What Standards Should FDA Apply in Ruling on Applications for Substantial Equivalence for Tobacco Products Under the Family Smoking Prevention and Tobacco Control Act of 2009
Food and Drug Law Institute
Mark Greenwold
In this issue of the Policy Forum (Volume 2, Number 18, September 26, 2012) Mark Greenwold, Senior Consultant for the Campaign for Tobacco-Free Kids, discusses the Tobacco Control Act of 2009. Specifically, he addresses the Act’s novel regulatory structure requiring that “new tobacco products” must be found to be “appropriate for the protection of the public health” before they can be marketed. Greenwold explores an exception to this requirement for tobacco products marketed after February 15, 2007 that are alleged to be “substantially equivalent” to a product sold prior to February 15, 2007. If the new product was marketed before March 23, 2011 and a substantial equivalence application was filed before that date, the new product can continue to be marketed indefinitely unless FDA denies the substantial equivalence application. Greenwold recommends that in evaluating substantial equivalence applications, FDA place the burden on manufacturers to prove that the product is substantially equivalent to an earlier product. This is the most effective way to ensure that public health is protected under the statute, Greenwold concludes.
