May 3rd, 2010
by Stacy L. Ehrlich and Reena P. Raman
The Family Smoking Prevention and Tobacco Control Act (FSPTCA) gives the Food and Drug Administration (FDA) broad authority to regulate the manufacture, marketing and sale of both current and new tobacco products. The FSPTCA includes provisions that:
• Restrict the advertising and marketing of tobacco products;
— Strengthen warning labels on cigarettes and smokeless tobacco products;
— Require tobacco manufacturers to report the ingredients of tobacco products to FDA;
— Prohibit terms such as “light,” “mild” and “low tar;” and
May 3rd, 2010
According to the Wall Street Journal, “The U.S. Food and Drug Administration rejected a request by cigarette giant Philip Morris USA to remove four members of a key tobacco-products advisory panel that the company said had extensive conflicts of interest.” The panel is intended to assess the role of smokeless tobacco products as a means of harm reduction for addicted smokers.
“In this case, I have to agree with Philip Morris, i.e. Altria,” says ACSH’s Dr. Elizabeth Whelan. “These panelists are biased. In these days of full disclosure and removing people from panels for financial conflicts, it appears that now the FDA is going to allow this purportedly impartial panel to include people who have interests in selling ineffective nicotine patches and gum while decrying the use of effective harm reduction methods, such as smokeless tobacco.”
April 30th, 2010
by GoozNews ~ 30 Apr 2010 08:21am
I’m for eliminating advisers with conflicts of interest from FDA advisory panels. I spent five years of my professional life advocating for that position. But finding myself in bed with the tobacco industry is a tad uncomfortable. The Wall Street Journal reports this morning that Altria’s Philip Morris subsidiary is objecting to four members of the FDA’s new tobacco advisory panel because they served as expert witnesses for plaintiffs who filed suit against the tobacco industry. Jonathan Samet at the University of Southern California, who chairs the committee, also advises companies that make smoking cessation products.
April 30th, 2010
Date: June 8, 2010 & June 9, 2010
Time: 8:30 a.m. – 5:00 p.m.
Location: Holiday Inn, The Ballrooms
2 Montgomery Village Avenue
Gaithersburg, Maryland 20879.
Hotel phone number is 301-948-8900.
Agenda
On June 8-9, 2010, the subcommittee will receive presentations and discuss the development of a list of harmful or potentially harmful constituents, including smoke constituents, in tobacco products. Topics for discussion will include the criteria for selection of the constituents, developing a proposed list of harmful or potentially harmful constituents, the rationale for including each constituent, and the acceptable analytical methods for assessing the quantity of each constituent. A second meeting of this subcommittee, to continue these discussions as necessary, and to include ancillary and normalization standards for the constituents, will be scheduled for the summer of 2010.
