February 28, 2013

Stanton A. Glantz, PhD

Will President Obama let Mitch Zeller do a great job at the FDA?

I was as surprised as everyone else when the FDA announced that Lawrence Deyton announced that he was leaving as head of the Center for Tobacco Products and that Mitch Zeller was becoming the new head.

Having some time to digest the change, I think that Mitch is a perfect person for the job.  Mitch has extensive experience at the FDA, including as David Kessler’s point person on tobacco, and, as a lawyer, will be well-positioned to go head-to-head with the FDA’s notoriously difficult lawyers.  He also has gone toe-to-toe with the tobacco companies and knows that they are fundamentally different from the pharmaceutical and medical device companies that the FDA is used to dealing with.

There is no question that Mitch could do a great job.  The question is whether the Administration will let him do a great job.  (There have been many media reports of the White House sitting on the FDA over issues such a food safety and women’s health.) 

So, here are the metrics I am going to use to judge the FDA under Mitch’s leadership at the Center for Tobacco Products:
1.       Ban menthol (and menthol analogs) as an additive, not just as a “characterizing flavor.”  The strong evidence that was available to TPSAC two years ago that banning menthol would improve public health has continued to grow.  Based on many discussions I have had, the FDA’s inaction on menthol has become the defining issue among many public health professionals and  the media for whether or not the Agency will be seriously engaging the tobacco industry.   (Moreover, tobacco companies use menthol to target Blacks, Hispanics, women and young people, the very constituents that the tobacco companies target with menthol.  President Obama owes it to them to get them out of the tobacco companies’ bulls’ eye.)
2.       Implement procedures that bring the FDA into compliance with FCTC Article 5.3.  The US may not have yet ratified the FCTC, but it is a signatory and, as such, is obligated not to do anything to  undermine the treaty.  While the FDA is stuck with having three nonvoting industry representatives on TPSAC (because they are written into the Family Smoking Prevention and Tobacco Control Act), there is nothing in the law that requires the FDA to treat the industry representatives as “colleagues” and the tobacco companies as “stakeholders” in the FDA’s mission as an agency charged with protecting the public health.  The FDA should start calling the tobacco companies “the regulated industry” and implement policies and procedures in accordance with the implementing guidelines for Article 5.3.  (Of course the tobacco companies will and should be allowed to submit public comments and otherwise communicate with the agency, but those communications should be done in a way consistent with Article 5.3.)
3.       Initiate an enforcement action to stop the cigarette companies from color coding “light” and “mild” cigarettes.  The companies have been thumbing their nose at the law for years now.  Not only do we have their instructions to retailers on what color packs to give consumers who as for “light” or “mild” cigarettes, but there is a strong and growing scientific literature demonstrating that the companies have succeeded in transmitting the same information to consumers that the words did.  (The Department of Justice should also bring this issue to Judge Kessler’s attention as a violation of her order in the RICO case.)

There are, of course, other important issues before the FDA that need to move forward, most notably the “deeming” rule in which the Agency asserts jurisdiction over other tobacco products and the rule defining “substantial equivalence.”  But, even once these draft rules are issued, it will be years before they have any practical effect.  The three items above are  the real measures of whether the Administration is going to seriously use the power the FDA has to protect public health now.



In addition to what you’ve written I would add that the new Director should immediately send a letter to the manufacturers of new/modified tobacco products introduced after March 23, 2011 (Pall Mall White and Black, Marlboro Black, etc.) asking them to remove these products from commercial distribution until they’ve obtained a valid license to market the products as required by the law. In order to acquire a license to market a new or modified product the product needs to be shown to be either substantially equivalent to an existing predicate product or to benefit public health. I’m not aware of any new/modified product licenses that have been granted by FDA, not should they be until a full and complete review has been completed. The irresponsible marketing of these new and modified products is tantamount to human experimentation without consent. A mere claim that the product appears to look similar to existing products is not sufficient to claim substantial equivalence, especially since consumer response is clearly influenced by the packaging which is clearly very different that other products. I would also ask the new Director to undertake an immediate review of provisionally approved new/modified products. According to the law, any new or modified product introduced between February 15, 2007 and March 22, 2011 can be introduced on a provisional basis, but can be removed from the market by FDA at any time IF the FDA determines that the product is not substantially equivalent or a net benefit public health per the FDA guidelines. I would recommend FDA undertake a review of the provisional products that have been introduced into the market to see if in fact the products have changed since introduction and if the products meet a standard of substantial equivalence or net public health benefit. If such a determination cannot be made based on available data the companies should be asked to remove the products from the marketplace. Mike Cummings


It is well said and right on the mark.  Mitch needs to be allowed to act and act now.
Cass Wheeler


I agree with Stan's post wholeheartedly. Mitch Zeller's appointment represents an incredible opportunity for the FDA to get serious about protecting people from tobacco, and, just as importantly, protecting policy-making bodies from Big Tobacco's interference and influence. 
Menthol's a clear example of tobacco industry influence informing policy not based in science, but in protecting Big Tobacco profits. Lorillard, the largest producer of menthol cigarettes in the US, aggressively lobbied, organized astroturf campaigns, and cried wolf about illicit trade (standard industry strategies we, Mr. Zeller particularly, know all too well) successfully blocking progress in this area, as is well-documented in this Wall Street Journal article: redir.aspx?C=z5gwJSYhmE-yOCEro5l5zYHt6eQe6s8I0Q9CKDIxa3p4kMfQvCGNUbW0CvNiYbk8U0dtdyhs4oo.&URL=http%3a%2f%2fonline.wsj.com%2farticle%2fSB10001424052970204685004576045862249685694.html" target="_blank";http://online.wsj.com/article/SB1000142405297020468500457604586224968569.... Lorillard's presence on the Tobacco Products Scientific Advisory Committee assured that its deadly interest was heard by policymakers. 
We're optimistic that Mitch Zeller will start to push the FDA in the right direction by banning menthol and not treating the tobacco industry as a stakeholder, but rather as a deadly industry that has no place at the policy-making table. 
John Stewart
Corporate Accountability
Director, Challenge Big Tobacco Campaign
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