Apparently frustrated with FDA’s delays in approving new tobacco products, Lorillard Tobacco Company has filed a citizen petition requesting that FDA exercise enforcement discretion to allow marketing of such products, so long as the manufacturer has submitted a report under Section 905(j) of the Tobacco Control Act at least 90 days before introducing the product.

Under the Tobacco Control Act, FDA has the authority to review and approve so-called “new tobacco products,” defined as products first marketed or modified after February 15, 2007. Manufacturers offering new tobacco products have two options: (1) submit a new tobacco product application, which requires a substantial amount of information, including clinical studies; or (2) submit a report under Section 905(j) of the Tobacco Control Act, showing the product is “substantially equivalent” to an existing product. “Substantially equivalent” products are those having the same characteristics, or where the different characteristics do not raise different public health issues.

Manufacturers introducing new tobacco products before March 22, 2011 (so-called “provisional products”) could continue to market the product without FDA approval, so long as the manufacturer submitted a substantial equivalence report before March 22, 2011, unless FDA determines that the products are not substantially equivalent. On the other hand, for manufacturers introducing new tobacco products after March 22, 2011, FDA takes the position that it must first approve the product before it can be commercially marketed. As a result, many manufacturers rushed to bring new products to market before March 22, 2011.

Manufacturers submitted scores of substantial equivalence reports before March 22, 2011. FDA apparently has not evaluated any of those reports, and has decided that it will not review these reports at this time. This is not an issue, because those manufacturers may market their products unless and until FDA issues an order finding that the products are not substantially equivalent.

Unfortunately, FDA also apparently has not evaluated any of the substantial equivalence reports submitted after March 22, 2011. According to Lorillard’s citizen petition, approximately 118 of these reports await FDA approval. This is a major issue, considering that these products cannot be marketed until FDA is able to review the application. This can be a more significant issue for manufacturers that have been forced to change their products since March 22, 2011 due to circumstances out of their control, since as a supplier that is no longer able to offer a key component.

Lorillard’s citizen petition asserts that FDA should review substantial equivalence reports within 90 days of submission. This position appears to be consistent with Section 910 of the Tobacco Control Act, which requires the submission of such reports at least 90 days prior to introduction into the market.

The citizen petition also requests that, if FDA is unable to conduct its review within 90 days, it should exercise enforcement discretion and allow the products to be marketed while FDA completes its review. This appears to be a common-sense solution to FDA’s apparent lack of resources to timely address critical market place demands.

Manufacturers with new tobacco products awaiting FDA approval, manufacturers that have changed their products since March 2011 and manufacturers planning to introduce new products will be eagerly anticipating FDA’s response to the citizen petition. Unfortunately, FDA still has several months to review and respond to the petition.

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