FDA Releases More Guidance on No-Tobacco-Sale Orders
SILVER SPRING, Md. — Six years after adding tobacco regulation to its list of responsibilities, the U.S. Food and Drug Administration (FDA) continues to advise retailers on regulations and policies — this time with a draft guidance on no-tobacco-sale orders (NTSO).
According to the FDA, an 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The draft guidance, "Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order," discusses topics intended to help retailers better understand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 the FDA may seek to issue an NTSO.
- The time period covered by an NTSO.
- What happens after an NTSO has been imposed on a retailer.
- How a consumer can learn which retailers have received NTSOs.
In conjunction with this draft guidance, the FDA updated a previously released guidance to reflect additional information about NTSOs. The updated guidance, "Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers Responses to Frequently Asked Questions," offers answers to common questions about civil money penalties and NTSOs.
The NTSO draft guidance is open for a 45-day public comment period, which began May 13.
To review the draft guidance, click here.