What is the Impact of the Rehberg Amendment on Tobacco Regulation? An Update

 Congressman Denny Rehberg of Montana offered  the following amendment which was adopted by the House Appropriation’s Committee:

“None of the funds made available by this Act may be used by the Food and Drug Administration 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.”

Conclusions reached  by the Campaign for Tobacco-Free Kids, American Cancer Society Cancer Action Network, American Heart Association and American Lung Association include:

“We strongly urge the full House of Representatives to reject this special interest giveaway to the tobacco industry that would harm the health of our nation’s children.”

“The Rehberg amendment would restrict the FDA’s ability to regulate the use of menthol in cigarettes.”

If the amendment becomes law, and if the TPSAC findings on the hard science were adopted, it would be difficult for FDA to conclude that menthol is a threat to public health because there is no discernible difference between menthol and non-menthol cigarettes when speaking of  mortality and morbidity (“hard science”) .

CRE personnel, it addition to having considerable experience on regulatory matters are well versed in federal budget issues. A relevant question regarding the amendment is how is it enforced? A precise reading of the amendment does not preclude the FDA from using prior year funding to work on menthol, which would not be covered by the said amendment. In addition,  since CTP is funded from industry funds   the wording in the appropriations bill would have to ensure that such funds are covered by the amendment.

Finally, since tomorrow FDA is going to announce:

 ”On the morning of July 21, 2011, the committee will discuss changes proposed  by committee members to the Tobacco Products Scientific Advisory Committee (TPSAC) Menthol Report submitted to the Agency on March 18, 2011”,

 the said amendment  may take on greater meaning.

CRE is conducting a review of the amendment. Our readers are encouraged to offer their views below.

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