Rehberg Amendment Could Undercut FDA Tobacco Regulation

Anti-tobacco groups believe it could prevent menthol ban

Published in CSP Daily News

WASHINGTON -- An amendment to the 2012 Agriculture Appropriations bill proposed by U.S. Representative Denny Rehberg (R-Mont.) that could undercut U.S. Food & Drug Administration (FDA) tobacco regulation efforts passed the House Appropriations Committee by a vote of 29 to 20 earlier this week. The amendment would prohibit funds going to the U.S. Food & Drug Administration (FDA) for rule-making activities or guidance unless the Secretary of Agriculture bases decisions on "hard science" and determines that the benefit of the rule or guidance justifies the action.

The appropriations [image-nocss] bill will fund the various programs within the Department of Agriculture and related agencies. In total, the legislation includes $125.5 billion in both discretionary and mandatory funding, a reduction of more than $7 billion from the President's request. The bill reduces discretionary spending by $2.7 billion from last year's level--a cut of more than $5 billion from the President's request.

According to a statement by the Campaign for Tobacco-Free Kids, American Cancer Society Cancer Action Network, American Heart Association and American Lung Association, while Rehberg stated that his amendment was not about tobacco, the amendment would curtail the FDA's authority to regulate the contents of tobacco products. It would severely limit the kind of evidence FDA could consider in regulating tobacco and other products and eliminate the FDA's ability to stop tobacco companies from adding ingredients that make their products more attractive to children and minorities, or more addictive and more difficult to quit using, the anti-tobacco groups said.

Among other things, said the groups, the Rehberg amendment would restrict the FDA's ability to regulate the use of menthol in cigarettes.

And according to the financial website Benzinbga,.com, in a report focusing on the tobacco industry, Morgan Stanley said that it remains confident that the FDA, "despite the breadth of its current regulatory authority over the US tobacco industry--is unlikely to ultimately ban or severely restrict the sale of menthol cigarettes, in large part due to the consistent scientific evidence that menthol cigarettes are no more harmful to the individual smoker than nonmenthol cigarettes (as well as the massive and predictable unintended consequences of a ban)."

It added, "While our favorable view is not predicated on any potential congressional oversight or limitation of the FDA, we believe that a little-noticed amendment passed ... by the House Appropriations Committee--if ultimately approved by Congress in the FY2012 budget--could have relevance to the FDA's consideration of menthol cigarettes and other potential tobacco product standards/regulation."

The full text of the Rehberg Amendment reads, "None of the funds made available by this Act may be used by the [FDA] to write, prepare, develop or publish a proposed, interim, or final rule, regulation or guidance that is intended to restrict the use of a substance or a compound unless the Secretary bases such rule, regulation or guidance on hard science (and not on such factors as cost and consumer behavior), and determines that the weight of toxicological evidence, epidemiological evidence, and risk assessments clearly justifies such action, including a demonstration that a product containing such substance or compound is more harmful to users than a product that does not contain such substance or compound, or in the case of pharmaceuticals, has been demonstrated by scientific study to have none of the purported benefits."

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