A Public Participation Forum for the FDA Center for Tobacco Products and its Federal Advisory Committee (TPSAC)

An Update of Earlier Research  MacKinac Center

The FDA has taken the unprecedented action in submitting a petition filed under the Data (Information) Quality Act to an advisory committee.  CRE applauds this action.

 As the Chairman of TPSAC has stated on a number of occasions, TPSAC is a scientific advisory committee not a policy committee.

 The standards for review in the DQA are not open to discussion; data underlying federal government regulatory actions must be reproducible, objective and unbiased. The decision of the DC Circuit Court in Prime Time declared that the DQA guidelines are binding on agencies.  The DQA precludes the intrusion of policy preferences into scientific risk assessments.

December 21, 2010 marks the tenth anniversary of the Data Quality Act (DQA), also known as the Information Quality Act, 44 U.S.C § 3516, note.

The DQA has deep roots developed over nearly a half-century as the result of a seed planted during the Johnson Administration which germinated in the Nixon Administration, was watered by the Carter Administration and whose product was harvested by the Reagan Administration, made available to the public in the Bush I Administration and subsequently enhanced by the Clinton Administration and promoted by the Bush II and Obama Administrations. See: http://thecre.com/ombpapers/SystemsAnalysisGroup.htm and http://thecre.com/quality/20010924_fedinfotriangle.html

Editor’s Note: Professor Siegel delivers a devastating analysis of the foundations of  FDA regulatory programs to reduce risk from tobacco use. Professor Siegel delivered an equally scathing analysis of a  Surgeon General’s report in 2006.

Hopefully, FDA is cognizant of the tendency of certain stakeholders to be over dramatic in their statements and will review the onslaught of the recent menthol initation/cessation studies with a critical eye.

Tuesday, December 14, 2010

See Federal Register notice below.

By TOM BREEN – Dec 8, 2010 1:04 PM ET

RALEIGH, N.C. (AP) — A possible federal ban on menthol cigarettes would put people out of work during the worst economy in generations, according to a union representing tobacco workers, which says its members are being overlooked.

Busloads of workers from Greensboro, represented by the Bakery, Confectionary, Tobacco Workers and Grain Millers International Union, traveled to Raleigh on Wednesday to protest outside a meeting of federal officials and various tobacco industry representatives.

“Soft” scientific studies dealing with menthol, those focused on initiation/cessation, have been reviewed in detail by CRE, see http://www.thecre.com/scur/

The Center for Regulatory Effectiveness, CRE,  does not arbitrarily dismiss the “soft” science studies;  to the contrary, in a number of instances they highlight areas of possible concern. However, very few of the “soft science studies are definitive.

In repeated statements to the FDA Advisory Committee, TPSAC, CRE has stated that the “hard” science studies, those based upon the  toxicology of specific disease endpoints  clearly demonstrate that there is no reason for concern; on the other hand the “soft” science studies fail to meet the mandatory standards set forth in the Data Quality Act.

WASHINGTON — While recently supporting the legalization of marijuana, progressives and members of the Obama Administration — as well as state and local elected officials — are considering cigarette prohibitions.

The Tobacco Products Scientific Advisory Committee of the U.S. Food and Drug Administration is seriously studying the effects of a “black market” that would be created if the government enacts a new prohibition on menthol cigarettes, according to a warning issued by the Law Enforcement Alliance of America.

Some groups argue the flavor of cigarette lures young African-Americans to smoke; others say prohibition would backfire

Dahleen Glanton, Tribune reporter

The longest Samuel Johnson has ever been able to give up menthol cigarettes is three months. Every time he tries to quit, he said, that cool, minty flavor that first drew him and other African-American smokers to menthols lures him back.

“Everybody has a habit and mine is smoking cigarettes,” said Johnson, 20, standing outside Harold Washington College downtown between classes with other young students, many of them puffing on menthols.