CASAA comments on FDA proposed “intended use” regulation of ecigs

by Carl V Phillips

CASAA recently submitted its comment about an FDA proposed rule, something they presumably intend to implement as soon as they “deem” e-cigarettes (and thus before they ban ~99.99% of them outright). The rule basically attempts to claw back much of what FDA was declared to not have the authority to do in Judge Leon’s landmark ruling. You can read more and link through to the FDA proposal at our Call To Action (which you can still respond to at the time of this writing, through Wednesday).

The short version is that not only would be e-cigarette manufacturers and vendors be prohibited from communicating the clearly accurate message that e-cigarettes are a low-risk alternative to cigarettes, as they are already prevented from doing, to the great detriment of real public health. But under this rule they would not even be able to suggest that e-cigarettes merely are a substitute for cigarettes. If they do, the FDA wishes to assert, this would be a disease treatment claim and thus subject their products to pharmaceutical regulation (which really means they would be banned immediately).

Um, yeah. Our submitted comment is posted at the main CASAA blog. (It is short enough to read in that format, unlike the last one, but if you prefer the formatted version it is here (pdf).) The highlights:

…the proposed rule exceeds the legitimate authority of FDA, and in so doing would impose restrictions that are clearly harmful for consumer interests and genuine public health.

Smoking itself is not a disease. It causes disease, but the act of smoking itself is a behavior and a consumer choice. The act of stopping smoking, by whatever means, is not a cure or treatment for disease, even though it is a health-promoting action. This is no different from the act of wearing a seatbelt or the act of substituting vegetable juice for soda. Seatbelts are not considered medical devices, and car manufacturers have often advised people to “buckle up for safety” as a substitute for the less healthy behavior of not doing so. A vegetable juice manufacturer is not selling a drug and is not governed by approved “indications” for their product. While they might not be allowed to say “avoid the diabetes risk from soda by drinking this,” they can certainly suggest you drink it instead of soda (leaving it to the consumer to infer why she might want to make that choice) and can generally use such phrases as “the smart alternative.” Therefore, it is clearly administrative overreach for FDA to assert that statements about using e-cigarettes instead of cigarettes should trigger treatment as a drug/device/combination product under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

….

The proposed rule asserts, “FDA has long considered claims related to smoking cessation in the context of curing or treating nicotine addiction and its symptoms to be within FDA’s ‘disease prong’ jurisdiction.” But smoking cessation in and of itself is not a cure or treatment any more than the act of smoking itself is a disease. E-cigarettes do not “cure” or “treat” nicotine addiction, but, rather, provide an acceptable and satisfying alternative for those who wish to reduce or eliminate their smoking habit. Indeed, many statements by FDA and other supporters of this proposal emphasize the fact that switching to e-cigarettes perpetuates “nicotine addiction and its symptoms” (setting aside the question of what that even means). This means the quoted claim is irrelevant to the use of e-cigarettes for smoking cessation.

….

Looking at the practical implications rather than legalisms, the effects of this rule would be flatly contrary to the stated goals and missions of FDA. FDA has repeatedly acknowledged that it is better for tobacco users to use low-risk products like e-cigarettes rather than to smoke. But this rule would remove an effective tool for making that happen despite providing no apparent benefit.

There is no claim of any material harm in the world that would be reduced by the imposition of this rule, so it is impossible to identify any benefit that could come from this regulatory overreach. FDA suggests that there is benefit to avoiding confusion between e-cigarettes and smoking cessation pharmaceuticals, but has provided no evidence that any material confusion exists, let alone enough to warrant regulatory action. Indeed, the claim is patently absurd to anyone familiar with consumers and the market: There is no way consumers are going to confuse a product that mimics cigarettes and that is sold alongside cigarettes in a convenience store — let alone up-market e-cigarette products sold by specialists — with a product that is marketed, supplied, and labeled as a pharmaceutical.

….

In the proposal, FDA disingenuously claims that, “The proposed rule is not expected to impose significant additional costs on manufacturers who make products made or derived from tobacco, or on drug and device manufacturers generally.” Setting aside whether that is even true, it blatantly ignores that the real costs of denying consumers accurate information is borne by consumers.

E-cigarette manufacturers’ statements that their products can be an attractive alternative to smoking, and that many people have successfully used e-cigarettes to reduce or completely replace their smoking, are beneficial to consumers and public health. That message is communicated by many parties who are concerned with public health and are outside FDA jurisdiction, and thus the message could never be fully censored by FDA action (despite the outlandish suggestions of some commenters on this proposal that FDA try to do just that). But manufacturers, due to their ability to mass-advertise and engage in point-of-sale communications to smokers, can often reach consumers who might not hear that message from other parties.

….

This proposed rule would probably actually foster the consumer confusion that FDA ostensibly is seeking to address. E-cigarette merchants would effectively have to pretend that the reason consumers should buy their products has nothing to do with them being a low-risk substitute for smoking.

….

In addition to cutting off communication that is beneficial for consumers and genuine public health, the rule would encourage exactly the kind of communication that FDA seems to find objectionable (and certainly the knee-jerk supporters of such restrictions on speech do). Manufacturers could and would still engage in marketing. But they would not be able to tell consumers that the purpose of the products is to facilitate and maintain smoking cessation. They would probably not even be allowed to say, “This webpage is for adult smokers only.” Instead, they would be left with no options other than highlighting the attractiveness and enjoyability of their products, without any caveats about how these are characteristics that are meant to appeal to smokers. Thus they would be forced to present their marketing messages in terms that might be as attractive to non-users of any tobacco product as they are to smokers.

That last bit is the most telling about FDA’s inability to properly regulate tobacco products. The FDA tobacco people write rules like “public health” people write conclusions to journal articles: They make vague references to supposed problems and then propose some unanalyzed action, effectively claiming, “the intervention we suggest is intended to fix all that and therefore — merely because we are suggesting it is for that purpose — that is what it will do.” Real regulators try to figure out what impacts their rules will actually have; they do not have luxury that ivory tower pontificators have to throw out random suggestions without assessing their impacts, knowing that their “policy recommendations” will never be taken seriously. FDA’s tobacco regulators are like ideologue revolutionaries who violently overthrow a government and then discover that actually governing requires a bit more than having opinions about how the world should be.