may, by regulation, require prior approval of statements made 
     on the label of a tobacco product. No regulation issued under 
     this subsection may require prior approval by the Secretary 
     of the content of any advertisement. No advertisement of a 
     tobacco product, published after the date of enactment of the 
     Youth Smoking Prevention and Public Health Protection Act 
     shall, with respect to the language of label statements as 
     prescribed under section 4 of the Cigarette Labeling and 
     Advertising Act and section 3 of the Comprehensive Smokeless 
     Tobacco Health Education Act of 1986 or the regulations 
     issued under such sections, be subject to the provisions of 
     sections 12 through 15 of the Federal Trade Commission Act 
     (15 U.S.C. 52 through 55).

     ``SEC. 904. SUBMISSION OF HEALTH INFORMATION TO THE 
                   SECRETARY.

       ``(a) Requirement.--Not later than 6 months after the date 
     of enactment of the Youth Smoking Prevention and Public 
     Health Protection Act, each tobacco product manufacturer or 
     importer of tobacco products, or agents thereof, shall submit 
     to the Secretary the following information:
       ``(1) A listing of all tobacco ingredients, substances and 
     compounds that are, on such date, added by the manufacturer 
     to the tobacco, paper, filter, or other component of each 
     tobacco product by brand and by quantity in each brand and 
     subbrand.
       ``(2) A description of the content, delivery, and form of 
     nicotine in each tobacco product measured in milligrams of 
     nicotine.
       ``(3) All documents (including underlying scientific 
     information) relating to research activities, and research 
     findings, conducted, supported, or possessed by the 
     manufacturer (or agents thereof) on the health, behavioral, 
     or physiologic effects of tobacco products, their 
     constituents, ingredients, and components, and tobacco 
     additives, described in paragraph (1).
       ``(4) All documents (including underlying scientific 
     information) relating to research activities, and research 
     findings, conducted, supported, or possessed by the 
     manufacturer (or agents thereof) that relate to the issue of 
     whether a reduction in risk to health from tobacco products 
     can occur upon the employment of technology available or 
     known to the manufacturer.
       ``(5) All documents (including underlying scientific 
     information) relating to marketing research involving the use 
     of tobacco products.

     An importer of a tobacco product not manufactured in the 
     United States shall supply the information required of a 
     tobacco product manufacturer under this subsection.
       ``(b) Annual Submission.--A tobacco product manufacturer or 
     importer that is required to submit information under 
     subsection (a) shall update such information on an annual 
     basis under a schedule determined by the Secretary.
       ``(c) Time for Submission.--
       ``(1) New products.--At least 90 days prior to the delivery 
     for introduction into interstate commerce of a tobacco 
     product not on the market on the date of enactment of the 
     Youth Smoking Prevention and Public Health Protection Act, 
     the manufacturer of such product shall provide the 
     information required under subsection (a) and such product 
     shall be subject to the annual submission under subsection 
     (b).
       ``(2) Modification of existing products.--If at any time a 
     tobacco product manufacturer adds to its tobacco products a 
     new tobacco additive, increases or decreases the quantity of 
     an existing tobacco additive or the nicotine content, 
     delivery, or form, or eliminates a tobacco additive from any 
     tobacco product, the manufacturer shall within 60 days of 
     such action so advise the Secretary in writing and reference 
     such modification in submissions made under subsection (b).

     ``SEC. 905. ANNUAL REGISTRATION.

       ``(a) Definitions.--In this section:
       ``(1) Manufacture, preparation, compounding, or 
     processing.--The term `manufacture, preparation, compounding, 
     or processing' shall include repackaging or otherwise 
     changing the container, wrapper, or labeling of any tobacco 
     product package in furtherance of the distribution of the 
     tobacco product from the original place of manufacture to the 
     person who makes final delivery or sale to the ultimate 
     consumer or user.
       ``(2) Name.--The term `name' shall include in the case of a 
     partnership the name of each partner and, in the case of a 
     corporation, the name of each corporate officer and director, 
     and the State of incorporation.
       ``(b) Registration by Owners and Operators.--On or before 
     December 31 of each year every person who owns or operates 
     any establishment in any State engaged in the manufacture, 
     preparation, compounding, or processing of a tobacco product 
     or tobacco products shall register with the Secretary the 
     name, places of business, and all such establishments of that 
     person.
       ``(c) Registration of New Owners and Operators.--Every 
     person upon first engaging in the manufacture, preparation, 
     compounding, or processing of a tobacco product or tobacco 
     products in any establishment owned or operated in any State 
     by that person shall immediately register with the Secretary 
     that person's name, place of business, and such 
     establishment.
       ``(d) Registration of Added Establishments.--Every person 
     required to register under subsection (b) or (c) shall 
     immediately register with the Secretary any additional 
     establishment which that person owns or operates in any State 
     and in which that person begins the manufacture, preparation, 
     compounding, or processing of a tobacco product or tobacco 
     products.
       ``(e) Uniform Product Identification System.--The Secretary 
     may by regulation prescribe a uniform system for the 
     identification of tobacco products and may require that 
     persons who are required to list such tobacco products under 
     subsection (i) shall list such tobacco products in accordance 
     with such system.
       ``(f) Public Access to Registration Information.--The 
     Secretary shall make available for inspection, to any person 
     so requesting, any registration filed under this section.
       ``(g) Biennial Inspection of Registered Establishments.--
     Every establishment in any State registered with the 
     Secretary under this section shall be subject to inspection 
     under section 704, and every such establishment engaged in 
     the manufacture, compounding, or processing of a tobacco 
     product or tobacco products shall be so inspected by one or 
     more officers or employees duly designated by the Secretary 
     at least once in the 2-year period beginning with the date of 
     registration of such establishment under this section and at 
     least once in every successive 2-year period thereafter.
       ``(h) Foreign Establishments May Register.--Any 
     establishment within any foreign country engaged in the 
     manufacture, preparation, compounding, or processing of a 
     tobacco product or tobacco products, may register under this 
     section under regulations promulgated by the Secretary. Such 
     regulations shall require such establishment to provide the 
     information required by subsection (i) of this section and 
     shall include provisions for registration of any such 
     establishment upon condition that adequate and effective 
     means are available, by arrangement with the government of 
     such foreign country or otherwise, to enable the Secretary to 
     determine from time to time whether tobacco products 
     manufactured, prepared, compounded, or processed in such 
     establishment, if imported or offered for import into the 
     United States, shall be refused admission on any of the 
     grounds set forth in section 801(a).
       ``(i) Registration Information.--
       ``(1) Product list.--Every person who registers with the 
     Secretary under subsection (b), (c),  or (d) shall, at the 
     time of registration under any such subsection, file with 
     the Secretary a list of all tobacco products which are 
     being manufactured, prepared, compounded, or processed by 
     that person for commercial distribution and which has not 
     been included in any list of tobacco products filed by 
     that person with the Secretary under this paragraph or 
     paragraph (2) before such time of registration. Such list 
     shall be prepared in such form and manner as the Secretary 
     may prescribe and shall be accompanied by--
       ``(A) in the case of a tobacco product contained in the 
     applicable list with respect to which a performance standard 
     has been established under section 907 or which is subject to 
     section 910, a reference to the authority for the marketing 
     of such tobacco product and a copy of all labeling for such 
     tobacco product;
       ``(B) in the case of any other tobacco product contained in 
     an applicable list, a copy of all consumer information and 
     other labeling for such tobacco product, a representative 
     sampling of advertisements for such tobacco product, and, 
     upon request made by the Secretary for good cause, a copy of 
     all advertisements for a particular tobacco product; and
       ``(C) if the registrant filing a list has determined that a 
     tobacco product contained in

[[Page S5605]]

     such list is not subject to a performance standard 
     established under section 907, a brief statement of the basis 
     upon which the registrant made such determination if the 
     Secretary requests such a statement with respect to that 
     particular tobacco product.
       ``(2) Biannual report of any change in product list.--Each 
     person who registers with the Secretary under this section 
     shall report to the Secretary once during the month of June 
     of each year and once during the month of December of each 
     year the following:
       ``(A) A list of each tobacco product introduced by the 
     registrant for commercial distribution which has not been 
     included in any list previously filed by that person with the 
     Secretary under this subparagraph or paragraph (1). A list 
     under this subparagraph shall list a tobacco product by its 
     established name and shall be accompanied by the other 
     information required by paragraph (1).
       ``(B) If since the date the registrant last made a report 
     under this paragraph that person has discontinued the 
     manufacture, preparation, compounding, or processing for 
     commercial distribution of a tobacco product included in a 
     list filed under subparagraph (A) or paragraph (1), notice of 
     such discontinuance, the date of such discontinuance, and the 
     identity of its established name.
       ``(C) If since the date the registrant reported under 
     subparagraph (B) a notice of discontinuance that person has 
     resumed the manufacture, preparation, compounding, or 
     processing for commercial distribution of the tobacco product 
     with respect to which such notice of discontinuance was 
     reported, notice of such resumption, the date of such 
     resumption, the identity of such tobacco product by 
     established name, and other information required by paragraph 
     (1), unless the registrant has previously reported such 
     resumption to the Secretary under this subparagraph.
       ``(D) Any material change in any information previously 
     submitted under this paragraph or paragraph (1).
       ``(j) Report Preceding Introduction of Certain 
     Substantially-equivalent Products Into Interstate Commerce.--
       ``(1) In general.--Each person who is required to register 
     under this section and who proposes to begin the introduction 
     or delivery for introduction into interstate commerce for 
     commercial distribution of a tobacco product intended for 
     human use that was not commercially marketed (other than for 
     test marketing) in the United States as of June 1, 2002, as 
     defined by the Secretary by regulation shall, at least 90 
     days before making such introduction or delivery, report to 
     the Secretary (in such form and manner as the Secretary shall 
     by regulation prescribe)--
       ``(A) the basis for such person's determination that the 
     tobacco product is substantially equivalent, within the 
     meaning of section 910, to a tobacco product commercially 
     marketed (other than for test marketing) in the United States 
     as of June 1, 2002, that is in compliance with the 
     requirements of this Act; and
       ``(B) action taken by such person to comply with the 
     requirements under section 907 that are applicable to the 
     tobacco product.
       ``(2) Application to certain post-june 1, 2002 products.--A 
     report under this subsection for a tobacco product that was 
     first introduced or delivered for introduction into 
     interstate commerce for commercial distribution in the United 
     States after June 1, 2002, and before the date of enactment 
     of the Youth Smoking Prevention and Public Health  Protection 
     Act shall be submitted to the Secretary within 6 months 
     after the date of enactment of that Act.

     ``SEC. 906. GENERAL PROVISIONS RESPECTING CONTROL OF TOBACCO 
                   PRODUCTS.

       ``(a) In General.--Any requirement established by or under 
     section 902, 903, 905, or 909 applicable to a tobacco product 
     shall apply to such tobacco product until the applicability 
     of the requirement to the tobacco product has been changed by 
     action taken under section 907, section 910, or subsection 
     (d) of this section, and any requirement established by or 
     under section 902, 903, 905, or 909 which is inconsistent 
     with a requirement imposed on such tobacco product under 
     section 907, section 910, or subsection (d) of this section 
     shall not apply to such tobacco product.
       ``(b) Information on Public Access and Comment.--Each 
     notice of proposed rulemaking under section  907, 908, 909, 
     or 910, or under this section, any other notice which is 
     published in the Federal Register with respect to any 
     other action taken under any such section and which states 
     the reasons for such action, and each publication of 
     findings required to be made in connection with rulemaking 
     under any such section shall set forth--
       ``(1) the manner in which interested persons may examine 
     data and other information on which the notice or findings is 
     based; and
       ``(2) the period within which interested persons may 
     present their comments on the notice or findings (including 
     the need therefore) orally or in writing, which period shall 
     be at least 60 days but may not exceed 90 days unless the 
     time is extended by the Secretary by a notice published in 
     the Federal Register stating good cause therefore.
       ``(c) Limited Confidentiality of Information.--Any 
     information reported to or otherwise obtained by the 
     Secretary or the Secretary's representative under section 
     904, 907, 908, 909, or 910 or 704, or under subsection (e) or 
     (f) of this section, which is exempt from disclosure under 
     subsection (a) of section 552 of title 5, United States Code, 
     by reason of subsection (b)(4) of that section shall be 
     considered confidential and shall not be disclosed, except 
     that the information may be disclosed to other officers or 
     employees concerned with carrying out this chapter, or when 
     relevant in any proceeding under this chapter.
       ``(d) Restrictions.--
       ``(1) In general.--The Secretary may by regulation require 
     restrictions on the sale and distribution of a tobacco 
     product, including restrictions on the access to, and the 
     advertising and promotion of, the tobacco product, if the 
     Secretary determines that such regulation would be 
     appropriate for the protection of the public health. The 
     Secretary may by regulation impose restrictions on the 
     advertising and promotion of tobacco products consistent with 
     and to full extent permitted by the first amendment to the 
     Constitution. The finding as to whether such regulation would 
     be appropriate for the protection of the public health shall 
     be determined with respect to the risks and benefits to the 
     population as a whole, including users and non-users of the 
     tobacco product, and taking into account--
       ``(A) the increased or decreased likelihood that existing 
     users of tobacco products will stop using such products; and
       ``(B) the increased or decreased likelihood that those who 
     do not use tobacco products will start using such products.

     No such regulation may require that the sale or distribution 
     of a tobacco product be limited to the written or oral 
     authorization of a practitioner licensed by law to prescribe 
     medical products.
       ``(2) Label statements.--The label of a tobacco product 
     shall bear such appropriate statements of the restrictions 
     required by a regulation under subsection (a) as the 
     Secretary may in such regulation prescribe.
       ``(3) Limitation.--No restriction under paragraph (1) may 
     prohibit the sale of any tobacco product in face-to face 
     transactions by a specific category of retail outlets.
       ``(e) Good Manufacturing Practice Requirements.--
       ``(1) Methods, facilities, and controls to conform.--
       ``(A) In general.--The Secretary may, in accordance with 
     subparagraph (B), prescribe regulations requiring that the 
     methods used in, and the facilities and controls used for, 
     the manufacture, pre-production design validation (including 
     a process to assess the performance of a tobacco product), 
     packing and storage of a tobacco product, conform to current 
     good manufacturing practice, as prescribed in such 
     regulations, to assure that the public health is protected 
     and that the tobacco product is in compliance with this 
     chapter.
       ``(B) Requirements.--The Secretary shall--
       ``(i) before promulgating any regulation under subparagraph 
     (A), afford an advisory committee an opportunity to submit 
     recommendations with respect to the regulation proposed to be 
     promulgated;
       ``(ii) before promulgating any regulation under 
     subparagraph (A), afford opportunity for an oral hearing;
       ``(iii) provide the advisory committee a reasonable time to 
     make its recommendation with respect to proposed regulations 
     under subparagraph (A); and
       ``(iv) in establishing the effective date of a regulation 
     promulgated under this subsection, take into account the 
     differences in the manner in which the different types of 
     tobacco products have historically been produced, the 
     financial resources of the different tobacco product 
     manufacturers, and the state of their existing manufacturing 
     facilities, and shall provide for a reasonable period of time 
     for such manufacturers to conform to good manufacturing 
     practices.
       ``(2) Exemptions; variances.--
       ``(A) Petition.--Any person subject to any requirement 
     prescribed under paragraph (1) may petition the Secretary for 
     a permanent or temporary exemption or variance from such 
     requirement. Such a petition shall be submitted to the 
     Secretary in such form and manner as the Secretary shall 
     prescribe and shall--
       ``(i) in the case of a petition for an exemption from a 
     requirement, set forth the basis for the petitioner's 
     determination that compliance with the requirement is not 
     required to assure that the tobacco product will be in 
     compliance with this chapter;
       ``(ii) in the case of a petition for a variance from a 
     requirement, set forth the methods proposed to be used in, 
     and the facilities and controls proposed to be used for, the 
     manufacture, packing, and storage of the tobacco product in 
     lieu of the methods, facilities, and controls prescribed by 
     the requirement; and
       ``(iii) contain such other information as the Secretary 
     shall prescribe.
       ``(B) Referral to advisory committee.--The Secretary may 
     refer to an advisory committee any petition submitted under 
     subparagraph (A). The advisory committee shall report its 
     recommendations to the Secretary with respect to a petition 
     referred to it within 60 days after the date of the 
     petition's referral. Within 60 days after--
       ``(i) the date the petition was submitted to the Secretary 
     under subparagraph (A); or
       ``(ii) the day after the petition was referred to an 
     advisory committee,
     whichever occurs later, the Secretary shall by order either 
     deny the petition or approve it.

[[Page S5606]]

       ``(C) Approval.--The Secretary may approve--
       ``(i) a petition for an exemption for a tobacco product 
     from a requirement if the Secretary determines that 
     compliance with such requirement is not required to assure 
     that the tobacco product will be in compliance with this 
     chapter; and
       ``(ii) a petition for a variance for a tobacco product from 
     a requirement if the Secretary determines that the methods to 
     be used in, and the facilities and controls to be used for, 
     the manufacture, packing, and storage of the tobacco product 
     in lieu of the methods, controls, and facilities prescribed 
     by the requirement are sufficient to assure that the tobacco 
     product will be in compliance with this chapter.
       ``(D) Conditions.--An order of the Secretary approving a 
     petition for a variance shall prescribe such conditions 
     respecting the methods used in, and the facilities and 
     controls used for, the manufacture, packing, and storage of 
     the tobacco product to be granted the variance under the 
     petition as may be necessary to assure that the tobacco 
     product will be in compliance with this chapter.
       ``(E) Hearing.--After the issuance of an order under 
     subparagraph (B) respecting a petition, the petitioner shall 
     have an opportunity for an informal hearing on such order.
       ``(3) Compliance.--Compliance with requirements under this 
     subsection shall not be required before the period ending 3 
     years after the date of enactment of the Youth Smoking 
     Prevention and Public Health Protection Act.
       ``(f) Exemption for Investigational Use.--The Secretary may 
     exempt tobacco products intended for investigational use from 
     this chapter under such conditions as the Secretary may 
     prescribe by regulation.
       ``(g) Research and Development.--The Secretary may enter 
     into contracts for research, testing, and demonstrations 
     respecting tobacco products and may obtain tobacco products 
     for research, testing, and demonstration purposes without 
     regard to section 3324(a) and (b) of title 31, United States 
     Code, and section 5 of title 41, United States Code.

     ``SEC. 907. PERFORMANCE STANDARDS.

       ``(a) In General.--
       ``(1) Finding required.--The Secretary may adopt 
     performance standards for a tobacco product if the Secretary 
     finds that a performance standard is appropriate for the 
     protection of the public health. This finding shall be 
     determined with respect to the risks and benefits to the 
     population as a whole, including users and non-users of the 
     tobacco product, and taking into account--
       ``(A) the increased or decreased likelihood that existing 
     users of tobacco products will stop using such products; and
       ``(B) the increased or decreased likelihood that those who 
     do not use tobacco products will start using such products.
       ``(2) Content of performance standards.--A performance 
     standard established under this section for a tobacco 
     product--
       ``(A) shall include provisions to provide performance that 
     is appropriate for the protection of the public health, 
     including provisions, where appropriate--
       ``(i) for the reduction or elimination of nicotine yields 
     of the product;
       ``(ii) for the reduction or elimination of other 
     constituents or harmful components of the product; or
       ``(iii) relating to any other requirement under (B);
       ``(B) shall, where necessary to be appropriate for the 
     protection of the public health, include--
       ``(i) provisions respecting the construction, components, 
     ingredients, and properties of the tobacco product;
       ``(ii) provisions for the testing (on a sample basis or, if 
     necessary, on an individual basis) of the tobacco product;
       ``(iii) provisions for the measurement of the performance 
     characteristics of the tobacco product;
       ``(iv) provisions requiring that the results of each or of 
     certain of the tests of the tobacco product required to be 
     made under clause (ii) show that the tobacco product is in 
     conformity with the portions of the standard for which the 
     test or tests were required; and
       ``(v) a provision requiring that the sale and distribution 
     of the tobacco product be restricted but only to the extent 
     that the sale and distribution of a tobacco product may be 
     restricted under a regulation under section 906(d); and
       ``(C) shall, where appropriate, require the use and 
     prescribe the form and content of labeling for the proper use 
     of the tobacco product.
       ``(3) Periodic re-evaluation of performance standards.--The 
     Secretary shall provide for periodic evaluation of 
     performance standards established under this section to 
     determine whether such standards should be changed to reflect 
     new medical, scientific, or other technological data. The 
     Secretary may provide for testing under paragraph (2) by any 
     person.
       ``(4) Involvement of other agencies; informed persons.--In 
     carrying out duties under this section, the Secretary shall, 
     to the maximum extent practicable--
       ``(A) use personnel, facilities, and other technical 
     support available in other Federal agencies;
       ``(B) consult with other Federal agencies concerned with 
     standard-setting and other nationally or internationally 
     recognized standard-setting entities; and
       ``(C) invite appropriate participation, through joint or 
     other conferences, workshops, or other means, by informed 
     persons representative of scientific, professional, industry, 
     or consumer organizations who in the Secretary's judgment can 
     make a significant contribution.
       ``(b) Establishment of Standards.--
       ``(1) Notice.--
       ``(A) In general.--The Secretary shall publish in the 
     Federal Register a notice of proposed rulemaking for the 
     establishment, amendment, or revocation of any performance 
     standard for a tobacco product.
       ``(B) Requirements of notice.--A notice of proposed 
     rulemaking for the establishment or amendment of a 
     performance standard for a tobacco product shall--
       ``(i) set forth a finding with supporting justification 
     that the performance standard is appropriate for the 
     protection of the public health;
       ``(ii) set forth proposed findings with respect to the risk 
     of illness or injury that the performance standard is 
     intended to reduce or eliminate; and
       ``(iii) invite interested persons to submit an existing 
     performance standard for the tobacco product, including a 
     draft or proposed performance standard, for consideration by 
     the Secretary.
       ``(C) Finding.--A notice of proposed rulemaking for the 
     revocation of a performance standard shall set forth a 
     finding with supporting justification that the performance 
     standard is no longer necessary to be appropriate for the 
     protection of the public health.
       ``(D) Consideration by secretary.--The Secretary shall 
     consider all information submitted in connection with a 
     proposed standard, including information concerning the 
     countervailing effects of the performance standard on the 
     health of adolescent tobacco users, adult tobacco users, or 
     non-tobacco users, such as the creation of a significant 
     demand for contraband or other tobacco products that do not 
     meet the requirements of this chapter and the significance of 
     such demand, and shall issue the standard if the Secretary 
     determines that the standard would be appropriate for the 
     protection of the public health.
       ``(E) Comment.--The Secretary shall provide for a comment 
     period of not less than 60 days.
       ``(2) Promulgation.--
       ``(A) In general.--After the expiration of the period for 
     comment on a notice of proposed rulemaking published under 
     paragraph (1) respecting a performance standard and after 
     consideration of such comments and any report from an 
     advisory committee, the Secretary shall--
       ``(i) promulgate a regulation establishing a performance 
     standard and publish in the Federal Register findings on the 
     matters referred to in paragraph (1); or
       ``(ii) publish a notice terminating the proceeding for the 
     development of the standard together with the reasons for 
     such termination.
       ``(B) Effective date.--A regulation establishing a 
     performance standard shall set forth the date or dates upon 
     which the standard shall take effect, but no such regulation 
     may take effect before one year after the date of its 
     publication unless the Secretary determines that an earlier 
     effective date is necessary for the protection of the public 
     health. Such date or dates shall be established so as to 
     minimize,  consistent with the public health, economic loss 
     to, and disruption or dislocation of, domestic and 
     international trade.
       ``(3) Special rule for standard banning class of product or 
     eliminating nicotine content.--Because of the importance of a 
     decision of the Secretary to issue a regulation establishing 
     a performance standard--
       ``(A) eliminating all cigarettes, all smokeless tobacco 
     products, or any similar class of tobacco products, or
       ``(B) requiring the reduction of nicotine yields of a 
     tobacco product to zero,

     it is appropriate for the Congress to have the opportunity to 
     review such a decision. Therefore, any such standard may not 
     take effect before a date that is 2 years after the President 
     notifies the Congress that a final regulation imposing the 
     restriction has been issued.
       ``(4) Amendment; revocation.--
       ``(A) Authority.--The Secretary, upon the Secretary's own 
     initiative or upon petition of an interested person may by a 
     regulation, promulgated in accordance with the requirements 
     of paragraphs (1) and (2)(B), amend or revoke a performance 
     standard.
       ``(B) Effective date.--The Secretary may declare a proposed 
     amendment of a performance standard to be effective on and 
     after its publication in the Federal Register and until the 
     effective date of any final action taken on such amendment if 
     the Secretary determines that making it so effective is in 
     the public interest.
       ``(5) Reference to Advisory Committee.--The Secretary--
       ``(A) may, on the Secretary's own initiative, refer a 
     proposed regulation for the establishment, amendment, or 
     revocation of a performance standard; or
       ``(B) shall, upon the request of an interested person which 
     demonstrates good cause for referral and which is made before 
     the expiration of the period for submission of comments on 
     such proposed regulation,

     refer such proposed regulation to an advisory committee, for 
     a report and recommendation

[[Page S5607]]

     with respect to any matter involved in the proposed 
     regulation which requires the exercise of scientific 
     judgment. If a proposed regulation is referred under this 
     paragraph to the advisory committee, the Secretary shall 
     provide the advisory committee with the data and information 
     on which such proposed regulation is based. The advisory 
     committee shall, within 60 days after the referral of a 
     proposed regulation and after independent study of the data 
     and information furnished to it by the Secretary and other 
     data and information before it, submit to the Secretary a 
     report and recommendation respecting such regulation, 
     together with all underlying data and information and a 
     statement of the reason or basis for the recommendation. A 
     copy of such report and recommendation shall be made public 
     by the Secretary.

     ``SEC. 908. NOTIFICATION AND OTHER REMEDIES.

       ``(a) Notification.--If the Secretary determines that--
       ``(1) a tobacco product which is introduced or delivered 
     for introduction into interstate commerce for commercial 
     distribution presents an unreasonable risk of substantial 
     harm to the public health; and
       ``(2) notification under this subsection is necessary to 
     eliminate the unreasonable risk of such harm and no more 
     practicable means is available under the provisions of this 
     chapter (other than this section) to eliminate such risk,

     the Secretary may issue such order as may be necessary to 
     assure that adequate notification is provided in an 
     appropriate form, by the persons and means best suited under 
     the circumstances involved, to all persons who should 
     properly receive such notification in order to eliminate such 
     risk. The Secretary may order notification by any appropriate 
     means, including public service announcements. Before issuing 
     an order under this subsection, the Secretary shall consult 
     with the persons who are to give notice under the order.
       ``(b) No Exemption From Other Liability.--Compliance with 
     an order issued under this section shall not relieve any 
     person from liability under Federal or State law. In awarding 
     damages for economic loss in an action brought for the 
     enforcement of any such liability, the value to the plaintiff 
     in such action of any remedy provided under such order shall 
     be taken into account.
       ``(c) Recall Authority.--
       ``(1) In general.--If the Secretary finds that there is a 
     reasonable probability that a tobacco product contains a 
     manufacturing or other defect not ordinarily contained in 
     tobacco products on the market that would cause serious, 
     adverse health consequences or death, the Secretary shall 
     issue an order requiring the appropriate person (including 
     the manufacturers, importers, distributors, or retailers of 
     the tobacco product) to immediately cease distribution of 
     such tobacco product. The order shall provide the person 
     subject to the order with an opportunity for an informal 
     hearing, to be held not later than 10 days after the date of 
     the issuance of the order, on the actions required by the 
     order and on whether the order should be amended to require a 
     recall of such tobacco product. If, after providing an 
     opportunity for such a hearing, the Secretary determines that 
     inadequate grounds exist to support the actions required by 
     the order, the Secretary shall vacate the order.
       ``(2) Amendment of order to require recall.--
       ``(A) In general.--If, after providing an opportunity for 
     an informal hearing under paragraph (1), the Secretary 
     determines that the order should be amended to include a 
     recall of the tobacco product with respect to which the order 
     was issued, the Secretary shall, except as provided in 
     subparagraph (B), amend the order to require a recall. The 
     Secretary shall specify a timetable in which the tobacco 
     product recall will occur and shall require periodic reports 
     to the Secretary describing the progress of the recall.
       ``(B) Notice.--An amended order under subparagraph (A)--
       ``(i) shall not include recall of a tobacco product from 
     individuals; and
       ``(ii) shall provide for notice to persons subject to the 
     risks associated with the use of such tobacco product.

     In providing the notice required by clause (ii), the 
     Secretary may use the assistance of retailers and other 
     persons who distributed such tobacco product. If a 
     significant number of such persons cannot be identified, the 
     Secretary shall notify such persons under section 705(b).
       ``(3) Remedy not exclusive.--The remedy provided by this 
     subsection shall be in addition to remedies provided by 
     subsection (a) of this section.

     ``SEC. 909. RECORDS AND REPORTS ON TOBACCO PRODUCTS.

       ``(a) In General.--Every person who is a tobacco product 
     manufacturer or importer of a tobacco product shall establish 
     and maintain such records, make such reports, and provide 
     such information, as the Secretary may by regulation 
     reasonably require to assure that such tobacco product is not 
     adulterated or misbranded and to otherwise protect public 
     health. Regulations prescribed under the preceding sentence--
       ``(1) may require a tobacco product manufacturer or 
     importer to report to the Secretary whenever the manufacturer 
     or importer receives or otherwise becomes aware of 
     information that reasonably suggests that one of its marketed 
     tobacco products may have caused or contributed to a serious 
     unexpected adverse experience associated with the use of the 
     product or any significant increase in the frequency of a 
     serious, expected adverse product experience;
       ``(2) shall require reporting of other significant adverse 
     tobacco product experiences as determined by the Secretary to 
     be necessary to be reported;
       ``(3) shall not impose requirements unduly burdensome to a 
     tobacco product manufacturer or importer, taking into account 
     the cost of complying with such requirements and the need for 
     the protection of the public health and the implementation of 
     this chapter;
       ``(4) when prescribing the procedure for making requests 
     for reports or information, shall require that each request 
     made under such regulations for submission of a report or 
     information to the Secretary state the reason or purpose for 
     such request and identify to the fullest extent practicable 
     such report or information;
       ``(5) when requiring submission of a report or information 
     to the Secretary, shall state the reason or purpose for the 
     submission of such report or information and identify to the 
     fullest extent practicable such report or information; and
       ``(6) may not require that the identity of any patient or 
     user be disclosed in records, reports, or information 
     required under this subsection unless required for the 
     medical welfare of an individual, to determine risks to 
     public health of a tobacco product, or to verify a record, 
     report, or information submitted under this chapter.

     In prescribing regulations under this subsection, the 
     Secretary shall have due regard for the professional ethics 
     of the medical profession and the interests of patients. The 
     prohibitions of paragraph (6) continue to apply to records, 
     reports, and information concerning any individual who has 
     been a patient, irrespective of whether or when he ceases to 
     be a patient.
       ``(b) Reports of Removals and Corrections.--
       ``(1) In general.--Except as provided in paragraph (2), the 
     Secretary shall by regulation require a tobacco product 
     manufacturer or importer of a tobacco product to report 
     promptly to the Secretary any corrective action taken or 
     removal from the market of a tobacco product undertaken by 
     such manufacturer or importer if the removal or correction 
     was undertaken--
       ``(A) to reduce a risk to health posed by the tobacco 
     product; or
       ``(B) to remedy a violation of this chapter caused by the 
     tobacco product which may present a risk to health.

     A tobacco product manufacturer or importer of a tobacco 
     product who undertakes a corrective action or removal from 
     the market of a tobacco product which is not required to be 
     reported under this subsection shall keep a record of such 
     correction or removal.
       ``(2) Exception.--No report of the corrective action or 
     removal of a tobacco product may be required under paragraph 
     (1) if a report of the corrective action or removal is 
     required and has been submitted under subsection (a).

     ``SEC. 910. PREMARKET REVIEW OF CERTAIN TOBACCO PRODUCTS.

       ``(a) In General.--
       ``(1) Premarket approval required.--
       ``(A) New products.--Approval under this section of an 
     application for premarket approval for any tobacco product 
     that is not commercially marketed (other than for test 
     marketing) in the United States as of June 1, 2002, is 
     required unless the manufacturer has submitted a report under 
     section 905(j), and the Secretary has issued an order that 
     the tobacco product is substantially equivalent to a tobacco 
     product commercially marketed (other than for test marketing) 
     in the United States as of June 1, 2002, that is in 
     compliance with the requirements of this Act.
       ``(B) Products introduced between June 1, 2002, and 
     enactment of this chapter.--Subparagraph (A) does not apply 
     to a tobacco product that--
       ``(i) was first introduced or delivered for introduction 
     into interstate commerce for commercial distribution in the 
     United States after June 1, 2002, and before the date of 
     enactment of the Youth Smoking Prevention and Public Health 
     Protection Act; and
       ``(ii) for which a report was submitted under section 
     905(j) within 6 months after such date,
     until the Secretary issues an order that the tobacco product 
     is substantially equivalent for purposes of this section or 
     requires premarket approval.
       ``(2) Substantially equivalent defined.--
       ``(A) In general.--For purposes of this section and section 
     905(j), the terms `substantially equivalent' or `substantial 
     equivalence' mean, with respect to the tobacco product being 
     compared to the predicate tobacco product, that the Secretary 
     by order has found that the tobacco product--
       ``(i) has the same characteristics as the predicate tobacco 
     product; or
       ``(ii) has different characteristics and the information 
     submitted contains information, including clinical data if 
     deemed necessary by the Secretary, that demonstrates that it 
     is not appropriate to regulate the product under this section 
     because the product does not raise different questions of 
     public health.
       ``(B) Characteristics.--For purposes of subparagraph (A), 
     the term `characteristics' means the materials, ingredients, 
     design, composition, heating source, or other features of a 
     tobacco product.

[[Page S5608]]

       ``(C) Limitation.--A tobacco product may not be found to be 
     substantially equivalent to a predicate tobacco product that 
     has been removed from the market at the initiative of the 
     Secretary or that has been determined by a judicial order to 
     be misbranded or adulterated.
       ``(3) Health information.--
       ``(A) Summary.--As part of a submission under section 
     905(j) respecting a tobacco product, the person required to 
     file a premarket notification under such section shall 
     provide an adequate summary of any health information related 
     to the tobacco product or state that such information will be 
     made available upon request by any person.
       ``(B) Required information.--Any summary under subparagraph 
     (A) respecting a tobacco product shall contain detailed 
     information regarding data concerning adverse health effects 
     and shall be made available to the public by the Secretary 
     within 30 days of the issuance of a determination that such 
     tobacco product is substantially equivalent to another 
     tobacco product.
       ``(b) Application.--
       ``(1) Contents.--An application for premarket approval 
     shall contain--
       ``(A) full reports of all information, published or known 
     to, or which should reasonably be known to, the applicant, 
     concerning investigations which have been made to show the 
     health risks of such tobacco product and whether such tobacco 
     product presents less risk than other tobacco products;
       ``(B) a full statement of the components, ingredients, and 
     properties, and of the principle or principles of operation, 
     of such tobacco product;
       ``(C) a full description of the methods used in, and the 
     facilities and controls used for, the manufacture, 
     processing, and, when relevant, packing and installation of, 
     such tobacco product;
       ``(D) an identifying reference to any performance standard 
     under section 907 which would be applicable to any aspect of 
     such tobacco product, and either adequate information to show 
     that such aspect of such tobacco product fully meets such 
     performance standard or adequate information to justify any 
     deviation from such standard;
       ``(E) such samples of such tobacco product and of 
     components thereof as the Secretary may reasonably require;
       ``(F) specimens of the labeling proposed to be used for 
     such tobacco product; and
       ``(G) such other information relevant to the subject matter 
     of the application as the Secretary may require.
       ``(2) Reference to advisory committee.--Upon receipt of an 
     application meeting the requirements set forth in paragraph 
     (1), the Secretary--
       ``(A) may, on the Secretary's own initiative; or
       ``(B) shall, upon the request of an applicant,

     refer such application to an advisory committee and for 
     submission (within such period as the Secretary  may 
     establish) of a report and recommendation respecting 
     approval of the application, together with all underlying 
     data and the reasons or basis for the recommendation.
       ``(c) Action on Application.--
       ``(1) Deadline.--
       ``(A) In general.--As promptly as possible, but in no event 
     later than 180 days after the receipt of an application under 
     subsection (b), the Secretary, after considering the report 
     and recommendation submitted under paragraph (2) of such 
     subsection, shall--
       ``(i) issue an order approving the application if the 
     Secretary finds that none of the grounds for denying approval 
     specified in paragraph (2) of this subsection applies; or
       ``(ii) deny approval of the application if the Secretary 
     finds (and sets forth the basis for such finding as part of 
     or accompanying such denial) that one or more grounds for 
     denial specified in paragraph (2) of this subsection apply.
       ``(B) Restrictions on sale and distribution.--An order 
     approving an application for a tobacco product may require as 
     a condition to such approval that the sale and distribution 
     of the tobacco product be restricted but only to the extent 
     that the sale and distribution of a tobacco product may be 
     restricted under a regulation under section 906(d).
       ``(2) Denial of approval.--The Secretary shall deny 
     approval of an application for a tobacco product if, upon the 
     basis of the information submitted to the Secretary as part 
     of the application and any other information before the 
     Secretary with respect to such tobacco product, the Secretary 
     finds that--
       ``(A) there is a lack of a showing that permitting such 
     tobacco product to be marketed would be appropriate for the 
     protection of the public health;
       ``(B) the methods used in, or the facilities or controls 
     used for, the manufacture, processing, or packing of such 
     tobacco product do not conform to the requirements of section 
     906(e);
       ``(C) based on a fair evaluation of all material facts, the 
     proposed labeling is false or misleading in any particular; 
     or
       ``(D) such tobacco product is not shown to conform in all 
     respects to a performance standard in effect under section 
     907, compliance with which is a condition to approval of the 
     application, and there is a lack of adequate information to 
     justify the deviation from such standard.
       ``(3) Denial information.--Any denial of an application 
     shall, insofar as the Secretary determines to be practicable, 
     be accompanied by a statement informing the applicant of the 
     measures required to place such application in approvable 
     form (which measures may include further research by the 
     applicant in accordance with one or more protocols prescribed 
     by the Secretary).
       ``(4) Basis for finding.--For purposes of this section, the 
     finding as to whether approval of a tobacco product is 
     appropriate for the protection of the public health shall be 
     determined with respect to the risks and benefits to the 
     population as a whole, including users and non-users of the 
     tobacco product, and taking into account--
       ``(A) the increased or decreased likelihood that existing 
     users of tobacco products will stop using such products; and
       ``(B) the increased or decreased likelihood that those who 
     do not use tobacco products will start using such products.
       ``(5) Basis for action.--
       ``(A) Investigations.--For purposes of paragraph (2)(A), 
     whether permitting a tobacco product to be marketed would be 
     appropriate for the protection of the public health shall, 
     when appropriate, be determined on the basis of well-
     controlled investigations, which may include one or more 
     clinical investigations by experts qualified by training and 
     experience to evaluate the tobacco product.
       ``(B) Other evidence.--If the Secretary determines that 
     there exists valid scientific evidence (other than evidence 
     derived from investigations described in subparagraph (A)) 
     which is sufficient to evaluate the tobacco product the 
     Secretary may authorize that the determination for purposes 
     of paragraph (2)(A) be made on the basis of such evidence.
       ``(d) Withdrawal and Temporary Suspension.--
       ``(1) In general.--The Secretary shall, upon obtaining, 
     where appropriate, advice on scientific matters from an 
     advisory committee, and after due notice and opportunity for 
     informal hearing to the holder of an approved application for 
     a tobacco product, issue an order withdrawing approval of the 
     application if the Secretary finds--
       ``(A) that the continued marketing of such tobacco product 
     no longer is appropriate for the protection of the public 
     health;
       ``(B) that the application contained or was accompanied by 
     an untrue statement of a material fact;
       ``(C) that the applicant--
       ``(i) has failed to establish a system for maintaining 
     records, or has repeatedly or deliberately failed to maintain 
     records or to make reports, required by an applicable 
     regulation under section 909;
       ``(ii) has refused to permit access to, or copying or 
     verification of, such records as required by section 704; or
       ``(iii) has not complied with the requirements of section 
     905;
       ``(D) on the basis of new information before the Secretary 
     with respect to such tobacco product, evaluated together with 
     the evidence before the Secretary when the application was  
     approved, that the methods used in, or the facilities and 
     controls used for, the manufacture, processing, packing, 
     or installation of such tobacco product do not conform 
     with the requirements of section 906(e) and were not 
     brought into conformity with such requirements within a 
     reasonable time after receipt of written notice from the 
     Secretary of nonconformity;
       ``(E) on the basis of new information before the Secretary, 
     evaluated together with the evidence before the Secretary 
     when the application was approved, that the labeling of such 
     tobacco product, based on a fair evaluation of all material 
     facts, is false or misleading in any particular and was not 
     corrected within a reasonable time after receipt of written 
     notice from the Secretary of such fact; or
       ``(F) on the basis of new information before the Secretary, 
     evaluated together with the evidence before the Secretary 
     when the application was approved, that such tobacco product 
     is not shown to conform in all respects to a performance 
     standard which is in effect under section 907, compliance 
     with which was a condition to approval of the application, 
     and that there is a lack of adequate information to justify 
     the deviation from such standard.
       ``(2) Appeal.--The holder of an application subject to an 
     order issued under paragraph (1) withdrawing approval of the 
     application may, by petition filed on or before the 30th day 
     after the date upon which such holder receives notice of such 
     withdrawal, obtain review thereof in accordance with 
     subsection (e).
       ``(3) Temporary suspension.--If, after providing an 
     opportunity for an informal hearing, the Secretary determines 
     there is reasonable probability that the continuation of 
     distribution of a tobacco product under an approved 
     application would cause serious, adverse health consequences 
     or death, that is greater than ordinarily caused by tobacco 
     products on the market, the Secretary shall by order 
     temporarily suspend the approval of the application approved 
     under this section. If the Secretary issues such an order, 
     the Secretary shall proceed expeditiously under paragraph (1) 
     to withdraw such application.
       ``(e) Service of Order.--An order issued by the Secretary 
     under this section shall be served--
       ``(1) in person by any officer or employee of the 
     department designated by the Secretary; or

[[Page S5609]]

       ``(2) by mailing the order by registered mail or certified 
     mail addressed to the applicant at the applicant's last known 
     address in the records of the Secretary.

     ``SEC. 911. JUDICIAL REVIEW.

       ``(a) Right To Review.--
       ``(1) In general.--Not later than 30 days after--
       ``(A) the promulgation of a regulation under section 907 
     establishing, amending, or revoking a performance standard 
     for a tobacco product; or
       ``(B) a denial of an application for approval under section 
     910(c),
     any person adversely affected by such regulation or order may 
     file a petition with the United States Court of Appeals for 
     the District of Columbia or for the circuit wherein such 
     person resides or has his or her principal place of business 
     for judicial review of such regulation or order.
       ``(2) Requirements.--
       ``(A) Copy of petition.--A copy of the petition filed under 
     paragraph (1) shall be transmitted by the clerk of the court 
     to the Secretary or other officer designated by the Secretary 
     for that purpose.
       ``(B) Record of proceedings.--With respect to an action 
     under paragraph (1), the Secretary shall file in the court 
     the record of the proceedings on which the Secretary based 
     the Secretary's regulation or order and each record or order 
     shall contain a statement of the reasons for its issuance and 
     the basis, on the record, for its issuance.
       ``(C) Definition.--For purposes of this section, the term 
     `record' means all notices and other matter published in the 
     Federal Register with respect to the regulation or order 
     reviewed, all information submitted to the Secretary with 
     respect to such regulation or order, proceedings of any panel 
     or advisory committee with respect to such regulation or 
     order, any hearing held with respect to such regulation or 
     order, and any other information identified by the Secretary, 
     in the administrative proceeding held with respect to such 
     regulation or order, as being relevant to such regulation or 
     order.
       ``(b) Court May Order Secretary To Make Additional 
     Findings.--
       ``(1) In general.--If the petitioner in an action under 
     subsection (a)(1) applies to the court for leave to adduce 
     additional data, views, or arguments respecting the 
     regulation or order being reviewed and shows to the 
     satisfaction of the court that such additional data, views, 
     or arguments are material and that there were reasonable 
     grounds for the petitioner's failure to adduce such data, 
     views, or arguments in the proceedings before the Secretary, 
     the court may order the Secretary to provide additional 
     opportunity for the oral presentation of data, views, or 
     arguments and for written submissions.
       ``(2) Modification of or additional findings.--The 
     Secretary may modify the Secretary's findings, or make new 
     findings by reason of the additional data, views, or 
     arguments under paragraph (1) and shall file with the court 
     such modified or new findings, and the Secretary's 
     recommendation, if any, for the modification or setting aside 
     of the regulation or order being reviewed, with the return of 
     such additional data, views, or arguments.
       ``(c) Standard of Review.--Upon the filing of the petition 
     under subsection (a) for judicial review of a regulation or 
     order, the court shall have jurisdiction to review the 
     regulation or order in accordance with chapter 7 of title 5, 
     United States Code, and to grant appropriate relief, 
     including interim relief, as provided in such chapter. A 
     regulation or order described in paragraph (1) or (2) of 
     subsection (a) shall not be affirmed if it is found to be 
     unsupported by substantial evidence on the record taken as a 
     whole.
       ``(d) Finality of Judgment.--The judgment of the court 
     affirming or setting aside, in whole or in part, any 
     regulation or order shall be final, subject to review by the 
     Supreme Court of the United States upon certiorari or 
     certification, as provided in section 1254 of title 28, 
     United States Code.
       ``(e) Other Remedies.--The remedies provided for in this 
     section shall be in addition to and not in lieu of any other 
     remedies provided by law.
       ``(f) Regulations and Orders Must Recite Basis in Record.--
     To facilitate judicial review under this section or under any 
     other provision of law or a regulation or order issued under 
     section 906, 907, 908, 909, 910, or 914, each such regulation 
     or order shall contain a statement of the reasons for its 
     issuance and the basis, in the record of the proceedings held 
     in connection with its issuance, for its issuance.

     ``SEC. 912. POSTMARKET SURVEILLANCE.

       ``(a) Discretionary Surveillance.--The Secretary may 
     require a tobacco product manufacturer to conduct postmarket 
     surveillance for a tobacco product of the manufacturer if the 
     Secretary determines that postmarket surveillance of the 
     tobacco product is necessary to protect the public health or 
     is necessary to provide information regarding the health 
     risks and other safety issues involving the tobacco product.
       ``(b) Surveillance Approval.--Each tobacco product 
     manufacturer required to conduct a surveillance of a tobacco 
     product under subsection (a) shall, within 30 days after 
     receiving notice that the manufacturer is required to conduct 
     such surveillance, submit, for the approval of the Secretary, 
     a protocol for the required surveillance. The Secretary, 
     within 60 days of the receipt of such protocol, shall 
     determine if the principal investigator proposed to be used 
     in the surveillance has sufficient qualifications and 
     experience to conduct such surveillance and if such protocol 
     will result in collection of useful data or other information 
     necessary to protect the public health. The Secretary may not 
     approve such a protocol until it has been reviewed by an 
     appropriately qualified scientific and technical review 
     committee established by the Secretary.

     ``SEC. 913. REDUCED RISK TOBACCO PRODUCTS.

       ``(a) Requirements.--
       ``(1) In general.--For purposes of this section, the term 
     `reduced risk tobacco product' means a tobacco product 
     designated by the Secretary under paragraph (2).
       ``(2) Designation.--
       ``(A) In general.--A product may be designated by the 
     Secretary as a reduced risk tobacco product if the Secretary 
     finds that the product will significantly reduce harm to 
     individuals caused by a tobacco product and is otherwise 
     appropriate to protect public health, based on an application 
     submitted by the manufacturer of the product (or other 
     responsible person) that--
       ``(i) demonstrates through testing on animals and short-
     term human testing that use of such product results in 
     ingestion or inhalation of a substantially lower yield of 
     toxic substances than use of conventional tobacco products; 
     and
       ``(ii) if required by the Secretary, includes studies of 
     the long-term health effects of the product.

     If such studies are required, the manufacturer may consult 
     with the Secretary regarding protocols for conducting the 
     studies.
       ``(B) Basis for finding.--In making the finding under 
     subparagraph (A), the Secretary shall take into account--
       ``(i) the risks and benefits to the population as a whole, 
     including both users of tobacco products and non-users of 
     tobacco products;
       ``(ii) the increased or decreased likelihood that existing 
     users of tobacco products will stop using such products 
     including reduced risk tobacco products;
       ``(iii) the increased or decreased likelihood that those 
     who do not use tobacco products will start to use such 
     products, including reduced risk tobacco products; and
       ``(iv) the risks and benefits to consumers from the use of 
     a reduced risk tobacco product as compared to the use of 
     products approved under chapter V to reduce exposure to 
     tobacco.
       ``(3) Marketing requirements.--A tobacco product may be 
     marketed and labeled as a reduced risk tobacco product if 
     it--
       ``(A) has been designated as a reduced risk tobacco product 
     by the Secretary under paragraph (2);
       ``(B) bears a label prescribed by the Secretary concerning 
     the product's contribution to reducing harm to health; and
       ``(C) complies with requirements prescribed by the 
     Secretary relating to marketing and advertising of the 
     product, and other provisions of this chapter as prescribed 
     by the Secretary.
       ``(b) Revocation of Designation.--At any time after the 
     date on which a tobacco product is designated as a reduced 
     risk tobacco product under this section the Secretary may, 
     after providing an opportunity for an informal hearing, 
     revoke such designation if the Secretary determines, based on 
     information not available at the time of the designation, 
     that--
       ``(1) the finding made under subsection (a)(2) is no longer 
     valid; or
       ``(2) the product is being marketed in violation of 
     subsection (a)(3).
       ``(c) Limitation.--A tobacco product that is designated as 
     a reduced risk tobacco product that is in compliance with 
     subsection (a) shall not be regulated as a drug or device.
       ``(d) Development of Reduced Risk Tobacco Product 
     Technology.--A tobacco product manufacturer shall provide 
     written notice to the Secretary upon the development or 
     acquisition by the manufacturer of any technology that would 
     reduce the risk of a tobacco product to the health of the 
     user for which the manufacturer is not seeking designation as 
     a `reduced risk tobacco product' under subsection (a).

     ``SEC. 914. EQUAL TREATMENT OF RETAIL OUTLETS.

       ``The Secretary shall issue regulations to require that 
     retail establishments for which the predominant business is 
     the sale of tobacco products comply with any advertising 
     restrictions applicable to retail establishments accessible 
     to individuals under the age of 18.

     ``SEC. 915. JURISDICTION OF AND COORDINATION WITH THE FEDERAL 
                   TRADE COMMISSION.

       ``(a) Jurisdiction.--
       ``(1) In general.--Except where expressly provided in this 
     chapter, nothing in this chapter shall be construed as 
     limiting or diminishing the authority of the Federal Trade 
     Commission to enforce the laws under its jurisdiction with 
     respect to the advertising, sale, or distribution of tobacco 
     products.
       ``(2) Enforcement.--Any advertising that violates this 
     chapter or a provision of the regulations referred to in 
     section 102 of the Youth Smoking Prevention and Public Health 
     Protection Act, is an unfair or deceptive act or practice 
     under section 5(a) of the Federal Trade Commission Act (15 
     U.S.C. 45(a)) and shall be considered a violation of a rule 
     promulgated under section 18 of that Act (15 U.S.C. 57a).
       ``(b) Coordination.--With respect to the requirements of 
     section 4 of the Federal Cigarette Labeling and Advertising 
     Act (15 U.S.C.

[[Page S5610]]

     1333) and section 3 of the Comprehensive Smokeless Tobacco 
     Health Education Act of 1986 (15 U.S.C. 4402)--
       ``(1) the Chairman of the Federal Trade Commission shall 
     coordinate with the Secretary concerning the enforcement of 
     such Act as such enforcement relates to unfair or deceptive 
     acts or practices in the advertising of cigarettes or 
     smokeless tobacco; and
       ``(2) the Secretary shall consult with the Chairman of such 
     Commission in revising the label statements and requirements 
     under such sections.

     ``SEC. 916. CONGRESSIONAL REVIEW PROVISIONS.

       ``In accordance with section 801 of title 5, United States 
     Code, the Congress shall review, and may disapprove, any rule 
     under this chapter that is subject to section 801. This 
     section does not apply to the regulations referred to in 
     section 102 of the Youth Smoking Prevention and Public Health 
     Protection Act.

     ``SEC. 917. REGULATION REQUIREMENT.

       ``(a) Testing, Reporting, and Disclosure.--Not later than 
     24 months after the date of enactment of the Youth Smoking 
     Prevention and Public Health Protection Act, the Secretary, 
     acting through the Commissioner of the Food and Drug 
     Administration, shall promulgate regulations under this Act 
     that meet the requirements of subsection (b).
       ``(b) Contents of Rules.--The regulations promulgated under 
     subsection (a) shall require the testing, reporting, and 
     disclosure of tobacco product smoke constituents and 
     ingredients that the Secretary determines should be disclosed 
     to the public in order to protect the public health. Such 
     constituents shall include tar, nicotine, carbon monoxide, 
     and such other smoke constituents or ingredients as the 
     Secretary may determine to be appropriate. The regulations 
     may require that tobacco product manufacturers, packagers, or 
     importers make such disclosures relating to tar and nicotine 
     through labels or advertising, and make such disclosures 
     regarding other smoke constituents or ingredients as the 
     Secretary determines are necessary to protect the public 
     health.
       ``(c) Authority.--The Food and Drug Administration shall 
     have the authority under this chapter to conduct or to 
     require the testing, reporting, or disclosure of tobacco 
     product smoke constituents.

     ``SEC. 918. PRESERVATION OF STATE AND LOCAL AUTHORITY.

       ``(a) Additional Requirements.--
       ``(1) In general.--Except as provided in paragraph (2), 
     nothing in this chapter, or rules promulgated under this 
     chapter, shall be construed to limit the authority of a 
     Federal agency (including the Armed Forces), a State or 
     political subdivision of a State, or the government of an 
     Indian tribe to enact, adopt, promulgate, and enforce any 
     law, rule, regulation, or other measure with respect to 
     tobacco products, including laws, rules, regulations, or 
     other measures relating to or prohibiting the sale, 
     distribution, possession, exposure to, or use of tobacco 
     products by individuals of any age that are in addition to, 
     or more stringent than, requirements established under this 
     chapter. No provision of this chapter shall limit or 
     otherwise affect any State, Tribal, or local taxation of 
     tobacco products.
       ``(2) Preemption of certain state and local requirements.--
       ``(A) In general.--Except as provided in subparagraph (B), 
     no State or political subdivision of a State may establish or 
     continue in effect with respect to a tobacco product any 
     requirement which is different from, or in addition to, any 
     requirement applicable under the provisions of this chapter 
     relating to performance standards, premarket approval, 
     adulteration, misbranding, registration, reporting, good 
     manufacturing standards, or reduced risk products.
       ``(B) Exception.--Subparagraph (A) does not apply to 
     requirements relating to the sale, use, or distribution of a 
     tobacco product including requirements related to the access 
     to, and the advertising and promotion of, a tobacco product.
       ``(b) Additional Restrictions on Underage Usage.--Nothing 
     in this chapter shall be construed to prevent a Federal 
     agency (including the Armed Forces), a State or a political 
     subdivision of a State, or the government of an Indian tribe 
     from adopting and enforcing additional measures that further 
     restrict or prohibit tobacco product sale to, use by, and 
     accessibility to individuals under the legal age of 
     purchase established by such agency, State, subdivision, 
     or government of an Indian tribe.
       ``(c) No Less Stringent.--Nothing in this chapter is 
     intended to supersede any State, local, or Tribal law that is 
     not less stringent than this chapter.
       ``(d) Rule of Construction Regarding Product Liability.--No 
     provision of this chapter relating to a tobacco product shall 
     be construed to modify or otherwise affect any action or the 
     liability of any person under the product liability law of 
     any State.
       ``(e) Waivers.--Upon the application of a State or 
     political subdivision thereof, the Secretary may, by 
     regulation promulgated after notice and an opportunity for an 
     oral hearing, exempt from subsection (a), under such 
     conditions as may be prescribed in such regulation, a 
     requirement of such State or political subdivision applicable 
     to a tobacco product if--
       ``(1) the requirement is more stringent than a requirement 
     applicable under the provisions described in subsection 
     (a)(1) which would be applicable to the tobacco product if an 
     exemption were not in effect under this subsection; or
       ``(2) the requirement--
       ``(A) is required by compelling local conditions; and
       ``(B) compliance with the requirement would not cause the 
     tobacco product to be in violation of any applicable 
     requirement of this chapter.

     ``SEC. 919. TOBACCO PRODUCTS SCIENTIFIC ADVISORY COMMITTEE.

       ``(a) Establishment.--Not later than 1 year after the date 
     of enactment of the Youth Smoking Prevention and Public 
     Health Protection Act, the Secretary shall establish a 9-
     member advisory committee, to be known as the `Tobacco 
     Products Scientific Advisory Committee'.
       ``(b) Membership.--
       ``(1) In general.--The Secretary shall appoint as members 
     of the Tobacco Products Scientific Advisory Committee 
     individuals who are technically qualified by training and 
     experience in the medicine, medical ethics, science, or 
     technology involving the manufacture, evaluation, or use of 
     tobacco products, who are of appropriately diversified 
     professional backgrounds. The committee shall be composed 
     of--
       ``(A) 3 individuals who are officers or employees of a 
     State or local government, or of the Federal government;
       ``(B) 2 individuals as representatives of interests of the 
     tobacco manufacturing industry;
       ``(C) 2 individuals as representatives of interests of 
     physicians and other health care professionals; and
       ``(D) 2 individuals as representatives of the general 
     public.
       ``(2) Limitation.--The Secretary may not appoint to the 
     Advisory Committee any individual who is in the regular full-
     time employ of the Food and Drug Administration or any agency 
     responsible for the enforcement of this Act. The Secretary 
     may appoint Federal officials as ex-officio members.
       ``(3) Chairperson.--The Secretary shall designate 1 of the 
     members of the Advisory Committee to serve as chairperson.
       ``(c) Duties.--The Tobacco Products Scientific Advisory 
     Committee shall provide advice, information, and 
     recommendations to the Secretary--
       ``(1) as provided in this chapter;
       ``(2) on the effects of the alteration of the nicotine 
     yields from tobacco products;
       ``(3) on whether there is a threshold level below which 
     nicotine yields do not produce dependence on the tobacco 
     product involved; and
       ``(4) on its review of other safety, dependence, or health 
     issues relating to tobacco products as requested by the 
     Secretary.
       ``(d) Compensation; Support; FACA.--
       ``(1) Compensation and travel.--Members of the Advisory 
     Committee who are not officers or employees of the United 
     States, while attending conferences or meetings of the 
     committee or otherwise engaged in its business, shall be 
     entitled to receive compensation at rates to be fixed by the 
     Secretary, which may not exceed the daily equivalent of the 
     rate in effect for level 4 of the Senior Executive Schedule 
     under section 5382 of title 5, United States Code, for each 
     day (including travel time) they are so engaged; and while so 
     serving away from their homes or regular places of business 
     each member may be allowed travel expenses, including per 
     diem in lieu of subsistence, as authorized by section 5703 of 
     title 5, United States Code, for persons in the Government 
     service employed intermittently.
       ``(2) Administrative support.--The Secretary shall furnish 
     the Advisory Committee clerical and other assistance.
       ``(3) Nonapplication of faca.--Section 14 of the Federal 
     Advisory Committee Act (5 U.S.C. App.) does not apply to the 
     Advisory Committee.
       ``(e) Proceedings of Advisory Panels and Committees.--The 
     Advisory Committee shall make and maintain a transcript of 
     any proceeding of the panel or committee. Each such panel and 
     committee shall delete from any transcript made under this 
     subsection information which is exempt from disclosure under 
     section 552(b) of title 5, United States Code.''.

     SEC. 102. CONSTRUCTION OF CURRENT REGULATIONS.

       (a) In General.--The final regulations promulgated by the 
     Secretary of Health and Human Services in the August 28, 
     1996, issue of the Federal Register (62 Fed. Reg. 44615-44618 
     beginning at ``part 897'') are hereby deemed to be lawful and 
     shall have the same legal force and effect as if such 
     regulations had been lawfully promulgated by the Secretary 
     under chapter IX and section 701 of the Federal Food, Drug, 
     and Cosmetic Act (as amended by this Act). Not later than 30 
     days after the date of enactment of this Act, the Secretary 
     shall republish such regulations in the Federal Register. 
     Such regulations shall take effect on the date that is 12 
     months after such date of enactment, except that the 
     Secretary may designate an earlier effective date. The 
     Secretary shall amend the designation of authority in such 
     regulations in accordance with this subsection.
       (b) Limitation on Advisory Opinions.--As of the date of 
     enactment of this Act, the following documents issued by the 
     Food and Drug Administration shall not constitute advisory 
     opinions under section 10.85(d)(1) of title 21, Code of 
     Federal Regulations, except as they apply to tobacco 
     products, and shall not be cited by the Secretary of Health 
     and Human Services or the Food and Drug Administration as 
     binding precedent:

[[Page S5611]]

       (1) The preamble to the proposed rule in the document 
     entitled ``Regulations Restricting the Sale and Distribution 
     of Cigarettes and Smokeless Tobacco Products to Protect 
     Children and Adolescents'' (60 Fed. Reg. 41314-41372 (August 
     11, 1995)).
       (2) The document entitled ``Nicotine in Cigarettes and 
     Smokeless Tobacco Products is a Drug and These Products Are 
     Nicotine Delivery Devices Under the Federal Food, Drug, and 
     Cosmetic Act'' (60 Fed. Reg. 41453-41787 (August 11, 1995)).
       (3) The preamble to the final rule in the document entitled 
     ``Regulations Restricting the Sale and Distribution of 
     Cigarettes and Smokeless Tobacco to Protect Children and 
     Adolescents'' (61 Fed. Reg. 44396-44615 (August 28, 1996)).
       (4) The document entitled ``Nicotine in Cigarettes and 
     Smokeless Tobacco is a Drug and These Products are Nicotine 
     Delivery Devices Under the Federal Food, Drug, and Cosmetic 
     Act; Jurisdictional Determination'' (61 Fed. Reg. 44619-45318 
     (August 28, 1996)).

     SEC. 103. CONFORMING AND OTHER AMENDMENTS TO GENERAL 
                   PROVISIONS.

       (a) Amendment of Federal Food, Drug, and Cosmetic Act.--
     Except as otherwise expressly provided, whenever in this 
     section an amendment is expressed in terms of an amendment 
     to, or repeal of, a section or other provision, the reference 
     is to a section or other provision of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 301 et seq.).
       (b) Section 301.--Section 301 (21 U.S.C. 331) is amended--
       (1) in subsection (a), by inserting ``tobacco product,'' 
     after ``device,'';
       (2) in subsection (b), by inserting ``tobacco product,'' 
     after ``device,'';
       (3) in subsection (c), by inserting ``tobacco product,'' 
     after ``device,'';
       (4) in subsection (e), by striking ``515(f), or 519'' and 
     inserting ``515(f), 519, or 909'';
       (5) in subsection (g), by inserting ``tobacco product,'' 
     after ``device,'';
       (6) in subsection (h), by inserting ``tobacco product,'' 
     after ``device,'';
       (7) in subsection (j), by striking ``708, or 721'' and 
     inserting ``708, 721, 904, 905, 906, 907, 908, or 909'';
       (8) in subsection (k), by inserting ``tobacco product,'' 
     after ``device,'';
       (9) by striking subsection (p) and inserting the following:
       ``(p) The failure to register in accordance with section 
     510 or 905, the failure to provide any information required 
     by section 510(j), 510(k), 905(i), or 905(j), or the failure 
     to provide a notice required by section 510(j)(2) or 
     905(j)(2).'';
       (10) by striking subsection (q)(1) and inserting the 
     following:
       ``(q)(1) The failure or refusal--
       ``(A) to comply with any requirement prescribed under 
     section 518, 520(g), 906(f), or 908;
       ``(B) to furnish any notification or other material or 
     information required by or under section 519, 520(g), 904, 
     906(f), or 909; or
       ``(C) to comply with a requirement under section 522 or 
     912.'';
       (11) in subsection (q)(2), by striking ``device,'' and 
     inserting ``device or tobacco product,'';
       (12) in subsection (r), by inserting ``or tobacco product'' 
     after ``device'' each time that it appears; and
       (13) by adding at the end the following:
       ``(aa) The sale of tobacco products in violation of a no-
     tobacco-sale order issued under section 303(f).''.
       (c) Section 303.--Section 303(f) (21 U.S.C. 333(f)) is 
     amended--
       (1) by striking the subsection heading and inserting the 
     following:
       ``(f) Civil Penalties; No-Tobacco-Sale Orders.--'';
       (2) in paragraph (1)(A), by inserting ``or tobacco 
     products'' after ``devices'';
       (3) by redesignating paragraphs (3), (4), and (5) as 
     paragraphs (4), (5), and (6), and inserting after paragraph 
     (2) the following:
       ``(3) If the Secretary finds that a person has committed 
     repeated violations of restrictions promulgated under section 
     906(d) at a particular retail outlet then the Secretary may 
     impose a no-tobacco-sale order on that person prohibiting the 
     sale of tobacco products in that outlet. A no-tobacco-sale 
     order may be imposed with a civil penalty under paragraph 
     (1).'';
       (4) in paragraph (4) as so redesignated--
       (A) in subparagraph (A)--
       (i) by striking ``assessed'' the first time it appears and 
     inserting ``assessed, or a no-tobacco-sale order may be 
     imposed,''; and
       (ii) by striking ``penalty'' and inserting ``penalty, or 
     upon whom a no-tobacco-order is to be imposed,'';
       (B) in subparagraph (B)--
       (i) by inserting after ``penalty,'' the following: ``or the 
     period to be covered by a no-tobacco-sale order,''; and
       (ii) by adding at the end the following: ``A no-tobacco-
     sale order permanently prohibiting an individual retail 
     outlet from selling tobacco products shall include provisions 
     that allow the outlet, after a specified period of time, to 
     request that the Secretary compromise, modify, or terminate 
     the order.''; and
       (C) by adding at the end, the following:
       ``(D) The Secretary may compromise, modify, or terminate, 
     with or without conditions, any no-tobacco-sale order.'';
       (5) in paragraph (5) as so redesignated--
       (A) by striking ``(3)(A)'' as redesignated, and inserting 
     ``(4)(A)'';
       (B) by inserting ``or the imposition of a no-tobacco-sale 
     order'' after ``penalty'' the first 2 places it appears; and
       (C) by striking ``issued.'' and inserting ``issued, or on 
     which the no-tobacco-sale order was imposed, as the case may 
     be.''; and
       (6) in paragraph (6), as so redesignated, by striking 
     ``paragraph (4)'' each place it appears and inserting 
     ``paragraph (5)''.
       (d) Section 304.--Section 304 (21 U.S.C. 334) is amended--
       (1) in subsection (a)(2)--
       (A) by striking ``and'' before ``(D)''; and
       (B) by striking ``device.'' and inserting the following: 
     ``, (E) Any adulterated or misbranded tobacco product.'';
       (2) in subsection (d)(1), by inserting ``tobacco product,'' 
     after ``device,'';
       (3) in subsection (g)(1), by inserting ``or tobacco 
     product'' after ``device'' each place it appears; and
       (4) in subsection (g)(2)(A), by inserting ``or tobacco 
     product'' after ``device'' each place it appears.
       (e) Section 702.--Section 702(a) (21 U.S.C. 372(a)) is 
     amended--
       (1) by inserting ``(1)'' after ``(a)''; and
       (2) by adding at the end thereof the following:
       ``(2) For a tobacco product, to the extent feasible, the 
     Secretary shall contract with the States in accordance with 
     paragraph (1) to carry out inspections of retailers in 
     connection with the enforcement of this Act.''.
       (f) Section 703.--Section 703 (21 U.S.C. 373) is amended--
       (1) by inserting ``tobacco product,'' after ``device,'' 
     each place it appears; and
       (2) by inserting ``tobacco products,'' after ``devices,'' 
     each place it appears.
       (g) Section 704.--Section 704 (21 U.S.C. 374) is amended--
       (1) in subsection (a)(1)(A), by inserting ``tobacco 
     products,'' after ``devices,'' each place it appears;
       (2) in subsection (a)(1)(B), by inserting ``or tobacco 
     product'' after ``restricted devices'' each place it appears; 
     and
       (3) in subsection (b), by inserting ``tobacco product,'' 
     after ``device,''.
       (h) Section 705.--Section 705(b) (21 U.S.C. 375(b)) is 
     amended by inserting ``tobacco products,'' after 
     ``devices,''.
       (i) Section 709.--Section 709 (21 U.S.C. 379) is amended by 
     inserting ``or tobacco product'' after ``device''.
       (j) Section 801.--Section 801 (21 U.S.C. 381) is amended--
       (1) in subsection (a)--
       (A) by inserting ``tobacco products,'' after ``devices,'' 
     the first time it appears;
       (B) by inserting ``or subsection (j) of section 905'' after 
     ``section 510''; and
       (C) by striking ``drugs or devices'' each time it appears 
     and inserting ``drugs, devices, or tobacco products'';
       (2) in subsection (e)--
       (A) in paragraph (1), by inserting ``tobacco product,'' 
     after ``device,''; and
       (B) by redesignating paragraph (4) as paragraph (5) and 
     inserting after paragraph (3), the following:
       ``(4) Paragraph (1) does not apply to any tobacco product--
       ``(A) which does not comply with an applicable requirement 
     of section 907 or 910; or
       ``(B) which under section 906(f) is exempt from either such 
     section.

     This paragraph does not apply if the Secretary has determined 
     that the exportation of the tobacco product is not contrary 
     to the public health and safety and has the approval of the 
     country to which it is intended for export or the tobacco 
     product is eligible for export under section 802.''.
       (k) Section 802.--Section 802 (21 U.S.C. 382) is amended--
       (1) in subsection (a), by striking ``device--'' and 
     inserting ``device or tobacco product--'';
       (2) in subsection (a)(1)(C), by striking ``and'' after the 
     semicolon;
       (3) in subsection (a)(2), by striking subparagraph (C) and 
     all that follows in that subsection and inserting the 
     following:
       ``(C) is a banned device under section 516; or
       ``(3) which, in the case of a tobacco product--
       ``(A) does not comply with an applicable requirement of 
     section 907 or 910; or
       ``(B) under section 906(f) is exempt from either such 
     section,

     is adulterated, misbranded, and in violation of such sections 
     or Act unless the export of the drug, device, or tobacco 
     product is, except as provided in subsection (f), authorized 
     under subsection (b), (c), (d), or (e) of this section or 
     section 801(e)(2) or 801(e)(4). If a drug, device, or tobacco 
     product described in paragraph (1), (2), or (3) may be 
     exported under subsection (b) and if an application for such 
     drug or device under section 505, 515, or 910 of this Act or 
     section 351 of the Public Health Service Act (42 U.S.C. 262) 
     was disapproved, the Secretary shall notify the appropriate 
     public health official of the country to which such drug, 
     device, or tobacco product will be exported of such 
     disapproval.'';
       (4) in subsection (b)(1)(A), by inserting ``or tobacco 
     product'' after ``device'' each time it appears;
       (5) in subsection (c), by inserting ``or tobacco product'' 
     after ``device'' and inserting ``or section 906(f)'' after 
     ``520(g).'';
       (6) in subsection (f), by inserting ``or tobacco product'' 
     after ``device'' each time it appears; and
       (7) in subsection (g), by inserting ``or tobacco product'' 
     after ``device'' each time it appears.

[[Page S5612]]

       (l) Section 1003.--Section 1003(d)(2)(C) (as redesignated 
     by section 101(a)) is amended--
       (1) by striking ``and'' after ``cosmetics,''; and
       (2) inserting a comma and ``and tobacco products'' after 
     ``devices''.
       (m) Effective Date for No-Tobacco-Sale Order Amendments.--
     The amendments made by subsection (c), other than the 
     amendment made by paragraph (2) of such subsection, shall 
     take effect only upon the promulgation of final regulations 
     by the Secretary of Health and Human Services--
       (1) defining the term ``repeated violation'', as used in 
     section 303(f) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 333(f)) as amended by subsection (c), by 
     identifying the number of violations of particular 
     requirements over a specified period of time that constitute 
     a repeated violation;
       (2) providing for notice to the retailer of each violation 
     at a particular retail outlet;
       (3) providing that a person may not be charged with a 
     violation at a particular retail outlet unless the Secretary 
     has provided notice to the retailer of all previous 
     violations at that outlet;
       (4) establishing a period of time during which, if there 
     are no violations by a particular retail outlet, that outlet 
     will not considered to have been the site of repeated 
     violations when the next violation occurs; and
       (5) providing that good faith reliance on false 
     identification does not constitute a violation of any minimum 
     age requirement for the sale of tobacco products.

  TITLE II--TOBACCO PRODUCT WARNINGS AND SMOKE CONSTITUENT DISCLOSURE

     SEC. 201. CIGARETTE LABEL AND ADVERTISING WARNINGS.

       (a) In General.--Section 4 of the Federal Cigarette 
     Labeling and Advertising Act (15 U.S.C. 1333) is amended to 
     read as follows:

     ``SEC. 4. LABELING.

       ``(a) Label Requirements.--
       ``(1) In general.--It shall be unlawful for any person to 
     manufacture, package, or import for sale or distribution 
     within the United States any cigarettes the package of which 
     fails to bear, in accordance with the requirements of this 
     section, one of the following labels:
     ``WARNING: Cigarettes are addictive''
     ``WARNING: Tobacco smoke can harm your children''
     ``WARNING: Cigarettes cause fatal lung disease''
     ``WARNING: Cigarettes cause cancer''
     ``WARNING: Cigarettes cause strokes and heart disease''
     ``WARNING: Smoking during pregnancy can harm your baby''
     ``WARNING: Smoking can kill you''
     ``WARNING: Tobacco smoke causes fatal lung disease in non-
     smokers''
     ``WARNING: Quitting smoking now greatly reduces serious risks 
     to your health''
       ``(2) Placement; typography; etc.--
       ``(A) In general.--Each label statement required by 
     paragraph (1) shall be located in the upper portion of the 
     front and rear panels of the package, directly on the package 
     underneath the cellophane or other clear wrapping. Except as 
     provided in subparagraph (B), each label statement shall 
     comprise at least the top 25 percent of the front and rear 
     panels of the package. The word ``WARNING'' shall appear in 
     capital letters and all text shall be in conspicuous and 
     legible 17-point type, unless the text of the label statement 
     would occupy more than 70 percent of such area, in which case 
     the text may be in a smaller conspicuous and legible type 
     size, provided that at least 60 percent of such area is 
     occupied by required text. The text shall be black on a white 
     background, or white on a black background, in a manner that 
     contrasts, by typography, layout, or color, with all other 
     printed material on the package, in an alternating fashion 
     under the plan submitted under subsection (b)(4).
       ``(B) Flip-top boxes.--For any cigarette brand package 
     manufactured or distributed before January 1, 2000, which 
     employs a flip-top style (if such packaging was used for that 
     brand in commerce prior to June 21, 1997), the label 
     statement required by paragraph (1) shall be located on the 
     flip-top area of the package, even if such area is less than 
     25 percent of the area of the front panel. Except as provided 
     in this paragraph, the provisions of this subsection shall 
     apply to such packages.
       ``(3) Does not apply to foreign distribution.--The 
     provisions of this subsection do not apply to a tobacco 
     product manufacturer or distributor of cigarettes which does 
     not manufacture, package, or import cigarettes for sale or 
     distribution within the United States.
       ``(b) Advertising Requirements.--
       ``(1) In general.--It shall be unlawful for any tobacco 
     product manufacturer, importer, distributor, or retailer of 
     cigarettes to advertise or cause to be advertised within the 
     United States any cigarette unless its advertising bears, in 
     accordance with the requirements of this section, one of the 
     labels specified in subsection (a) of this section.
       ``(2) Typography, etc.--Each label statement required by 
     subsection (a) of this section in cigarette advertising shall 
     comply with the standards set forth in this paragraph. For 
     press and poster advertisements, each such statement and 
     (where applicable) any required statement relating to tar, 
     nicotine, or other constituent yield shall comprise at least 
     20 percent of the area of the advertisement and shall appear 
     in a conspicuous and prominent format and location at the top 
     of each advertisement within the trim area. The Secretary may 
     revise the required type sizes in such area in such manner as 
     the Secretary determines appropriate. The word ``WARNING'' 
     shall appear in capital letters, and each label statement 
     shall appear in conspicuous and legible type. The text of the 
     label statement shall be black if the background is white and 
     white if the background is black, under the plan submitted 
     under paragraph (4) of this subsection. The label statements 
     shall be enclosed by a rectangular border that is the same 
     color as the letters of the statements and that is the width 
     of the first downstroke of the capital ``W'' of the word 
     ``WARNING'' in the label statements. The text of such label 
     statements shall be in a typeface pro rata to the following 
     requirements: 45-point type for a whole-page broadsheet 
     newspaper advertisement; 39-point type for a half-page 
     broadsheet newspaper advertisement; 39-point type for a 
     whole-page tabloid newspaper advertisement; 27-point type for 
     a half-page tabloid newspaper advertisement; 31.5-point type 
     for a double page spread magazine or whole-page magazine 
     advertisement; 22.5-point type for a 28 centimeter by 3 
     column advertisement; and 15-point type for a 20 centimeter 
     by 2 column advertisement. The label statements shall be in 
     English, except that in the case of--
       ``(A) an advertisement that appears in a newspaper, 
     magazine, periodical, or other publication that is not in 
     English, the statements shall appear in the predominant 
     language of the publication; and
       ``(B) in the case of any other advertisement that is not in 
     English, the statements shall appear in the same language as 
     that principally used in the advertisement.
       ``(3) Adjustment by secretary.--The Secretary may, through 
     a rulemaking under section 553 of title 5, United States 
     Code, adjust the format and type sizes for the label 
     statements required by this section or the text, format, and 
     type sizes of any required tar, nicotine yield, or other 
     constituent disclosures, or to establish the text, format, 
     and type sizes for any other disclosures required under the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et. 
     seq.). The text of any such label statements or disclosures 
     shall be required to appear only within the  20 percent area 
     of cigarette advertisements provided by paragraph (2) of 
     this subsection. The Secretary shall promulgate 
     regulations which provide for adjustments in the format 
     and type sizes of any text required to appear in such area 
     to ensure that the total text required to appear by law 
     will fit within such area.
       ``(4) Marketing requirements.--
       ``(A) The label statements specified in subsection (a)(1) 
     shall be randomly displayed in each 12-month period, in as 
     equal a number of times as is possible on each brand of the 
     product and be randomly distributed in all areas of the 
     United States in which the product is marketed in accordance 
     with a plan submitted by the tobacco product manufacturer, 
     importer, distributor, or retailer and approved by the 
     Secretary.
       ``(B) The label statements specified in subsection (a)(1) 
     shall be rotated quarterly in alternating sequence in 
     advertisements for each brand of cigarettes in accordance 
     with a plan submitted by the tobacco product manufacturer, 
     importer, distributor, or retailer to, and approved by, the 
     Secretary.
       ``(C) The Secretary shall review each plan submitted under 
     subparagraph (B) and approve it if the plan--
       ``(i) will provide for the equal distribution and display 
     on packaging and the rotation required in advertising under 
     this subsection; and
       ``(ii) assures that all of the labels required under this 
     section will be displayed by the tobacco product 
     manufacturer, importer, distributor, or retailer at the same 
     time.''.
       (b) Repeal of Prohibition on State Restriction.--Section 5 
     of the Federal Cigarette Labeling and Advertising Act (15 
     U.S.C. 1334) is amended--
       (1) by striking ``(a) Additional Statements.--'' in 
     subsection (a); and
       (2) by striking subsection (b).

     SEC. 202. AUTHORITY TO REVISE CIGARETTE WARNING LABEL 
                   STATEMENTS.

       Section 4 of the Federal Cigarette Labeling and Advertising 
     Act ( 15 U.S.C. 1333), as amended by section 301 of this 
     title, is further amended by adding at the end the following:
       ``(c) Change in Required Statements.--The Secretary may, by 
     a rulemaking conducted under section 553 of title 5, United 
     States Code, adjust the format, type size, and text of any of 
     the warning label statements required by subsection (a) of 
     this section, or establish the format, type size, and text of 
     any other disclosures required under the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 301 et seq.), if the Secretary 
     finds that such a change would promote greater public 
     understanding of the risks associated with the use of tobacco 
     products.''.

     SEC. 203. SMOKELESS TOBACCO LABELS AND ADVERTISING WARNINGS.

       Section 3 of the Comprehensive Smokeless Tobacco Health 
     Education Act of 1986 (15 U.S.C. 4402) is amended to read as 
     follows:

     ``SEC. 3. SMOKELESS TOBACCO WARNING.

       ``(a) General Rule.--
       ``(1) It shall be unlawful for any person to manufacture, 
     package, or import for sale or distribution within the United 
     States any smokeless tobacco product unless the product 
     package bears, in accordance with the requirements of this 
     Act, one of the following labels:

[[Page S5613]]

     ``WARNING: This product can cause mouth cancer''
     ``WARNING: This product can cause gum disease and tooth 
     loss''
     ``WARNING: This product is not a safe alternative to 
     cigarettes''
     ``WARNING: Smokeless tobacco is addic-tive''
       ``(2) Each label statement required by paragraph (1) shall 
     be--
       ``(A) located on the 2 principal display panels of the 
     package, and each label statement shall comprise at least 25 
     percent of each such display panel; and
       ``(B) in 17-point conspicuous and legible type and in black 
     text on a white background, or white text on a black 
     background, in a manner that contrasts by typography, layout, 
     or color, with all other printed material on the package, in 
     an alternating fashion under the plan submitted under 
     subsection (b)(3), except that if the text of a label 
     statement would occupy more than 70 percent of the area 
     specified by subparagraph (A), such text may appear in a 
     smaller type size, so long as at least 60 percent of such 
     warning area is occupied by the label statement.
       ``(3) The label statements required by paragraph (1) shall 
     be introduced by each tobacco product manufacturer, packager, 
     importer, distributor, or retailer of smokeless tobacco 
     products concurrently into the distribution chain of such 
     products.
       ``(4) The provisions of this subsection do not apply to a 
     tobacco product manufacturer or distributor of any smokeless 
     tobacco product that does not manufacture, package, or import 
     smokeless tobacco products for sale or distribution within 
     the United States.
       ``(b) Required Labels.--
       ``(1) It shall be unlawful for any tobacco product 
     manufacturer, packager, importer, distributor, or retailer of 
     smokeless tobacco products to advertise or cause to be 
     advertised within the United States any smokeless tobacco 
     product unless its advertising bears, in accordance with the 
     requirements of this section, one of the labels specified in 
     subsection (a).
       ``(2) Each label statement required by subsection (a) in 
     smokeless tobacco advertising shall comply with the standards 
     set forth in this paragraph. For press and poster 
     advertisements, each such statement and (where applicable) 
     any required  statement relating to tar, nicotine, or other 
     constituent yield shall--
       ``(A) comprise at least 20 percent of the area of the 
     advertisement, and the warning area shall be delineated by a 
     dividing line of contrasting color from the advertisement; 
     and
       ``(B) the word ``WARNING'' shall appear in capital letters 
     and each label statement shall appear in conspicuous and 
     legible type. The text of the label statement shall be black 
     on a white background, or white on a black background, in an 
     alternating fashion under the plan submitted under paragraph 
     (3).
       ``(3)(A) The label statements specified in subsection 
     (a)(1) shall be randomly displayed in each 12-month period, 
     in as equal a number of times as is possible on each brand of 
     the product and be randomly distributed in all areas of the 
     United States in which the product is marketed in accordance 
     with a plan submitted by the tobacco product manufacturer, 
     importer, distributor, or retailer and approved by the 
     Secretary.
       ``(B) The label statements specified in subsection (a)(1) 
     shall be rotated quarterly in alternating sequence in 
     advertisements for each brand of smokeless tobacco product in 
     accordance with a plan submitted by the tobacco product 
     manufacturer, importer, distributor, or retailer to, and 
     approved by, the Secretary.
       ``(C) The Secretary shall review each plan submitted under 
     subparagraph (B) and approve it if the plan--
       ``(i) will provide for the equal distribution and display 
     on packaging and the rotation required in advertising under 
     this subsection; and
       ``(ii) assures that all of the labels required under this 
     section will be displayed by the tobacco product 
     manufacturer, importer, distributor, or retailer at the same 
     time.
       ``(c) Television and Radio Advertising.--It is unlawful to 
     advertise smokeless tobacco on any medium of electronic 
     communications subject to the jurisdiction of the Federal 
     Communications Commission.''.

     SEC. 204. AUTHORITY TO REVISE SMOKELESS TOBACCO PRODUCT 
                   WARNING LABEL STATEMENTS.

       Section 3 of, as amended by section 303 of this title, is 
     further amended by adding at the end the following:
       ``(d) Authority To Revise Warning Label Statements.--The 
     Secretary may, by a rulemaking conducted under section 553 of 
     title 5, United States Code, adjust the format, type size, 
     and text of any of the warning label statements required by 
     subsection (a) of this section, or establish the format, type 
     size, and text of any other disclosures required under the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), 
     if the Secretary finds that such a change would promote 
     greater public understanding of the risks associated with the 
     use of smokeless tobacco products.''.

     SEC. 205. TAR, NICOTINE, AND OTHER SMOKE CONSTITUENT 
                   DISCLOSURE TO THE PUBLIC.

       Section 4(a) of the Federal Cigarette Labeling and 
     Advertising Act (15 U.S.C. 1333 (a)), as amended by section 
     301 of this title, is further amended by adding at the end 
     the following:
       ``(4)(A) The Secretary shall, by a rulemaking conducted 
     under section 553 of title 5, United States Code, determine 
     (in the Secretary's sole discretion) whether cigarette and 
     other tobacco product manufacturers shall be required to 
     include in the area of each cigarette advertisement specified 
     by subsection (b) of this section, or on the package label, 
     or both, the tar and nicotine yields of the advertised or 
     packaged brand. Any such disclosure shall be in accordance 
     with the methodology established under such regulations, 
     shall conform to the type size requirements of subsection (b) 
     of this section, and shall appear within the area specified 
     in subsection (b) of this section.
       ``(B) Any differences between the requirements established 
     by the Secretary under subparagraph (A) and tar and nicotine 
     yield reporting requirements established by the Federal Trade 
     Commission shall be resolved by a memorandum of understanding 
     between the Secretary and the Federal Trade Commission.
       ``(C) In addition to the disclosures required by 
     subparagraph (A) of this paragraph, the Secretary may, under 
     a rulemaking conducted under section 553 of title 5, United 
     States Code, prescribe disclosure requirements regarding the 
     level of any cigarette or other tobacco product smoke 
     constituent. Any such disclosure may be required if the 
     Secretary determines that disclosure would be of benefit to 
     the public health, or otherwise would increase consumer 
     awareness of the health consequences of the use of tobacco 
     products, except that no such prescribed disclosure shall be 
     required on the face of any cigarette package or 
     advertisement. Nothing in this section shall prohibit the 
     Secretary from requiring such prescribed disclosure through a 
     cigarette or other tobacco product package or advertisement 
     insert, or by any other means under the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 301 et seq.).''.

                          ____________________