| Total Program Resources (FY 2000): | $000 | FTEs | |
| 68,000 | 40 |
Smoking is the leading preventable cause of death in the United States. Every year, another one million young people become regular smokers and one-third of them will eventually die prematurely as a result of their smoking. The average teenage smoker starts smoking at 14 ½ years of age and becomes a daily smoker by the age of 18.
Tobacco products are responsible for more than 400,000 deaths annually due to cancer, respiratory illness, heart disease, and other health problems. According to the Centers for Disease Control and Prevention (CDC), health care costs associated with smoking soared to more than $50 billion in 1993.
The Tobacco Program seeks to promote and protect the health of our nation's youth by reducing the number of young people who begin to use and become addicted to tobacco products each year. FDA's long-term goal is a 50 percent decline in young people's use of tobacco within seven years of program implementation. To help reach this goal, FDA will work with other organizations within the Department of Health and Human Services (DHHS) such as the Substance Abuse & Mental Health Services Administration (SAMHSA), CDC, and the National Cancer Institute (NCI).
FDA's role is threefold: enforcement and evaluation, compliance outreach, and product regulation. FDA's overall goals are to reduce the access and appeal of tobacco products to young people, to enlist retailers' and other stakeholders' assistance in these efforts, and to develop regulatory procedures for cigarettes and smokeless tobacco products. FDA's efforts are supported by and coordinated with activities in other agencies within DHHS. For example, SAMHSA uses its authority to withhold substance abuse grants to states that do not achieve required access compliance rates by retailers and also conducts surveys to gather information about tobacco use. CDC's Office of Smoking and Health is primarily involved with public education, research, and surveys. Finally, NCI is also involved in research and education programs. FDA will utilize data gathered by these agencies to both carry out and evaluate its tobacco program. FDA will also work closely with state governments, especially in its enforcement role. The ultimate goal of these combined and coordinated efforts will be a significant reduction of tobacco use by young people.
On April 25, 1997, the District Court in Greensboro, North Carolina, ruled that FDA has jurisdiction under the Federal, Food, Drug and Cosmetic Act (FD&C Act) to regulate nicotine-containing cigarettes and smokeless tobacco as drug delivery devices. The Court upheld all restrictions involving youth access and labeling and struck down, as unsupported by statutory authority, the Agency's advertising restrictions. The Court stayed implementation of all provisions, except those involving age and ID, pending appeal. Appeal was taken and oral argument was held in August 1997 and reargued on June 9, 1998 in the Fourth Circuit Court of Appeals. On August 13, 1998, the Fourth Circuit issued its decision, finding the FDA's assertion of jurisdiction and issuance of regulations invalid. The government is seeking review of this decision by the Supreme Court. Pending the Supreme Court's review (or decision not to hear the case), the Court of Appeals' mandate is stayed and the Agency is continuing to enforce the age and ID provisions.
| Resources: | $42,000,000 | 29 FTEs |
Performance Goals:
Rationale:
To achieve a reduction in the addiction to and death from the use of tobacco products by young people, FDA's rule attempts to limit the availability and appeal of tobacco products to young people. The rule limits the access that young people have to tobacco products by setting a minimum age of purchase at 18, requiring that retailers check a photo identification of all customers under the age of 27 when purchasing tobacco, banning self-service and vending machine sales, and banning free samples. The rule would limit the appeal of these products by imposing stringent restrictions on most advertising media including banning outdoor advertising within 1000 feet of schools and public playgrounds, limiting most print advertising to a black and white text only format, banning all non-tobacco items identified with a tobacco brand and banning brand name sponsorship of sporting and entertainment events.
Approaches, Skills, Technology, and External Factors:
FDA enforces the access restrictions currently in effect primarily through the commissioning of state and local regulatory officials, who conduct unannounced purchase attempts using young people under the age of 18. In FY 2000, the Agency intends to expand its enforcement efforts to have commissioned agents inspect every identified retail outlet at least once every other year (assuming there are 500,000 retailers) and reinspect each violative retailer within three months after notifying the retailer of the violation or after adjudication of civil money penalty. The Agency also intends to establish its own enforcement program in those states that are unable or unwilling to contract with the Agency. If all provisions of the rule are in effect, FDA will also check retailer compliance with the prohibitions against self-service displays, vending machines and certain types of advertising.
Under the current enforcement plan, retailers who do not sell tobacco products to the minor receive a letter informing them that they are in compliance with the rule. Those who do sell to the minor receive a letter informing them that they have violated the rule, and that another compliance check may occur in the near future. If on the second purchase attempt the retailer sells to the minor, the Agency seeks a $250 civil money penalty. Penalties escalate for subsequent violations of the access restrictions in effect: third violation-$1500; fourth violation- $5000; fifth violation- $10,000. In FY 1999, FDA began investigations of retailers who have been found to have already violated the rule twice. The Agency anticipates seeking civil money penalties for third violations within the first quarter of FY 1999. A penalty schedule for violations of other portions of the regulation will be developed when these provisions go into effect.
In FY 2000, the Agency intends to expand its enforcement program by inspecting 400,000 retailers each year, as opposed to the 200,000 inspected yearly with FY 1998 and FY 1999 money. Because the Agency is unable to inspect all known retailers each year, it will use some of its FY 2000 budget to create targeted demonstration-enforcement areas. Although the vast majority of inspections will be distributed randomly within each state, the targeted demonstration areas will be subject to more intense outreach and enforcement efforts in an attempt to measure the effectiveness of different mixes of interventions and levels of effort on sales of tobacco products to minors. These projects will allow the Agency to plan for more effective use of its enforcement dollars in the future. In addition, assuming other parts of the tobacco regulation are in effect, the Agency will increase the investigators' responsibilities during each check to include checking on the removal of vending machines and self-service displays and illegal advertising. Fewer compliance checks will result if the additional provisions of the rule go into effect because longer and more complicated checks will be required.
The Agency has begun analyzing methods to monitor industry compliance with the restrictions on advertising even though these provisions are not yet in effect. For example, the tobacco rule prohibits all outdoor advertising within 1,000 feet of schools and playgrounds, as measured from the perimeter of the property. FDA has looked at satellite or computer mapping technology as an aid in determining the appropriate 1000-foot area around schools and public playgrounds. This technology can then be made available to state and local government agencies as well as to private groups who can report violations to FDA. Similarly, the tobacco rule requires that all advertising appear in black and white text-only format except in publications read primarily by adults, as measured by a percentage and gross number of adult readers. FDA has met with industry officials in an attempt to identify an appropriate methodology for measuring adult and youth readership of publications.
Performance Goals, Data Sources, and Baselines:
Goal Statement: Conduct 400,000 compliance checks and select certain sites to target for intensified enforcement efforts to determine the effectiveness of different levels of effort.
Data Sources: FDA Tobacco database
Baseline Data:
FY 1997:
Conducted 6,464 compliance checks under a pilot program in 10 states (about 1.3% to 2.6% of the estimated 500,000 to one million retailers of cigarettes
and smokeless tobacco products).
FY 1998:
FDA conducted approximately 39,439 compliance checks in FY 1998 and contracted to have approximately 189,000 compliance checks performed
by September 1999 with FY 1998 funding.
FY 1999:
In FY 1999, the FDA will contract to have 200,000 compliance checks performed. In FY 1998, FDA entered into contracts with 41 states, the District of
Columbia and the Virgin Islands. FDA will use federal investigators to perform the compliance checks in any state that does not sign a contract with the Agency.
Goal Statement: Conduct follow-up compliance checks of 100 percent of retailers found to be in violation of the rule.
Data Sources: FDA Tobacco database
Baseline Data: Baseline data is being developed as the compliance check program is being implemented.
Goal Statement: Ensure the elimination of certain forms of advertising, especially outdoor advertising within 1000 feet of schools and playgrounds (including transit advertising) and specialty item distribution such as hats and tee shirts with tobacco logos.
Data Sources: Federal Trade Commission industry-wide data on advertising expenditures
Baseline Data:
Dollars spent on advertising:
Cigarette advertising, 1996:
Specialty item distribution: $544,345,000
Outdoor: 292,261,000
Transit: 28,865,000
Total: $865,471,000
Smokeless tobacco advertising, 1995:
Distribution bearing names (specialty items): $9,915,589
Outdoor: 1,474,121
Total: $11,389,710
| Resources: | $22,000,000 | 6 FTEs |
Performance Goals:
Rationale:
A strong outreach program is one of the most effective ways to increase awareness of and compliance with FDA's restrictions. Currently, the rule requires retailers to check photo identification of every customer under the age of 27 to ensure that no cigarettes or smokeless tobacco products are sold to anyone under the age of 18. Eventually, retailers who operate stores that are accessible to individuals under the age of 18 will have to remove all products from self-service displays and vending machines and relocate them to an area under the retailers control, and to remove illegal advertising. In most cases, retailers will not know all the details of the restrictions that have been placed upon their sale of tobacco. To make it easier for the retailer to understand the new restrictions as well as to enhance compliance with the rules, outreach efforts should be as comprehensive as possible. Moreover, the materials and efforts made to reach retailers should be as useful and informative as possible.
Approaches, Skills, Technology, and External Factors:
FDA uses a multitude of media and approaches to ensure the greatest reach and utility of its messages. FDA maintains a toll free hot line and an Internet site, which permit easy access to answers for frequently asked questions; brochures; and materials. Stores are mailed retailer kits, which include explanations of the requirements, and posters and materials which help explain the rules to customers and assist in defusing customer anger or anxiety. In addition, advertising is placed on radio, in newspapers, and on billboards reminding retailers of their responsibility. These materials are regularly updated and mailed to new retailers or retailers who request the information. In FY 1999, FDA will develop and launch a revised retailer campaign which will build on the increases in retailer knowledge and awareness achieved during 1998. In FY 2000, FDA will continue to update and modestly expand its outreach activities to achieve greater coverage.
FDA is conducting a national advertising campaign aimed at raising retailers' awareness of the new regulations and motivating them to comply. The campaign's primary target audience is managers and clerks in stores that sell tobacco. The campaign was first introduced in FY 1998 in one media market in one state for a four-week period. A survey was conducted in two markets each in ten states (one treatment and one control) to assess the effect of the media campaign in raising retailer awareness of and compliance with the regulations. A total of 2000 managers and clerks were surveyed immediately prior to the campaign and another 2000 were surveyed after the campaign. The data have been collected and are analyzed. FDA intends to continue measuring the effectiveness of its outreach efforts in this manner and to compare results over time.
Performance Goals, Data Sources, and Baselines:
Goal Statement: Maintain the percentage of known retailers of cigarettes and smokeless tobacco products who are aware of the FDA tobacco rule at no less than 90 percent and increase the percentage of retailers who understand the age and ID provisions of the rule to 50 percent.
Data Sources: FDA sponsored surveys of known retailers of cigarettes and smokeless tobacco products to determine awareness and attitude changes.
Baseline Data: A survey was tested in two markets each in ten states in FY 1998. The results are analyzed and will be used to develop baseline data. Based on this limited survey of retailers:
Goal Statement: Promote availability of free FDA retailer information kits, used to remind customers and young people about the requirements of the FDA tobacco rule, to at least 400,000 retailers of cigarettes and smokeless tobacco products and provide kits to those who request them.
Data Sources: FDA tobacco database
Baseline Data: In FY 1998, approximately 400,000 retailer kits had been mailed.
| Resources: | $4,000,000 | 5 FTEs |
Performance Goal:
Rationale:
FDA is regulating cigarettes and smokeless tobacco products under the restricted medical device provisions of the Food, Drug and Cosmetic Act (FD&C Act). The FD&C Act requires that all medical devices be classified according to the level of controls necessary to provide reasonable assurance that the product will be safe and effective (see Section 513 of the FD&C Act). Depending upon the classification adopted for tobacco products, it may be appropriate for the Agency to develop performance standards which could include provisions regarding the construction, components and ingredients, and properties of the device and provisions for the testing of the device. All devices are also subject to the requirement that they conform to quality system regulations pursuant to 21 CFR, Part 820. The application of the Act's requirements to tobacco is essential to ensure that the health consequences of products or their ingredients, additives or constituents are made less harmful in order to reduce the death and disease caused by tobacco use.
Approaches, Skills, Technology, and External Factors:
In FY 1999, FDA will begin to address the immediate issues posed by new products and nicotine replacement therapies. In addition, the Agency may begin exploring the questions associated with product regulation including questions raised by classification and quality system regulations. In FY 2000, the Agency will continue the establishment of a regulatory framework necessary to properly analyze the issues related to current and new products. Specifically, it will consider convening an interdisciplinary panel from sister agencies within DHHS including, but not limited to, the National Cancer Institute, the National Heart, Lung and Blood Institute, the Office on Smoking and Health and the National Institute on Drug Abuse to consider and propose appropriate performance standards.
FDA will conduct systematic reviews and evaluations of new and established products that state or imply that they are less harmful.
In FY 2000, the Agency will begin to examine the inspection process by reviewing the practices of the tobacco companies and will continue to assist them in coming into compliance with quality system regulations.
In FY 2000, the Agency will use internal and outside experts, including personnel from sister agencies within DHHS, to begin a review and analysis of ingredients, constituents, and additives.
Performance Goals, Data Sources, and Baselines:
Goal Statement: To the fullest extent permitted under any court order, establish the scientific and regulatory framework to address the challenges posed by new and novel nicotine-containing tobacco products as well as issues raised by current products and replacement therapies.
Data Sources: Internal Agency documents will substantiate progress made.
Baseline Data: These programs have yet to be established and therefore the baseline is zero.
FDA is enforcing the restrictions on youth access that are currently in effect by training and commissioning state regulatory officials, who conduct unannounced purchase attempts using young people under the age of 18 to determine if retailers will sell to minors. The results of each attempt are faxed or mailed to FDA by the state officials. FDA has established a computerized Tobacco database to gather these results, prepare follow-up compliance check forms, send notification of the results to the retailer and ultimately, if necessary, to prepare documents to seek civil money penalties. The database will contain an inventory of retailers of cigarettes and smokeless tobacco products as they are identified. The database allows FDA to track the number of compliance checks, the number of violations (total and broken down by type of store, state, etc.), the number of civil money penalty actions, etc. The data will permit FDA to measure the progress of its enforcement program. However, the data is not statistically projectable, because it is not based on a random sampling of retailers.
In addition, a survey was conducted in two markets each in ten states (one treatment and one control) to assess the effect of the media campaign on raising retailer awareness of and compliance with the regulations. A total of 2000 managers and clerks were surveyed immediately prior to the campaign and another 2000 were surveyed after the campaign. The data have been collected and are analyzed. FDA intends to continue measuring the effectiveness of its outreach efforts in this manner and to compare results over time.
The Federal Trade Commission (FTC) collects and publishes industry-wide data on advertising expenditures by category (e.g., newspapers, outdoor advertising, specialty items). FDA intends to establish the baseline for its advertising goal from FTC data indicating levels of expenditures for each category for the base year, and measuring decreases in spending for each subsequent year. Although this data source cannot measure all of the changes required by the rule (conversion of advertising in publications to black and white text only), it should be able to document whether expenditures for banned advertising (e.g. hats and tee shirts with logos) has ceased and whether declines in expenditures are observed for heavily restricted advertising (e.g. outdoor advertising is banned within 1000 feet of schools and playgrounds and is otherwise restricted to black and white text only format). In addition, the Agency will discuss with FTC the possibility of including additional questions in their survey of company advertising expenditures to help us more accurately measure compliance with our rule.
FDA's tobacco program is not fully in effect. A court order has stayed implementation of most of the regulation. Until other parts of the rule are in effect, more elaborate measurement cannot begin. FDA is working closely with CDC's Office on Smoking and Health, SAMHSA and the Data Council of DHHS to devise and conduct surveys to measure success in reducing initiation and use of tobacco by young people. The Agency is also monitoring compliance with the rule, assessing buy rates, determining reach and effect of outreach efforts, and assessing the risks of various components of tobacco products to determine whether it is possible to reduce the overall health risks associated with tobacco products. One of the first responsibilities of the Tobacco Program following lifting of the court stay or enactment of comprehensive legislation, will be to devise and implement a surveillance mechanism to establish bench mark levels for these goals including but not limited to youth tobacco initiation and use rates and risk levels of current products and ingredients. This surveillance effort will enable the Agency to validly measure progress.
Next: Appendix 1 | Back to Table of Contents