March 22, 2011 Deadline to File Reports of "Substantial Equivalence" for Certain Tobacco Products
The Food and Drug Administration ("FDA") issued guidance on January 5, 2011 to clarify how tobacco products introduced or changed after February 15, 2007 must be reviewed by FDA.
A tobacco manufacturer is required to obtain an order from FDA before it may sell a new tobacco product. A new product is any tobacco product not commercially marketed in the United States as of February 15, 2007, including any modification
after February 15, 2007 to a tobacco product that was commercially marketed in the United States as of February 15, 2007. A tobacco product commercially available in the United States as of February 15, 2007 is considered to be "grandfathered"
or a "predicate tobacco product" and may continue to be marketed.
A manufacturer may introduce a new product to market or make changes to a grandfathered one if it is able to show this product is "substantially equivalent" to a single predicate tobacco product being commercially marketed
in the United States as of February 15, 2007. This means that the new product must have the same characteristics (e.g. ingredients, design, composition, heating source) as the predicate tobacco product, or it may have different characteristics
when the information submitted indicates that the product does not raise different questions of public health.
Reports of "substantial equivalence" are due to be filed at FDA on or before March 22, 2011 for all tobacco products that were not commercially marketed as of February 15, 2007, specifically those introduced or changed
between February 15, 2007 and March 22, 2011. Reports not filed by March 22, 2011 will result in enforcement action, including removal of the product from the market. After March 22, 2011, these reports must be filed at least 90
days before introducing a tobacco product not commercially marketed in the United States as of February 15, 2007. Any company that has introduced a new product or made any changes to their grandfathered products will need, at a minimum,
to submit a report by March 22, 2011. A side-by-side quantitative and qualitative comparison of the new or changed tobacco product with the predicate product must be submitted.
The guidance is extremely broad, requiring any change made since February 15, 2007 to the characteristics of a tobacco product to be reported to FDA. For example, the new guidelines capture certain changes made by virtually every
company to make cigarettes comply with state "fire safe" laws, by requiring FDA approval for these same changes mandated by states.
Troutman Sanders Tobacco Team advises clients about federal and state regulatory requirements applicable to tobacco products. Contact us with your questions about this Advisory or any tobacco related matter.