[Congressional Record (Bound Edition), Volume 147 (2001), Part 8]
[Extensions of Remarks]
[Pages 10900-10902]
[From the U.S. Government Publishing Office, www.gpo.gov]



              NATIONAL YOUTH SMOKING REDUCTION ACT OF 2001

                                 ______
                                 

                             HON. TOM DAVIS

                              of virginia

                    in the house of representatives

                        Thursday, June 14, 2001

  Mr. DAVIS of Virginia. Mr. Speaker, I am very pleased to introduce 
the National Youth Smoking Reduction Act of 2001, which gives the Food 
and Drug Administration (FDA) comprehensive, effective authority to 
oversee the tobacco industry. As the name implies, the primary focus of 
this bill is to keep our children away from tobacco products--to 
protect them from being targeted by the tobacco industry, to keep them 
from becoming addicted, to keep them healthier and stronger without the 
detrimental effects of tobacco.
  I would especially like to thank my co-sponsors, Representatives 
Towns, Gillmor, Collin Peterson, Linder, Mark Green, Mike Doyle, 
Collins, Sweeney, Bono, Granger, Terry Ferguson, Schrock, and Grucci, 
for their leadership on this important issue.
  Where does my interest in curbing tobacco use come from? My father 
died of emphysema, and my wife is a doctor. I have three children of my 
own, and it would break my heart to see them fall prey to the marketing 
tactics that ensnare children and get them started on tobacco and down 
the road to disease and suffering. Moreover, I can see with my own eyes 
the dangers presented by tobacco use, and I believe there is a need to 
do something about the situation.
  I should note that this is not the first time I have acted against 
tobacco. Back in the mid-1980s, as a member of the Fairfax County Board 
of Supervisors, I introduced the first ordinance in the Commonwealth of 
Virginia to designate non-smoking areas in restaurants.
  I have tried to take a sensible approach to what is clearly a 
sensitive and polarizing issue. Some believe FDA has no role in 
regulating tobacco. Many would prefer FDA to have complete authority 
over tobacco, up to and including banning the use of tobacco products 
outright. I am promoting an approach that will allow FDA to take 
important steps in protecting our citizens, especially children, from 
the dangers of tobacco. However, I stop short of an abolitionist 
stance, because I believe that if an adult chooses to use tobacco 
products, he or she should legally be able to do so. If we ban tobacco 
use, or leave room for tobacco products to be altered in a way that 
makes them unacceptable to adult consumers, an illegal market to obtain 
such products will surely arise. This, ultimately, will be more harmful 
to the public health than if we never did anything at all. My bill 
leaves the authority to ban the use of tobacco products, or to 
eliminate nicotine completely from them, where that authority belongs: 
the Congress.
  In addition, my bill allows for ``reduced-risk'' tobacco products. 
This is an area I believe could be very important in weaning existing 
tobacco users from more dangerous products--making it easier for them 
to quit, or at least giving them options that are less dangerous than 
the ones they are currently using.
  I have sought to improve upon S. 190, which has been introduced in 
the other body. Like that bill, mine allows FDA to remove harmful 
substances from tobacco products, whether or not they are already on 
the market. It improves upon S. 190 by codifying the marketing and 
access restrictions found in the Master Settlement Agreement and the 
1996 FDA regulation. These restrictions will go into effect shortly 
after enactment of the bill, and will subject them to federal 
enforcement. Furthermore, my bill directs FDA to regulate descriptors, 
such as ``light'' and ``ultralight'', and allows FDA to ban their use 
if they determine them to be misleading. I have also extended my bill 
to cover ``bidis'' and other tobacco products specifically directed 
towards children.
  Mr. Speaker there are other important additions included in my bill, 
which are described in the attached section-by-section analysis. I urge 
your careful consideration of this extremely important legislation.

                The National Youth Smoking Reduction Act

       Section-by-Section Summary: The ``National Youth Smoking 
     Reduction Act of 2001,'' among other things, creates a new 
     chapter IX of the Federal Food, Drug, and Cosmetics Act 
     (FDCA) to provide explicit authority to FDA to regulate 
     tobacco products. The bill creates a separate chapter in the 
     FDCA for tobacco products and thus expressly directs FDA to 
     maintain a distinct regulatory program for tobacco products. 
     The new FDCA chapter IX for tobacco products provides for 
     comprehensive regulation of tobacco products.
       The provisions of this new FDCA tobacco products chapter 
     are based on the FDCA's device provisions, but some changes 
     were made to make the provisions more appropriate for tobacco 
     products. The most significant change is that the current 
     statutory standard of ``reasonable assurance of safety and 
     effectiveness,'' which is relied on when FDA makes a range of 
     decisions for devices, was changed to ``appropriate for the 
     protection of the public health,'' a standard which is more 
     appropriate for tobacco products.


                   FDCA CHAPTER IX--TOBACCO PRODUCTS

     Section 901--FDA authority over tobacco products
       Clarifies that nothing in chapter IX shall be construed to 
     affect the regulation of drugs and devices under chapter V 
     that are not tobacco products under the FDCA.
       Also clarifies that chapter IX does not apply to tobacco 
     leaf that is not in the possession of the manufacturer, or to 
     producers of tobacco leaf; including tobacco growers, tobacco 
     warehouses, and tobacco grower cooperatives.
       Also clarifies that FDA employees may not enter onto a farm 
     owned by a producer of tobacco leaf without the producer's 
     written consent.
     Section 902--Adulterated tobacco products, and

     Section 903--Misbranding tobacco products
       Defines the conditions under which a tobacco product will 
     be adulterated or misbranded under the FDCA, and subject to 
     enforcement action. These provisions are similar to device 
     law provisions, but are tailored to tobacco product 
     regulation.
       Section 903(b) authorizes the Secretary to require by 
     regulation the prior approval of statements made on the label 
     of a tobacco product, and explicitly states that no 
     regulation issued under this subsection may require the prior 
     approval by the Secretary of the content of any 
     advertisement. This is similar to a device law provision.
     Section 904--Submission of health information to the 
         secretary
       Within 6 months of enactment (and annually thereafter), 
     each tobacco product manufacturer or importer must, among 
     other document requirements, submit to FDA:
       All documents relating to research activities, research 
     findings, conducted, supported, or possessed by the 
     manufacturer on tobacco or tobacco-related products;
       All documents relating to research concerning the use of 
     technology to reduce health risks associated with the use of 
     tobacco; and
       All documents relating to marketing research on tobacco 
     products.
     Section 905--Annual registration
       Tobacco manufacturers are required to register each year 
     with FDA in order to provide name and place of business 
     information, as well as to provide lists of tobacco products 
     manufactured by the establishment, and other information. 
     Entities registered with FDA are subject to inspection every 
     two years.
     Section 906--General provisions respecting control of tobacco 
         products
       Provides authorities relating to the general regulation of 
     tobacco products. This section includes protections for trade 
     secret information similar to those for devices.

[[Page 10901]]

       Under Section 906(d), the FDA through regulation may 
     require that a tobacco product be restricted to sale or 
     distribution upon such conditions, 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 prevention of, or 
     decrease in, the use of tobacco products by children under 
     the age at which tobacco products may be legally purchased.
       FDA may not require that the sale or distribution of a 
     tobacco product be limited to prescription use only.
       FDA is precluded from prohibiting tobacco product sales in 
     face-to-face transactions by specific categories of retail 
     outlets (for example, a ban on sales of cigarettes by gas 
     stations).
       Under Section 906(e), the FDA is authorized to promulgate 
     regulations requiring that the methods used in, and the 
     facilities and controls used for, the manufacture, pre-
     production design validation, packing, storage, and 
     installation of a tobacco product conform to good 
     manufacturing practice (GMPs) to assure that the public 
     health is protected.
       Prior to issuing GMP regulations, FDA is to consider 
     recommendations from an advisory committee.
       The bill makes explicit that the Secretary has the 
     authority to grant either temporary or permanent exemptions 
     or variances from a GMP requirement.
     Section 907--Performance standards
       FDA may promulgate performance standards for tobacco 
     products if FDA determines that a standard is appropriate for 
     protection of the public health. This authority is 
     essentially the same as that for devices.
       A decision as to whether a performance standard would be 
     appropriate for the protection of the public health is to be 
     determined with respect to the risks and benefits to the 
     population as a whole, including users and non-users of the 
     tobacco product.
       Performance Standards must be promulgated through 
     rulemaking, and interested persons may request that a 
     proposed standard be referred by FDA to an advisory committee 
     for recommendations on scientific issues.
       Congress has the sole authority to approve any standard 
     that eliminates all cigarettes, all smokeless tobacco 
     products, or any similar class of tobacco products, or that 
     reduces nicotine to zero. Also, no performance standard can 
     render a tobacco product unacceptable for adult consumption.
     Section 908--Notification and recall authority
       Provides authority for FDA to order public notification if 
     it determines that a tobacco product presents an unreasonable 
     risk of substantial harm to public health, and such 
     notification is necessary to eliminate that unreasonable 
     risk. In addition:
       FDA may issue cease and desist orders and order recalls of 
     particular tobacco products where the Secretary finds that a 
     tobacco product contains a manufacturing or other defect that 
     is not ordinarily contained in tobacco products on the market 
     and would cause serious, adverse health consequences or 
     death.
       The section's notification and recall provisions do not 
     relieve any individual from liability under state or federal 
     law.
     Section 909--Records and reports on tobacco products
       FDA may, by regulation, require a tobacco manufacturer or 
     importer to report any information that 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.
     Section 910--Premarket review of certain tobacco products
       Provides for premarket review of new tobacco products that 
     have the potential to increase the risks to consumers from 
     conventional tobacco products being marketed at the time of 
     the application.
     Section 911--Judicial review
       This provision provides judicial review procedures beyond 
     the Administrative Procedure Act for FDA actions involving 
     performance standards and premarket approval applications. 
     This provision provides the same procedures as the parallel 
     provision in device law.
     Section 912--Reduced risk tobacco products
       This section ensures that only those products designated by 
     FDA as a ``Reduced Risk Tobacco Product'' may be marketed and 
     labeled as such.
       FDA may designate a product as a ``reduced risk tobacco 
     product'' if it finds that ``the product is demonstrated to 
     significantly reduce of harm to individuals caused by a 
     tobacco product and is otherwise appropriate to protect the 
     public health.''
       A product designated as a ``reduced risk tobacco product'' 
     is required to comply with certain marketing and labeling 
     requirements. However, the FDA shall not prohibit 
     communication that such product is a ``reduced risk tobacco 
     product.''
       FDA may revoke such designation after providing an 
     opportunity for an informal hearing.
       A manufacturer of a tobacco product is required to provide 
     written notice to FDA upon the development or acquisition of 
     any technology that would reduce the risk of such products to 
     the health of the user for which the manufacturer is not 
     seeking designation as a ``Reduced Risk Tobacco Product'' 
     under this section.
     Section 913--Preservation of state and local authority
       The section makes clear that except as expressly provided, 
     states and localities may adopt and enforce tobacco product 
     requirements that are in addition to, or more stringent than 
     requirements established under FDCA chapter IX. Where a 
     requirement of a State or locality is more stringent, the 
     requirement of the State or locality shall apply.
       No provisions of chapter IX relating to tobacco products 
     shall be construed to modify or otherwise affect any action 
     or the liability of any person under the product liability 
     laws of any State.
     Section 914--Equal treatment of retail outlets
       Directs FDA to 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.
     Section 915--Access and marketing restrictions
       Prescribes specific marketing and access restrictions for 
     tobacco products. (FDA may impose additional restrictions on 
     marketing and access pursuant to section 906(d), as described 
     above.) The requirements provided in this section track the 
     vast majority of the marketing and access restrictions 
     promulgated by FDA in its 1996 final rule, which was later 
     nullified by the Supreme Court. The requirements also 
     incorporate, with applicability to all, the marketing 
     restrictions imposed on some tobacco product manufacturers 
     under their settlement with the State Attorneys General.
       Establishes a federal minimum age of 18 for tobacco product 
     sales and requires proof of age of any individual younger 
     than 26. Authorizes FDA to contract with the states for the 
     enforcement of minimum age laws.
       Prohibits the use of vending machines and the distribution 
     of free samples of tobacco products, except in adult-only 
     facilities where minors are prohibited from entering.
       Bans tobacco advertisements in any outdoor location, in any 
     transit vehicle or facility, and in any youth-oriented 
     publication. A youth-oriented publication is defined as any 
     publication whose readers younger than 18 years of age 
     constitute more than 15 percent of total readership or that 
     is read by 2 million or more persons younger than 18 years of 
     age.
       Bans tobacco-brand-name sponsorships of any athletic, 
     musical, artistic, or other social or cultural event.
       Bans the use of cartoon characters in any tobacco 
     advertisement, promotion or labeling. Also bans manufacturers 
     from distributing branded tobacco product apparel or other 
     merchandise.
       Prohibits any action by a tobacco business that has the 
     primary purpose of encouraging tobacco use by minors or that 
     directly or indirectly targets youth in the advertising, 
     promotion, or marketing of tobacco products.
       Prohibits manufacturers from making any payment to any 
     other person for the display, reference, or use as a prop of 
     any tobacco product or tobacco product advertisement in any 
     motion picture, television show, theatrical performance, 
     music recording or performance, or video game.
     Section 916--Mandatory disclosures
       Prescribes specific disclosure requirements related to 
     tobacco product ingredients, the use of domestic and foreign 
     tobacco leaf, and the use of terms such as ``light'' or ``low 
     tar.''
       Directs FDA to issue regulations requiring the disclosure 
     to consumers of tobacco product ingredients on a brand-by-
     brand basis following the model of ingredient disclosure used 
     for foods, under which spices, flavorings, and colorings may 
     be listed as such.
       Directs FDA to issue regulations requiring the disclosure 
     on each package of tobacco product of the percentage of 
     domestic and foreign tobacco in that brand.
       Requires tobacco product manufacturers to include a 
     specific disclaimer in any advertisement which classifies a 
     tobacco product according to its tar yield or the yield to 
     consumers of any substance, such as by using terms like 
     ``light'' or ``low tar.'' The disclaimer required is: 
     ``[Brand] not shown to be less hazardous than other [type of 
     tobacco product].'' Directs FDA to promulgate additional 
     regulations relating to the use of such terms to ensure that 
     they are not false or misleading.
     Regulatory record
       For purposes of promulgating regulations pursuant to 
     section 906(d) on advertising and access, the materials 
     collected by the FDA in promulgating the 1996 regulations 
     will have the same legal status as if they had been collected 
     pursuant to this statute.

[[Page 10902]]


     Conforming and other amendments
       These amendments to the general provisions ensure that the 
     full range of compliance, enforcement, and other general 
     authorities available to FDA for other products are available 
     for tobacco products.
       Prevents FDA from restricting the sale of tobacco products 
     in face-to-face transactions to certain categories of retail 
     outlets. Allows FDA to issue, after an administrative hearing 
     before an Administrative Law Judge, a no tobacco sale order 
     prohibiting the sale of tobacco products at a particular 
     retail outlet based on repeated violations by that outlet.
       Prior to using its authority to issue a no tobacco sale 
     order, FDA must promulgate through notice-and-comment rule-
     making regulations that include a definition of the term 
     ``repeated violations,'' provisions for notice to the 
     retailer of each violation, and a provision that good faith 
     reliance on false identification does not constitute a 
     violation of any FDA minimum age requirement for the sale of 
     tobacco products.
       Amends the Federal Cigarette Labeling and Advertising Act 
     and the Comprehensive Smokeless Tobacco Health Education Act, 
     to give the FDA the responsibility for ensuring that the 
     various warning labels currently used on tobacco products 
     continue to be used as to protect public health, within 
     certain pack and advertisement size limits. FDA has the 
     authority to revise the warnings.
       In less than 2 years after enactment, the FDA shall 
     promulgate rules requiring testing, reporting, and disclosure 
     of tobacco product smoke constituents and ingredients, such 
     as tar, nicotine, and carbon monoxide, that the FDA 
     determines should be disclosed to the public in order to 
     protect the public health.

     

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