WASHINGTON, D.C. — Three federal lawmakers have formally requested that the Food and Drug Administration (FDA) rethink their proposed grandfather date included in the agency's regulations currently on the table as the date creates an unfair market advantage.
The regulations, which were released in April 2014, would apply to cigars, electronic cigarettes and other tobacco products. The proposed regulations set a grandfather date of Feb. 15, 2007, the exact date applied to cigarettes, for the newly deemed products.
U.S. Reps. John Boehner (R-Ohio), Kevin McCarthy (R-Calif.) and Fred Upton (R-Mich.) have made a request to Sylvia Burwell, the Secretary of the U.S. Department of Health and Human Services, asking that she consider the date inappropriate for the newly deemed products. The legislators raised concerns that the date impedes innovation and imposes unnecessary regulatory burdens and obstacles on the FDA and the industries.
February 15, 2007 was the date that the Tobacco Control Act was introduced to the 110th Congress and was therefore adopted as the date. The date does create inequality between currently regulated tobacco products and newly deemed tobacco products.
The U.S. Reps explain.
"Because of the passage of time, many pre-February 15, 2007 cigars are unavailable for regulatory comparison. Additionally, most e-vapor products did not exist at that time, meaning there will be virtually no 'predicate' products in these categories. Further, FDA did not even consider e-vapor products to be tobacco products until 2011.
"Even if such 'predicate' products could be found, manufacturers would still be required to file Substantial Equivalence applications with FDA, adding dramatically to FDA's enormous backlog of such applications. As a practical matter, many newly deemed products could be removed from the market. For those products lacking a 'predicate,' the cost and barriers surrounding a new product submission would largely prevent new entries, posing an unwarranted regulatory barrier to innovation."
Lawmakers have stated that cigarettes, smokeless tobacco and roll-your-own tobacco did not face this type of barrier to market entry because the grandfather date for these products was two years before the regulation date. The Tobacco Control Act was enacted in 2009. If the FDA publishes its final rule next year, the grandfather date for newly deemed products will be eight years before regulation.
"This is a critical issue, and we request that manufacturers of newly deemed tobacco products have the same market entry opportunities as manufacturers of cigarettes and other currently regulated tobacco products. Specifically, manufacturers of these products suggested in comments to FDA that the grandfather date for them be set at either April 25, 2014 (the date the proposed deeming regulation was published) or the date the final rule is published," they wrote. "We believe either is preferable to the current proposal, as it will treat equally those products regulated in 2009 and those FDA seeks to regulate now. Any final provision on this issue should ensure equity among all regulated tobacco products and encourage innovation while achieving the purpose of the law."
The American Vaping Association (AVA) responded positively to the Senators request.
"We are thrilled to see prominent members of Congress call for the FDA to make changes to its proposed rules for vapor products," said George Conley, president of AVA. "Without significant revisions, the proposed regulatory regime threatens both public health and thousands of American small- and medium-sized businesses. The FDA's own economic analysis recognizes that the regulation will lead to the vast majority of vapor products being removed from the market."