On February 7, 2019, FDA filed complaints against two locations of retail chain giants Walgreen Co (“Walgreens”) and Circle K Stores Inc. (“Circle K”) seeking No-Tobacco-Sale Orders (NTSO). According to the Agency’s media statement, FDA seeks to bar the two specific retail locations from selling tobacco products for 30 days. The two retail outlets that are the subject of these NTSO actions are a Walgreens store in Miami, Florida, and a Circle K store in Charleston, South Carolina. FDA claims that Walgreens is currently the top violator among pharmacies that sell tobacco products, with 22 percent of the stores inspected by the FDA having illegally sold tobacco products to minors. The NTSO action against the Miami Walgreens outlet follows the issuance of more than 1,550 warning letters and 240 civil money penalty actions against Walgreens stores nationwide for unlawful tobacco product sales to minors. This is, however, the first NTSO action taken against a Walgreens store.

UNITED STATES – NOVEMBER 9 – The outside of the Food and Drug Administration headquarters is seen in White Oak, Md., on Monday, November 9, 2015. The FDA is a federal agency of the United States Department of Health and Human Services and has been in commission since 1906. (Photo By Al Drago/CQ Roll Call)

The law provides that the FDA may pursue an NTSO against a specific retail outlet (one location only) that has committed a total of five or more repeated violations of federal tobacco regulations within 36 months. After the FDA initiates an NTSO action by filing a complaint, the retailer has the opportunity to respond to the complaint, and must generally do so within 30 days.

Retailers who receive an NTSO complaint from the FDA may either:

  • enter into a settlement agreement with the agency that results in a final order issued by the Administrative Law Judge (ALJ), or

  • respond to the court with an Answer and choose to go to a full hearing before an ALJ.

In determining the period of a NTSO, the FDA considers the nature, circumstances, extent, and gravity of the violations and, with respect to the violator, ability to pay, effect on ability to continue to do business, any history of prior such violations, the degree of culpability, and such other matters as justice may require.

If an NTSO goes into effect, the retailer is responsible for ensuring that the establishment does not sell tobacco products during the specified period.