On November 24, the Speaker of the House John Boehner, House Majority Leader Kevin McCarthy, and Fred Upton, the Chairman of the Energy and Commerce Committee, wrote to the Secretary of the Department of Health and Human Services challenging the proposed “grandfather” date for premarket review of the newly “deemed” tobacco products. According to the proposed regulation, the grandfather date for purposes of premarket review of e-cigarettes, cigars and pipe tobacco would remain at February 15, 2007 – which is the date for other currently regulated tobacco products such as cigarettes, smokeless, and roll-your-own tobacco. These products have been regulated since the Tobacco Control Act was enacted in 2009.
In the letter, the representatives state that it is “inappropriate to apply the current February 15, 2007 grandfather date to newly deemed products” for a variety of reasons, one of which being the difficulty in finding a predicate product for cigars that would be available for regulatory comparison nearly eight years later. They also state that the FDA did not consider e-vapor products to be tobacco products until 2011, and note that most e-vapor products were not even in the market in 2007.
The letter also notes that the FDA already has an “enormous” accumulation of Substantial Equivalence applications, and adding even more applications for cigars, e-cigarettes, and other deemed products would only increase their backlog. Additionally, some companies would be unable to identify a predicate product, thus causing products to be removed from the market and unqualified for provisional status. The letter points out that the regulatory barriers surrounding new product applications would pose an “unwarranted regulatory barrier to innovation.”
The representatives point out that the original 2007 grandfather date was based on the date that the Tobacco Control Act was introduced in Congress. By that logic, they assert that either April 25, 2014 (the date the proposed regulation was issued), or the date that the regulation is made final would be “preferable to the current proposal,” and that “[a]ny final provision on this issue should ensure equity among all regulated tobacco products and encourage innovation while achieving the purpose of the law.”
The full text of the letter can be read here.
For questions and/or comments, please contact Bryan Haynes, at 804.697.1420 or by email.