CQ TODAY – REGULATORY POLICY
April 2, 2008 – 8:24 p.m.
Bill to Force FDA Tobacco Regulation Moves Through Energy and Commerce

An increasingly bipartisan bill that would require the Food and Drug Administration to regulate tobacco products advanced from a House panel on Wednesday, setting up its passage by the full House.

The Energy and Commerce Committee approved, 38-12, the bill (HR 1108). A House leadership aide said timing for floor debate is uncertain.

Written by Henry A. Waxman, D-Calif., the measure would give the FDA authority to evaluate product claims by tobacco companies, approve their advertising and warning labels, and control nicotine levels in their products.

Democrats won support for the legislation from 11 Republicans on the committee, including one — Mike Rogers of Michigan — who had voted against the bill when the Health Subcommittee marked it up March 13.

A Senate version of the bill (S 625) was approved by the Health, Education, Labor and Pensions Committee on Aug. 1. A spokeswoman for HELP Chairman Edward M. Kennedy, D-Mass., said the full Senate is expected to debate the bill “in the next few months.”

Energy and Commerce Republicans complimented the committee’s chairman, John. D. Dingell, D-Mich., for negotiating with them to change many provisions of the bill between the subcommittee and full committee markups. Dingell’s changes also persuaded several small tobacco companies and the National Association of Convenience Stores to drop their opposition to the bill.

The changes were incorporated into a manager’s amendment that the committee adopted by voice vote.

Some midsize tobacco companies still oppose the bill. The 12 “no” votes all came from Republicans, some of whom cited the measure’s potential effect on the FDA itself.

“If we’re going to regulate tobacco, I think it should be done at the Federal Trade Commission and not as a health issue at the Food and Drug Administration,” said Joe L. Barton of Texas, the senior Republican on the committee.

“This bill will only serve to complicate the Food and Drug Administration’s mission and overburden it even more,” said Michael C. Burgess, R-Texas, who also voted against it. “It is incongruous that the FDA would be able to regulate a product that is as inherently dangerous as tobacco.”

GOP Amendments

The committee rejected nine amendments offered by Republicans, including one by Burgess that would have allowed the FDA to ban tobacco outright. Rogers and Steve Buyer, R-Ind., offered five amendments that would have delayed implementation of the bill for up to 10 years after its enactment, in order to allow the FDA time to improve its regulation of food, drugs, medical devices and overseas factories.

The agency has been beleaguered in recent years by reports that it cannot adequately fulfill its existing responsibilities. Democrats largely agree but say that simply delaying implementation of tobacco regulation won’t help fix the agency’s problems; instead, they want to give it more money.

Three Republican amendments were adopted, all on voice votes.

One, by Buyer, would remove language from the bill that he said might have allowed the FDA to award no-bid research grants.

Another by Buyer would require the Federal Trade Commission to study whether the tobacco industry becomes more concentrated and less competitive, should the bill become law.

Midsize tobacco companies such as Lorillard and R.J. Reynolds oppose the bill, in part because they believe industry giant Philip Morris USA will be able to more easily afford regulation and thus attain a market advantage. Philip Morris supports the bill.

The third adopted Republican amendment, by Vito J. Fossella, R-N.Y., would require the government to study the health effects of “cross-border trade in tobacco products,” including smuggled and counterfeit products.

Dingell’s Changes

Dingell’s manager’s amendment made a host of changes aimed at pacifying both industry groups and Republicans.

Convenience stores won provisions requiring the regulation of tobacco sales beyond over-the-counter transactions — putting Internet and mail-order retailers on the same footing as them.

Other provisions would require the government to consider whether retailers had programs in place to prevent sales of tobacco products to minors, and whether they had been subject to state fines, before prohibiting stores from selling tobacco products or issuing fines in response to violations.

Tobacco companies employing fewer than 350 people won provisions giving them more time to comply with product-testing and reporting requirements in the bill and allowing them to jointly purchase laboratory testing services.

Growers won provisions requiring foreignA--produced tobacco to be subject to the same limits on pesticides and other chemicals and meet the same standards that the FDA might apply to domestic leaf.

Tobacco opponents won language to ensure that tobacco companies won’t be able to claim that “smoke-free” or similarly labeled products have lower health risks.

The amendment also clarifies the user fee provisions of the bill, which Republicans had said were worded in a way that made the fee a tax. That raised jurisdictional issues; the Ways and Means Committee has authority over all tax issues. Under the amendment, the fees would be assessed by the Health and Human Services Department (HHS) and would be dedicated only to the FDA’s tobacco activities.

Opponents of the bill also won more time to comply with it. Under Dingell’s amendment, HHS would be required to issue a rule implementing the law six months after it is enacted. The original bill required a rule within 30 days.

Leah Nylen contributed to this story.

Source: CQ Today
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