From a press release: March 13th, 2008
House Health Subcommittee Passes FDA Bill
Late on Tuesday, March 11th, the U.S. House Subcommittee on Health approved by a voice vote H.R. 1108, the bill that would grant the U.S. Food and Drug Administration the authority to regulate cigarettes and smokeless tobacco products. Then, on a roll-call vote of 18-9, the Subcommittee on Health voted to send the FDA bill to the full House Energy and Commerce Committee for consideration. The 18 representatives voting in favor of sending the bill to the House Energy and Commerce included all the Democrats on the subcommittee joined by one Republican member.
Amendments to the FDA Bill
The Republicans on the House Subcommittee on Health planned to submit some thirty amendments to the FDA bill for the Subcommittee on Health to consider, but most amendments were withdrawn or defeated by a voice vote. However, two amendments offered by Republicans were adopted. One significant amendment offered by Republican Nathan Deal of Georgia and approved by the subcommittee requires that any future regulations or expansion of regulations proposed by the FDA must go through a rulemaking process. This means that the FDA would need to publish any new proposed regulations and allow the public to submit comments on the new rules. This rulemaking requirement partially addresses NATO’s concern that the FDA would have had the authority to adopt even more restrictive regulations on cigarettes and smokeless tobacco products and even extend regulations to cigars, little cigars and pipe tobacco without any further public input or action by Congress.
As drafted, the FDA bill assesses user fees on tobacco manufacturers to pay for the agency’s costs incurred to administer the proposed regulations. The second amendment passed by the Subcommittee on Health and authored by Republican Michael Burgess of Texas requires that these user fees be the only source to fund the FDA tobacco regulations and prohibits any other funds from the U.S. Treasury from being used to make up any shortfall in the user fee revenue.
FDA Bill Moves to Full House Energy and Commerce Committee
With H.R. 1108 being passed by the Subcommittee on Health, the bill now moves to the full House Energy and Commerce Committee. While there is no scheduled date for the full committee to take up consideration of the FDA bill, it is expected that the committee may bring the bill up sometime in late March or April.
Last year, the FDA bill was approved by the U.S. Senate Health, Education, Labor and Pensions Committee, but the Senate version of the bill has not been taken up for debate by the full Senate.