Bringing Accountability to the FDA Menthol Proceedings

The House Judiciary Committee held a hearing on October 25th to consider the proposed Regulatory Accountability Act of 2011.  The bill would mandate analysis of the costs and benefits of any attempt by FDA to ban menthol cigarettes.  The bill would also allow judicial enforcement of the bill’s analytic requirements. Such analysis would shed new light on proposals to outlaw menthol cigarettes.  The legislation would mandate the analysis of the key issues CRE has raised to the TPSAC and FDA including:

    1.   The public health consequences from the sale of counterfeit cigarettes which contain far higher levels of lead, mercury and other toxins than legal products; and

   2.   Increased underage smoking resulting from growth in the contraband market (which does not check purchaser ages).

Thus, unsupported and/or biased assumptions and data used by the agency regarding the real world impact of a menthol ban would be subject to administrative and, if needed, judicial challenge. 

The hearing focused new attention on the importance of agency compliance with the existing statutory requirements contained in the Data Quality Act directing agencies to disseminate only accurate and objective data. All FDA data disseminations are, of course, subject to the DQA’s administrative requirements for correction of information not meeting the standards for quality, objectivity and integrity contained in the statute and OMB’s guidance documents.

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