[Congressional Record Volume 146, Number 38 (Thursday, March 30, 2000)]
[Senate]
[Pages S1990-S1993]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. REED (for himself and Mr. Bingaman):
  S. 2333. A bill to amend the Federal Food, Drug, and Cosmetic Act to 
grant the Food and Drug Administration the authority to regulate the 
manufacture, sale, and distribution of tobacco and other products 
containing nicotine, tar, additives, and other potentially harmful 
constituents and for other purposes; to the Committee on Health, 
Education, Labor, and Pensions.


                TOBACCO REGULATORY FAIRNESS ACT OF 2000

 Mr. REED. Mr. President, I rise today to introduce legislation 
with my distinguished colleague, Senator Bingaman, that we hope will 
mark the beginning of a dialogue on an issue that has tremendous 
implications for our nation's public health, and more specifically, the 
health and well-being of our children. Today, we are introducing the 
``Tobacco Regulatory Fairness Act of 2000''.
  The goal of this legislation is quite simple--to grant the Food and 
Drug Administration (FDA) the authority it needs to regulate the 
manufacture, labeling, advertising, distribution and sale of tobacco 
products.
  A week ago, the Supreme Court ruled 5 to 4 that the FDA does not have 
the authority to regulate tobacco products, thus nullifying regulations 
promulgated by the agency in August 1996.

[[Page S1991]]

 While a slim majority of the court found that the agency lacked the 
jurisdiction necessary to act on this class of products, the Justices 
in the majority and minority both opinions acknowledged the clear 
threat unregulated tobacco products poses to public health. In the 
majority opinion, Justice Sandra Day O'Connor stated that tobacco was 
``perhaps the single most significant threat to public health in the 
United States.'' Similarly, Justice Stephen G. Breyer, a former 
professor of mine at Harvard University School of Law, pointed out in 
the dissenting opinion that FDA's ability to regulate tobacco products 
clearly fit into its basic authority, ``the overall protection of the 
public health.''
  Although the court upheld the 1998 ruling by the United States Court 
of Appeals for the Fourth Circuit, the decision does not dispute, and, 
in fact, it reaffirms that the FDA is the most appropriate agency to 
regulate tobacco products, given the general scope of its authority and 
its emphasis on protecting the public health. Now, it is a matter of 
Congress taking action to clearly give the FDA the long overdue 
authority it requires.
  So today, I introduce this legislation as a challenge to my 
colleagues to do what is right--to debate and pass legislation that 
will once and for all give FDA the tools it needs to enact regulations 
that will help to protect children and others from the dangers of 
tobacco.
  After the long and protracted debate in the Senate two years ago on 
the McCain tobacco bill, I am sure that most of my colleagues are 
familiar with the numerous statistics that are often cited in relation 
to the dangers of smoking and its devastating impact on society in 
terms of health care costs, lost productivity, disability, and loss of 
life. However, I believe these figures bear repeating. It is estimated 
that today, some 50 million Americans are addicted to tobacco, and one 
out of every three long-term users will die from a disease related to 
their tobacco use.
  The cost of tobacco use not only results in lives lost, but also has 
a considerable toll on health care expenses. It is estimated that the 
health care costs associated with treating tobacco-related disease 
totals over $80 billion a year--with almost half being paid for by 
taxpayer financed health care programs.
  We also know that tobacco addiction is clearly a problem that starts 
with children: almost 90 percent of adult smokers started using tobacco 
at or before age 18. Each year, one million children become regular 
smokers--and one-third of them will die prematurely of lung cancer, 
emphysema, and similar tobacco caused diseases. Unless current trends 
are reversed, five million kids under 18 alive today will die from 
tobacco related diseases.
  In Rhode Island, while overall cigarette use is declining slightly, 
it has increased by more than 25 percent among high-schoolers. 
Currently, over one-third of New England high school students under age 
18 use tobacco products. In Rhode Island, over one third of high school 
students smoke.
  Indeed, tobacco use continues to permeate the ranks of the young. For 
decades, the tobacco industry has ingeniously promoted its products. It 
has done so with total disregard for the health of its customers. It 
has relied upon cool, youthful images to sell its products. The tobacco 
industry has taken an addiction that prematurely kills and dressed it 
up as a glamorous symbol of success and sex appeal.
  By providing the FDA with the appropriate and unambiguous authority, 
we can be assured that these products comply with minimum health and 
safety standards. Tobacco should be regulated in the same way every 
other product we consume is regulated.
  I will concede that there are some formidable challenges ahead--but 
these challenges are not insurmountable. During the 1998 debate on the 
McCain tobacco bill, a majority of my colleagues on both sides of the 
aisle agreed our country needed a national tobacco control policy. 
While we may not have succeeded then, we cannot and must not allow the 
progress the FDA has made in limiting minors' access to tobacco be 
lost.
  We all know that tobacco is a substance that not only reduces the 
quality of one's life in the short term, but with lifelong use results 
in untimely death. We have an opportunity this year to make a real 
difference. Through the legislation I am introducing today, I call my 
colleagues to action in the ongoing fight to protect the long term 
health of the children of this country.
  I urge my colleagues to join me in this commitment to enacting 
legislation granting FDA the authority to regulate tobacco products.
  Mr. President, I ask unanimous consent to have 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. 2333

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

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Tobacco Regulatory Fairness 
     Act of 2000''.

     SEC. 2. FINDINGS.

       Congress makes the following findings:
       (1) Cigarette smoking and tobacco use cause approximately 
     450,000 deaths each year in the United States.
       (2) Cigarette smoking accounts for approximately 
     $65,000,000,000 in lost productivity and health care costs.
       (3) In spite of the well-established dangers of cigarette 
     smoking and tobacco use, there is no Federal agency that has 
     any authority to regulate the manufacture, sale, 
     distribution, and use of tobacco products.
       (4) The tobacco industry spends approximately 
     $4,000,000,000 each year to promote tobacco products.
       (5) Each day 3,000 children try cigarettes for the first 
     time, many of whom become lifelong addicted smokers.
       (6) There is no minimum age requirement in Federal law that 
     an individual must reach to legally buy cigarettes and other 
     tobacco products.
       (7) The Food and Drug Administration is the most qualified 
     Federal agency to regulate tobacco products.
       (8) It is inconsistent for the Food and Drug Administration 
     to regulate the manufacture, sale, and distribution of other 
     nicotine-containing products used as substitutes for 
     cigarette smoking and tobacco use and not be able to regulate 
     tobacco products in a comparable manner.

     SEC. 3. DEFINITIONS.

       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 cigarettes, cigars, 
     little cigars, pipe tobacco, smokeless tobacco, snuff, and 
     chewing tobacco.
       ``(ll) The term `tobacco additive' means any substance the 
     intended use of which results or may reasonably be expected 
     to result, directly or indirectly, in its becoming a 
     component or otherwise affecting the characteristics of any 
     tobacco product.
       ``(mm) The term `constituent' means any element of 
     cigarette mainstream or sidestream smoke which is present in 
     quantities which represent a potential health hazard or where 
     the health effect is unknown.
       ``(nn) The term `tar' means mainstream total articulate 
     matter minus nicotine and water.''.

     SEC. 4. ENFORCEMENT.

       Section 301 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 331) is amended--
       (1) in subsections (a), (b), (c), (g), and (k), by striking 
     ``or cosmetic'' and inserting ``cosmetic, or tobacco 
     product''; and
       (2) by adding at the end the following:
       ``(u) The manufacture, sale, distribution, and advertising 
     of tobacco products in violation of regulations promulgated 
     by the Secretary pursuant to chapter X.''.

     SEC. 5. REGULATION OF TOBACCO PRODUCTS.

       The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
     seq.) is amended by adding at the end the following:

                     ``CHAPTER X--TOBACCO PRODUCTS

     ``SEC. 1000. REGULATION OF TOBACCO PRODUCTS.

       ``(a) Regulations.--Not later than 1 year after the date on 
     which the Secretary receives the recommendations described in 
     section 1003(f), the Secretary shall promulgate regulations 
     governing the manufacture, sale, and distribution of tobacco 
     products in accordance with the provisions of the chapter.
       ``(b) Food and Drug Administration.--Regulations 
     promulgated under subsection (a) shall designate the Food and 
     Drug Administration as the Federal agency that regulates the 
     manufacture, distribution, and sale of tobacco products.
       ``(c) Limitation.--Regulations promulgated under subsection 
     (a) may not prohibit the manufacture, distribution, or sale 
     of a tobacco product solely on the basis that such product 
     causes a disease.
       ``(d) Sale or distribution.--Under regulations promulgated 
     under subsection (a) it shall be unlawful to--
       ``(1) sell a tobacco product to an individual under the age 
     of 18 years;
       ``(2) sell a tobacco product to an individual if such 
     tobacco product is intended for use by an individual under 
     the age of 18 years; and
       ``(3) sell or distribute a tobacco product if the label of 
     such product does not display the following statement: 
     `Federal Law Prohibits Sale To Minors'.
       ``(e) Manufacturing.--Regulations promulgated under 
     subsection (a) governing the manufacture of tobacco products 
     shall--

[[Page S1992]]

       ``(1) require that all additives used in the manufacture of 
     tobacco products are safe; and
       ``(2) classify as a drug any nicotine-containing product 
     that does not meet the definition of a tobacco product.

     ``SEC. 1001. ADULTERATED TOBACCO PRODUCTS.

       ``(a) In general.--A tobacco product shall be deemed to be 
     adulterated--
       ``(1) if such product 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 such product injurious to health;
       ``(2) if such product has been prepared, packed, or held 
     under insanitary conditions in which such product may have 
     been contaminated with filth, or in which such product may 
     have been rendered injurious to health; and
       ``(3) if the container for such product is composed, in 
     whole or in part, of any poisonous or deleterious substance 
     that may render the contents of such product injurious to 
     health.
       ``(b) Regulations.--The Secretary may by regulation 
     prescribe good manufacturing practices for tobacco products. 
     Such regulations may be modeled after current good 
     manufacturing practice regulations for other products 
     regulated under this Act.

     ``SEC. 1002. MISBRANDED TOBACCO PRODUCTS.

       ``A tobacco product shall be deemed to be misbranded--
       ``(1) if the labeling of such product is false or 
     misleading in any particular;
       ``(2) if in package form unless such product bears a label 
     containing--
       ``(A) the name and place of business of the tobacco product 
     manufacturer, packer, or distributor; and
       ``(B) an accurate statement of the quantity of the contents 
     in terms of weight, measure, or numerical count,
     except that under subparagraph (B) of this paragraph 
     reasonable variations shall be permitted, and exemptions as 
     to small packages shall be established, by regulations 
     promulgated 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 such product has an established name, unless its 
     label bears, to the exclusion of any other nonproprietary 
     name, its established name is prominently printed in type as 
     required by the Secretary by regulation;
       ``(5) if the Secretary has issued regulations requiring 
     that the labeling of such product bear adequate directions 
     for use, or adequate warnings against use by children, that 
     are necessary for the protection of users unless the labeling 
     of such product conforms in all respects to such regulations; 
     and
       ``(6) if such product was manufactured, prepared, 
     propagated, or processed in an establishment not duly 
     registered as required under section 1004.

     ``SEC. 1003. ADVISORY COMMITTEE.

       ``(a) Establishment.--There is established in the Food and 
     Drug Administration a Tobacco and Nicotine Products Advisory 
     Committee (hereafter referred to as the `advisory 
     committee').
       ``(b) Purpose.--The advisory committee shall assist the 
     Secretary in developing the regulations described in section 
     1000.
       ``(c) Membership.--
       ``(1) In general.--Not later than 60 days after the date of 
     enactment of this chapter, the Secretary shall appoint to the 
     advisory committee 10 individuals who are qualified by 
     training and experience to evaluate and make recommendations 
     regarding regulations governing the manufacture, 
     distribution, sale, labeling and advertising of tobacco 
     products.
       ``(2) Experts.--The members described under paragraph (1), 
     not including the chairperson of such advisory committee, 
     shall consist of--
       ``(A) one expert in the field of nicotine addiction;
       ``(B) one expert in the field of pharmacology;
       ``(C) one expert in the field of food and drug law;
       ``(D) one expert in the field of public education;
       ``(E) one expert in the field of toxicology;
       ``(F) two experts representing the interests of family 
     medicine, internal medicine, or pediatrics; and
       ``(G) two consumer representatives from the public health 
     community.
       ``(3) Ex officio.--The advisory committee shall have the 
     following as ex officio members:
       ``(A) The Director of the National Cancer Institute.
       ``(B) The Director of the National Heart, Lung, and Blood 
     Institute.
       ``(C) The Director of National Institute on Drug Abuse.
       ``(D) The Director of the Centers for Disease Control and 
     Prevention.
       ``(E) The Surgeon General of the Public Health Service.
       ``(4) Chairperson.--The chairperson of the advisory 
     committee shall be appointed by the Secretary with the advice 
     and consent of the Commissioner of Food and Drugs.
       ``(d) Function.--The advisory committee shall--
       ``(1) review the available scientific evidence on the 
     effects of tobacco products on human health;
       ``(2) review the manufacturing process of tobacco products, 
     including the use of additives, sprayed on chemicals, product 
     development, and product manipulation;
       ``(3) review the role of nicotine as part of the smoking 
     habit, including its addictive properties and health effects; 
     and
       ``(4) review current Federal, State, and local laws 
     governing the manufacture, distribution, sale, labeling and 
     advertising of tobacco products.
       ``(e) Authority.--The advisory committee may hold hearings 
     and receive testimony and evidence as the committee 
     determines to be appropriate.
       ``(f) Recommendations.--Not later than 1 year after the 
     Secretary has appointed all members to the advisory 
     committee, such committee shall prepare and submit 
     recommendations regarding regulations to be promulgated under 
     section 1000 to the Secretary.

     ``SEC. 1004. REGISTRATION.

       ``Not later than 120 days after the date of enactment of 
     this chapter, any manufacturer directly or indirectly engaged 
     in the manufacture, distribution, or sale of tobacco products 
     shall register with the Secretary the name and place of 
     business of such manufacturer.

     ``SEC. 1005. ADVERTISING.

       ``(a) Regulations.--The Federal Trade Commission, after 
     consultation with the Secretary and upon receipt of approval 
     by the Secretary, shall promulgate regulations governing the 
     advertising of all tobacco products.
       ``(b) Labels.--The Federal Trade Commission, after 
     consultation with the Secretary and upon receipt of approval 
     by the Secretary, may promulgate regulations that--
       ``(1) modify the warning labels required by the Federal 
     Cigarette Labeling and Advertising Act (15 U.S.C. 1331 et 
     seq.) and the Comprehensive Smokeless Tobacco Health 
     Education Act of 1986 (15 U.S.C. 4401 et seq.) if the 
     modification in the content of the label does not weaken the 
     health message contained in the label and is in the best 
     interests of the public health as determined by the 
     Secretary; and
       ``(2) increase the size and placement of such required 
     labels.''.

     SEC. 6. CONFORMING AMENDMENTS.

       (a) Records.--Section 703 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 373) is amended--
       (1) by striking ``or cosmetics'' each place it appears and 
     inserting ``cosmetics, or tobacco products''; and
       (2) by striking ``or cosmetic'' each place it appears and 
     inserting ``cosmetic, or tobacco product''.
       (b) Factory Inspections.--Section 704 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 374) is amended--
       (1) in subsection (a)(1)--
       (A) by striking ``or cosmetics'' each place it appears and 
     inserting ``cosmetics, or tobacco products''; and
       (B) by striking ``or restricted devices'' each place it 
     appears and inserting ``restricted devices, or tobacco 
     products''; and
       (2) in subsection (b), by striking ``or cosmetic'' and 
     inserting ``cosmetic, or tobacco product''.

 Mr. BINGAMAN. Mr. President, today I am very proud to be here 
with my friend and colleague, Senator Jack Reed, to introduce the 
Tobacco Regulation Fairness Act of 2000.
  I urge all of my colleagues in the Senate to join this effort, for it 
is time for Congress to take action. We must ensure that the Food and 
Drug Administration can regulate the manufacture, labeling, 
advertising, distribution and sale of tobacco products.
  While many are disappointed with last week's Supreme Court ruling on 
FDA regulation of tobacco products, the ruling reflects reality. 
Congress has not acted to give FDA the authority it needs to regulate 
tobacco products. The Supreme Court's decision underscores this fact 
and heightens the need for Congress to pass meaningful and 
comprehensive legislation to ensure FDA authority over tobacco 
products.
  This legislation is the key to preventing tobacco use by teenagers 
and adolescents and to preventing the sales of tobacco products to 
children. If we can prevent kids from smoking, we can head off a 
tremendous amount of human disease and suffering, medical costs, and 
loss of life. While even tobacco companies say that they are against 
kids smoking, we must look at the facts. According to the American 
Cancer Society, in the course of this Congress, almost 600,000 children 
will try tobacco products for the first time. Of those, nearly 200,000 
will become addicted to nicotine. Additionally, over more than 90,000 
people will die from tobacco related cancers.
  In 1997, a study by the Center for Disease Control showed that 
children and adolescents were able to buy tobacco products 67 percent 
of the times they

[[Page S1993]]

tried. The CDC found that most young smokers were able to buy their own 
cigarettes and were seldom asked for identification. While strides have 
been made in the past 2 years, it is imperative that change continue. 
The bottom line is that the Supreme Court made its decision and 
Congress must act so that we can continue to make inroads into youth 
smoking prevention.
  Mr. President, this legislation designates the Food and Drug 
Administration as the Federal agency that regulates the manufacture, 
distribution and sale of tobacco products. This Act will serve to 
provide the Secretary of Health and Human Services with the authority 
to promulgate regulations governing the manufacture, sale and 
distribution of tobacco products. Additionally, the legislation also 
establishes a federal minimum age of sale of tobacco products of 18 and 
require the label to state ``Federal Law Prohibits Sale to Minors.''
  Mr. President, in 1989 and again in 1992, I introduced a bill to 
require the Food and Drug Administration to regulate the manufacture 
and sale of tobacco products. ``The Tobacco Health and Safety Act of 
1992'' had a companion bill with Representative Michael Synar in the 
House. These bills were very similar legislative attempts to regulate 
tobacco by bringing it under the jurisdiction of the Federal Food and 
Drug Administration.
  I believed then and I believe now that the FDA is the appropriate 
regulatory entity to address this vital issue. To do anything else is 
unacceptable. It is time to give the FDA the full authority to regulate 
the manufacture, sale, labeling, advertising, and promotion of tobacco 
products.
  The bill we introduce today is a fair and equitable approach to the 
issue. It represents a strong commitment to health promotion and 
disease prevention. I urge my colleagues to support this bill and work 
with us to act upon this as a public health issue before we adjourn 
this year.
                                 ______