Copyright 2000 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2000
The Synar Amendment requires states and territories to enact a law prohibiting the sale of tobacco to minors and to enforce that law in a manner that could reasonably be expected to decrease the availability of tobacco to minors.
To determine whether the Department of Health and Human Services (DHHS) and applicant states and territories are complying with the Synar Amendment.
Block grant applications from 59 states and territories describing activities during federal fiscal year 1997.
Whether applicants had enacted a tobacco sales law without loopholes, conducted enforcement inspections, penalized violators, and conducted a valid statewide survey with violation rates below the permissible threshold, and whether DHHS actions were consistent with the statutory requirements of the Synar Amendment.
Three applicants had laws containing loopholes, 8 failed to conduct enforcement inspections, 8 failed to prosecute violators, 6 failed to conduct a valid survey, and 8 failed to demonstrate compliance with violation rate targets. Fifteen applicants failed 1 or more criteria, but none was ultimately penalized by DHHS. Fourteen sources of bias were identified in state survey protocols that could substantially lower reported violation rates.
A few states did a remarkable job with enforcement, while many others made little effort. Because the DHHS regulations are so weak and DHHS is willing to accept biased surveys, states can be in full compliance with the regulations without ever enforcing their laws or having any impact on the availability of tobacco to minors.
IN JULY 1992, Congress enacted a law commonly known as the Synar Amendment after its sponsor, the late US Representative Mike Synar (Oklahoma).1 This law makes block grants to states from the Substance Abuse and Mental Health Services Administration (SAMHSA) under the Department of Health and Human Services (DHHS), contingent on states enacting and enforcing a prohibition on the sale of tobacco to minors.1 Congress allowed states until 1994 to enact a law and "enforce the law . . . in a manner that can reasonably be expected to reduce the extent to which tobacco products are available to individuals under the age of 18."1 To this end, states are required to conduct "random, unannounced inspections to ensure compliance with the law."1 Congress required DHHS to reduce block grant funding to noncompliant states by 40% for all states that were out of compliance in 1997.1 States whose legislatures did not convene during either 1993 or 1994, the "delay states" (Arkansas, Kentucky, Montana, Nevada, North Dakota, Oregon, Texas, and Wyoming), were allowed until 1995 to enact and enforce a state law.1
The Synar Amendment is the law as created by Congress. The DHHS was given responsibility for writing the federal regulations to define in practical terms what states must do to ensure that the intent of Congress as expressed in the Synar Amendment is satisfied.2 However, in stark contrast to the law they are designed to implement, the regulations do not require states to enforce their laws.2 Nor are states required to conduct "inspections to ensure compliance with the law." Instead, the regulations require states to conduct an annual randomized statewide survey to measure merchant compliance and to demonstrate that the proportion of merchants violating the law is decreasing. The DHHS has established timelines for each state and territory to reach a violation rate of 20%.3,4 Although Congress mandated that DHHS "shall" withhold funding from noncompliant states, the regulations inserted 2 loopholes allowing DHHS to waive any penalty after taking other factors into consideration or when "extraordinary circumstances" pertain.1,2
An audit of state and federal compliance with the Synar Amendment during fiscal year 1996 concluded that the regulations do not require states to reduce violation rates to a point where the availability of tobacco to minors would be affected.3 The DHHS was criticized for failing to require states to use valid, standardized survey protocols.3 Very few states or territories had implemented effective enforcement programs, 15 had failed to conduct enforcement inspections, 18 had failed to provide any evidence of a merchant being penalized for violating the law, and 1 territory failed to conduct a survey.3 No state or territory was penalized for its performance during fiscal year 1996.3
The statewide surveys conducted in 1996 served only as a baseline against which future progress would be measured. The current study examines the performance of the states, territories, and DHHS during the second fiscal year during which the Synar regulations were in effect.
Throughout this report, the term state shall include the District of Columbia and 8 US territories (American Samoa, Federated States of Micronesia, Guam, Republic of the Marshall Islands, Northern Mariana Islands, Palau, Puerto Rico, and the US Virgin Islands). All states file an annual block grant application with SAMHSA.5 States must describe how the state law was enforced during the preceding fiscal year, plans for enforcement in the upcoming year, and the methods and results of their statewide survey.5 States must also certify that they are effectively enforcing a law prohibiting the sale of tobacco to minors.5
In July 1998, a federal Freedom of Information Act request was filed for each state's fiscal year 1998 application and relevant correspondence between SAMHSA and the states. These applications describe state activities during fiscal year 1997. State names will be used to reference these materials. If, after review of these materials, it appeared that the state had not enforced its law, a letter was sent to the state seeking clarification.
The following 5 criteria were used to judge state performance.
The Synar statute requires states to have "in effect a law providing that it is unlawful for any manufacturer, retailer, or distributor of tobacco products to sell or distribute any such product to any individual under the age of 18."1 The Synar law does not specify that there must be a penalty for selling tobacco to minors. However, it does require states to "enforce the law," and it is difficult to conceive how a law could be enforced if there is no penalty.1 State laws were audited to determine whether DHHS requires states to have penalties for "any" person who sells tobacco to a minor.1
Congress required states to "annually conduct random, unannounced inspections to ensure compliance with the law."1 The DHHS has interpreted this language as a requirement for states to conduct surveys to estimate merchant compliance.2 However, surveys do not "ensure" compliance with the law, they measure it. For the purposes of this audit, states had to produce evidence that test purchases were conducted for the purpose of enforcing the law.
Congress required states to "enforce the law . . . in a manner that can reasonably be expected to reduce the extent to which tobacco products are available to individuals under the age of 18."1 As evidence of enforcement, the state must have prosecuted and penalized at least 1 merchant who was caught selling tobacco to a minor during the 1997 fiscal year. Warnings, either oral or written, do not constitute enforcement.
The SAMHSA instructed states to conduct a scientific randomized unannounced survey during the fiscal year having a 95% confidence interval of ±3 percentage points2,6- 8 (memorandum to DHHS Secretary Donna Shalala from Nelba Chavez, PhD, administrator of the Substance Abuse and Mental Health Services Administration, September 29, 1998). It was determined whether states had completed valid surveys.
This requirement does not apply to the 8 delay states for which 1997 represented the baseline assessment.
Actions of DHHS were audited to answer the following questions:
Did DHHS require states to enact laws that include penalties for anyone violating the law?
Did DHHS require states to provide evidence that they are enforcing their laws by prosecuting and penalizing violators?
Did DHHS require states to report the results of a valid survey conducted during the 1997 fiscal year?
Did DHHS require states to meet their negotiated compliance targets?
Did DHHS allow states that failed to meet their targets to renegotiate weaker targets?
Did DHHS apply the mandated funding sanctions to states that failed to meet the statutory requirements of the Synar Amendment or the implementing regulations as described above?
I audited all materials used in this study. Before I submitted the manuscript for publication, I shared it with DHHS to allow them the opportunity to identify any factual inaccuracies or to supply additional information. I received no response in the 11 weeks before submission of the final revision of the manuscript. Previous correspondence has made it clear that DHHS is working with an interpretation of the Synar Amendment that differs from that presented here (Nelba Chavez, PhD, written communication, October 6, 1998).
The applications, comprising 2600 pages, were released by DHHS in October 1999, 2 years after they had been submitted by the states.
All 59 states had laws prohibiting the sale of tobacco to minors (Table 1). Three states' laws do not include penalties for all violators. In Maryland, there is no penalty for selling to a minor from a vending machine that displays a warning sign. In Montana, store owners cannot be penalized for selling to minors until their fifth offense within a 3-year period. In the Northern Mariana Islands, it is not illegal to sell tobacco to a minor if the tobacco is not for the minor's own use. The legislature twice refused to amend this law.
Seventeen states made at least marginal improvements in their laws (California, Colorado, Connecticut, Hawaii, Idaho, Indiana, Iowa, Louisiana, Maine, Minnesota, Mississippi, New Hampshire, New York, Texas, Vermont, West Virginia, Puerto Rico), while several legislatures rejected improvements to laws or included provisions that weaken enforcement (Alabama, Arkansas, Hawaii, Iowa, Louisiana, New Mexico, Northern Mariana Islands). The Arkansas law puts the tobacco industry in charge of enforcement by granting it from 4 to 6 seats on an 8-seat Tobacco Control Board that oversees license suspensions.9
States are required to "describe in detail the State's activities used to enforce the law(s) in FFY 1997."5 Eight states did not provide evidence that any inspections had been coupled with prosecutions in 1997, compared with 15 states in 1996 (Table 1).
Eight states did not provide evidence that merchants had been prosecuted during the 1997 fiscal year, compared with 18 for 1996. With the exceptions of Guam and the Marshall Islands, each of these states had observed merchants violating the law. Only 32 states indicated that they provided any funding to support enforcement.
Six states failed to conduct valid unannounced randomized surveys within the 1997 fiscal year (Delaware, Idaho, Rhode Island, Guam, Marshall Islands, Northern Mariana Islands). Delaware, Rhode Island, Guam, and the Marshall Islands did not complete surveys during the 1997 fiscal year. In Delaware and Rhode Island, survey completion was hampered by legislation that allowed only the police to conduct compliance surveys. Guam blamed its failure to conduct the survey on severe weather. The Marshall Islanders felt that conducting a compliance survey would violate cultural values regarding respect for elders. The Idaho survey was invalid because the randomly selected retailers were targeted for a special educational intervention and forewarned of the inspections. The survey was also conducted immediately after the media blitz concerning the implementation of the Food and Drug Administration regulations regarding tobacco sales to minors.10 In the Northern Mariana Islands, merchants with previous violations were removed from the sampling list before randomization.
The DHHS allows states to use any protocol they choose to conduct test purchases, but it instructs states to use the same protocol each year. The DHHS has made no effort to ensure that the tests faithfully reproduce the interaction that occurs when an underage smoker attempts to purchase tobacco. States (perhaps unintentionally) bias their surveys to produce lower violation rates by (1) using young youths (at least 22 states included youths under the age of 15 years in their surveys, some as young as 10 years); (2) excluding youths who appear older than average for their age (Alaska, Florida, Indiana, Kentucky, Nevada, Federated States of Micronesia); (3) using inexperienced nonsmoking youths (almost every state); (4) using youths unfamiliar to the retailer (all states); (5) undersampling vending machines or bars, which have much higher violation rates (at least 11 states); (6) having youths request change to use a vending machine (Michigan); (7) forewarning merchants (Idaho); (8) providing immediate notification of violations (Florida, Virginia); (9) conducting surveys immediately after an intervention (Idaho); (10) having an adult in the store (Delaware, Illinois, Texas, and many others); (11) having the youths ask the clerk for cigarettes in preference to using self-service displays (most states); (12) excluding regions where enforcement is less active (Utah, Alaska, and many of the island states); (13) prohibiting youths from lying about their age (all states); and (14) prohibiting youths from showing proof of age (all but 14 states). Clerks made a sale after underage youths presented their true proof of age 9% of the time in South Dakota and 11% of the time in Utah. Half of the illegal sales in Oregon's survey occurred after the minor showed proof of age, meaning that Oregon's violation rate could have been artificially cut in half by not allowing the use of proof of age. California reported violation rates of 18% for clerk-assisted sales compared with 36% for self-service sales. Higher violation rates for self-service sales were also reported by Colorado, Delaware, Massachusetts, Virginia, Washington, and West Virginia. While using youths who are familiar to the merchant is not a practical option, using unfamiliar youths does introduce bias.
States may bias their surveys in the direction of higher violation rates by excluding liquor stores, which typically have the best compliance rates, or by employing adults over the legal age limit to act as minors (Wyoming, Puerto Rico).
The lack of standardized protocols dictates caution when comparing state violation rates. Figure 1 presents a comparison of state violation rates obtained through the use of 16- to 17-year-old youths. States that are not represented did not submit valid surveys (Delaware, Idaho, Rhode Island, Guam, Marshall Islands, Northern Mariana Islands), did not provide age-stratified data as required (Florida, Kentucky, Micronesia), or did not employ 16- or 17-year-old youths in their compliance surveys (Wyoming, Puerto Rico, Virgin Islands). Violation rates ranged from 8% in Vermont to 83% in the Northern Mariana Islands.
Rate of illegal sales to 16- and 17-year-old youths during compliance surveys. States and territories that are omitted did not provide data for this age category.
For the 6 states that did not submit valid surveys (Delaware, Idaho, Rhode Island, Guam, Marshall Islands, Northern Mariana Islands), it could not be determined whether the state violation rate was within 3 percentage points of the target set by DHHS for that state in 1997. North Carolina and Puerto Rico had violation rates more than 3 percentage points above their targets. Puerto Rico's violation rate was unchanged at 92%, high above the target goal of 76%. Puerto Rico was the only state that conducted a valid survey but did not report an improved compliance rate. North Carolina had a target of 41% but reported a violation rate of 45%.
A total of 15 states failed 1 of these 5 criteria.
The DHHS did not raise any issue with the 3 states that allow the sale of tobacco to minors without penalty under prescribed circumstances.
In an e-mail to the Alaska Department of Health and Social Services, Division of Alcoholism and Drug Abuse (which did enforce its law), DHHS indicated that the Synar statute requires states to enforce their laws (Sandie Johnson, project officer at the federal Substance Abuse and Mental Health Services Administration, e-mail, June 8, 1998). Nevertheless, DHHS did not raise the lack of enforcement as an issue affecting eligibility for funding with any of the 8 states that provided no evidence that their laws had been enforced.
Delaware, Guam, and Rhode Island did not complete surveys during the 1997 fiscal year and all were given written warnings. The DHHS noted that Idaho had forewarned the merchants it had selected for inspection, but DHHS did not make it an issue. The DHHS did not comment on the failure by Utah and the Northern Mariana Islands to implement valid randomization. The DHHS did not make the lack of a survey an issue with the Marshall Islands.
Puerto Rico and North Carolina received warning letters concerning their failure to come within 3 percentage points of their targets (memorandum to DHHS Secretary Donna Shalala from Nelba Chavez, PhD, September 29, 1998).
Delaware was allowed to renegotiate a weaker compliance target.
The DHHS found only 4 states (Delaware, Rhode Island, Guam, and Puerto Rico) to be in violation of the Synar regulations (memoranda to DHHS Secretary Donna Shalala from Nelba Chavez, PhD, September 29, 1998, and August 10, 1998). Delaware was granted an "extraordinary circumstances" exemption in exchange for agreeing to update its list of tobacco vendors, perform inspections, prosecute merchants, and follow up on violators within a year (memorandum to DHHS Secretary Donna Shalala from Nelba Chavez, PhD, September 29, 1998). There was no factual basis for a finding of extraordinary circumstances (same memorandum). Rhode Island had its funding held up for almost a year because it did not conduct a survey. In 1996, ignoring DHHS recommendations for a model law, Rhode Island enacted a law allowing only local police to perform compliance checks.11 After one local police department was sued for conducting compliance checks, others refused to participate in the survey. The DHHS granted an "extraordinary circumstances" exemption and ultimately provided full funding. Guam's failure to conduct a survey was attributed to 16 typhoons within a 5-month period and a major airline crash, which occupied their small health department. These were truly extraordinary circumstances and were recognized as such by DHHS. Puerto Rico's previously unenforceable law was replaced with a law that did not go into effect until 1998 and thus had no impact during 1997. By the time a penalty was being considered in 1998, the violation rate had fallen to 37%, meeting the state's targets out to the year 2001. On this basis, Puerto Rico was granted an extraordinary circumstances exemption.
North Carolina, with a 44% violation rate and an estimated 12,000 merchants, had successfully prosecuted only 40 cases. Its law is preemptive, does not require licensing, does not allow for civil prosecution, and restricts who can perform compliance tests. All of these features violate the principles of a model youth access law as outlined by DHHS.11 Only the Northern Mariana Islands reported a higher violation rate for youths aged 16 to 17 years (Figure 1). North Carolina was given full funding after "other factors" were considered. Among these factors were that "it has vigorously enforced its youth tobacco control laws and has made significant progress in advancing legislation and merchant and community education"(Nelba Chavez, PhD, written communication, December 27, 1999).
By the end of federal fiscal year 1997, with only 1 exception, merchant compliance with tobacco sales laws had improved in every state in which it was measured. Nonetheless, violation rates in all but a handful of states remained so high that national adolescent surveys showed no change in the perceived availability of tobacco through 1997.12 Violation rates under 10%, as measured by youths 16 to 17 years of age, were achieved within a few years in a small number of states, such as Vermont, which had funded statewide enforcement programs. In the majority of states, however, relevant laws were either rudimentary or crafted to impede enforcement.13,14 Enforcement of the laws in the majority of states was unfunded, sparse, and disorganized, conducted on a temporary ad hoc basis by local governments. Improvements in compliance in many states may have been attributable in large measure to the extensive publicity surrounding the implementation on February 28, 1997, of the Food and Drug Administration regulations prohibiting the sale of tobacco to minors, even though enforcement of these regulations did not begin during 1997.10
Measured violation rates are strongly influenced by the age of the youth used to purchase tobacco, with older youths unveiling much higher violation rates.15 Even when measured with the use of 16-year-old youths, violation rates of 20% have had no impact on the availability of tobacco to minors.16 As violation rates are reduced to 20%, illegal sales to underage smokers are not reduced, they are merely concentrated among fewer retailers. The DHHS has been criticized for allowing states too much time (up to 11 years) to reach a goal that is too weak to affect tobacco use by youths (a 20% violation rate).3 In practice, the DHHS standards are much weaker than they appear because DHHS has allowed states to use youths down to the age of 10 years to measure compliance. This allows states to mask higher violation rates by employing preteens and young adolescents to conduct their surveys. By way of illustration, violation rates of 20%, 21%, and 22% were reported by Michigan, Texas, and Arkansas, respectively. All have attained the ultimate DHHS goal of coming within the 3–percentage point confidence interval of 20%. The violation rate for 16- to 17-year-old youths was also 20% in Michigan, but it was 39% in Texas and 33% in Arkansas. Texas brought its overall violation rate down by conducting most of its test purchases with youths younger than 16 years. Similarly, Arkansas, without ever having enforced its law, reached the DHHS goal by using youths down to 11 years of age.
I identified 14 different sources of bias in state sampling and purchasing protocols that would suggest that violation rates reported by most states greatly exaggerate the difficulty that real underage smokers face in purchasing tobacco. While DHHS encourages states to use sound sampling techniques to produce statistically precise results,6- 8 it has not shown concern over whether the measures used are scientifically valid. Through the use of young adolescents, biased sampling, and artificial purchasing protocols, states such as Arkansas can meet the weak compliance goals set by DHHS without ever enforcing their laws or having any impact on the availability of tobacco to minors.
In addition to overlooking these serious methodological problems, DHHS ultimately chose not to penalize states for including loopholes in their laws, for failing to enforce their laws, for failing to submit a randomized unannounced survey, or for failing to meet the violation rate goal it set for the state. Although, to its credit, DHHS did delay the delivery of block grants to a few states, it is unclear what a state would have to do to actually lose its funding, as violations of every aspect of the law and regulations have been permitted.
Although the US territories received the same materials and instructions from DHHS as did the states, some claimed that a lack of clear instructions from DHHS was responsible for their inaction. One territory claimed that cultural taboos prevented them from conducting inspections and enforcement. It appears that foreign policy considerations have seriously hindered the implementation of the Synar law in many US territories.
With the possible exception of Guam, state failures resulted from a lack of planning, a failure to commit resources, or the intentional action or inaction of state officials. With little real threat of sanction from DHHS, many state legislatures have taken the side of the tobacco lobby by enacting laws that actually hamper enforcement (Arkansas, Montana, Wisconsin).3,13
By the end of 1997, the report card for the Synar Amendment was mixed. Spurred on by the amendment, a minority of states had demonstrated that sincere enforcement efforts can rapidly reduce violation rates to less than 10% for youths 16 to 17 years of age. This is very encouraging for the public health community. On the other hand, the very weak standards set by DHHS and its willingness to accept biased surveys from states means that states that do not want to reduce the sale of tobacco to minors do not have to do so to remain in compliance with the DHHS regulations. In DHHS' implementation of the Synar Amendment, the sincere goal of protecting children from tobacco has been secondary to the need to avoid the politically volatile situation of penalizing states for their failures. With the recent Supreme Court decision striking down the Food and Drug Administration regulations,17 the Synar Amendment remains as the only federal law aimed at protecting children from tobacco.
Accepted for publication March 31, 2000.
This project was supported by a grant from the Robert Wood Johnson Foundation, Princeton, NJ.
Reprints: Joseph R. DiFranza, MD, Department of Family Medicine and Community Health, 55 Lake Ave, University of Massachusetts Medical School, Worcester, MA 01655 (e-mail: firstname.lastname@example.org).
DiFranza JR. State and Federal Compliance With the Synar AmendmentFederal Fiscal Year 1997. Arch Pediatr Adolesc Med. 2000;154(9):936-942. doi:10.1001/archpedi.154.9.936