As previously reported, the FDA current is accepting comments on their plans to possibly ban flavors in e-liquid and other tobacco products, and the docket has been overwhelmed with an unprecedented number of comments. Most of these are pro-ban and anti-vape spam. RegulatorWatch.com recently reported in its RegWatch video series that the bulk of these comments, about 250,000, were not even one-click form-letters generated by astroturfing campaigns, but rather were pure fakes, uploaded by bots which were eventually blocked. RegWatch’s Brent Stafford (who has written for The Daily Vaper) called this a “disruption campaign” and credibly speculated that this was an effort to force the FDA to ignore the entire comments process, or give them an excuse to do so if they want.
In addition to the bot submissions, which were effectively a denial-of-service attack that ground the comment process to a halt, tobacco controllers are abusing the process in other ways. The purpose of the comment process for a science-based regulatory agency is not to tally political opinions, but to collect decision-relevant information. At the time of this writing, the count of comments submitted to the docket stands at over 500,000, about five times the largest imaginable number of legitimate comments.
A few hundred of the comments are presumably the normal FDA docket submissions by industry and other experts providing scientific information, which is the main purpose of FDA dockets, along with the usual in-depth presentations of disinformation by tobacco controllers. An unknown number — presumably many tens of thousands based on what happened for previous important dockets — are from vapors and other product users. Most of them will have reported their own experience with flavors, particularly including how flavors in vapor products helped them give up cigarettes. This is additional decision-relevant scientific information, providing details that are unavailable from mere statistical reports. These testimonials also reflect the experience of the primary stakeholders.
By contrast, astroturfing organized by tobacco control is neither scientific information nor the voice of stakeholders. Random non-consumers reciting talking points is an inappropriate use of the comment docket. It seems very unlikely there are more than 100,000 legitimate comments. Thus a bit of arithmetic reveals that there are more than 100,000 other comments, in addition to the 250,000, that are either additional bot posts or “just fill in your name and click” form-letters. Presumably most such spam is pro-ban.
In light of this, I have submitted a brief comment to the docket and publish it here as an open-letter.
From: Carl V Phillips, PhD (consumer advocate, analyst, reporter)
To: FDA Center for Tobacco Products
Re: Docket FDA-2017-N-6565, Regulation of Flavors in Tobacco Products
9 July 2018
I am writing to comment not on the substance of the proposed regulations (I am confident that others have provided what information I could, in more detail than I currently have time for), but on the comment process itself. Tobacco control activists have turned this process itself into an issue, and so comments on it are warranted.
As I understand, FDA has identified over a quarter of a million bot-submitted comments that are basically content-free beyond expressing political support for banning flavors. Based on the current number of submissions and the plausible number of legitimate submissions, it appears that there must be well over 100,000 additional spam comments, either machine-generated or one-click form letters from non-stakeholders. I expect approximately all of these are also substance-free prohibitionist political statements.
You have also received numerous comments — probably tens of thousands — that are testimonials from vapers and other consumers about their personal experiences with flavored products. Many of these include testimony about how the attractive flavors of low-risk products played a critical role in helping former smokers quit smoking. In contrast with the pro-ban spam, these testimonials contain decision-relevant scientific information. They provide evidence about the high cost of banning flavors — in terms of both consumer welfare and health effects from continued smoking — and nuances and details that are absent from any statistical summary. These are the voices of the primary stakeholders, consumers of the products in question, whose concerns should be paramount in the regulatory process.
You are obligated by process to read and consider these information-rich comments. Moreover, if FDA genuinely wishes to pursue a legitimate regulatory mission, those testimonials provide critical information for making your decisions. In making a decision about a widely-used drug or device, you would not just ignore the nearly-unanimous views of every consumer who actually uses it, would you?
By contrast, astroturfed prohibitionist spam, whether uploaded by bots or by people clicking to send a form letter, should get zero consideration. It is content-free, and merely reprints a few tobacco control political groups’ talking-points. These points are undoubtedly included, probably word-for-word, in the comments submitted by those groups. You are, of course, obliged to read and consider the substantive comments from these political groups (though you would be wise to approach them with the assumption that the authors really do not know what they are talking about). But the echoing of some of their claims by people who have no clue about the accuracy of the words they are parroting, no personal knowledge to contribute, and absolutely no claim to being stakeholders, should be ignored.
I am sure I do not have to remind you that the comments docket for a scientific agency is not a referendum. You have no grounds for letting the numbers of comments influence your decisions. Similarly, it would be grossly inappropriate to report tallies in your public statements as if this were a referendum. In addition to this being improper behavior for a scientific regulator, it will invite more technical nightmares for you by encouraging tobacco controllers to launch more such attacks.
I would also like to remind you that your obligation to read and consider all of the consumer testimonials, and other legitimate comments, is in no way reduced as a result of bot- or human-generated prohibitionist spam overwhelming your systems. Some activists (presumably including those who caused the problem) will try to spin this as a “both sides” issue. Indeed, their primary goal may be to get you to treat legitimate consumer testimonials the same way you treat the tobacco control spam. Doing so would be a serious failure of proper governance, as well as a violation of your own rules.
Legitimate consumer advocates — genuine stakeholder representatives — have encouraged consumers to report useful information, based on personal knowledge, which is a proper contribution to the docket. This is not at all similar to tobacco controllers trying to overwhelm you with vacuous astroturfed comments, sent by computer programs and other non-stakeholders, that interfere with rather than contribute to the goals of the comment process.
Perhaps a bit of reflection is in order, about who is trying to make FDA regulations more legitimate and science-based, and who is trying to bully and scam you into enacting their extremist, oppressive special-interest goals.
Thank you for your attention.
Vapers and other consumers who wish to inform the FDA about their experiences can follow the guidelines and suggestions offered by CASAA. There is still a week to get your comment in.