FDA Releases Final Guidance on No-Tobacco-Sale Orders
SILVER SPRING, Md. — The Food and Drug Administration (FDA) released final guidance on its authority to issue a No-Tobacco-Sale Order (NTSO).
A NTSO is a ban on selling tobacco products for a period of time for retailers who have repeatedly violated certain restrictions on the sale and distribution of tobacco products.
The final guidance, "Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order," discusses topics intended to help retailers better understand and comply with NTSOs, such as:
- When FDA may seek to issue a NTSO;
- The time period covered by a NTSO;
- What happens after a NTSO has been imposed on a retailer; and
- How a consumer can learn which retailers have received NTSOs.
According to the final guidance, the FDA considers there to be "repeated violations" if there are at least five violations of requirements issued at a particular outlet; each of the five violations represents the second or subsequent violation of a particular requirement; and each of the five violations occurs within 36 months.
The current policy is to consider each retail location to be a separate retail outlet when determining if there are repeated violations that provide grounds for FDA to seek a NTSO.
In determining the time period covered by a NTSO or amount of a civil money penalty, the agency will take into account 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, and the degree of culpability.
The FDA added that a person is entitled to a hearing before entry of a NTSO.
To read the full guidance, click here.