FDA Issues New Retailer Fact Sheet on Violation Warning Letters

Thomas A. Briant, NATO Executive Director

The FDA has issued a one-page fact sheet titled "Overview: Tobacco Retailer Warning Letters" to explain why warning letters are issued to tobacco retailers, what a retailer needs to do if a warning letter is received, and what FDA tobacco regulations apply to retailers.

A copy of the fact sheet accompanies this Tobacco E-News bulletin.

Those staff members whose responsibilities include FDA tobacco regulation compliance should be provided with a copy of the fact sheet.

According to the FDA's website, as of this past August 31, the FDA had conducted 103,078 retail store inspections in the states under contract to carry out these compliance checks. A map showing the states that are currently conducting FDA retail compliance inspections accompanies this bulletin. Of the sites inspected, 95.2% successfully passed the inspections without any violations. There have also been 4,602 warning letters issued to retailers for possible violations of FDA tobacco regulations and also 386 civil money penalty complaints seeking a fine for a second or subsequent violation of the tobacco regulations at the same store.

For reference, below is a schedule of the fines that the FDA is allowed to impose for violations of the tobacco regulations by a retailer:

  • First violation, no fine, but the issuance of a warning letter.
  • Second violation within a 12-month period, a fine not to exceed $250.
  • Third violation within a 24-month period, a fine not to exceed $500.
  • Fourth violation within a 24-month period, a fine not to exceed $2,000.
  • Fifth violation within a 36-month period, a fine not to exceed $5,000.
  • Sixth or subsequent violation within a 48-month period, a fine not to exceed $10,000.

As indicated in the FDA's new fact sheet, a warning letter will include the date and, if a tobacco product is sold to a minor, the time a store was inspected, an explanation of the violation, a request for the retailer to correct the violation and how to respond to the FDA in writing to correct the violation and prevent future violations.