Introduction to Product Regulation Under the Family Smoking Prevention & Tobacco Control Act

Transcription

1 Introduction to Product Regulation Under the Family Smoking Prevention & Tobacco Control Act Presentation for the Tobacco Merchants Association by John Manthei May 23, 2011 Latham & Watkins operates worldwide as a limited liability partnership organized under the laws of the State of Delaware (USA) with affiliated limited liability partnerships conducting the practice in the United Kingdom, France, Italy and Singapore and an affiliated partnership conducting the practice in Hong Kong and Japan. Latham & Watkins practices in Saudi Arabia in association with the Law Office of Mohammed Al-Sheikh. Copyright 2011 Latham & Watkins. All Rights Reserved.

2 Products Subject to the Act The Family Smoking Prevention & Tobacco Control Act ( FSPTCA or the Act ) grants FDA authority over Cigarettes Cigarette tobacco Roll-your-own tobacco Smokeless tobacco Any other tobacco products made subject by FDA regulation 1 Tobacco products are defined as any product made or derived from tobacco that is intended for human consumption, including any component, part or accessory 2 1. See 901(b) of the Federal Food, Drug and Cosmetic Act ( FDCA ), added by 101 of the FSPTCA 2. See FDCA 201(rr)(1), added by 101 of the FSPTCA

3 Products Subject to the Act (cont d) FDA currently does NOT have authority to regulate Cigars E-cigarettes Note, however, FDA has indicated its intent to regulate these types of products through its rulemaking authority granted under the Act

4 Pathways to Market Under the Act New tobacco products require FDA pre-market review 1 New tobacco products are defined as those not commercially marketed in the United States on February 15, 2007, including products marketed on the grandfather date that have been modified since such time 2 Therefore, to lawfully market a tobacco product, it must be: Grandfathered; 3 Substantially Equivalent ( SE ) to a grandfathered product; 4 Exempt from SE requirements; 5 An approved new tobacco product; 6 or An approved Modified Risk Tobacco Product ( MRTP ) 7 1. See FDCA 910(a)(1), added by 101 of the FSPTCA 2. Id. as interpreted by FDA Draft Guidance: Establishing that a Tobacco Product was Commercially Marketed in the United States as of February 15, See FDCA 910(a)(1), added by 101 of the FSPTCA 4. See FDCA 905(j), added by 101 of the FSPTCA 5. See FDCA 905(j)(3), added by 101 of the FSPTCA 6. See FDCA 910(c), added by 101 of the FSPTCA 7. See FDCA 911, added by 101 of the FSPTCA

5 Establishing Grandfather Status Statutory definition excludes: Products marketed before, but not on February 15, 2007 Products only in test marketing on February 15, 2007 Products marketed after February 15, 2007 FDA issued draft guidance on April 22, 2011 titled Establishing that a Tobacco Product was Commercially Marketed in the United States as of February 15, 2007, which provides recommendations for how to establish that a tobacco product is grandfathered and therefore not subject to the pre-market requirements of the Act

6 Establishing Grandfather Status (cont d) FDA draft guidance provides examples of evidence that may be relied upon to demonstrate grandfather status: Dated copies of advertisements Dated catalog pages Dated promotional material Dated trade publications Dated manufacturing documents Dated bills of lading, freight bills or waybills Manufacturers may submit requests for review of a tobacco product s status to the Center for Tobacco Products Grandfathered Tobacco Product Team

7 Substantial Equivalence The Act defines a substantially equivalent tobacco product as one that has the same characteristics as a predicate tobacco product (i.e. a product on the market on 2/15/07), or a product that has different characteristics than the predicate but information submitted to FDA demonstrates that it is not appropriate to regulate the product as a new tobacco product because it does not raise different questions of public health 1 This SE concept borrows heavily from the FDA model established for pre-market review of medical devices Versions of the Act were introduced by the 105 th through 110 th Congresses until eventually passed by the 111 th Congress in 2009 Yet, no meaningful legislative history exists on key interpretive issues that might inform the meaning of the above definition 1. See FDCA 910(a), added by 101 of the FSPTCA

8 Substantial Equivalence Reports Recent FDA guidance issued on January 5, 2011 titled Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products, provides recommendations and information related to the submission and review of documentation necessary to satisfy the SE standard set forth in the statute The guidance was issued to provide clarity in advance of the March 22, 2011 statutory deadline It was implemented immediately without prior public comment, however, FDA is currently accepting comments on the document FDA still intends to initiate rulemaking that would formally establish requirements and standards for substantial equivalence

9 Substantial Equivalence Exemptions The Act requires FDA to establish regulations exempting otherwise grandfathered tobacco products that have been subject to minor modifications since February 15, FDA issued a proposed rule on January 5, 2011 titled Exemptions from Substantial Equivalence Requirements for Tobacco Products, which: Describes the process and criteria for requesting an exemption from the SE requirements, including submission of detailed info Does not establish categories of minor modifications or identify specific modifications that meet statutory criteria for exemption Comments were due by March 22, See FDCA 905(j)(3), added by 101 of the FSPTCA