Post by lestrout on Jul 2, 2016 16:19:32 GMT -5
I just got this nice response from my Congressman Costello. I am impressed by the thoroughness of the following. Is anyone else hopeful?
"Thank you for contacting me regarding H.R. 2058, the FDA Deeming Authority Clarification Act of 2015. I appreciate hearing from you and welcome the opportunity to respond.
H.R. 2058 was introduced by Representative Tom Cole of Oklahoma and would revise U.S. Food and Drug Administration (FDA) authority to regulate certain, new tobacco products. In particular, H.R. 2058 would revise the predicate date as of which new tobacco products would become subject to FDA authority. Under 2009’s Tobacco Control Act, those tobacco products introduced after February 15, 2007, which are “deemed” substantially equivalent to existing tobacco products, would be subject to FDA approval and regulation. H.R. 2058 would move this predicate date from February 15, 2007, to that date on which the FDA issues its final regulations regarding “deemed” tobacco products.
As you may know, in May 2016, the FDA issued final regulations regarding “deemed” tobacco products. In particular, those regulations would expand that agency’s authority to regulate e-cigarettes, all cigars, hookah, pipe tobacco, nicotine gels, and other products, effective as of August 8, 2016. These regulations did not alter the February 15, 2007 predicate date, set forth in Tobacco Control Act. For more information on these FDA regulations, please visit: www.fda.gov/TobaccoProducts/default.htm.
H.R. 2058 is currently under consideration by the House Committee on Energy and Commerce. While I am not a member of that committee, please know that should this legislation reach the floor of the U.S. House of Representatives for a vote, I will be sure to keep your thoughts in mind.
In addition, you may also be interested to know that Representative Cole successfully offered an amendment to H.R. 5054, the Fiscal Year 2017 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, which would address concerns about the predicate date. Specifically, this amendment would prevent funding appropriated to the FDA for the upcoming fiscal year from being used to take any administrative or regulatory actions towards those “deemed” tobacco products as of the February 2007 predicate date. This amendment was adopted by that committee on April 19th, 2016 by a vote of 31-19. At this time, H.R. 5054 awaits consideration by the full U.S. House of Representatives.
As we continue our work in Congress, please do not hesitate to contact my team in Washington, DC at (202) 225-4315 or visit www.costello.house.gov to share your thoughts on legislation or policy impacting you. In addition, I encourage you to sign up for my weekly e-newsletter to stay up-to-date on what I’m working on each week in Congress. To receive future legislative updates on specific issues of interest to you, please click here.
It is my privilege to serve you in Congress, and I look forward to your continued input throughout my term.
Best wishes,
Ryan Costello
Member of Congress"
I wonder if we should also interact with the Committee on Energy and Commerce?
hp
les
"Thank you for contacting me regarding H.R. 2058, the FDA Deeming Authority Clarification Act of 2015. I appreciate hearing from you and welcome the opportunity to respond.
H.R. 2058 was introduced by Representative Tom Cole of Oklahoma and would revise U.S. Food and Drug Administration (FDA) authority to regulate certain, new tobacco products. In particular, H.R. 2058 would revise the predicate date as of which new tobacco products would become subject to FDA authority. Under 2009’s Tobacco Control Act, those tobacco products introduced after February 15, 2007, which are “deemed” substantially equivalent to existing tobacco products, would be subject to FDA approval and regulation. H.R. 2058 would move this predicate date from February 15, 2007, to that date on which the FDA issues its final regulations regarding “deemed” tobacco products.
As you may know, in May 2016, the FDA issued final regulations regarding “deemed” tobacco products. In particular, those regulations would expand that agency’s authority to regulate e-cigarettes, all cigars, hookah, pipe tobacco, nicotine gels, and other products, effective as of August 8, 2016. These regulations did not alter the February 15, 2007 predicate date, set forth in Tobacco Control Act. For more information on these FDA regulations, please visit: www.fda.gov/TobaccoProducts/default.htm.
H.R. 2058 is currently under consideration by the House Committee on Energy and Commerce. While I am not a member of that committee, please know that should this legislation reach the floor of the U.S. House of Representatives for a vote, I will be sure to keep your thoughts in mind.
In addition, you may also be interested to know that Representative Cole successfully offered an amendment to H.R. 5054, the Fiscal Year 2017 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, which would address concerns about the predicate date. Specifically, this amendment would prevent funding appropriated to the FDA for the upcoming fiscal year from being used to take any administrative or regulatory actions towards those “deemed” tobacco products as of the February 2007 predicate date. This amendment was adopted by that committee on April 19th, 2016 by a vote of 31-19. At this time, H.R. 5054 awaits consideration by the full U.S. House of Representatives.
As we continue our work in Congress, please do not hesitate to contact my team in Washington, DC at (202) 225-4315 or visit www.costello.house.gov to share your thoughts on legislation or policy impacting you. In addition, I encourage you to sign up for my weekly e-newsletter to stay up-to-date on what I’m working on each week in Congress. To receive future legislative updates on specific issues of interest to you, please click here.
It is my privilege to serve you in Congress, and I look forward to your continued input throughout my term.
Best wishes,
Ryan Costello
Member of Congress"
I wonder if we should also interact with the Committee on Energy and Commerce?
hp
les
