FDA removes first 4 tobacco products from market: 3513 to go

I don't consider myself an expert of the labyrinthine statutory provisions of the Tobacco Control Act or the FD&C Act, of which the former is a part. Generally, many laws as enacted by Congress are lengthy and often codified in different places in the United States Code. It can be more than a little daunting to figure these things out.
 
However, I can make some general observations that might be helpful to the discussion. First, the "substantial equivalence" measure has been in the underlying Food, Drug and Cosmetic Act for some time. For example, the FDA has long been required to bar the sale of medical devices that are not "substantially equivalent to a predicate device." Such devices are deemed "misbranded." 
 
The FD&C Act is Chapter 9 of Title 21 USC. The "substantially equivalent" standard appears in several places in earlier versions of the FD&C Act. Neither Congress, the FDA or those subject to FDA regulation are unfamiliar with it. It also is included in the text of Public Law111-31, June 22, 2009 (Family Smoking Prevention and Tobacco Control and Federal Retirement Reform), as enacted by Congress. The relevant portions of that Act are codified under " Tobacco Products,"  and are subchapter IX of chapter 9, Title 21.
 
Thus, the "substantially equivalent" standard is part of the law that the FDA is required to follow and implement. Implementation may be done with the adoption of Rules that end up in the Code of Federal Regulations, but the fundamental test is part of the law. The FDA must follow the law as it is written.
 
Second, there is a legal difference between action taken against "misbranded" products that are determined not to be "substantially equivalent" products and implementing regulations concerning existing products. I think this action is an important step in gaining control of those products that can fit within the SE test and the "misbranded" definition. So far as I know, the standard is unrelated to any provisions that can be applied to existing products. 
 
Third, in my opinion, it is crucially important and prudent for the FDA to exercise caution. I  think the FDA is understandably and appropriately cautious regarding regulation of cigarette components or ingredients. The downside of acting too precipitously is too great. If the FDA does not proceed carefully, it risks losing completely its ability to regulate some aspects of the Industry and its products and marketing methods. For example, if I recall correctly, Indonesia appealed to the WTO when the FDA banned "kreteks" and the WTO ruled in Indonesia's favor. I don't know the status of "kreteks" now, but if the WTO can enforce its ruling or a federal court endorses it, the FDA will not be able to keep clove cigarettes out of the U.S market.
 
I believe the FDA  may also being understandably cautious with regard to other nicotine-based products, such as e-cigarettes. The federal court has shown some reluctance to rule in FDA's favor in challenges to its regulatory efforts that are brought against it by tobacco manufacturers. I think that is what happened with the proposed graphic warning labels. As a consequence of that ruling, I think the FDA may be quite restricted in actions it can undertake regarding warning labels. A similar ruling on other things of interest to all of us, such as menthol, or e-cigarettes, for example, might be fatal to efforts to regulate those things or activities: Once the court rules that the proposed rule is not within the FDA's authority, FDA is bound by that ruling (absent a change in the law by Congress).
 
While what seems axiomatic to us, and beyond cavil, to require prompt, if not immediate action, is not a basis for intemperate regulatory initiatives. I hope we will continue to be supportive of the FDA's efforts, albeit with continuing critical input regarding its actions or proposed actions, the risks of novel products, as well as existing ones, and what I and others regard as unfair, deceptive, misleading, and probably ill-intentioned marketing activities of the Industry and its sycophants. The nature of federal regulatory action makes it a very difficult and time-consuming process. The results of the process may be rendered meaningless by manufacturer appeals to the federal courts. The Industry also is able to quickly react and develop strategies to avoid new regulatory efforts, much more quickly than regulators usually are able to deal with them, given the constraints on the rule making process. I believe those who work in the FDA on these matters are committed, hardworking professionals embarked on a largely under-appreciated and difficult mission.
 
In the state cases against the Industry, we were not held up by that kind of process; we were able to sue simply for violations of other, existing laws (in Washington's case, the state's antitrust laws). We did not have to engage in prolonged fact finding hearings and other activities, and the predictable appeals of our actions, all of which slow the pace of regulation. 
 
The alternative to FDA regulation, I suppose, would be a return to ultimately counterproductive federal initiatives (such as the earlier "warning label" law that stymied state efforts to require stronger warnings), the somewhat haphazard "control" that the FTC could assert regarding marketing practices and the vicissitudes of legal action by individuals or states. In my opinion, individuals can't afford to bring those cases and also in my estimation, they can't be won. The probability of another round of legal attacks by a group of states, again in my opinion, is almost zero. Considering those alternatives, I think the best chance to try to control the nicotine monster is to continue our work, demonstrating that the new products are also unreasonably dangerous to the public welfare and continuing to stress the evidence supporting increasingly severe restrictions regarding existing products. With that background and with other input, and though perhaps incrementally and too slowly for our tastes, I continue to believe that the FDA should be able to, and will effectively address and regulate tobacco and nicotine matters.
 
Jon Ferguson
Former Senior Assistant Attorney General and 
Chief of Complex Litigation Division
Office of the Attorney General
State of Washington
Lead trial attorney for Washington in&nbsp;<em;State of Washington v. American Tobacco Co., et al.</em;

Thanks for an informative tour through the roadblocks and tarpits. It provides some reasons for FDA's caution.
However over the four years since Kennedy-DeWine went into effect, 2 million Americans were killed by this product -- and you would be hard pressed to identify a single thing FDA did over that entire time that reduced that body count by even one life. That might be reckoned a high cost of caution.
I agree that the industry will always be more nimble than FDA. Indeed I think that's beyond dispute. That doesn't take FDA off the hook to do the things that are within its power to do, however. FDA has simply fallen down on descriptors, pack warnings, and menthol.
I disagree that the alternatives to FDA regulation are limited to federal action, or state or individual litigation. We can implement policies that reduce smoking: smokefree workplaces and public places, strong counter-advertising campaigns that expose industry deception and manipulation, tobacco free pharmacies,&nbsp; tobacco free campuses, smokefree movies, smokefree housing, denormalization. These things work. In the context of FDA discussions we tend to forget this. We don't need FDA to do any of them. Again, this hardly lets FDA off the hook to do its job, but these things are more effective than anything FDA is empowered to do, let alone is likely to ever get done.
Jon Krueger