- FAMRI Center
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.