ONDCP Seal
 PolicyPolicy
IV. Agency Budget Summaries

FOOD AND DRUG ADMINISTRATION


  1. RESOURCE SUMMARY

  2. METHODOLOGY

    • The resources used in the Alcohol and Tobacco program area are determined by the active workload expended in carrying out FDA's efforts to implement the President's Executive Order calling for the regulation of nicotine - containing tobacco products.

  3. PROGRAM SUMMARY

    • As a result of an FDA regulation in 1996 restricting the sale and availability of tobacco products to minors, FDA is working to reduce the availability and appeal of tobacco products to children and teenagers and educate young people about the health risks of tobacco use. FDA's goal for this program is 50 percent decline in young people's use of tobacco over the next seven years.

    • On August 23, 1996, FDA issued its final rule for its regulations concerning nicotine-containing cigarettes and smokeless tobacco products. The final rule limits the availability of tobacco products to young people. This also limits the access that young people have to tobacco products by setting a minimum age of purchase, 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. This rule limits the appeal these products have for young people by imposing stringent advertising restrictions on most advertising media, including banning billboards within 1,000 feet of schools and playgrounds, banning all non-tobacco items identified with a tobacco brand, and banning sponsorship of events by tobacco companies.

    • FDA will develop a strong outreach program geared toward retailers, state and local health and law enforcement officials, the public and the media, as one of the most effective ways to increase compliance with the new Executive Order. Specifically, regional conferences with major organizations; distributing briefing materials to retailers informing them of their responsibilities; establishing a toll-free hotline for retailers; and, distributing information on the rule through trade publications are planned for implementation in FY 1998.

    • In addition, FDA will produce and distribute compliance policy guides to each affected industry -- manufacturers, distributors, and other affected parties. Individual outreach efforts will include the development of briefing materials and the initiation of conferences with a wide array of public health, law enforcement and other officials. Community organizations, parent groups, voluntary health groups and others will be provided information to help raise awareness of the tobacco rule and encourage compliance.

    • FDA will establish necessary training for those state and local officials who will help enforce FDA's rule. Following this training, selected state and local officials will be commissioned to conduct compliance and enforcement activities on behalf of the Agency. FDA's long term goal is a 50 percent decline in young people's use of tobacco within seven years of program implementation.

  4. BUDGET SUMMARY

    1998 Program

    Goal 1: Educate and enable America's youth to reject illegal drugs as well as the use of alcohol and tobacco.

    • The total drug control request for Goal 1 activities for FY 1998 is $34 million. The 1998 enacted level includes resources for direct regional conferences with major organizations; distributing briefing materials to retailers informing them of their responsibilities; establishment of a toll-free hotline for retailers; and providing information on the rule through trade publications.

    1999 Request

    Goal 1: Educate and enable America's youth to reject illegal drugs as well as the use of alcohol and tobacco.

    • The total drug control request for Goal 1 activities for FY 1999 is $134.0 million, a net increase of $100 million over FY 1998. The 1999 request includes the following enhancements:

      • FDA will significantly expand the outreach and enforcement activities that will be initiated in FY 1998. With increased funding of $100 million in FY 1999, FDA will see fundamental progress in all states -- in partnerships with state and local authorities -- to reduce young people's use of tobacco products.

      • Primarily, FDA will engage in three activities: Outreach, Enforcement, and Product Regulation. A sizeable portion of the funds will be provided to state and local officials who will help enforce the rule by conducting investigations to ensure tobacco products are not sold to minors. FDA will use this $100 million increase to expand their efforts to work to reduce the availability and appeal of tobacco products to children and teenagers and educate young people about the health risks of tobacco use.

  5. PROGRAM ACCOMPLISHMENTS

    • In FY 1996, FDA's anti-drug activities focused on: (1) a continuation of the Agency's investigation of the role of nicotine in tobacco use and the design and manufacture of tobacco products that had begun in FY 1994; and (2) the development and promulgation of the Agency's final rule on youth tobacco use issued in August 1996.

    • In FY 1997, FDA undertook to create an entirely new program to effectuate its jurisdiction and to implement its final rule to ensure that retailers are aware of, and in compliance with, the new rules prohibiting sales of tobacco to minors.

    • The goal of this program is a 50 percent decline in young people's use of tobacco within seven years of all provisions in the final rule going in to effect. To do this, the FDA engaged in two major activities in FY 1997, enforcement and outreach. In this first year of implementation, most of the program's funds were expended for contracts for investigations to ensure that tobacco products are not sold to minors and to ensure that those industries directly affected by the rule know what their new responsibilities are.