Earlier this month, FDA issued draft guidance addressing substantial equivalence of new tobacco products.  In doing so, FDA provided tobacco manufacturers with much needed guidance on FDA’s “current thinking” on this subject.  Comments on the draft guidance are due by November 8, 2011.

Among other issues, the draft guidance addresses the following subjects:

  • Brand Names – FDA announced that a change to the brand name of a tobacco product, even if the product itself remains unchanged, renders a tobacco product a new tobacco product subject to the Tobacco Control Act’s substantial equivalence requirements.  Similarly, marketing a tobacco brand under an additional brand name renders the product a new tobacco product.
  • Labels and Packaging – FDA clarified that merely changing brand name descriptors from “mild” or “light” (as required by the TCA) do not render the product a new tobacco product under the TCA.  FDA also clarified that the inclusion of graphic warning labels, as mandated by the TCA, does not render the product a new tobacco product.  Similarly, changing products from hard pack to soft pack (or vice versa) or design changes to packaging do not render the products new tobacco products.  All of these principles seemed relatively self-evident, although FDA had not previously been able to provide answers to these questions.
  • Specifications – Simply changing suppliers for an additive, if the specification for the additive remains unchanged, does not render the tobacco product a new tobacco product.  However, according to FDA, even minor changes to specifications render the product a new tobacco product.
  • Fire-Safe Paper – FDA addressed one of the most frequently-asked questions — whether the use of fire-safe paper, as mandated by all states’ laws over the last several years, renders the tobacco product a new tobacco product.  Although the addition of fire-safe paper was a new requirement in almost all states following the Feburary 15, 2007 date for new tobacco products, and studies have shown that fire-safe paper does not alter a cigarette’s toxicological properties, FDA announced that fire-safe paper renders a product a new tobacco product.  This position substantially increases the number of products subject to review as new tobacco products.

For questions and/or comments, please contact Bryan Haynes, at 804.697.1420 or by email.