Description
This guidance describes FDA’s current thinking with respect to imposing a no-tobacco-sale order (NTSO) on a retailer who has committed repeated violations of restrictions promulgated under section 906(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 301 et seq.), including FDA’s “Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents,” codified at 21 CFR part 1140. It supplements FDA’s current policies as described in FDA’s guidance for FDA and tobacco retailers,Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers.
Scope & Applicability
Product Classes
2Regulated products including those containing nicotine from any source.
Subject of the analytical testing method validation; regulatory submission for a tobacco product
Stakeholders
1Any person, government, or entity who sells tobacco products to individuals for personal consumption; Entity subject to No-Tobacco-Sale Orders and compliance requirements.
Regulatory Context
Attributes
1Maximum penalty for a third and subsequent NTSO violation.
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See Also (8)
- Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers Responses to Frequently Asked Questions (*Revised): Guidance for Industry (Status: Final)
- Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank: Guidance for Responsible Parties, Submitters of Certain Applications and Submissions to FDA, and FDA Staff (Status: Final)
- Civil Money Penalties and No-Tobacco-Sale Orders For Tobacco Retailers (*Revised): Guidance for Industry (Status: Final)
- FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements: Guidance for Industry (Status: Final)
- Prohibition of Distributing Free Samples of Tobacco Products: Guidance for Industry (Status: Final)
- Tobacco Retailer Training Programs: Guidance for Industry (Status: Final)
- Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents: Guidance for Industry (Status: Final)
- Submission of Warning Plans for Cigarettes and Smokeless Tobacco Products: Draft Guidance for Industry (Status: Draft)