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Altria James E Altria James E. Dillard Ill Senior Vice President Altria Client Services Regulatory Affairs August 8, 2014 Via Courier/Hand-Delivery Division of Dockets Management (HF A-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, Maryland 20852 Re: Docket No. FDA-2014-N-0189 (RIN 0910-AG38) (79 Fed. Reg. 23142) (April25, 2014)- Comments on Proposed Rule "Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and FSPTCA; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products" Altria Client Services Inc. ("ALCS"), on behalf of John Middleton Co. ("Middleton"), 1 submits the following two separate comments on the Food and Drug Administration's ("FDA" or "the Agency") Notice of Proposed Rulemaking ("Proposed Rule") on the deeming of tobacco products subject to the Food, Drug, and Cosmetic Act ("FDCA"), as amended by the Family Smoking Prevention and Tobacco Control Act ("FSPTCA")? • General Comments • Descriptor Ban Comments We appreciate the opportunity to submit these documents in response to the Proposed Rule. Sf !~~ James E. Dillard III 1 Middleton is a wholly-owned indirect subsidiary of Altria Group, Inc. ALCS provides certain services, including regulatory affairs, to the Altria family of companies. "We" and "our" are used throughout these comments to refer to Middleton, except where the context requires otherwise. 2 79 Fed. Reg. 23142 (Apr. 25, 2014). Altria Client Services Inc. 2325 Bells Road Richmond, Virginia 23234 (804) 335-2679 James. E. [email protected] James E. Dillard III Senior Vice President Regulatory Affairs August 8, 2014 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, Maryland 20852 Re: Docket No. FDA-2014-N-0189 (RIN 0910-AG38) (79 Fed. Reg. 23142) (April 25, 2014) – Comments on Proposed Rule “Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and FSPTCA; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products” (General Comments on behalf of John Middleton Co.) Altria Client Services Inc. (“ALCS”), on behalf of John Middleton Co. (“Middleton”),1 appreciates the opportunity to comment on the Food and Drug Administration’s (“FDA” or “the Agency”) Notice of Proposed Rulemaking (“Proposed Rule”) on the deeming of tobacco products subject to the Food, Drug, and Cosmetic Act (“FDCA”), as amended by the Family Smoking Prevention and Tobacco Control Act (“FSPTCA”).2 Altria, on behalf of its tobacco operating companies, supported the passage of the FSPTCA because it believed that a comprehensive regulatory framework, thoughtfully implemented, can contribute to resolving many of the complex issues that surround tobacco products. With the Proposed Rule, FDA has the opportunity to bring all tobacco products under a single, public health regulatory authority. We support FDA extending appropriate regulatory authority over all tobacco products. FDA should apply the provisions of the FSPTCA in a science- and evidence- based manner and reflective of the particular aspects and history of different tobacco product categories, including cigars and pipe tobacco. 1 Middleton is a wholly-owned indirect subsidiary of Altria Group, Inc. ALCS provides certain services, including regulatory affairs, to the Altria family of companies. “We” and “our” are used throughout these comments to refer to Middleton, except where the context requires otherwise. 2 79 Fed. Reg. 23142 (Apr. 25, 2014). Altria Client Services Inc. 2325 Bells Road Richmond, Virginia 23234 (804) 335-2679 [email protected] Our comments are organized as follows: I. Executive Summary II. Background Information about Middleton and Its Products III. FDA’s Adherence to Guiding Principles and Fundamental Legal Requirements Will Help Ensure Successful Implementation of the Deeming Regulation IV. Premium Cigars Should Be Subject to Deeming V. Middleton Supports FDA’s Proposal to Establish a Federal Minimum Age to Purchase Deemed Tobacco Products VI. Health Warnings Should Be Uniform for All Tobacco Products in a Category and Allow Communication of Brand Equity VII. Any Action FDA Takes with Regard to Flavored Cigars and Pipe Tobacco Must Be Science- and Evidence-Based and Should Respect Adult Tobacco Consumer Preferences VIII. Meaningful Testing for Harmful and Potentially Harmful Constituents Will Require a Category Specific List of Constituents, Testing Protocols, Validated Consensus Standards and Certified Reference Products IX. Conclusion I. Executive Summary Middleton is a manufacturer of machine-made large cigars and pipe tobacco. Middleton supported passage of the FSPTCA and supports FDA extending appropriate regulatory authority over all tobacco products in a manner that reflects the attributes of each tobacco product category. As it finalizes the Proposed Rule, FDA should apply certain key principles. First, FDA must base its regulations and decisions on science and evidence to protect the integrity of its decision- making process and provide a consistent and predictable regulatory environment. Second, FDA should preserve and respect the choices of adult tobacco consumers while limiting access to minors. Third, FDA must ensure that it does not violate Constitutional principles. Fourth, regulation should apply equally to all manufacturers of tobacco products in a category. In addition to these foundational principles, Middleton comments on several specific topics that are important to Middleton as a manufacturer of cigars and pipe tobacco. Middleton believes that premium cigars should be regulated by FDA. Given FDA’s statements in the preamble to the Proposed Rule that “all cigars are harmful and potentially addictive,”3 we do not believe that certain cigars should be exempted from regulation. Moreover, FDA’s attempt to define a class of cigars that would be exempted from regulation is not supported by evidence, 3 79 Fed. Reg. at 23143, 23150. 2 may motivate some manufacturers to evade regulation by changing their cigars, and could communicate an unintended message to consumers about the health risks of cigars. As FDA deems products, it should not reflexively extend provisions of the FSPTCA that simply should not apply to certain deemed products. Specifically, any blanket extension by FDA of the cigarette “descriptor” prohibition in Section 911 to categorically ban use of the word “mild” in Middleton’s BLACK & MILD® trademark would run afoul of the FSPTCA, the Administrative Procedure Act, and the Constitution. In light of the importance of this issue to Middleton, we have filed separate comments to this docket specifically on this topic.4 Middleton supports FDA’s proposal to establish a nationwide minimum age of 18 to purchase cigars and pipe tobacco. There are inconsistencies between the health warning requirements for cigars and pipe tobacco that FDA proposes and existing federal and state warning requirements. FDA should resolve regulatory inconsistencies by establishing a uniform regime of national warning requirements that is appropriate for the protection of the public health, prevents consumer confusion, establishes clear compliance obligations for manufacturers, and is consistent with Constitutional requirements. If FDA decides to act with regard to cigars and pipe tobacco marketed with characterizing flavors, it should follow the process established in Section 907 of the FSPTCA. This approach would guarantee the opportunity for public notice and comment, science-based regulatory decision-making, and uniform application of any product standards. FDA must be mindful of the need for clear definitions and the importance of respecting adult consumer choice. With regard to testing and reporting of harmful and potentially harmful constituents (“HPHC”) for deemed products, the Agency should recognize the differences between currently regulated tobacco products and cigars and pipe tobacco in particular. FDA will need to develop tobacco category-specific HPHC lists, establish protocols and validated consensus standards, develop certified reference materials, and implement laboratory proficiency testing. II. Background Information about Middleton and Its Products Founded in 1856 as a pipe tobacco retailer, Middleton is a leading manufacturer of cigars and pipe tobacco, operating two facilities in Pennsylvania that employ more than 400 people. Middleton’s cigar portfolio is led by the BLACK & MILD® brand family. Middleton’s top pipe tobacco brands are PRINCE ALBERT®, CARTER HALL®, and MIDDLETON’S CHERRY BLEND®. 4 See John Middleton Co. Comments on Docket No. FDA-2014-N-0189 (RIN 0910-AG38) (79 Fed. Reg. 23142) (April 25, 2014) – Comments on Proposed Rule “Deeming Tobacco Products Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and FSPTCA; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products” (Aug. 8, 2014). (Descriptor Ban Comments on behalf of John Middleton Co.) 3 All of Middleton’s cigars are classified as large cigars for federal excise tax purposes.5 The majority of Middleton’s cigars are tipped, with a plastic or wood mouthpiece. Middleton’s cigars are machine-made, with machines used for rod making, tip application and final packing. With this combination of tax classification and machine manufacturing,
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