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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U.S. Food and Drug Administration (FDA) continues to advise retailers on regulations and policies — this time with a draft guidance on no-tobacco-sale orders (NTSO).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The draft guidance, "Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order," discusses topics intended to help retailers better understand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In conjunction with this draft guidance, the FDA updated a previously released guidance to reflect additional information about NTSOs.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The NTSO draft guidance is open for a 45-day public comment period, which began May 13.

To review the draft guidance, click here.

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