Tuesday, September 29, 2015

CASAA Comment on FDA's Proposed Regulation of Safety Packaging and Labeling for E-Cigarettes and Dissolvable Smokeless Tobacco

To: U.S. Food and Drug Administration

From: Carl V Phillips, PhD
Chief Scientific Officer
The Consumer Advocates for Smoke-free Alternatives Association 

27 September 2015
Comment Tracking Number: 1jz-8ld2-jrka


Re: CASAA comments on ANPRM “Nicotine Exposure Warnings and Child-resistant Packaging for Liquid Nicotine, Nicotine- Containing E-Liquid(s), and Other Tobacco Products” (Docket No. FDA-2015-N-1514)

This comment on Docket No. FDA-2015-N-1514 (advance notice of proposed rulemaking (ANPRM), “Nicotine Exposure Warnings and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco Products”) is submitted on behalf of The Consumer Advocates for Smoke-free Alternatives Association (CASAA). CASAA is a 501(c)(4) nonprofit public health and education NGO that is the leading representative of consumers who use or might in the future use smoke-free tobacco/nicotine products. It is a U.S. membership organization with over 70,000 members. CASAA is not an industry group and does not represent the interests of industry.

Our comments focus on the ANPRM regarding e-cigarettes and their components, and on dissolvable smokeless tobacco products. We are specifically not commenting on the genuinely novel products mentioned in the ANPRM (lotions, gels, and drinks) because we do not believe they play an important enough role in tobacco products consumption to be of substantial concern to the consumers we represent. Moreover, no such products with any apparent market appeal exist currently, and it is difficult to comment on the categories without a concrete touchstone.

The rules under consideration in the ANPRM, taken in isolation, could provide modest net benefits. However, the current proposal for FDA to acquire the authority to cause these results (the “deeming”) has such enormous costs that it swamps the modest potential benefits from this rule (as well as every other concrete action FDA has suggested it might pursue following the deeming). The deeming, as drafted, is a ban-by-paperwork of >99% of e-cigarette products on the market [http://blog.casaa.org/2014/05/casaas-comment-to-omboira-regarding.html], including those that are most liked by consumers and most effective for quitting smoking, which is a terrible policy and grossly inappropriate policy making. That policy would do enormous harm to consumers, and thus to society as a whole, and we continue to oppose it, as detailed in our comment on that docket [http://casaa.org/uploads/CASAA-FDA-Comment-8-7-14.pdf]. Neither our observations below that there are potential benefits from these rules in isolation, nor anyone else’s such observations, constitutes an argument that the proposed deeming is appropriate public policy. The existence of a single benefit is obviously not sufficient to endorse a public policy initiative.

We would like to further call attention to the cost-benefit tradeoff implications of this passage from the ANPRM:

The FD&C Act also provides FDA with authority to adopt a tobacco product standard under section 907 of the FD&C Act if the Secretary finds that it is appropriate for the protection of the public health.

In making such a finding under either section 906(d)(1) or section 907 of the FD&C Act, the Secretary must consider: (1) The risks and benefits to the population as a whole, including users and nonusers of tobacco products; (2) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and (3) the increased or decreased likelihood that those who do not use tobacco products will start using such products.

Given that the products we are addressing are orders of magnitude less harmful than the cigarettes they substitute for, any safety warning labels that have the unintended consequence of scaring would-be users of these products into continuing smoking would clearly increase risks. Given the magnitude of the populations under consideration (a handful of dangerous poisoning cases in history, versus tens of millions of American smokers who might consider switching) even a tiny effect on discouraging switching could swamp the greatest theoretical benefit that could come from averting accidental poisoning in terms of the health effects for the population as a whole.

The modesty of the potential benefits
As with any consumer product, it is in the best interests of consumers – and thus society as a whole – to have regulations that mandate accurate warnings and reasonable safety features. This is contingent on the details being appropriate, and in particular, that these methods are not abused to sow disinformation or intentionally create barriers to consumer access to products.

Appropriate hazard regulation requires a recognition of the genuine level of hazard; without that, it is just special-interest activism disguised as regulation. The key reality in the present context is that while e-cigarette liquid and other products that contain nicotine are potentially hazardous, they are not particularly toxic compared to countless common consumer goods such as OTC pharmaceuticals and cleaning supplies. There is alarmist rhetoric about poisonings from e-cigarette liquid, but it does not reflect reality. The only serious poisoning case associated with these products that we are aware of being reported in the USA, the fatality of a toddler, is said to not have been from a standard e-cigarette consumer product, but rather from a high-concentration nicotine solution that is used by manufacturers (in this case, a do-it-yourself manufacturer) to make the much less concentrated e-cigarette liquid.

There is much engineered alarm about the number of calls to poison control hotlines related to e-cigarettes. But the totals are small compared to calls about various household products and pharmaceuticals. This is clearly true when the absolute number is considered, and also remains true on a per-consumer basis given that millions of Americans have e-cigarettes in their possession. The alarm is engineered by hyping the relative increase in such calls over calendar time, in spite of this being inevitable and uninteresting: Everything associated with e-cigarettes has obviously seen large relative increases compared to a time when their use was rare. If an appropriate baseline is used, and especially if the trend is normalized for increasing use of the products, the number of calls is flat or declining. There has even been an absolute decrease, without normalizing for quantity consumed, as reported by Kevin Chatham-Stephens of CDC to FDA [http://www.fda.gov/downloads/TobaccoProducts/NewsEvents/UCM454403.pdf, p.520; https://www.youtube.com/watch?v=rQSRG6hmh-c, at and around 2:02:00].

Moreover, these counts reflect alarm, not harm. The most recent report from the American Association of Poison Control Centers showed an order of magnitude fewer calls about e-cigarettes than about homeopathic agents. The recipe for a call to poison control is {exposure + worry}, and the unrealistic worry about these products – which is the natural result of their novelty as well as the engineered result of scare tactic disinformation placed in the popular press by their detractors – increases the number of calls about inconsequential exposures.

Thus, to the extent that the quantity of poison control calls informs regulatory decisions, it should be seen as quite reassuring, contrary to what is implied in the ANPRM.

The lack of observed serious poisonings is not at all surprising. Dilute solutions of nicotine are not highly toxic. There is a widespread myth that a mere 60 mg of nicotine is a lethal dose for an adult, but it has long been obvious that this is incorrect and that this number was merely uncritically repeated. Exposures on that order of magnitude are not fatal. The only evidenced-based attempt to estimate an LD50 for nicotine, based on documented cases of people consistently recovering from much higher exposures, puts it in the order of 1500 mg for adults [http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3880486/]. This is well above the content of bottles of e-cigarette liquid that are available through normal consumer channels. Additionally, swallowing e-cigarette liquid is not a very effective delivery method for nicotine, and it is very likely to prompt spontaneous emesis that eliminates a large portion of the liquid [http://emergency.cdc.gov/agent/nicotine/casedef.asp]. It is difficult to imagine any scenario resulting in a potentially fatal dose of nicotine being accidentally absorbed dermally.

Responsible manufacturers are already using child-resistant packaging, including the major e-cigarette liquid manufacturers and, to our knowledge, all manufacturers of dissolvable tobacco products available in the USA. Consumers of open-system e-cigarettes – who are generally well informed by vendors and social networks to an extent that is far greater than the real information delivery of warning labels – have become generally aware of the “keep out of reach of children” message. This is clearly demonstrated by the decline in poison control calls associated with e-cigarettes even though the number of consumers who possess these products has continued to increase dramatically.

However, none of these observations suggest that there is no benefit to good child safety regulation for these products. All else equal, it is wise to mandate appropriate child-resistant packaging rather than to allow some manufacturers to not use it. Similarly, there is no reason to not provide the limited educational value provided by “keep out of reach” messages. Even though the risk from these products is small, it is worth further reducing so long as all the costs of the intervention – including the materials costs that are ultimately paid by the consumer and impact on consumers’ ease of use of the product – are reasonable, and no consumer misperception is created.

What follows here sets aside the enormous costs that would be created by the deeming proposal that would allow the presently proposed rulemaking, and considers the proposed rules as if they were to be implemented in isolation. Nothing here should be interpreted as implying that benefits from the latter could possibly justify the enormous harm from the former.

Exposure warnings
Including or mandating safety warning labels about the risks of accidental exposure to a product are an established practice for a wide variety of consumer goods. It is generally accepted as being a wise practice. A warning of toxicity on products that are already generally understood by consumers to pose a toxic exposure hazard are not particularly informative. Nonetheless, they have value in informing the few unaware consumers and serve as a useful reminder to the others. In addition, uniform mandated warnings benefit consumers by helping maintain a diverse marketplace in which every merchant does not have to reinvent the wheel, trying to figure out what warnings are useful and what words best protect the merchant from unreasonable civil liability that can result from careless consumer behavior. Furthermore, standardized warnings would foreclose the current absurd practice of some manufacturers placing every conceivable warning their lawyers can formulate on the packaging; such over-warning is effectively the same as no warning (except possibly in terms of forestalling product liability suits) because the useful and appropriate information is so buried in superfluous verbiage such that all warnings are ignored. Thus, accurate and concise warnings on tobacco products that pose an accidental poisoning hazard (e-cigarette liquid; dissolvable smokeless tobacco products) or a physical choking hazard (e-cigarette cartridges; certain dissolvable smokeless tobacco products) should appear on the labels.

It is critical that accidental exposure warnings be used exclusively to accurately warn about that hazard, and not be used as a stalking horse for manipulating public opinion or discouraging the intended use of the products. No doubt many opponents of the use of e-cigarettes and other tobacco products will seize upon this as an opportunity to encourage the FDA to make the warning labels do one or both of those. This must be avoided. Even if FDA were to ultimately seek to further those goals, that is a policy decision that should be reviewed as a policy decision, not snuck in under the guise of regulation about a technical focused goal. Moreover, to the extent that exposure safety warnings are perceived by consumers as being propaganda, they will be ignored, and thus not fulfill the legitimate goal of providing useful safety advice. Additionally, associating exposure warning labels with manipulative propaganda will make consumers more likely to dismiss all warning labels on other products, creating greater safety hazards overall.

In particular, it is inevitable that there will be pressure to overstate the hazards from nicotine poisoning. Some anti-tobacco extremists believe that it is better to make any claim – true or false – that discourages the use of nicotine-containing products, in particular by causing unrealistic concern about their health impacts. Doing so would be an unethical and improper public policy in itself, and is especially likely to cause consumers who recognize that it is being done (which will include a large portion of committed e-cigarette consumers) to become more inclined to dismiss legitimate warning labels on these and other products, creating a broader social harm. The consumer interest in e-cigarettes has resulted in widespread knowledge that the U.S. government is guilty of overstating the hazards from nicotine with unscientific claims [e.g., http://www.cdc.gov/niosh/idlh/54115.html, where the CDC endorse the erroneous claim that 60 mg is a lethal oral dose for adults]; it is particularly important to avoid this in the safety warnings. Any use of safety warning labels to try to vilify the products or nicotine – as will undoubtedly be advocated by some extremist special-interest comments on this docket – would be evidence that FDA is foregoing a science-based approach to regulating these products.

In short, these safety warning labels should follow the accepted standards for such labels on other similarly-hazardous consumer products. The labels should be no more and no less dire or detailed than those found on other consumer products or pharmaceuticals that pose similar hazards, and they should mimic the content and language used for warnings about other somewhat hazardous household goods.

It is difficult to see how any labeling beyond typical generic information – to keep out of the reach of children and call poison control in the event of an accidental overdose – could be considered an appropriate warning. The ANPRM hints at the intention to make specific mention of the toxicity of nicotine. Not only does this invite the overstatement of the hazard from that molecule, as addressed above, but it is also inconsistent with accepted standards for safety warnings. A bottle of e-cigarette refill liquid is less of a hazard than many household cleaners and other common consumer products, but the warning about accidental exposure on the latter do not include details about what molecule poses the toxic hazard. The substantive phrases on those products basically just say “keep out of the reach of children” and advise calling poison control. There is no apparent reason to even mention nicotine in the warning: For nicotine-containing liquids, unlike with most consumer products that pose some poisoning hazard, it is already widely understood what the active ingredient is; yet accidental exposure warnings for those other products do not go into detail about the chemical of concern. Such information clearly has been judged by the experts to not be useful detail. Thus any messaging about the toxicity of nicotine can only be seen as an attempt to vilify nicotine under the guise of safety warnings.

In terms of accidental poisoning hazard, the obvious comparison products for dissolvable smokeless tobacco products are NRT products, particularly the lozenge version, which is a sweet-flavored solid whose hazards include choking and nicotine overdose. While the latter have a great deal of medical labeling, FDA CDER has already determined that the safety warnings about accidental overdose should be a simple message that is similar to that for other household products, not a discourse on nicotine. If FDA wants to add information about use of the product as intended, as is provided with NRT products, that calls for separate rulemaking; it would be clearly inappropriate to sneak that in under the guise of accidental exposure warnings. NRT accidental exposure labeling basically instructs consumers to keep the product out of the reach of children and pets and provide poison control hotline information. Keeping out of reach is good advice and would be useful to mandate for all of the products addressed by the ANPRM.

It is standard advice in accidental poisoning hazard warning labels to instruct consumers to call poison control hotlines. There is little downside to offering such advice from the perspective of helping consumers in the event of an accidental exposure. However, in the present context it should be noted that this could substantially increase the number of poison control calls that follow trivial accidental exposures, creating the illusion of increased accidental poisonings when it merely increased the reporting of unimportant exposures. In addition, such an increase would inevitably be used by those who seek to foment alarm rather than provide accurate assessments. If poison control hotline personnel are not properly educated about the relatively low toxicity of the quantity of nicotine found in consumer products, this could also create substantial wasteful medical costs if, for example, those experiencing trivial exposures are routinely advised to seek emergency medical care.

E-cigarette refill cartridges are of a size and shape that create a choking and ingestion hazard which might not be obvious to all consumers. This suggests that there should be an explicit warning that the product is a choking/swallowing hazard for small children.

It is difficult to conceive of any poisoning warning for e-cigarette refill products beyond the aforementioned “keep out of reach” and hotline information that would be informative and useful. As noted, these products pose some risk to children, but not more than other common consumer goods. The ingestion poisoning warning should be similar to warnings on medicines and detergents.

The one exception relates to the possibility of dermal exposure. Consumers are generally less aware of the importance of dermal exposure (to anything), as compared to ingestion, so a warning about it could have genuine information value. Any such warning should avoid overstating the hazard, given the limited absorption that results from realistic levels of exposure (e.g., “Avoid prolonged skin contact. In case of accidental exposure, wash affected area with soap and water.”). Similar language appears on many comparably toxic household liquids, and properly reflects the lack of direness for typical levels of accidental dermal exposure. Transitory exposure to a few drops of e-cigarette liquid is common for most consumers of these products and the effects of that are no different from the intentional use of the products; the warnings should not suggest otherwise. Indeed, the ad hoc warnings that certain manufacturers have been using that include dire warnings about skin contact have become running jokes in the consumer community. Including such inappropriate warnings is exactly the kind of mistake that can undermine the credibility of legitimate warnings.

A very small minority of the e-cigarette liquid products on the market pose a notably greater poisoning hazard than others. As noted above, the only apparent case of fatal poisoning from any product addressed herein (other than NRT) was from manufacturing feedstock with a concentration greater than is found in actual e-cigarette liquid. To the extent that such products are available to consumers and assuming FDA has jurisdiction over their labeling, they (and only they) should be treated like other industrial chemicals that pose serious poisoning hazards, and include much stronger warnings than the modestly toxic consumer products.

Even the highest nicotine content bottles of actual refill liquid (e.g., 30 ml bottles of 3.6% nicotine) pose little hazard in comparison to the feedstock liquid. Nonetheless, a good case can be made that large and/or high-concentration bottles of consumer product warrant a special label that calls attention to their greater hazard. Consumers who know (correctly) that a typical bottle (say, 10 ml of 1.2% nicotine) poses minimal hazard under any realistic accidental exposure scenario might inappropriately extrapolate that knowledge to higher-nicotine products. Thus FDA should consider additional label along the lines of “This product contains a higher-than-average concentration of nicotine” or “This bottle contains more nicotine than most refill bottles.” The legitimate purpose of this would be to help consumers differentiate when accidental exposure risks are real (though still very small) from when they are so utterly trivial that any warning is really inappropriate. It defeats the purpose of warning labels to conflate the two.

Unlike for some toxins, there is no known specific advice to be offered about accidental exposure to nicotine (e.g., a common household item that can be eaten to neutralize its effects). Thus the only apparent specific medical advice that appears to possibly be warranted for these warning labels is about inducing vomiting. We are aware of discussions in the e-cigarette consumer community about the wisdom of doing so in the event of a child swallowing a substantial quantity of liquid; discussants often think that doing so is wise. It is our understanding that the current conventional wisdom in poison control is that inducing vomiting is seldom recommended because it is inefficient and harmful in itself (the only exceptions being poisons like methanol that cause irreversible effects extremely rapidly, unlike ingested nicotine). We claim no specific expertise on this point and recognize that the best evidence-based medicine practices are subject to change. Thus we merely observe that this appears to be the single specific bit of medical advice that is warranted for the labels: Based on FDA’s expert interpretation of poison control best-practice, the labels perhaps should discourage (or encourage – whichever is optimal) consumers regarding inducing vomiting.

The packaging and appearance of the products has no apparent bearing on any of the above observations. The appropriate warnings should appear on all products. The only product characteristic that might legitimately change the intensity of safety warnings, especially large high-concentration quantities of nicotine, is addressed above. If there is genuine evidence that particular product appearance characteristics create a greater hazard – not just the junk-science chatter about children being magically attracted to shiny objects – then this observation could be revisited. But absent such evidence, any such differentiation would clearly be a thinly-veiled misuse of safety warnings to alter packages to make them unattractive to consumers.

There is no conceivable justification for rotating different warnings, as is done with package warnings about cigarette consumption. There is only one legitimate message here: That accidental poisoning is possible and how it can easily be avoided. That should be conveyed on every package of the relevant products and, consistent with other consumer products that pose similar risks, should be done in a matter-of-fact way, without bells-and-whistles to try to attract attention at the expense of clear, appropriate communication. Inclusion of graphics that do not appear on other somewhat-hazardous consumer products or pharmaceuticals would be a clear indication that the goal here is something other than providing appropriate hazard prevention.

Mandating appropriate child-resistant packaging is warranted for all of the products mentioned herein. It would provide a benefit to consumers at a reasonable cost, and a federal rule would avoid the serious threat to consumers from the patchwork of inappropriate packaging requirements that would likely appear in its absence (a point discussed further in the next section about preemption). If regulations and packaging had to be designed de novo, imposing such rules might entail huge costs. But because applicable packaging already exists for countless products, it is a relatively simple matter to just extend its use. Child-resistant packaging also tends to serve as a more effective warning reminder than does warning text. This does not mean it should supplant text warnings; the arguments in favor of each stand on their own merits, regardless of what is done with the other.

Standard child-resistant bottle caps for e-cigarette liquid are easily obtained and used by manufacturers, thanks to their efficient mass production and required use for many other products. Indeed, responsible manufacturers of e-cigarette liquid products have already adopted this practice voluntarily. (To provide you with more information on that point that may not be easily obtained elsewhere, we are asking our members who offer public comments to provide an estimate of the rate of such practice from their own experience. This could offer a better practical measure than manufacturer reports since it is inherently weighted by what products consumers actually see.)

The questions in the ANPRM imply that FDA is considering writing novel rules for the packaging of these products. That would clearly be inappropriate. The federal government already has an established and well-tested set of standards, with technical details, for packaging in the form of the Poison Prevention Packaging Act (PPPA), as administered by the Federal Trade Commission. These regulations apply to countless products that pose similar risks and are used by consumers ad lib. There is no conceivable reason why the technical details of the regulation should involve anything other than identifying a relevantly similar consumer product and applying the technical language for their packaging, either by reference or copy-paste. The questions in the ANPRM about what form any of these packaging regulations should take (physical characteristics vs. performance based) are red herrings; the new regulations should simply mimic accepted best practice.

To minimize any choking hazard, e-cigarette refill cartridges should be sold in child-resistant packages that release only one cartridge at a time (to avoid someone opening a three-pack and leaving two sitting on the kitchen table). There are many common packaging methods that provide this feature. Since such packaging could also provide other benefits – tamper and shoplifting resistance; maintaining product quality; helping consumers keep track of the rest of the package contents – the costs of this are easily justifiable and would, we believe, result in a net benefit for consumers.

Given that there are inexpensive and easy methods that are generally considered adequate for packaging consumer products with similar hazards, there is no justification for any requirement that imposes substantial expense or burden. It would obviously be possible to mandate packages that are needlessly expensive, ugly, or excessively difficult for adult consumers to open. But given that appropriate technologies exist, any such requirements would clearly be an attempt to harm consumers under the guise of safety regulation. For example, any packaging requirement for dissolvable tobacco products that is more restrictive than what has been determined to be acceptable for the basically identical (in terms of accidental exposure) NRT products would be a clear example of attempting to lower the product quality under the guise of safety.

Mandating details of e-cigarette liquid bottles beyond child-resistance, as suggested in the ANPRM, serves no apparent legitimate purpose. If the “keep out of reach” warning is ignored and the cap is opened by a child, there is a risk of ingestion or topical exposure, regardless of further details. If an adult consumer opens the bottle for its intended use, he already has the incentive to be careful and not waste the contents by spilling. If a particular bottle design is prone to spilling or splashing, market pressures will be sufficient to ensure it is replaced with a better technology. If there were a dire risk to the user from a bit of dermal or ocular exposure, perhaps a regulatory requirement would be warranted, but such risks are sufficiently trivial that regulatory intervention is clearly inappropriate.

It is impossible to prevent consumers from defeating child-resistant packaging by transferring the contents or disabling the mechanisms, for these products or any others. The most important way to reduce such risk is to make sure that opening a package is not so difficult that the consumer opens it once and transfers the contents to avoid having to open it again. In the present case, it is also useful to avoid making the package ugly or awkward. Many vapers express appreciation for the artwork on some e-cigarette liquid bottles, and thus have an incentive to not subvert the original packaging. Efforts by some anti-tobacco activists to make the packaging unattractive, either by prohibiting attractive artwork or imposing unattractive mandatory labels, will dramatically increase the incentive to discard the original bottle in favor of decanting. Similarly, packages for e-cigarette cartridges or smokeless tobacco products that include labeling consumers consider to be offensive or are inconvenient to put in one’s pocket might also inspire unpackaging or repackaging.

Finally, consumers of these products should have the right to request non-resistant packaging, and manufacturers should have the right to fulfill such requests, in consideration of the many adults who have difficulty opening child-resistant packaging. This is in keeping with such allowances for CDER-regulated or PPPA-regulated products. Such packaging could come with additional appropriate warning messages, as is required under PPPA, and/or require a representation by the consumer that the product is not child-resistant or intended for households with young children.

FDA labeling and packaging mandates should explicitly preempt state and local regulations. Federal regulations about packaging or labeling, including those imposed by FDA, almost always preempt state and local regulations, and do so for very good reasons. Whatever regulations are imposed at the federal level should be the right ones. If greater restrictions are legitimately warranted, they should be included at the federal level, and thus there should be no local discretion about them. State and local authorities do not possess expertise in these matters, and thus should not override FDA decisions. State and local actions in this arena tend to stem entirely from the whims of non-expert elected officials. Whatever one might say about such whims leading to, say, funding anti-use campaigns, this is clearly not a good way to make technical safety policy. Moreover, a patchwork of packaging and labeling requirements interferes (often intentionally and unconstitutionally) with interstate commerce. Among the benefits to consumers of the proposed rulemaking would be optimizing the packaging and labeling nationwide, thus avoiding this.

Though it has no material effect on the requirements, FDA should stop using the phrase “liquid nicotine.” It tends to suggest both scientific illiteracy and a manipulative agenda.

One would not describe beer as “liquid alcohol,” and yet that is almost perfectly analogous. As FDA presumably realizes, nicotine is a liquid at STP. In scientific contexts, constructions like this are reserved for reference to chemicals other than in their “normal” state (e.g., “liquid nitrogen”). “Liquid nicotine” is used in scientifically illiterate contexts, like pop news stories, because the writers and readers have no idea that nicotine is a liquid. Additionally, the word “liquid” tends to be used to elicit alarm for political purposes (e.g., calling soda “liquid candy”). Science-based regulators should not descend into such error and word games.

More important – and again, FDA obviously knows this – e-cigarette liquid is not nicotine and thus not “nicotine liquid,” but rather is a very dilute mixture of nicotine (like beer is a dilute mixture of alcohol), which is very different. The phrase “liquid nicotine” explicitly claims otherwise, and is presumably intentionally used by political actors because of this. Again, science-based regulators should not be party to such mischaracterization. It is not difficult to properly describe these products. FDA can just as easily use the scientifically accurate and non-misleading phrase “nicotine-containing liquids,” and should choose this or some other accurate phrase rather than the embarrassing and misleading (arguably to the extent of violating federal information quality rules) “liquid nicotine.”

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