January 30, 2012

Stanton A. Glantz, PhD

Five US senators call on FDA to do its job and actually regulate the tobacco industry

Five US Senators -- Frank Lautenberg, Dick Durbin, Tom Harkin, Sherrod Brown, and Richard Blumenthal -- have written a letter to the FDA Commissioner urging the FDA to get the lead out and start effectively protecting consumers.

Among other things, the senators pointed out that, "cigarette companies continue to deceptively market their products, misleading consumers about the health consequences that come from smoking.  For example, American Spirit Cigarettes, made by Reynolds American subsidiary the Sante Fe Natural Tobacco Company, claim to be 'natural' and 'organic,' implying that these cigarettes are better for smokers' health.  Likewise, Philip Morris Company sells Marlboro Smooths as well as Virgina Slims, whose names have similar 'healthy' connotations.  Additionally, companies use colors to suggest that some cigarettes are safer.  Marlboro now uses Gold and Silver as code for 'light' and 'ultra light.'"

These concerns mirror increasing frustration I am hearing broadly across the health community.

It is no secret that I was skeptical that FDA regulation would come to anything.  While the FDA proposed good graphical warning labels, they accompanied their rule with an economic cost-benefit analysis that wildly overstated the costs and even more wildly understated the benefits, something Judge Leon seized on in his ruling against the warning labels.

And, of course, there is menthol.  Rather than acting on the FDA's Tobacco Products Scientific Advisory Committee conclusion that public health would benefit from removing menthol, the Agency embarked on its own additional report and peer review which will then be put out for more public comment -- which the industry will respond with voluminous "comments" that the FDA will then have to deal with, creating more delays.

And all  the time, the cigarette companies will merrily keep pushing menthol to African Americans, women and kids.

It's time for public health join with these senators and start demanding publicly that the FDA do its job.  Or we could all just admit that the agency has become so gummed up in its own internal culture that just sees the tobacco companies as one more "stakeholder" (rather than the racketeers they are) and stop wasting our time trying to convince an elephant to fly.



All this is very unfortunate. The FDA tobacco law, as badly written as it is, still puts powerful tools in the hands of FDA that it could use, if it so desired, to fairly and strictly regulate the manufacturing and marketing of tobacco products in a way that would effectively reduce tobacco-attributable illness and death. The question is why has FDA opted not do do so? They appear to be investing their time and energy in duplicating interventions already largely in place as a result of the Master Settlement Agreement and prior federal law, while avoiding sensible action on menthol and on other manufacturing and marketing issues that could really make a difference.I have always been and continue to be a strong supporter of a strong and effective FDA. It hurts to see the agency stumble so badly in an area where they could be taking action to protect the health of the public in new and powerful ways.
Joel L. Nitzkin, MD mailto:[email protected]";jln-md@mindspring.com

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