Wednesday, March 29, 2017

Problems Multiply for Proposed FDA Smokeless Tobacco Rule

The FDA on January 23 published a proposed smokeless tobacco (ST) regulation that would require a radical reduction in levels of N-nitrosonornicotine (NNN), a tobacco-specific nitrosamine.  I documented (here) that the rule is based on erroneous calculations of ST risks; others have since raised additional concerns.

Scott Ballin, Health Policy Advisor to the University of Virginia’s Morven Dialogues, observes that the FDA ignored its statutory requirement, when setting product standards, to “invite appropriate participation though joint conferences, workshops, or other means, by informed persons representative of scientific, professional, industry, agricultural or consumer organizations who in the Secretary's judgment can make a significant contribution.”

Brian Fojtik, Senior Fellow at the Reason Foundation, notes (here) that the FDA invited participation from selected stakeholders: “Within hours of publication in the [Federal] Register, a comment was filed by a coalition of interest groups collaboratively (American Academy of Pediatrics, Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco Free Kids and Truth Initiative) . . . a reasonable person is left wondering how six large organizations could possibly have each reviewed a highly technical, 50-page rule, reached conclusions on the rule’s specific merits and crafted a collaborative response that all agreed to sign within hours of the rule’s publication in the Register.  Even in the most forgiving of lights, the appearance is unseemly and should necessitate the withdrawal of the proposed rule.”

Another major error in the FDA’s proposed rule-making process was identified by Altria in a March 3 comment submission.  The agency filed a regulatory impact analysis (here) for the rule, estimating that 30% of moist snuff products currently meet the 1 ppm dry-weight limit (Table 3, panel A).  However, FDA miscalculated the wet-weight to dry-weight conversion, invalidating the estimate. 

Moist snuff is about 50% water; when it is dried, the level of any agent in the remaining tobacco will double.  The FDA did the reverse, calculating that a product with 2 ppm NNN wet-weight would have 1 ppm dry weight.  The correct conversion is 0.5 ppm wet-weight to 1.0 ppm dry weight.  Almost no moist snuff products on the U.S. market are at 0.5 ppm wet weight.

Altria urged the FDA to withdraw the proposed rule because it “would fail to provide a scientifically valid formula for manufacturers to measure and maintain records of NNN levels on a dry weight basis in order to demonstrate compliance with the product standard.”

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