SUPPLEMENTARY INFORMATION: ( printed page 25272)

I. Background

In the Federal Register of March 19, 2010 (75 FR 13225), FDA published final regulations restricting the sale and distribution of cigarettes and smokeless tobacco to protect children and adolescents. This guidance document discusses FDA's intended enforcement policies with respect to two provisions of the final regulations restricting the sale and distribution of cigarettes and smokeless tobacco to protect children and adolescents.

One provision, § 1140.16(a) (21 CFR 1140.16(a)), specifies that manufacturers may not use a trade or brand name of a nontobacco product as the trade or brand name for a cigarette or smokeless tobacco product unless the trade or brand name was on both the tobacco product and a nontobacco product sold in the United States on January 1, 1995. FDA is aware of concerns regarding this provision and is considering what changes, if any, would be appropriate to address those concerns.¹ While FDA has this issue under consideration, it intends to exercise its enforcement discretion concerning § 1140.16(a) (21 CFR 1140.16(a)) not to commence enforcement actions under this provision for the duration of its consideration where:

(1) The trade or brand name of the cigarettes or smokeless tobacco product was registered, or the product was marketed, in the United States on or before June 22, 2009; or

(2) The first marketing or registration in the United States of the tobacco product occurs before the first marketing or registration in the United States of the nontobacco product bearing the same name; provided, however, that the tobacco and nontobacco product are not owned, manufactured, or distributed by the same, related, or affiliated entities (including as a licensee).

The second provision is § 1140.32(a) (21 CFR 1140.32(a)). Under this section of the final rule, manufacturers, distributors, and retailers must use only black text on a white background for labeling or advertising (with certain exceptions). The United States District Court for the Western District of Kentucky recently issued an order permanently enjoining FDA from enforcing § 1140.32(a) (formerly 21 CFR 897.32(a) of the 1996 final rule that published in the Federal Register of August 28, 1996 (61 FR 44396)) ( Commonwealth Brands, Inc. v. United States, No. 1:09-CV-117-M (W.D. Ky. Jan. 4, 2010)). As required by section 102 of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), the effective date for § 1140.32(a) is June 22, 2010. At this time, however, in light of the court's order in Commonwealth Brands, FDA intends to exercise its enforcement discretion concerning § 1140.32(a) not to commence enforcement actions under this provision during the pendency of the litigation irrespective of whether the entity is a party to the pending lawsuit or located in the Western District of Kentucky.

FDA intends that the exercise of enforcement discretion expressed in this guidance document for §§ 1140.16(a) and 1140.32(a) begin upon the effective date of the final rule (June 22, 2010). In accordance with FDA's GGP regulation (§ 10.115 (21 CFR 10.115)), you may comment on this guidance at any time. The agency will consider your comments and determine whether to revise the guidance at a later date.

II. Significance of Guidance

FDA is issuing this guidance document as a level 1 guidance consistent with FDA's GGP regulation (§ 10.115). This guidance document is being implemented immediately without prior public comment under § 10.115(g)(2) because the agency has determined that prior public participation is not feasible or appropriate. This document provides guidance on regulations that are required by statute (section 102 of the Tobacco Control Act); moreover, the statute directs that the regulations take effect on June 22, 2010 (section 102(a)(2)(F) of the Tobacco Control Act). It is important that FDA explain its enforcement policy for these two provisions before that date.

III. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) electronic or written comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

An electronic version of the guidance document is available on the Internet at http://www.regulations.gov and http://www.fda.gov/​TobaccoProducts/​GuidanceComplianceRegulatoryInformation/​default.htm.