On May 31, 2011, the House Appropriations Committee, by a vote of 29 to 20 largely along party lines, adopted an amendment to the 2012 Agriculture and Food and Drug Administration Appropriations Bill introduced by Congressman Denny Rehberg (R-MT). The amendment would require the Food and Drug Administration (FDA) to base the regulation of the content of any product on "hard science" as opposed to economic, behavioral or marketing data. While the amendment is not specifically directed at tobacco products, the text appears tailored to the debate over menthol cigarettes. Tobacco control supporters have decried the amendment, as it would impose more rigorous requirements on any restrictions on cigarettes and other tobacco products, including any ban on menthol cigarettes.
The Rehberg amendment would add an explicit scientific "weight of the evidence" test to any FDA standard intended to regulate a substance or a compound. It would also require the FDA to find that a product containing such a substance is more harmful than a similar product without the compound. This standard is far more rigorous than the current tobacco product standard requirements. The amendment would further direct the FDA not to consider factors such as "cost and consumer behavior," in direct contrast to the existing mandate which directs the FDA to consider how standards will impact tobacco use among the public.
The Rehberg standard is also significantly more rigorous than the standard used to reach the conclusions of the Menthol Report issued by the Tobacco Products Scientific Advisory Committee (TPSAC) that will form the foundation of any action the FDA takes regarding menthol cigarettes. Such an increased standard could effectively nullify the conclusions reached to date by the TPSAC, requiring the FDA to initiate its own, more rigorous, analysis of menthol.
While there is a fairly good chance that the Amendment will pass in the House, it is unlikely to be supported by the Senate. However, it may cause the FDA to look more closely at the research and standards used to support its regulatory decisions, and is likely to be raised by the House in future FDA oversight hearings.