Two Federal Programs Conduct Compliance Inspections on Tobacco Retailers

Thomas A. Briant, NATO Executive Director

Both the U.S. Food and Drug Administration (FDA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) conduct compliance inspections on retailers that sell tobacco products. While both of these federal agency programs seek to reduce and prevent access to tobacco products by minors, there are important differences between each program.

Below is a summary of the similarities and differences in the FDA and SAMHSA retail inspection programs:

  • Date of Enactment: The SAMHSA program is referred to as the Synar Amendment and was adopted in July of 1992. The FDA program was a part of the Family Smoking Prevention and Tobacco Control Act enacted in June of 2009.
  • Scope of Program: The Synar Amendment applies to all 50 states and requires that each state (1) have a law in effect prohibiting the sale of all tobacco products to anyone under 18, (2) conduct annual, unannounced inspections of stores that sell tobacco products to determine if a sale is made to a minor and (3) achieve a success rate of at least 80% in not selling tobacco products to minors. States laws under the Synar Amendment are not required to mandate the examination of a photographic ID when selling tobacco products to a customer.                                                                                 The FDA law prohibits retailers from selling cigarettes, roll-your-own tobacco and smokeless tobacco to any person younger than 18. The agency is authorized to contract, where feasible, with the 50 states and the District of Columbia along with the five U.S. territories. Currently, 37 states and the District of Columbia are under contract with the agency to perform compliance inspections. The FDA inspection program is also used to enforce other provisions of the Family Smoking Prevention and Tobacco Control Act including the marketing and promotion of these kinds of tobacco products. Violations may result in warning letters, fines and other enforcement options.  There is no specific success rate target for states to meet like in the Synar Amendment.
  • Retailer Success Rates: According to the 2011 Annual Synar Report issued by SAMHSA, the weighted average retailer violation rate for selling tobacco products to minors was 40.1% in 1997, the first year that states conducted Synar inspections. For Fiscal Year 2011, SAMHSA reports that this average retailer violation rate declined to 8.5% nationally which translates into a 91.5% success rate. According to the FDA's website, as of July 31, 2012, the 37 states and the District of Columbia have conducted 95,630 retail store inspections of which 3,831 have been issued a warning letter for selling tobacco products to a minor or some other federal tobacco regulation violation and 322 civil money penalty complaints seeking a fine have been issued. This means that approximately 95.7% of retailers inspected passed the inspection without any violations.

Accompanying this article are copies of the SAMHSA 2011 Annual Synar Report and a document titled "A Strategic Partnership" issued by both SAMHSA and FDA describing the respective retail inspection programs of these two federal agencies. Also, a map accompanying this article shows in blue the states that are under contract with the FDA for conducting compliance inspections.