FDA Releases Responses to Questions on Civil Money Penalties

Tobacco retailers may submit questions on the issue at any time.

December 04, 2013

WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) has announced the availability of the guidance entitled “Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked Questions.” This guidance provides information in response to questions that FDA has received regarding the issuance of civil money penalties for violations of regulations issued under the Federal Food, Drug, and Cosmetic Act (FD&C Act) relating to tobacco products in retail outlets.

This guidance provides information in response to frequently asked questions that the Center for Tobacco Products (CTP) has received from retailers and other interested stakeholders regarding the issuance of civil money penalties for violations of the FD&C Act requirements relating to tobacco products in retail outlets. In particular, the guidance provides information about CTP’s enforcement of 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 and about procedures the Agency follows when it initiates enforcement actions.

The penalty schedule mentioned in this document is only for violations of rules issued under section 906(d) of the FD&C Act by a retail outlet. FDA may seek other general or enhanced penalties under section 303(f)(9) of the FD&C Act for other kinds of violations not addressed in this document.

Retailers are asked to submit electronic comments at any time via the website www.regulations.gov or written comments sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

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