Editor’s Note: As in all statements made by CRE they are all presented on an Interactive Public Docket which allows the public to offer their views on the subjects presented herein.
This afternoon the Public Health Law Center of the William Mitchell College of Law held a webinar titled “Pressing the FDA on Menthol”
The Presenters included:
•Ellen Vargyas – General Counsel and Corporate Secretary at American Legacy Foundation
•Dr. Philip S. Gardiner – Social & Behavioral Sciences and Neurosciences and Nicotine Dependence Research Administrator for the Tobacco Related Disease Research Program, Universityof CaliforniaOffice of the President
•Joelle Lester – Staff Attorney for the Tobacco Control Legal Consortium
Statements:
Dr. Yerger
Dr. Yerger stated that a recent federal report on youth smoking had no mention of menthol in the Executive Summary. CRE: A possible reason for its absence is the existence of contraband.
Dr. Gardiner
Dr. Gardiner stated that concerns for menthol have not been receiving much attention. CRE: A possible explanation is that press coverage has been reduced as a result of time needed by FDA to review a very extensive record and to ensure that its recommendations are science-based.
Twenty million adults use menthol, one million adolescents and 82% of African Americans. No mention of the impact of the adverse health effects of contraband.
His presentation on menthol as a cessation inhibitor was somewhat selective in the studies that were cited.
Ms. Vargas
Ms. Vargas said that it is not easy to issue a regulation on menthol and that any resultant regulation will probably be subject to extensive litigation.
She stated that the FDA must address:
— Risks and benefits to the population as a whole, including users and non-users of tobacco products.
— Increased or decreased likelihood that current users will stop using tobacco products.
— Increased or decreased likelihood those non users will start using products.
Ms. Vargas stated that the tobacco industry made a forceful presentation on the existence of contraband with a menthol ban.
Ms Vargas emphasized the point that TPSAC said there was no difference in the health effects of an individual as to whether menthol or non-menthol cigarettes are used.
The FDA has a number of options under consideration. Ms. Vegas believes a primary consideration is whether the rule can sustain a legal challenge. This consideration is even more significant given that the agency lost its first major challenge over graphic warnings.
Since the courts have not been supportive of CTR’s recent efforts Ms. Vargas suggests that the FDA might consider performing additional research prior to proposing a rule.
Ms. Vargas stated there are a number of decision-makers beyond the Center for Tobacco Products, including OMB’s Office of Information and Regulatory Affairs.
Mr. Jensen
Influencing agencies is different from influencing Congress. Menthol proponents should engage the FDA.
Mr. Jensen stated that Consortium will file a Citizens Petition to engage the FDA on the regulation of menthol. CRE notes that the FDA can not adopt either the petition or any of its component parts unless the FDA first determines that the underlying data is compliant with the Data Quality Act.
Statements Made During the Question and Answer Segment
There is need for a phase-in if a menthol ban is put into place.
OMB is reviewing FDA documents.
From a legal defense standpoint, more studies on cessation would be helpful.
One participant stated that FDA concluded that it needed more data to ban menthol.
There is going to have to be major interventions by advocate groups to move the ball.
There is no evidence of contraband as a result of a menthol ban.