FDA Agent Inspections Underway

The FDA releases new webinars explaining what happens during these inspections.

November 09, 2023

The U.S. Food and Drug Administration has begun inspections at retail establishments that sell tobacco products. The Center for Tobacco Products (CTP) will conduct compliance check inspections in brick-and-mortar retailer locations across the United States, in U.S. territories and on tribal land.

The two compliance checks are:

The CTP has created new webinars on both these checks, available at the links above.

In Advertising and Labeling Inspections, the FDA inspector will issue an FDA Form 482–Notice of Inspection to the establishment. The inspector will then ask to speak with whoever is in charge and present and ask that person to provide the establishment’s name, physical address, telephone number and ownership information. Then the inspector will check that the establishment is in compliance with the following laws and regulations.:

  • Do not give away free samples of tobacco products, except for smokeless tobacco from a “qualified adult-only facility.”
  • Do not break open cigarette or smokeless tobacco packages to sell products in smaller amounts.
  • Do not sell cigarette packages containing fewer than 20 cigarettes.
  • Do not sell single cigarettes (also called “loosies”).
  • Do not sell cigarettes, cigarette tobacco or roll-your-own tobacco that contains a characterizing flavor (except menthol or tobacco flavor).
  • Do not sell products that lack the required premarket authorization.
  • Ensure that the required warning statements are on all tobacco products.

During Undercover Buy inspections, retailers will not be aware that they are being inspected by the FDA. An underage purchaser under the supervision of an inspector will attempt to purchase a tobacco product. The inspection will allow the FDA to determine whether the retailer is in violation by selling a tobacco product to an individual under the age of 21 or failing to request the photo ID of a person under the age of 27 who attempts to purchase a tobacco product. 

Other violations may be noted by the undercover inspector during the inspection as well, including but not limited to the sale of individual cigarettes and the ability to access a self-service display in an area that is not restricted by age.

If an inspector reports that an underage purchaser was able to enter the establishment and make a tobacco purchase during an inspection, the FDA will mail a compliance check inspection notice shortly after the inspection.

If any potential violations are found during an inspection, the inspector will send them to the FDA. Once the FDA has reviewed the evidence, if violations are found, the Agency will send Advisory Actions (e.g., warning letters) to retailers the first time an inspection reveals violations.

Check out the FDA’s Advertising and Labeling Inspections and Undercover Buy Inspections webinars for more information on the inspections.