Yesterday’s FDA draft deeming regulation regarding e-cigarettes, other smoke-free alternatives, and other products is not as bad on its face as it might have been. However, a full review -- in the context of background knowledge and institutional analysis -- reveals that the proposed regulation is inappropriate, ill-founded, and potentially devastating for consumers.
1. The proposed regulation of non-combustible tobacco products, particularly including e-cigarettes, does almost nothing to address any real problems.
With the exception of ingredient labeling requirements, which benefit consumers, and bans on sales to minors, which we also support, this appears to be a classic case of a solution in search of a problem. FDA presents only speculative claims of harms or risks from smoke-free products. To the extent that they identify potential problems, there is no reason to believe that the proposed regulations will address them.
For example, there are vague assertions that regulation will address problems of unsanitary manufacturing processes or contamination. Addressing these would benefit consumers. But the regulations, which primarily involve busy-work information filings and applications, would do nothing to address such problems. Another example is the repeated claims about fixing consumer misperceptions. There is no evidence that consumers are misinformed. But even if they are misinformed, there is no apparent way the proposed restrictions would change that. Indeed, we believe the proposed regulations would increase confusion.
FDA implies that their filing and application processes address these speculative problems, but they do not. They would have us believe that their HPHC (hazardous and potentially hazardous chemicals) reporting process, where manufacturers are required to measure and catalog the quantities of a list of chemicals in products, is a solution. But such reporting is nearly useless for educating consumers, as was made clear when FDA and TPSAC discussed how to try to make it useful in a meeting last year. It does nothing to prevent occasional contamination problems and is not sufficient knowledge for determining which products might pose higher risks, though it will inevitably be interpreted as such.
Similarly, they declare that their application process for allowing new or “substantially equivalent” products onto the market protects good products and eliminates bad ones. But there is no evidence that their process actually accomplishes this. Moreover, that process is hopelessly backlogged merely trying to regulate cigarettes and smokeless tobacco; they will be even less capable of dealing with applications about far more complicated and varying e-cigarettes. FDA actions, discussions, and statements about the approval process strongly suggest that for manufacturers to get filings approved, they will have to provide information that is next-to-impossible to produce.
2. There is no recognition of consumer interests.
The consumers are the primary stakeholders in this process, yet FDA displays an utter disregard for their interests. Discussions of the cost of the proposed regulations focus entirely on the compliance costs for manufacturers. There is no apparent awareness of the costs imposed on consumers. It is telling that the logon password for yesterday’s FDA phone broadcast about the regulations was “industry.”
There are signals that FDA would take actions that are harmful to consumers. FDA is aggressively soliciting reasons to ban e-cigarette flavors and there are several hints that they intend to take this step. Buried in the middle of a nondescript paragraph is the observation that they would gain the authority to impose whatever unspecified restrictions on additives and constituents they want. Reading between the lines indicates they would be inclined to ban any product variation that appears to be slightly higher risk than an alternative (but still very low risk compared to smoking), regardless of whether consumers preferred it.
FDA consistently insists that e-cigarettes and other smoke-free products cannot be considered smoking cessation aids and asserts (contrary to overwhelming evidence) that they are not effective as such. Yet this regulation says that the only reason for allowing a new (which means post-2007) product onto the market is that it is useful for smoking cessation. This might just be the self-contraction that unrealistic rhetoric often leads to, but it might signal an intention to ban most everything.
3. The rules would eliminate the small businesses that provide the high-quality e-cigarette products that experienced vapers prefer.
The filing requirements that would be imposed on manufacturers would put small-sized, and probably medium-sized, companies out of business. Only a half dozen large manufacturers (particularly including the major traditional tobacco companies and their suppliers) would be able to meet these requirements. Moreover, any smaller manufacturer that was able to complete the filings would face the prospect of being instantly put out of business by the FDA’s ruling as soon as the grace period (24 months) expires and FDA gets through the backlog and rules on their applications. Thus, these regulations appear to eliminate the vast majority of e-cigarette manufacturers approximately two years after they take effect.
FDA repeatedly asks for comments on how the requirements could be made non-fatal for small manufacturers. But this appears to be disingenuous; there is simply no way to reconcile the burdens imposed by proposed requirements with the resources of small and medium specialty businesses that make higher quality e-cigarette components.
4. The scientific claims made by FDA are flawed and biased.
We are very concerned with FDA’s apparently tenuous grasp of the relevant science. They ignore the bulk of what is known, repeatedly misinterpret studies, and accept as fact politically-motivated assertions of authors. They have some out-and-out factual errors in their review of the science, but far worse is the spin and innuendo. They cherry-pick single sources with particular conclusions about topics that are far more uncertain when all the evidence is considered. In almost every case, the uncritical acceptance of bad information tends to justify restrictions and deny the harms they will inflict on the public with these restrictions. This bodes ill for what they will accept as new evidence in response to their requested comments.
By contrast, they downplay overwhelmingly obvious facts about the benefits of e-cigarettes. For example, they present the statement that e-cigarettes reduce exposures to toxicants compared to smoking, something that is true beyond a doubt, with the caveats “some researchers have stated” and “may.” They similarly downplay the evidence about e-cigarettes’ effectiveness in aiding smoking cessation.
(We expect to provide more details about the scientific errors and spin at the antiTHRlies.com blog over the coming weeks.)
It is this biased view of the science that will presumably be used to evaluate product applications, determine the content of warning labels, and otherwise control communication. In particular, FDA implies that a new tobacco product can only be justified if it is effective for harm reduction (a term they blatantly avoid). Yet FDA’s evaluation of e-cigarettes seems to deny they are effective. Given that the harm reduction potential of e-cigarettes is supported by about as much evidence as is imaginable for any new product, It is difficult to see how they could reach a favorable ruling about any product.
FDA asks for comments about many aspects of the proposed regulation, including evidentiary support. They do not do this for most of their tenuous scientific assertions, however. Furthermore, they demonstrate a willingness to accept most anything as evidence if it supports their inclinations. Since they will inevitably get comments from someone providing ostensible evidence to support every claim they want to make, and since they demonstrate a tendency to cherry-pick and uncritically report such claims, this suggests that FDA will conclude that they have adequate support for every additional restriction they wish to impose.
It is our current assessment that these proposed regulations are not in the best interests of consumers. They include some good provisions, but do far more harm than good. They are based on arbitrary claims and rationalizations. Should the regulations be finalized as currently formulated and implied, we are prepared to marshal our resources to file a lawsuit on behalf of consumers.
We expect to provide further analysis on Monday, April 28th, 2014. In the next week or two, we will issue a Call to Action detailing how the proposed regulations affect consumers along with suggested actions so that consumers can respond most effectively. Please remember that a comment to the FDA regulations made on Day 1 is given no more weight than a comment made on Day 75. We urge the vaping community and others interested in opposing regulation that discourages tobacco harm reduction to await further analysis before acting. There is no benefit in acting or opining precipitously.