A Strategic Partnership

The Food and Drug Administration’s (FDA) Tobacco Retail Compliance Inspection Contracts and 

the Substance Abuse and Mental Health Services Administration’s (SAMHSA) Synar Program 

In July 1992, the Alcohol, Drug Abuse, and Mental Health Administration Reorganization Act 

(P.L. 102-321) became law, which includes the Synar amendment (section 1926) aimed at decreasing 

youth access to tobacco. 

On June 22, 2009, the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) 

became law granting the Food and Drug Administration (FDA) authority to regulate the manufacture, 

marketing, and distribution of tobacco products to protect the public health generally and to reduce 

tobacco use by minors. Currently the law applies to cigarettes, smokeless tobacco and cigarette tobacco.

SAMHSA and FDA are collaborating to ensure that their separate programs work together to help reach 

the shared goal of reducing youth access to, and use of, tobacco products.

Overview of Programs

FDA’s Tobacco Retail Compliance 

Inspection Contracts

SAMHSA’s Synar Program

The Tobacco Control Act authorizes 

FDA to contract, where feasible, with 

States, the District of Columbia, five 

U.S. Territories (American Samoa, 

Commonwealth of the Northern Mariana 

Islands, Guam, Puerto Rico, and the 

U.S. Virgin Islands), and American Indian 

Tribes to assist with inspections of retail 

establishments. 

Section 102 of the Tobacco Control 

Act required FDA to re-issue its 1996 

final regulation restricting the sale and 

distribution of cigarettes and smokeless 

tobacco products. The rule contains 

provisions designed to limit young 

people’s access to tobacco products, as 

well as restrictions on marketing to curb 

the appeal of these products to minors. 

The youth access and advertising 

regulations took effect on June 22, 2010 

(21 C.F.R. Part 1140). 

The Synar regulation is applicable to the 50 States, the 

District of Columbia, and eight U.S. Territories (American 

Samoa, Commonwealth of the Northern Mariana Islands, 

Federated States of Micronesia, Guam, Marshall Islands, 

Palau, Puerto Rico, and the U.S. Virgin Islands). It is not 

applicable to American Indian Tribes.

The Synar regulation requires States and U.S. Territories (as 

a condition of receiving their full Substance Abuse Prevention 

and Treatment Block Grant (SAPT BG) awards) to:

• Have in effect a law prohibiting any manufacturer, 

retailer, or distributor of tobacco products from selling 

or distributing such products to any individual younger 

than age 18; 

• Enforce this law; 

• Conduct annual, unannounced inspections of retail 

tobacco outlets in a way that provides a valid probability 

sample of tobacco sales outlets accessible to minors; 

• Negotiate interim target rates and a date to achieve a 

noncompliance rate of no more than 20 percent; and

• Submit an annual report detailing State and Territorial 

activities to enforce its law.

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Differences between the FDA’s Tobacco Retail Compliance 

Inspection Contracts and SAMHSA’s Synar Program

FDA SAMHSA

Among other things, the FDA’s reissued 

regulation restricts youth access to cigarettes and 

smokeless tobacco by: 

• Prohibiting retailers from selling cigarettes, 

roll-your-own tobacco, smokeless tobacco, or 

cigarette tobacco to any person younger than 

age 18;

• Requiring retailers to examine photographic 

identification of anyone under the age of 27 

who attempts to purchase these products; and

• Banning vending machines and self-service 

displays, except in facilities where the retailer 

ensures that no person younger than 18 

years of age is present, or permitted to enter, 

at any time. 

The Synar regulation requires States to enact 

State laws making it illegal for retailers to sell 

tobacco products to minors. 

These State laws are not required under the 

Synar regulation to include a photo identification 

requirement or a ban on vending machines and 

self-service displays.

• All compliance check inspections completed 

under the FDA contracts are for enforcement 

purposes, and violations may lead to Warning 

Letters, Civil Money Penalties, or other 

enforcement options. 

• There is no requirement that compliance 

check inspections conducted under the FDA 

contracts be conducted at a statistically 

representative sample of tobacco outlets, 

although FDA requires its contractors to 

conduct inspections in a variety of different 

locations, outlet types, and communities, 

including minority communities as directed by 

Section 105 of the Tobacco Control Act.

• The Synar regulation requires States to 

assess compliance with State youth access 

laws via a statistically valid survey of youthaccessible tobacco retailers. Inspections 

completed for purposes of the Synar survey 

may include a State-level enforcement 

component, or they may not. 

• The Synar regulation requires States to 

enforce State youth access laws, but explicitly 

forbids States from using Substance Abuse 

Prevention & Treatment Block Grant (SAPT 

BG) money to fund enforcement.

• The FDA regulation does not include a 

specific performance target.

• The Synar regulation sets a performance 

target (States must prove that the retailer 

violation rate is 20 percent or less via the 

statistically valid survey described above) and 

an incentive to comply (potential loss of SAPT 

BG funds). 
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Protecting our kids and the nation’s health from tobacco 

Relationship between SAMHSA’s State Synar Program and the 

FDA’s Tobacco Retail Compliance Contracts

Category Description 

Use of Inspection 

Data

States and U.S. Territories that are awarded FDA contracts may use data 

from FDA compliance check inspections for Synar reporting as long as the 

inspections are completed at the retail tobacco outlets randomly sampled for 

the Synar survey. Specifically, FDA recommends that the contractor offer the 

State Synar Program the option of having a portion of the compliance check 

inspections conducted under the FDA contract completed at those retail 

tobacco outlets randomly sampled for the Synar survey. 

Option to Combine 

Inspections

If the contractor chooses to conduct FDA compliance check inspections 

at those outlets randomly selected for the Synar sample or for 

other tobacco enforcement efforts, the compliance check inspections 

must follow FDA’s protocol and must be conducted by the 

FDA-commissioned inspectors. 

Funding

FDA funds cannot be used to support any contractor work beyond the FDA 

inspectional requirements (e.g., filling out the Synar form or other inspection 

forms, or obtaining and completing additional evidence for a charge specific to 

State, Territorial, or local law). 

Implementation 

Plan

FDA contractors that wish to use FDA inspection data toward Synar reporting 

should discuss their plans with their FDA representative. They must also inform 

their SAMHSA/Center for Substance Abuse Prevention (CSAP) State Project 

Officer of their intention and work with him/her to make any needed changes 

to Appendix B or Appendix C of the Annual Synar Report, if applicable.

Vending Machines

The FDA regulation restricts the sale of cigarettes and smokeless tobacco from 

vending machines. If FDA has contracted with a State to enforce this provision, 

that State is no longer required to include vending machines in their annual 

Synar surveys. States should contact their SAMHSA/CSAP State Project 

Officer for more information.

Continued on next page
Contact Us 1-877-CTP-1373

AskCTP@fda.hhs.gov • www.fda.gov/tobacco

FDA Center for Tobacco Products

9200 Corporate Blvd • Rockville, MD 20850-3229

Center for Tobacco Products | U.S. Food and Drug Administration | www.fda.gov/tobacco | Page 4

Protecting our kids and the nation’s health from tobacco 

State Enforcement

States and U.S. Territories that choose to use data from FDA compliance 

check inspections toward Synar reporting must continue to show evidence 

of enforcement of State youth access laws in order to meet Synar regulation 

requirements.

Retailer Violation 

Rate 

As a requirement of the Synar regulation, States will continue to be held 

accountable for meeting or achieving a retailer violation rate below the 20 

percent target. Because of this performance target, States will need to 

continue conducting ancillary youth tobacco access prevention activities, such 

as merchant education and community mobilization, to help reduce the retailer 

violation rate.

Confidentiality of 

FDA Inspection 

Data 

In States that maintain separate FDA and Synar programs, individuals 

commissioned by the FDA may share general information about the FDA 

regulations with other agencies, but may not share information about specific 

sites being inspected, or the outcomes of those inspections, until a final 

determination of compliance or non-compliance has been made and posted 

to the FDA website. Information on all completed FDA inspections can 

be found in a database searchable by State, city, zip code, retailer name, 

decision type, and decision date at: http://www.fda.gov/TobaccoProducts/

GuidanceComplianceRegulatoryInformation/ucm232109.htm. State Synar 

programs may wish to use this data to identify retailers and/or geographic areas 

that need additional retailer education and follow-up enforcement inspections.