June 6, 2016
Noel Brewer and his colleagues just published an important paper. “Effect of Pictorial Cigarette Pack Warnings on Changes in Smoking Behavior: A Randomized Clinical Trial,” in JAMA Internal Medicine in which they demonstrated that graphic warning labels on cigarette packages will save lives in America. This study, as close to a real-world test that I can imagine, gave smokers their own brand of cigarettes, except with graphic warning labels pasted on them. Brewer and colleagues then followed the smokers for a month and found that the smokers randomized to the graphic warnings had increased intentions to quit, more forgoing of cigarettes, more quit attempts, and more successfully quitting smoking.
The control group got packs with text warnings on the side of the pack, like the US, unlike most of the rest of the world, still has.
I don’t know what more evidence the FDA and, more important, the White House, should need to implement state-of-the art circa 2000 graphic warning labels. (True state of the art is plain packaging.)
Here is the abstract for the paper:
June 6, 2016
FDA courageously stated in its final version of the deeming rule that it submitted to the White House that menthol flavored products would be treated the same as other flavored products (such as chocolate and gummy bear), and therefore all newly deemed menthol products would have been ordered off of the market by November 6, 2016. To market a flavored (including menthol) product after that date, the tobacco and e-cigarette companies would have been required to present evidence to FDA proving that the products were entitled to receive marketing authorization because they protected the public health. As detailed below, the FDA presented overwhelming evidence, supported by comments it received on the proposed deeming rule, that menthol, candy, and fruit-flavored tobacco products attracted youth to tobacco use and deterred quitting.
June 2, 2016
Lauren Lempert and I just published “Packaging colour research by tobacco companies: The pack as a product characteristic” in Tobacco Control. This paper shows that the industry treats pack color as an “ingredient” interchangeably with the contents of the physical cigarette to create “new prodcuts.” This evidence has important implications for FDA “substantial equivalence” determinations demonstrating that changes to packaging should not be considered substantially equivalent to existing products.
The main paper presents the relevant internal tobacco industry documents that prove this point. There is also an extensive appendix with the legal analysis showing why, under the provisions of the Family Smoking Prevention and Tobacco Control Act the FDA should not consider products that have packaging changes “substantially equivalent.”
Here is the abstract:
June 2, 2016
Given how many years any new rule takes, the FDA should take the 17 pages OMB deleted from the deeming rule and issue that as a new rule right now. You can read the changes the White House made from what the FDA wanted to do here.
Here is the TFK press release on the subject, which I completely support.
White House Missed Opportunity to Protect Kids by Deleting Provision to Remove Flavored E-Cigarettes and Cigars from the Market
May. 31 2016
WASHINGTON, D.C. – On May 5, the Obama Administration issued a long-awaited rule extending Food and Drug Administration (FDA) oversight to all tobacco products, including electronic cigarettes and cigars. On May 27, the Administration published a “redline” version of the rule showing changes made by the White House Office of Management and Budget (OMB) after the FDA submitted the rule to OMB for final review. In a key change, OMB deleted a provision that would have removed flavored e-cigarettes, cigars, hookah and other newly regulated products from the market by November 2016. This provision would have included menthol-flavored products.
June 1, 2016
Since 2007, the Motion Picture Association of America's rating system has labeled a small fraction (11%) of all the US top-grossing, youth-rated movies with tobacco. This week's rating bulletin recently announced two more films labeled for smoking:
The Magnificent Seven | "Rated PG-13 for extended and intense sequences of Western violence, and for historical smoking, some language and suggestive material."
Starring Denzel Washington, Chris Pratt, Ethan Hawke
Distributor: Sony
US release: 23 September 2016
Little Men | "Rated PG for thematic elements, smoking and some language."
Starring Greg Kinnear
Distributor: Magnolia/2929 Entertainment (independent)
US release: 5 August 2016
Learn more |