The SAMHSA regulation maintains the objective of reducing the sale of tobacco products to minors, while providing latitude and support for State implementation.

The Department of Health and Human Services (HHS) has submitted for publication the final regulation implementing section 1926 of the Public Health Service (PHS) Act prohibiting the sale or distribution of tobacco products to minors.

After considering the comments received from the health community, State agencies, and tobacco product manufacturers and retailers, the Secretary finalized the Substance Abuse and Mental Health Services Administration (SAMHSA) regulation as one key step in a strategic Administration-wide approach to reducing youth tobacco use.

The SAMHSA regulation implementing the Synar Amendment requires the State to:

The Secretary is required by statute to withhold all funds from States that have not enacted the required prohibitions and to decrease the annual Substance Abuse Prevention and Treatment (SAPT) Block Grant award for States that do not comply with the enforcement and reporting requirements.

States were required in their first applicable fiscal year, and all subsequent fiscal years, to have in place a law prohibiting the sale or distribution of tobacco products to minors.

All States were in compliance with this requirement for FY 1995. The Department will continue to review revisions to States' laws on an annual basis.

The Department will allow States the needed flexibility in determining which strategies are most appropriate for meeting the compliance standards and enforcement requirements of the regulation. States may implement tobacco licensing of retailers and penalties/fines. They are, however, not required to do so.

The Department requires that the State designate an agency within the State to be responsible for implementing the State law. Enforcement of the law may be done by enforcement agencies, Single State Agencies for Substance Abuse Prevention and Treatment (SSAs), State Health Departments, private entities or a combination of these and other organizations.

For the first two applicable fiscal years, States must conduct a reasonable number of random, unannounced inspections of outlets (both over-the-counter and vending machines) to ensure compliance with the law.

For the third applicable and all subsequent fiscal years, States will conduct random, unannounced inspections of outlets that represent a probability sample of outlets accessible to youth. The sample must reflect the distribution of the population under age 18 throughout the State and the distribution of outlets throughout the State. Table I depicts the inspection requirements.

The regulation does not require the use of "stings," (i.e., use of minors in inspections). This method has been found to be effective and efficient. States are free to use other methods for performing inspections. However, the Department strongly urges any State that intends to use an alternative method to work with the Department in advance of implementation to show that the method validly measures compliance through random, unannounced inspections, and ensures that the inspection approach will produce the data necessary to determine that the State meets the compliance standard.

The State will not be required to conduct targeted inspections of outlets that failed under previously random, unannounced inspections. However, targeted inspections are an appropriate method of controlling youth access to tobacco products and may be considered by the Secretary in making a determination if a State is found to be in substantial compliance with the inspection failure rate.

* - Random, unannounced inspections

The design of the sampling method scheduled for the third and subsequent fiscal years requires a method for providing a probability sample of outlets accessible to youth. The sample must reflect the distribution of the population under age 18 throughout the State and the distribution of outlets that are accessible to youth throughout the State. In identifying outlets that are accessible to youth, States may want to take into consideration characteristics such as their proximity to gathering places for youth. For additional information on Sample Design, see Section VII, of the CDC Stop The Sale: Prevent The Addiction, A Program Guide for Reducing Youth Access (1995).

States with complete centralized license lists can use these lists as a sampling frame. Other States can utilize commercial business lists that can be purchased from a variety of sources. These lists may not reflect the total universe of tobacco outlets and, therefore, may need to be supplemented. For additional information on Compliance Checks, see Section VI of the CDC program guide.

States must present to the Secretary as part of their fourth applicable fiscal year application, interim performance targets for achieving in the future a maximum inspection failure rate of 20%. As a baseline the State should use the results of the random, unannounced inspections conducted during the previous fiscal year. Although a target date for all States achieving the 20% rate has not been set, each State will be expected to submit and negotiate a reasonable strategy for achieving this goal over several years.

States in their first applicable fiscal year application for funds were required to: 1) submit a copy of the State law regarding the sale or distribution of tobacco products to minors; and 2) explain what activities they would undertake during their second applicable fiscal year to enforce the law.

In their second and third applicable fiscal year applications, States were or are required to submit the following: 1) a copy of any changes made to their tobacco law; 2) a summary of their enforcement efforts during the previous fiscal year; 3) the results of the random unannounced inspections conducted during the previous fiscal year; and 4) a summary of the success that the State has had in reducing the availability of tobacco products to minors.

For the fourth and all subsequent fiscal year applications, States must submit the following: 1) a copy of any changes made to their tobacco law; 2) a summary of their enforcement efforts during the previous fiscal year; 3) the results of the random unannounced inspections conducted during the previous fiscal year; 4) a summary of the success that the State has had in reducing the availability of tobacco products to minors; 5) a description of how they conducted their random, unannounced inspections including a description of their sampling design; and 6) their strategy, timelines and yearly milestones for achieving in the future an inspection failure rate of 20 percent.

The primary costs of complying with this regulation involve expenses for inspection and enforcement. While no data are available regarding the cost of enforcement, the Department does not believe these costs need to be substantial. The cost of statewide inspections would vary by State. Costs will decrease as compliance reaches 100%, because there will be fewer violations and fewer enforcement actions necessary. State costs would also decrease if the FDA proposed regulations take effect, since the FDA tobacco rules would make it easier for States to enforce State youth access laws. In addition, SAMHSA has modified the regulation to allow use of SAPT Block Grant prevention setaside funds to pay for the costs associated with developing a sampling mechanism and conducting random, unannounced, inspections. States may not use SAPT Block Grant funds for other enforcement activities.

States may use funds from the Centers for Disease Control and Prevention's (CDC) Preventive Health and Health Services Block Grant for sample design, inspections and other enforcement purposes.

States may also implement a system of self-financing licensure, and civil penalty system as a method of offsetting the costs of retailer inspections.

In order to be eligible for SAPT Block Grant funds, all States must have a law prohibiting the sale or distribution of tobacco products to minors.

If the Secretary determines that a State did not comply with the enforcement stipulated in this regulation, the statute (42 USC 300X-26(c)) requires the Secretary to reduce by 10 percent that State's SAPT Block Grant allotment for non-compliance in their first applicable fiscal, 20 percent for noncompliance in their second applicable fiscal year, 30 percent for noncompliance in their third applicable year and 40 percent for non compliance in their fourth and all subsequent fiscal years. For most States FY 1997 is their fourth applicable fiscal year.

Detailed information on prevention strategies for youth access to tobacco products can be found in the Centers for Disease Control and Prevention's "Stop The Sale: Prevent The Addiction" Program Guide for Reducing Youth Access to Tobacco (1995).

[Federal Register Citation, Vol. 61, No. 13, January 19, 1996]

For more information regarding this regulation, please refer to "Tobacco Regulation for Substance Abuse Prevention and Treatment Block Grant -- Final Rule" published by the Department of Health and Human Services, Substance Abuse and Mental Health Services Administration.

Susan Marsiglia Gray, MPH
National Synar Program Coordinator
Division of State Programs
Center for Substance Abuse Prevention
Substance Abuse and Mental Health Services Administration
One Choke Cherry Road, Room 4-1041
Rockville, MD 20857
(240) 276-2568
Susan.Marsiglia@samhsa.hhs.gov