The U.S. Food and Drug Administration (FDA) has been under pressure to issue guidance and regulations implementing upcoming deadlines under the new tobacco law. Recently, there has been a flurry of activity within the FDA as that agency works to promulgate such regulations and guidance. The following are the most recent FDA issuances and activities related to the implementation of the Family Smoking Prevention and Control Act. Chief among these recent issuances from FDA is the guidance regarding the upcoming ban on descriptors and the ability to sell through old product. AWMA is pleased to report that the agency heeded our concerns with respect to the sell through of old product bearing descriptors, such as “Light” or “Low”. AWMA issued a recent memo on this issue and a link to the FDA guidance can be found here:
http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm214597.htm

FDA Guidance on Harmful & Potentially Harmful Constituents in Tobacco
In addition, the FDA recently issued guidance on the “Harmful and Potentially Harmful Constituents’ in Tobacco Products as Used in Section 904(e) of the Federal Food, Drug and Cosmetic Act”. Section 904(e) of the Federal Food, Drug, and Cosmetic Act (FDCA or the Act) (21 U.S.C. 387d(e)), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Public Law 111-31) requires FDA to establish a list of harmful and potentially harmful constituents, including smoke constituents, to health in each tobacco product by brand and by quantity in each brand and sub-brand (the HPHC list). This guidance document discusses the meaning of “harmful and potentially harmful constituent” in the context of implementing the HPHC list requirement.

A link is provided here to this guidance:
http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm214598.htm

FDA Guidance for Distributors on Restricting the Sale and Distribution of Cigarettes & Smokeless Tobacco
The agency also issued guidance intended to assist manufacturers, distributors, retailers, and others who sell cigarettes and/or smokeless tobacco in understanding the final Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents and to explain what you should do in order to comply with the regulations. This guidance included a provision indicating that retailers will be required to obtain photo ID from anyone who appears to be under 27 years of age and states that self service displays and vending machines will be prohibited in any facility where people under 18 are allowed to enter at any time. In addition, this new guidance includes provisions pertaining to what constitutes “labeling and advertising” materials under the new law. Specifically, the new guidance states the scope of permissible forms of labeling and advertising for distributors that includes:

§1140.30(a)(1) describes the forms of labeling and advertising that are covered under the regulations. A manufacturer, distributor, or retailer can distribute labeling and advertising that 24 Contains Nonbinding Recommendations
bears a cigarette or smokeless tobacco brand name (or any other indicia of tobacco product identification) in or on:

• Newspapers;
• Magazines;
• periodicals or other publications, whether periodic or of limited distribution;
• billboards, posters, and placards;
• non-point-of-sale promotional material, including direct mail;
• point-of-sale promotional material;
• audio or video formats delivered at point-of-sale;

The link to this guidance is found here:
http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM214424.pdf

FDA Guidance on the Enforcement Policy Concerning Rotational Warning Plans for Smokeless Tobacco Products
The agency issued guidance on the new rotational warning labels mandated under the new tobacco law.
The new warning labels required by Section 3 of the Smokeless Tobacco Act must begin to rotate in advertising for smokeless tobacco products beginning on June 22, 2010, and must be distributed and displayed on the packaging of smokeless tobacco products manufactured on or after June 22, 2010, as set forth in Section 3(b)(3) of the Smokeless Tobacco Act. Section 204(b) of the Tobacco Control Act; Section 3(b)(3) of the Smokeless Tobacco Act. In addition, on or after July 22, 2010, manufacturers may not introduce any smokeless tobacco product into domestic commerce unless its packaging complies with Section 3 of the Smokeless Tobacco Act. Id. Among the requirements in Section 3(b)(3) is that the rotation of label statements on packaging and advertising for each brand of smokeless tobacco must be “in accordance with a plan submitted by the tobacco product manufacturer, importer, distributor, or retailer” to, and approved by, FDA. Id.

It is important to note that under this guidance, the FDA states:

At this time, as an exercise of enforcement discretion, FDA does not intend to commence or recommend enforcement of the requirement that a smokeless tobacco manufacturer, distributor, importer, or retailer must have an FDA-approved rotational warning plan so long as a rotational warning plan has been submitted to FDA by July 22, 2010. FDA believes that allowing additional time for the review of rotational warning plans will permit an orderly transition of regulatory authority from the FTC to FDA to review and approve rotational warning plans

http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm214474.htm

Finally, AWMA participated in a May 26th FDA Web Dialogue on the Development of a Tobacco Retailer Education Campaign. A summary of this conference call can be found at this link:

http://www.webdialogues.net/cs/fdatobacco-retailereducation-home/view/di/218?x-t=home