5600 Fishers Lane • Rockville, MD 20857 

www.samhsa.gov • 1-877-SAMHSA-7 (1-877-726-4727) 

Single State Authorities 

State Substance Abuse Prevention Agencies 

State Synar Coordinators 

SUBJECT: Revision to the Substance Abuse and Mental Health Services Administration 

(SAMHSA) Synar Guidance on Tobacco Regulation for the Substance Abuse 

Prevention and Treatment Block Grant (SABG), in Response to Public Law (PL) 

116-94 Appropriations Bill signed into law on December 20, 2019, which 

Increased the Minimum Age for Purchasing Tobacco Products from 18 to 21. 

BACKGROUND 

In July 1992, Congress enacted the Alcohol, Drug Abuse, and Mental Health Administration 

Reorganization Act (PL 102-321), which includes an amendment to Section 1926 of the Public 

Health Service Act (42U.S.C. 300x-26) aimed at decreasing youth access to tobacco. This 

amendment, named for its sponsor, Congressman Mike Synar of Oklahoma, requires states (that 

is, all states, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, and six Pacific 

jurisdictions) to enact and enforce laws prohibiting the sale or distribution of tobacco products to 

individuals under the age of 18. States must follow the Synar Amendment to receive their full 

SABG awards. 

On January 19, 1996, SAMHSA published “Tobacco Regulation for Substance Abuse 

Prevention and Treatment Block Grants” in the Federal Register, amending 45 C.F.R. Part 96 to 

add section 96.130 – State Law Regarding the Sale of Tobacco Products to Individuals Under the 

Age of 18 – known as the Synar regulation. SAMHSA then revised and issued guidance 

documents, providing instructions to states on compliance rate goals, use of funds, state reporting 

requirements, conforming amendments, and penalties. 

PL 116-94, signed on December 20, 2019, supersedes this legislation, and increased the 

minimum age for tobacco sales from 18 to 21. PL 116-94 also amends section 906(d) of the 

Federal Food, Drug, and Cosmetic Act of 1938, the General Provisions Respecting Control of 

Tobacco Products, raising the federal minimum age for sale of tobacco products from 18 to 21 

years and instructing the Food and Drug Administration to make conforming changes to 

regulations about the sale and distribution of tobacco products to carry out the amendments made 

by PL 116-94. These conforming changes include increasing the minimum age of sale for 

tobacco products from 18 to 21 years of age, increasing the minimum age for age verification by 

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SYNAR Guidance 

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means of photographic identification from under the age of 27 to under the age of 30, and 

increasing the minimum age of individuals that may be present or permitted to enter facilities 

that maintain vending machines or self-service displays that sell tobacco products from 18 years 

to 21 years of age. 

In accordance with PL 116-94, this Revision to Guidance notice updates previously issued 

SAMHSA guidance in 2011 as it relates to compliance rate goals, use of funds, state reporting 

requirements, conforming amendments, and penalties. This Tobacco 21 Revision to Guidance 

notice also outlines the three-year transition period for implementation and compliance. 

GUIDANCE REVISIONS 

Compliance Rate Goals 

The Compliance Rate Goals outlined in Implementing the Synar Regulation (revised 2011), 

requires that “...each state reduce its [Retail Violation Rate] RVR to 20 percent or less...” A 

violation is defined as “the fraction (or percentage) of tobacco-selling outlets in a state that are 

accessible to minors and sell tobacco to them. The objective of the Synar survey is to estimate 

this rate using sampling techniques and survey inspection.” 

PL 116-94 does not change the compliance rate goal of 20 percent or less. However, the 

definition of a violation is expanded to include tobacco-selling outlets in a state that are 

accessible to anyone under the age of 21. 

Use of Funds 

The Synar regulation states that “states may not use the Block Grant to fund the enforcement of 

their statute, except that they may expend funds from the primary prevention set-aside of their 

Block Grant allotment under 45 CFR 96.124(b)(1) for carrying out the administrative aspects of 

the requirements, such as the development of the sample design and the conducting of the 

inspections” [45 CFR 96.130(j)]. 

This Revision to Guidance notice clarifies that the prevention set-aside may be used to fund 

revisions to states’ Synar programs to comply with PL 116-94. 

State Reporting Requirements 

The State Reporting Requirements in Implementing the Synar Regulation (revised 2011) outlines 

that “states are required to report their sampling methodology and results of the annual Synar 

survey as a part of the Annual Synar Report no later than December 31.” This includes the state’s 

sampling methodology, Synar survey results, Synar inspection report, and the Synar inspection 

protocol. This Revision to Guidance notice does not change the requirement to submit an Annual 

Synar Report, but does require that states revise their methodology, inspection reports, and 

inspection protocols to include the revised age requirements (under 21). In addition, the Synar 

survey results must now include results for sales to youth and young adults under the age of 21. 

Substance Abuse and Mental Health Services Administration 

1-877-SAMHSA-7 (1-877-726-4727) • 1-800-487-4889 (TDD) • www.samhsa.gov 
 

 

 

 

 

 

 

 

 

 

SYNAR Guidance 

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Conforming Amendments 

SAMHSA’s previously issued 2011 guidance on Implementing the Synar Regulation explains 

that, for states to be in compliance with the Synar regulations, states must “enact a law 

prohibiting any manufacturer, retailer, or distributor of tobacco products from selling or 

distributing such products to any individual under age 18.” 

PL 116-94 removes the requirements for enacting state laws. Therefore, states do not need to 

demonstrate a change in state law to maintain compliance with Synar. However, SAMHSA’s 

2011 guidance further requires that states “enforce underage access laws to a degree that 

reasonably can be expected to reduce the illegal sale of tobacco products to individuals under age 

18.” PL 116-94 increases the minimum age to 21. Therefore, states are expected to enforce 

underage access to reduce the illegal sale of tobacco products to individuals under the age of 21. 

Penalty 

SAMHSA’s 2011 guidance on Implementing the Synar Regulation explains that “failure to 

comply with the requirements of the Synar Regulation can result in a State losing up to 40 

percent of its Federal Block Grant funds for substance abuse prevention and treatment.” 

Revisions to the definition of compliance are outlined above, including enforcement to reduce 

illegal sales to individuals under the age of 21, completing annual reporting requirements, and 

demonstrating a Retail Violation Rate of 20 percent or less. 

PL 116-94 revises the penalty to up to 10 percent of the SABG and codifies a negotiated 

alternate penalty. Instead of taking the 10 percent penalty, states that are found out of 

compliance (report a Retail Violation Rate above 20 percent) may elect to submit a corrective 

action plan to the Assistant Secretary for Mental Health and Substance Use within 90 days of 

receipt of notice that they are not in compliance with the Synar regulations, which outlines 

strategies they will take to reduce the Retail Violation Rate to 20 percent or less. States may not 

use SABG funds to pay for these activities and must find alternate sources of funds to cover 

these costs. 

CITATIONS IN LAW 

Section 1926 of the Public Health Service Act (42 U.S.C. 300x-26) Further Consolidated 

Appropriations Act, 2020 (PL 116-94). 

CITATIONS IN REGULATIONS 

“Tobacco Regulation for Substance Abuse Prevention and Treatment REGULATIONS: Block 

Grants” by SAMHSA (61 FR 1492, Jan. 19, 1996); 45 C.F.R. §96.130. 

“Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as 

Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale 

Substance Abuse and Mental Health Services Administration 

1-877-SAMHSA-7 (1-877-726-4727) • 1-800-487-4889 (TDD) • www.samhsa.gov 
SYNAR Guidance 

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and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products” 

(81 FR 28974 May 10, 2016). 

“Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to 

Protect Children and Adolescents” (75 FR 13225, March 19, 2010). 

CITATIONS IN GUIDANCE 

Implementing the Synar Regulation, Sample Design Guidance, published 2011. 

EFFECTIVE DATE 

States are expected to complete the transition to conform to the Tobacco 21 guidance revisions 

within their Synar program by December 31, 2022. The Synar penalties will be enforced starting 

with the December 2023 Annual Synar Report for Retail Violation Rates that exceed 20 percent 

between January 1, 2023 and September 30, 2023. 

INQUIRIES 

Inquiries related to this correspondence should be submitted to SAMHSA Government Project 

Officers designated for each state/jurisdiction. 

Miriam E. Delphin-Rittmon, Ph.D. 

Assistant Secretary for Mental Health 

and Substance Use 

Substance Abuse and Mental Health Services Administration 

1-877-SAMHSA-7 (1-877-726-4727) • 1-800-487-4889 (TDD) • www.samhsa.gov