Guidance further addresses what changes render a product a "new tobacco product," when streamlined SE reports are appropriate; Controversial issues remain

On September 8, 2015 the U.S. Food and Drug Administration issued a second edition of its March 2015 Guidance "Demonstrating the Substantial Equivalence of a New Tobacco Product."

Under the Tobacco Control Act, "new tobacco products" (i.e., products introduced to the U.S. market after February 15, 2007 or modified in certain ways after that date) must be approved under a premarket tobacco product application (PMTA), unless exempted. Manufacturers can obtain an exemption by submitting a Substantial Equivalence (SE) Report to FDA and obtaining an order finding that the new tobacco product is both substantially equivalent to a tobacco product commercially marketed in the U.S. as of February 15, 2007, and in compliance with the requirements of the Tobacco Control Act.

The Guidance:

  • Explains whether and when a change to a tobacco product's label, product quantity in the package, additives, or specifications renders that product a "new tobacco product" subject to premarket review;
  • Explains that a manufacturer may submit streamlined SE reports for certain modifications to labels and changes to product quantity;
  • Explains FDA's plans and processes for review of the streamlined SE reports; and
  • Responds to several general SE process questions.

Notably, FDA added 10 new questions and responses to the revised Guidance, which address:

  • Whether a change in a product label renders a product a "new tobacco product" requiring a PMTA;
  • The types of changes that make a product's label distinct from the predicate;
  • The purpose that is served by the submission of the Same Characteristics SE Report;
  • How FDA will review Same Characteristics SE Reports;
  • Whether or not it is necessary to submit the product label as part of a Same Characteristics SE Report;
  • Whether a Same Characteristics SE Report may be used if a manufacturer commercially markets a cigarette product as "Brand A" as of February 15, 2007, but also intends to commercially market an otherwise identical (i.e., same characteristics) tobacco product as "Brand AtoZ" except that "Brand AtoZ" has a different brand name ink-stamped on each stick or omits the brand name ink-stamp that appears on each stick of the predicate product;
  • Whether a change to a product quantity in the package renders a product a "new tobacco product" requiring a PMTA;
  • The purpose that is served by the submission of the Product Quantity Change SE Reports;
  • How FDA will review Product Quantity Change SE Reports; and
  • If in addition to changing the product quantity there is a change to the name of a product, whether the Product Quantity Change SE Report can be used.

The revised Guidance also provides further direction with regard to the streamlined SE report process and changes that may render a product a "new tobacco product". These include certain: label changes; changes to a product quantity; and differences in ink-stamping of products. There are also two new appendices in the revised Guidance providing a sample "Same Characteristics SE Report" cover letter and a sample "Same Characteristics SE Report".

Unfortunately, some of the issues that were controversial in the September 2011 draft version of the Guidance still remain. For example, the Guidance essentially requires industry to obtain FDA pre-approval of label changes, despite the fact that FDA can only pre-approve such changes when a label makes a "modified risk" claim and when the Agency issues pre-approval regulation through the procedures set forth in the Administrative Procedure Act (APA) (i.e., notice-and-comment rulemaking). Several tobacco companies voluntarily dismissed their suit against FDA related to the March 2015 version of the Guidance when the Agency said it would not take enforcement action against rebranded products before the Guidance was finalized. Now that the second edition of the Guidance has been issued, it is not clear whether such enforcement discretion will continue.