Civil Money Penalties and No-Tobacco-Sale Orders For Tobacco Retailers
This guidance document is intended to describe FDA’s current policies with respect to civil money penalties and no-tobacco-sale orders for retailers who violate Federal Food, Drug, and Cosmetic Act (“FDCA”) (21 U.S.C. 301 et seq.) requirements relating to tobacco products, including the requirement that tobacco products may not be sold or distributed in violation of FDA’s “Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents.” (75 FR 13225, codified at 21 C.F.R. Part 1140). With the finalization of this guidance document, several provisions in the Family Smoking Prevention and Tobacco Control Act (“Tobacco Control Act” or “TCA”) (Public Law 111-31) that relate to civil money penalties and no-tobacco-sale orders are effective. Section 103(q)(3) of the TCA.
The guidance document discusses:
- How does FDA intend to identify violations of the FDCA relating to tobacco products?
- Does good-faith reliance on the presentation of a false government-issued ID constitute a violation of minimum-age requirements for the sale of tobacco products?
- When may FDA decide to seek civil money penalties and/or no-tobacco-sale orders?
- Procedures that apply if FDA seeks civil money penalties and/or no-tobacco-sale orders
- What amount of civil money penalty may be assessed for a violation of the FDCA relating to tobacco products (including a violation of regulations issued under Section 906(d) of the FDCA)?
- What factors must FDA consider when seeking a no-tobacco-sale order, and how long may such an order run?