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

Bloomberg

The Food and Drug Administration said it will issue preliminary findings on the health effects of menthol cigarettes this year after outside advisers review an internal report starting next month.

The U.S. market for menthol tobacco products is $25 billion a year, or about 30 percent of cigarette sales, according to data compiled by Bloomberg Government. Lorillard Inc. (LO) of Greensboro, North Carolina, makes the best-selling brand, Newport, with sales of $5 billion a year. Marlboro Menthol, made by Richmond, Virginia-based Altria Group Inc. (MO) and the Kool and Salem brands sold by Reynolds American Inc. (RAI) of Winston Salem, North Carolina, are other leading brands.

East Peoria  Times Courrier

 The proponents of a menthol ban continue to deluge the American public with studies and press statements supporting their position.

In the past several days consider:

FDA Must Ban Menthol Smokes, Louis Sullivan, Atlanta Constitution

Tobacco Giants Engage in ‘Predatory Marketing’, Stanford School of Medicine

Preceding the aforementioned actions, the American Public Health Association released a number of studies supporting a ban.

Much in the same way that water will always flow downhill, the public can expect to continue to be inundated by studies proposing a ban sponsored by organizations whose alleged mission is to protect the public health.

theage.com.au

AUSTRALIA’S plan for plain cigarette packaging has drawn fire from a bloc of poor countries, many of them reliant on money from growing tobacco.

The Dominican Republic has led a push backed by eight countries at a meeting of the World Trade Organisation in Geneva, saying it had ”serious and grave concerns” that the plain packs would hurt tobacco producers in small and vulnerable economies.

An official WTO report of proceedings said ”support or sympathy” for the Dominican Republic argument came from Honduras, Nicaragua, Ukraine, the Philippines, Zambia, Mexico, Cuba and Ecuador.

South China Morning Post

CSP Daily News

ROCKVILLE, Md. — July 21 and 22 are dates tobacco manufacturers and convenience retailers may want to circle on their calendars. The Food and Drug Administration’s Tobacco Products Scientific Advisory Committee (TPSAC) has placed both smokeless tobacco and menthol on the agenda for its two-day meeting then.

CSP Daily News

As deadline approaches, FDA explains “proposed changes” to TPSAC report

By Linda Abu-Shalback Zid

ROCKVILLE, Md. — As the deadline approaches for the Food & Drug Administration (FDA) Center for Tobacco Products to provide a menthol review status, questions have arisen about “proposed changes” to the Tobacco Products Scientific Advisory Committee’s (TPSAC) menthol report.

According to a Federal Register notice, at an upcoming meeting on July 21, “The committee will consider and deliberate on proposed changes to the report and adopt amendments that constitute the advice of the committee.”

 With each passing day, new evidence demonstrates the extreme adverse health impacts sustained by smoking contraband tobacco.

Nonetheless the public health community refuses to address this matter. Why?  CRE suspects that the public health community simply can not come to grips with the simple fact that if one is to smoke they are better off smoking legal products than illegal products.

It appears that a fair number of the public health community believe if you ignore a problem it will go away.

WASHINGTON, May 30, 2011 /PRNewswire-USNewswire/ — The Data Quality Act continues to be used by the public to correct erroneous information disseminated by the Federal government. However, its companion legislation goes virtually unnoticed because OMB under the Clinton Administration emasculated the statute by prescribing overly restrictive regulations which were infinitely more limiting than required by statute.  

The Data Access Act states that federal agencies must make available to the public all research and underlying data developed under a federal award. The term “all” means all; OMB in its implementing regulations stated, however, that the only reports covered by the Data Access Act were those reports which carry the “force and effect of law”, meaning only those reports which change one’s legal rights — a tiny fraction of the reports which were to be covered by the Act.

CRE Note: Subsequent to the issuance of the TPSAC report a number of groups are flooding the market with additional studies which, in the mind of the authors, highlight the need for additional regulatory action on menthol.  Surprisingly, none of the studies address the central issue identified by CRE:  A menthol ban will result in the introduction of contraband cigarettes which present a far greater threat to smokers and non-smokers than legal products.  It seems the public health community does not want to recognize publicly, even though they are convinced of the accuracy of the underlying data compiled by CRE because they have never criticized it,  that if one is to smoke,  you had better not smoke contraband.

 Congressman Denny Rehberg of Montana offered  the following amendment which was adopted by the House Appropriation’s Committee:

“None of the funds made available by this Act may be used by the Food and Drug Administration to write, prepare, develop or publish a proposed, interim, or final rule, regulation or guidance that is intended to restrict the use of a substance or a compound unless the Secretary bases such rule, regulation or guidance on hard science (and not on such factors as cost and consumer behavior), and determines that the weight of toxicological evidence, epidemiological evidence, and risk assessments clearly justifies such action, including a demonstration that a product containing such substance or compound is more harmful to users than a product that does not contain such substance or compound, or in the case of pharmaceuticals, has been demonstrated by scientific study to have none of the purported benefits.”