A Reply From Congressman Kevin Brady of Texas
Member of Congress
8th District of Texas
Committee on Ways and Means
Chairman, Subcommittee on Health
Subcommittee on Trade
Joint Economic Committee Vice Chairman
Joint Committee on Taxation
September 16, 2015
Dear Mr. Ingling:
Thank you for contacting me with your support for H.R. 2058, the Food and Drug Administration (FDA) Deeming Authority Clarification Act. I appreciate your input on this issue, and it is an honor to serve you in Congress.
On April 24, 2014, the FDA proposed a new rule, known as a "deeming regulation," that would grant it the ability to regulate additional tobacco products, including e-cigarettes, cigars, and pipe tobacco. Within this rule is a provision that requires products introduced after February 15, 2007, to acquire FDA approval before being allowed to sell. As a result, various products that would fall under this rule would be effectively banned until they receive FDA approval.
On November 24, 2014, Speaker John Boehner, House Majority Leader Kevin McCarthy, and Chairman Fred Upton sent a letter to the Secretary of Health and Human Services, the Commissioner of the FDA, and the Director of the FDA's Center for Tobacco Products expressing their concern with the proposal. In the letter they requested that the grandfather date be moved to April 25, 2014. This would save manufacturers of these new products from a burdensome regulatory process that hampers innovation, harms small businesses, and inevitably leaves consumers without many of their products.
The FDA Deeming Authority Clarification Act moves the February 15, 2007, cutoff date to the date of the deeming regulation, allowing products that have been introduced since 2007 to continue to be sold, pending FDA approval. H.R. 2058 is pending before the House Energy and Commerce Subcommittee on Health.
Setting the grandfather date eight years prior to the final regulation will cause a critical economic issue that will leave many cigar and e-vapor products at a disadvantage and cause additional regulatory burden that may cause many products to be removed from the market. Please know that I intend to pay very close attention to the issue to ensure the government does not create an uneven playing field. While I am not a member of this Committee, please know that I will keep your thoughts in mind should this legislation be brought to the floor of the House of Representatives.
Again, thank you for letting me know your opinion. Let's keep in touch, and if I can be of help in the future, don't hesitate to let me know.
Eighth District of Texas
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