Written by Sam F. Halabi, Assistant Professor of Law at the University of Tulsa, this Forum discusses what the author identifies as shortcomings in the current regulations governing modified risk tobacco products (MRTPs) and his proposals for amendments to address these issues. Halabi addresses the controversy over the propriety of giving legal sanction to MRTPs and outlines the tobacco health-claim regulation cycle that has typified public policy management of health claims asserted by tobacco manufacturers. The author continues by summarizing the Tobacco Control Act’s approach to regulating MRTPs, demonstrating how section 911’s regulatory regime repeats, in his assessment, past errors.
Halabi recommends that Congress repeal section 916(a)(2)(A) preemption as it applies to MRTPs; establish a Postmarket Surveillance Deviation Incentive Program modeled on Medicare’s recovery audit contractors so that independent, incentive-driven market actors capture the extent of consumers’ perception, use and perhaps misuse of MRTPs; and, remove MRTP applicants from control and reporting of postmarketing surveillance protocols under section 911.
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