FDA Issues Final Guidance on No-Tobacco-Sale Orders

Agency will host webinar this week to discuss guidance and compliance for NTSOs.

August 31, 2015

WASHINGTON – On Friday, the FDA issued a final guidance regarding the agency’s authority to issue a No-Tobacco-Sale Order (NTSO).

Under the Family Smoking Prevention and Tobacco Control Act—the federal law that granted the FDA the authority to regulate tobacco products—the FDA was authorized to conduct retail compliance inspections and impose fines for violations that could culminate in a no-tobacco-sales order (NTSO) for repeated violations of the federal tobacco regulations. Essentially, 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 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 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

The FDA has provided a Guidance web page for retailers seeking more information on NTSO policies the agency will also hold a live webinar this Weds., September 2, at 2 p.m. (EDT) to discuss the guidance.  Additional information on participating in the webinar is available on the FDA Tobacco Compliance Webinars webpage.

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