April 13, 2014

Stanton A. Glantz, PhD

Important empirical evidence that tobacco companies are successfully flaunting the ban on promoting light and mild cigarettes

Greg Connolly and Hillel Alpert recently published an important paper in Tobacco Control, "Has the tobacco industry evaded the FDA's ban on ‘Light’ cigarette descriptors?," that presents empirical evidence that the ciagrette companies have effectively nullified the ban on selling cigarettes with the misleading descriptors "light" and "mild" that are in both the Family Smoking Prevention and Tobacco Control Act and Judge Gladys Kessler's RICO decision.
Here is the abstract from the paper:

Background Under the Family Smoking Prevention and Tobacco Control Act (FSPTCA), the Food and Drug Administration (FDA) banned the use of “Lights” descriptors or similar terms on tobacco products that convey messages of reduced risk. Manufacturers eliminated terms explicitly stated and substituted colour name descriptors corresponding to the banned terms. This paper examines whether the tobacco industry complied with or circumvented the law and potential FDA regulatory actions.

Methods Philip Morris retailer manuals, manufacturers' annual reports filed with the Massachusetts Department of Public Health, a national public opinion survey, and market-wide cigarette sales data were examined.

Results Manufacturers substituted “Gold” for “Light” and “Silver” for “Ultra-light” in the names of Marlboro sub-brands, and “Blue”, “Gold”, and “Silver” for banned descriptors in sub-brand names. Percent filter ventilation levels, used to generate the smoke yield ranges associated with “Lights” categories, appear to have been reassigned to the new colour brand name descriptors. Following the ban, 92% of smokers reported they could easily identify their usual brands, and 68% correctly named the package colour associated with their usual brand, while sales for “Lights” cigarettes remained unchanged.

Conclusions Tobacco manufacturers appear to have evaded a critical element of the FSPTCA, the ban on misleading descriptors that convey reduced health risk messages. The FPSTCA provides regulatory mechanisms, including banning these products as adulterated (Section 902). Manufacturers could then apply for pre-market approval as new products and produce evidence for FDA evaluation and determination whether or not sales of these products are in the public health interest.

This information has been available to  the FDA for a long time, since Greg preseted it at a meeting at Harvard attended by FDA staff, but the agency is yet to do anything with it.  Likewise, the RICO decision prohibits promoting cigarettes with these implied health claims, but the Department of Justice has not filed any actions wityh Judge Kessler to clamp down of the companies' ignoring her order.
 
The public health intervenors should bring this information to Judge Kessler's attention.  Maybe that will force the Obama Administration to move to enforce the law.

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