Tuesday, November 12, 2019

The Bias Against E-Cigarettes in Medical Research: An Example from the American Heart Association Annual Meeting

Later this week, the American Heart Association will hold its annual scientific conference in Philadelphia. In anticipation of the conference, the American Heart Association issued a press release yesterday announcing the results of a new study on e-cigarettes that will presented at the conference. The headline of the press release is:

"E-cigarettes take serious toll on heart health, not safer than traditional cigarettes."

One of the two papers that is being presented which purportedly support the conclusion that e-cigarettes are no safer than tobacco cigarettes in terms of heart health is a study of cholesterol levels in e-cigarette users compared to current smokers and nonsmokers.

The study is described as follows:

"Researchers evaluated healthy adults (ages 21-45) without existing cardiovascular disease and taking no daily medications in the Cardiovascular Injury due to Tobacco Use (CITU) Study. The study's 476 participants included 94 non-smokers; 45 e-cig smokers; 52 e-cig and t-cig smokers; and 285 t-cig smokers. Analysis was adjusted for age, race, sex, and non-smokers, sole e-cig or t-cig use, or combination e-cig and t-cig use."

The findings were as follows:
  • "Total cholesterol was lower and the bad cholesterol, LDL, was higher in sole e-cigarette users compared to nonsmokers.
  • Good cholesterol, HDL, was lower in dual smokers."
 And the study conclusion was as follows:

"Although primary care providers and patients may think that the use of e-cigarettes by cigarette smokers makes heart health sense, our study shows e-cigarette use is also related to differences in cholesterol levels. The best option is to use FDA-approved methods to aid in smoking cessation, along with behavioral counseling."

The Rest of the Story

This study found a cross-sectional association between e-cigarette use and riskier lipoprotein (cholesterol) profiles. Based on that cross-sectional correlation, the investigators conclude that e-cigarette use leads to higher "bad" cholesterol levels and therefore, switching from smoking to vaping does not improve cardiovascular health.

But let's examine this more closely.

In a cross-sectional study, you have to be very careful in extrapolating from correlation to causation because this type of study design is very susceptible to confounding -- that is, a third variable that is associated with both smoking/vaping status and cholesterol levels and makes it look like they are related but the relationship is actually driven by this third variable.

In this example, there is a very strong potential confounder: diet. It is very likely that smokers and former smokers have significantly less healthy diets than nonsmokers and therefore, worse cholesterol profiles. There may be differences in physical activity as well, which would lead to a finding of worse cholesterol profiles in current and former smokers than in nonsmokers.

In fact, studies have shown (example) that when you compare cholesterol levels in former smokers and nonsmokers, the former smokers have worse cholesterol profiles. Since most vapers are former smokers, it is almost certainly the case that vapers have worse cholesterol profiles than nonsmokers.

Thus, this paper provides no evidence of any effect of vaping on cholesterol levels. That relationship is completely confounded by diet and physical activity, and it has already been demonstrated in the literature that former smokers have worse cholesterol profiles than nonsmokers, even before e-cigarettes were ever invented!

This is why I think that the conclusion of this paper (that e-cigarette use leads to an unhealthy cholesterol profile and that vaping is therefore just as dangerous as smoking in terms of heart health) is unwarranted and indicates a bias against e-cigarettes.

Even if vaping did increase LDL cholesterol and lower HDL cholesterol, this wouldn't indicate that vaping is more dangerous than smoking. There are many other impacts of smoking on cardiovascular health that would need to be examined. And most importantly, one would need to understand the long-term effects of vaping before concluding that it is more dangerous than smoking.

The worst part of this story, however, isn't the evident bias against e-cigarettes in the research. The worst part of the story is the recommendation that smokers not switch to e-cigarettes in order to quit smoking. That is really bad advice. The reality is that 90% of smokers who try to quit using nicotine replacement therapy will fail. So advising vapers to try nicotine patches is tantamount to telling 90% of them to go back to smoking. Moreover, the best scientific evidence available - a randomized clinical trial - showed that e-cigarettes are twice as effective as the nicotine patch for smoking cessation.

The rest of the story is that the bias against e-cigarettes is leading to unfounded scientific conclusions, deceptive communications to the public about the health effects of e-cigarettes, and misguided medical advice.

Monday, November 11, 2019

CDC and Anti-E-Cigarette Researcher Still Clinging to Faint Hope that Traditional E-Cigarettes are Causing Outbreak

It is now apparent that, as many of us figured out months ago, the use of vitamin E acetate oil as a thickening agent in THC vaping cartridges and perhaps other counterfeit or adulterated black market vaping products is causing the vaping-associated respiratory illness outbreak. Nevertheless, the CDC and at least one prominent anti-e-cigarette researcher have not yet given up in their attempt to pin the outbreak on traditional e-cigarettes which they apparently despise.

The CDC continues to term this outbreak "E-cigarette, or vaping, product use associated lung injury." This is an extremely odd name, especially because of the strange and confusing use of the two commas which decimates the grammar of the name and is obviously contrived in an attempt to implicate traditional e-cigarettes. First of all, the name is redundant. By using the term "vaping," e-cigarettes would be included, as using an e-cigarette is a form of vaping. So the term "e-cigarettes" is completely unnecessary. Second, there is no evidence that "e-cigarettes" are involved in the outbreak. The original name the CDC gave to the outbreak was VARI ("vaping-associated respiratory illness). The fact that it changed the name to EVALI, even after having quite conclusive evidence that traditional e-cigarettes were not involved, suggests that the CDC was intentionally trying to use the outbreak to implicate traditional e-cigarettes, despite the lack of any hard evidence. That they are continuing to use this name even after finding that every confirmed case in which testing was done revealed vitamin E acetate in the lungs confirms that this term was chosen to intentionally confuse the public into believing that e-cigarettes are causing the outbreak.

In addition, now that its back is against the wall because the evidence is almost conclusive in demonstrating that traditional e-cigarettes are not involved, the CDC is resorting to an explanation for which there is absolutely no evidence: that not one, but two substances are causing the outbreak. And they continue to insist that no single compound is associated with the cases, which is not true based on their most recent findings. 

Specifically, the CDC continues to state: "No one compound or ingredient has emerged as the cause of these illnesses to date; and it may be that there is more than one cause of this outbreak."

This contriving of a new explanation for the outbreak in light of evidence that it is not related to traditional e-cigarettes is not restricted to the CDC. A prominent anti-e-cigarette researcher has also developed a new theory to explain the outbreak: it is caused by a synergistic effect between nicotine and vitamin E acetate oil.

Specifically, Dr. Stan Glantz writes: "E-cigarettes, whether THC or nicotine, deliver a wide range of toxins to the lungs, several of whom are likely contributing to EVALI and other adverse health effects. In addition, as illustrated by the fact that nicotine metabolites were detected in most of the people, there is always the possibility that the THC and nicotine e-cigarettes are acting synergistically to increase disease risk."

The Rest of the Story

It is now quite clear that the CDC and many opponents of the use of e-cigarettes for harm reduction were actually hoping that the outbreak was being caused by traditional e-cigarettes so that they could use the outbreak to further demonize these products. They used the outbreak as an excuse to implicate e-cigarettes and even when the evidence began pointing in a different direction, they didn't allow the evidence to sway their pre-conceived opinions or determination to put the blame on electronic cigarettes.

And now that their original theory has been blown out of the water, rather than acknowledge that the outbreak is due to a new thickening agent that was developed for use primarily in the black market THC vape cartridge industry, they are coming up with novel, contrived explanations in a last gasp attempt to be able to pin this on traditional e-cigarettes.

However, when 100% of case patients tested positive for vitamin E acetate oil, there is no need to invoke an alternative theory for which there is absolutely no evidence. There is no need to argue that there are two causes to the outbreak, nor is there even a shred of evidence that nicotine works synergistically to cause the reported lung injuries. This is not even a plausible explanation, as a large proportion of the cases occurred among patients who reported only using THC vape products (and these reports are trustworthy since the under-reporting is likely to be in the opposite direction).

It is interesting to analyze this story from a psychological lens. Doing that, I can only conclude that anti-e-cigarette researchers, health groups, and health agencies were actually hoping that the outbreak would be due to traditional e-cigarettes and I honestly think they are disappointed to find out that is not the case. But they are still not willing to concede defeat. They will invoke all kinds of contrived explanations to keep their fading hopes alive.

Friday, November 08, 2019

CDC Announces "Major Breakthrough" that I Recognized and Reported Two Months Ago; Outbreak is Almost Certainly Not Associated with Legal Nicotine Vapes

Minutes ago, the Centers for Disease Control and Prevention (CDC) announced what they called a "major breakthrough" in its investigation of the vaping-associated respiratory illness outbreak. They tested lung tissue samples from 29 case patients and all 29 (100%) were found to contain vitamin E acetate oil.

This finding does represent a major breakthrough for four reasons:

1. The vitamin E acetate oil was detected in the actual lung tissue of the case patients.

2. The vitamin E acetate oil was detected in every single one of the lung tissue samples from these 29 case patients.

3.  The samples came from 10 different states, confirming that the outbreak seems to have a common cause, rather than geographic variation.

4. Three of the patients whose lung samples revealed vitamin E acetate had reported using only nicotine-containing products, thus confirming that there is significant under-reporting which may explain why about 11% of the patients do not report vaping THC.

This is significant because although not all of the case patients admitted to using THC vapes, the finding of vitamin E acetate in their lungs essentially proves that they were indeed vaping THC oils. This does not mean that they were lying; they may simply not have known what was in the product they were vaping, especially since most of these products are purchased off the black market or obtained from friends or dealers.

The finding is also significant because it provides a marker for vaping products that should not be used and makes it easier for state cannabis regulators to identify those legal THC cartridges that should be immediately pulled from the shelves. Fortunately, many cannabis testing laboratories have developed methodologies for detecting vitamin E acetate.

Every state should immediately require the testing of every legal, THC vaping liquid for vitamin E acetate before it goes on the shelves (or remains on the shelves), unless there is some other definitive mechanism for ensuring that the product does not contain vitamin E acetate oil.

At this point, it is time for state policy makers and politicians to immediately discontinue their conflation of this outbreak with the problem of youth e-cigarette use. It is time for all policy makers, health agencies, and health professionals to immediately stop stating or implying that legal, nicotine-containing e-liquids have anything to do with the outbreak.

At this point, it is also clear that states which have issued emergency regulations to ban e-cigarettes or flavored e-cigarettes are not justified in using their emergency powers for this purpose since it is almost assuredly the case that those store-bought products have nothing to do with the outbreak. While health department officials could argue that flavored e-cigarette bans are designed to address the problem of youth vaping, that problem is not in any sense an "emergency" so the executive branch in those states is abusing its power (and violating the separation of powers clause of the Constitution). Essentially, those states used the outbreak as an excuse to implement vape product bans while bypassing the legislative process. These bans should now all be struck down.

Finally, it is time for every state to issue clear and unequivocal statements that the outbreak is due to the use of THC vape carts and that the public, especially youth, should immediately stop vaping THC products, unless they are obtained legally from a dispensary which can verify that there is no vitamin E acetate oil in the product.

Note that this still does not demonstrate that it is the vitamin E acetate oil itself that is causing the illness, although that remains a possibility. It could also be the case that there is a contaminant contained in the vitamin E acetate oil that is causing chemical respiratory toxicity. It also remains possible that counterfeit and adulterated "nicotine" e-liquids are involved, as illicit manufacturers or dealers may be adding vitamin E acetate oil to otherwise legitimate products or hiding the tainted products in what appears to be legitimate packaging, but is actually counterfeit.

The Rest of the Story

I checked back through my posts and found that on September 5 (more than two months ago), I had reported the same conclusion as was reached today by the CDC in a post entitled:

"ALERT: Major Breakthrough in Investigation of "Mysterious" Lung Disease Outbreak"

In that post, I noted that every single patient who used THC vape cartridges in New York State and provided product samples had at least one cart that contained vitamin E acetate oil.

I wrote: "On my blog, I first issued a warning about the use of black market THC oils on August 25, and then on August 28 I blogged and tweeted an unequivocal warning, since the CDC had failed to do so.. .. It will be interesting to see how long it takes the CDC to issue an unequivocal warning to the public that they should absolutely not vape marijuana using THC vape carts obtained off the street."

"This emerging story shows the dangers of bias in public health. The long-standing bias of the CDC against vaping has resulted in the agency failing to warn the public in clear and specific terms about the risks associated with the use of bootleg THC vape carts and instead, issuing warnings against "vaping" and "e-cigarettes" generally and making meaningless statements like "e-cigarette aerosol is not harmless water vapor."

"The CDC and other health agencies and some anti-tobacco groups have gone to great lengths to protect the illicit cannabis industry. But they have no problem with attacking the e-cigarette companies and telling ex-smokers to return to smoking rather than continuing to vape."

Today's announcement confirms that in fact, the CDC's failure to appropriately warn the public about the role of THC vape carts in this outbreak, and the same failure among many state health departments, has almost certainly led to additional cases of the illness that would not have occurred if they had not used the outbreak as an excuse to demonize e-cigarettes. How many lives could have been saved and how many severe illnesses averted if they had simply told the truth from the beginning? 

Thursday, November 07, 2019

Wisconsin Physician Warns Public That A Single Puff from a Nicotine Vape Could Kill You

There is an inordinate amount of unjustified hysteria about the dangers of electronic cigarettes. And it continues to drive me crazy to read article after article which talks about how a 17-year-old youth almost died and had to be put on a ventilator for several days and then immediately transitions to a discussion of the health dangers of nicotine-containing e-cigarettes, which dominates the remainder of the article. If you're lucky, there is at most one sentence which parenthetically notes that the youth was vaping THC.

It is also tremendously frustrating to read statement after statement from the CDC in which it notes that 89% of the outbreak case patients admitted to vaping THC obtained off the black market and then immediately undermines that point by emphasizing that "no single product" has been identified which explains 100% of the cases (as if an epidemiologic investigation ever finds a single common exposure).

Yet despite the general hysteria and the specific conflation of the respiratory disease outbreak with the problem of youth e-cigarette use, today's story has to take the cake.

The Rest of the Story

In an article by Milwaukee's NBC news station, a physician warns the public that a single puff of a nicotine e-cigarette could kill you.

Specifically, he is quoted as stating that: "It literally can kill you the first time you try it."

Perhaps he is talking about black market THC vape carts, which aren't going to kill you in one puff but could potentially lead to respiratory illness in a matter of days of use. In that case, perhaps this can be viewed as just severe exaggeration.

But later in the article, we find out that is not the case. He is quoted as stating: "Probably most of them [the case patients] we see are nicotine. There's really no one particular substrate that causes it."

This goes way beyond exaggeration. It is blatantly lying to the public. The truth is that 89% of the case patients nationally have admitted to vaping THC, and black market THC products have been found to contain large amounts of vitamin E acetate oil. Both the FDA and the CDC agree that the predominant cause of the outbreak is the vaping of THC-containing liquids, not nicotine liquids.

The rest of the story is that according to this physician, smoking must be much safer than using e-cigarettes. After all, it typically takes three or four decades before smoking causes disease, but an e-cigarette can kill you after just a single puff.

Policy Makers are Deceiving Themselves if They Believe Banning Flavored E-Cigarettes is Going to End Youth Vaping of Flavored Products

Major Exemption in Proposed Flavor Ban Leaves Most Kid-Friendly Flavors on the Market

The most basic premise of the proposal to ban flavored e-cigarettes is that it will protect youth by preventing them from vaping flavored e-liquids. The flavors are the problem, so if we ban the flavors, we'll take care of the problem.

Or so the thinking goes.

The Rest of the Story

The problem is that politicians are deceiving themselves if they think that a ban on flavored e-cigarettes is going to prevent youth from accessing flavored e-liquids. The truth is that all of the following flavors are exempt from the ban and will remain on the market, easily accessible to youth.

The exempted flavors include all of the following:

  •          "Mario Carts Vanilla Glue,"
  •      "Heavy Hitters Vape Strawberry,"
  •      "Honey,"
  •      "Gelato,"
  •      "Blueberry,"
  •      "Banana Sherbet,"
  •      "Jillybean,"
  •      "Super Lemon Haze,"
  •      "Romulan Grapefruit,"
  •      "Sour Tangie,"
  •      "Biscotti,"
  •      "Pineapple Express,"
  •      "Mango,"
  •      "Juicy Melon,"
  •      "Strawnana,"
  •      "Granddaddy Purp,"
  •      "Forbidden Fruit,"
  •      "Lemon Lime,"
  •      "Golden Goat,"
  •      "Butter,"
  •      "Orange Cream,"
  •      "Banana Cream,"
  •      "Strawberry Banana,"
  •      "Grapevine,"
  •      "Lime Sorbet,"
  •      "Potent Pineapple,"
  •      "Pure Pear,"
  •      "Red Apple,"
  •      "Blue Raz,"
  •      "Strawberry Sherbet,"
  •      "Grape Soda,"
  •       "Pink Sherbet,"
  •      "Cactus Cooler,"
  •      "Sunset Sherbet Sauce,"
  •      "Sunset Gelato,"
  •      "It's Yo Birthday,"
  •      "Wedding Cookies,"
  •      "Orange Cookies,"
  •      "Girl Scout Cookies,"
  •      "Grape Pie,"
  •      "Cookies n Cream,"
  •       "Apple Jacks,"
  •          "Banana OG,"
  •          "Birthday Cake,"
  •          "Black Berry Kush,"
  •          "Blue Dream,"
  •          "Blueberry Kush,"
  •          "Bubble Gum,"
  •          "Candy Land,"
  •          "Cherry Pie,"
  •          "Cotton Candy,"
  •          "Fruity Pebbles,"
  •          "Gelato,"
  •          "Grape Ape,"
  •          "Grape Stomper,"
  •          "Green Crack,"
  •          "Honey Berry,"
  •          "Honey Dew,"
  •          "Ice Blue Raspberry,"
  •          "Key Lime Pie,"
  •          "Lemon Berry,"
  •          "Lemon Head,"
  •          "Lemon Slushie,"
  •          "LSD,"
  •          "Mai Tai,"
  •          "Mango Kush,"
  •          "Maui Wowie,"
  •          "Mimosa,"
  •          "Mojito,"
  •          "Orange Chai,"
  •          "Orange Cookies,"
  •          "Orange Daiquiri,"
  •          "Peach,"
  •          "Pineapple Express,"
  •          "Pot of Gold,"
  •          "Purple Punch,"
  •          "Rose Gold,"
  •          "Russian Cream,"
  •          "Sour Apple,"
  •          "Strawberry Shortcake,"
  •          "Sweet Aromatic,"
  •          "Tangie,"
  •          "Vanilla Kush,"
  •          "Water Melon,"
  •          "Wedding Cake," and
  •          "Zskittlez."
All of these flavors will remain on the market, despite what policy makers are telling the public. The truth is that while flavored e-liquids that contain nicotine will be banned, all of the above flavors, which are available in THC vape cartridges, will remain on the market.

You can now easily see why a ban on flavored nicotine e-liquids will not work. Youth will simply switch over to many of the sweet, fruity, alcohol-based, and other attractive flavors that are readily available in THC vape products.

The tragedy, of course, is that these flavored THC e-liquids are precisely the ones that are killing many people and causing life-threatening illness among close to 2,000 people, mostly youth and young adults. Banning flavored nicotine e-liquids is not going to prevent 17-year-olds from dying due to respiratory failure. But it will likely increase the number of kids who die from respiratory failure.

With flavors like Girl Scout Cookies, Cookies and Cream, Mimosa, Banana Sherbet, It's Yo Birthday, Russian Cream, Gelato, Grape Soda, Potent Pineapple, and Super Lemon Haze available, do you really think that youth are just going to completely stop vaping?

In the short time that JUUL has limited access to many of its flavors (such as mango and creme), youth have just shifted over to vaping the mint-flavored JUUL pods. They didn't stop vaping because some flavors were taken off the market. Youth are resourceful, vaping is cool, and they will simply switch to whatever flavors are available.

Those flavors will be vape juices like Zskittlez, Bubble Gum, Cotton Candy, and Cherry Pie.

And the only difference will be that instead of the risk of mild respiratory irritation (with most nicotine-containing e-liquids) or nicotine addiction (with JUUL), the major risk for our nation's youth will now be DEATH from lipoid pneumonia or chemical pneumonitis. How is that good public health policy?

Sunday, November 03, 2019

CDC and State Health Departments are Wrong to Inform the Public that Some Case Patients Used Only Nicotine E-Liquids

Because the CDC and state health departments have deliberately been conflating the respiratory disease outbreak with the general problem of youth vaping, they have not been clear in communicating the scientific evidence regarding the type of products that are most likely causing the outbreak. Because of the confusion they have created, a large number of state officials, health practitioners, and media outlets have been incorrectly reporting that a substantial proportion of the outbreak case patients used only nicotine-containing e-cigarettes.

For example, in its legal brief opposing a temporary restraining order against its emergency order banning the sale of vaping products, the state of Massachusetts claimed that "17% [of outbreak case patients] used only nicotine."

As another example, one chest physician told the public that about 15% of outbreak case patients: "used only nicotine-based products."

Another physician writing for UpToDate claimed that 15% of case patients "used products with nicotine but not THC."

Newsweek reported that about 16% of case patients "used only nicotine."

Yahoo also reported that a subset of the case patients "used only nicotine-containing products."

NBC News, too, reported that: "16 percent [of case patients] used only nicotine products."

The Rest of the Story

These statements are simply not true, or at least they are not backed up by solid evidence. It is not the case that 15% of case patients used only nicotine products. The evidence is actually that 15% (it's now down to 11%) of case patients did not admit to using products other than nicotine-containing e-liquids. The difference between these claims might sound minor, but it has immense public health implications.

A story published today out of Indiana illustrates why this distinction is so important. The article reports that a young male in Indiana developed vaping-associated respiratory illness and claimed to have only used nicotine-containing products. But it turns out that he really didn't know what was in the product because it was given to him, and he just assumed it was a nicotine-based product because "that’s what is mostly in vapes." Subsequent testing of the e-liquid in question revealed that it actually contained THC. But the patient had no idea that he was vaping THC oil.

What the CDC and many state health department officials don't seem to realize is that youth are not obtaining their vaping products by purchasing them at stores. They are mostly obtaining them from friends or school distributors, off the internet, or from street shops or dealers. For this reason, many youth vapers really have no way to know what is in their e-liquids. 

Moreover, as the Indiana story illustrates, even if a youth knows they are vaping THC oil, there is a strong incentive not to report it. The youth in question was expelled from school indefinitely and his mother is fighting the school system to have him reinstated. 

Furthermore, the CDC - until very recently - did not recommend that physicians conduct THC drug screens on patients, which ensured that it would not be possible to link all of the cases to the use of THC. To the best of my knowledge, the CDC has not confirmed a single outbreak case who tested negative for THC use. In light of this, I think it is irresponsible for physicians or other health practitioners or groups to report that a certain percentage of patients "did not use" THC vaping products.

The lack of understanding of youth vaping culture also explains why proposals to ban flavored e-cigarettes are misguided and will be ineffective and why claims that it is the flavors that are responsible for teen vaping are too simplistic. Youth are not vaping because they like flavors. They are vaping because they like vaping. Vaping is what's cool, not the particular type of e-liquid that you are vaping. 

Moreover, youth will vape whatever cartridges are being supplied by the kids who serve as the distribution channels in their schools. The majority of kids are not making autonomous decisions about what to vape. They are vaping what's available. The supply is largely determined by a small number of distributors. All the kids in a school know who those distributors are. The distributors essentially control the supply. 

This is why flavored e-cigarette bans will not necessarily get rid of the problem of youth vaping. What these bans will do, however, is: (1) facilitate a transition towards the use of THC oils; and (2) facilitate a shift towards the distribution of black market e-liquids. It is precisely these types of products that are causing the outbreak in the first place. This is why banning flavors will do nothing to curtail the outbreak but may make it much worse. And it will likely lead to more serious problems in the future.

A final possibility that needs to be considered is that some patients may actually be using nicotine-containing products, but contaminated THC oils may still be the reason for their illness. This is because there are bootleg, adulterated, and counterfeit products on the market in which a nicotine e-liquid is mixed with THC oil. In fact, lab testing of products recovered from case patients in two states has detected the presence of adulterated cartridges that contain both nicotine and THC.

We are still a long way from concluding that any cases of this outbreak have been caused by nicotine-only e-liquids and we are even further away from concluding that any cases have been caused by traditional nicotine-containing e-liquids sold by retail stores. In that light, bans on the sale of electronic cigarettes - even just flavored ones - are a terrible public policy that will do little to protect youth but will do a lot to put them at substantially higher risk of severe harm.

Why I Think the FDA's Imminent Ban on Flavored E-Cigarettes is Unlawful

I expect the FDA to announce soon that it is banning the sale of all flavored e-cigarettes, with the exception of tobacco and probably mint and menthol as well.

As you know, when an executive agency issues a regulation, it is required by the Administrative Procedures Act (APA) to go through a formal rule-making process, which at a minimum requires that the agency publish the proposed rule in the Federal Register, allow public comment on the rule, and then respond to the comments before actually issuing the rule. This process can take one to two years.

The question you may be asking is: How can the FDA ban flavored e-cigarettes without issuing a rule that bans flavored e-cigarettes and that goes through the required APA process?

I expect that the FDA is going to use its enforcement authority, rather than a formal rule-making process, to "promulgate" a de-facto ban on the sale of most flavored e-cigarettes, exempting only tobacco, mint, and menthol flavors.

I believe they will attempt to escape the required public input and due process requirements of administrative rule-making by issuing a "guidance" regarding its enforcement of the pre-market tobacco application (PMTA) requirement, whose enforcement it is currently holding off on until May 2020.

So what the FDA will likely do is to issue a guidance announcing that it is going to use its enforcement authority to enforce the PMTA requirement "immediately" for all flavored e-cigarettes. This means that any flavored e-cigarette that has not yet submitted a PMTA (which is every flavored e-cigarette) will have to be taken off the market until they submit and gain approval of a PMTA (which will be never for almost all companies except for the cigarette companies and perhaps a few of the largest independent companies). So not only will most flavored e-cigarettes have to come off the market but what does remain of the market will be handed over to the tobacco companies.

So the following question arises:

Is It Legal for the FDA to Ban Flavored E-Cigarettes By Issuing a Guidance and/or Using Its Enforcement Authority Regarding PMTAs?

The answer, I believe, is no, for three major reasons.

1. Such a guidance would violate the Executive Order on Promoting the Rule of Law Through Improved Agency Guidance Documents and the Executive Order on Promoting the Rule of Law Through Transparency and Fairness in Civil Administrative Enforcement and Adjudication

On October 9, 2019, the president issued an executive order that requires for any significant guidance document:

"a period of public notice and comment of at least 30 days before issuance of a final guidance document, and a public response from the agency to major concerns raised in comments, except when the agency for good cause finds (and incorporates such finding and a brief statement of reasons therefor into the guidance document) that notice and public comment thereon are impracticable, unnecessary, or contrary to the public interest."

The rationale for this executive order seems to perfectly describe what the FDA is doing here and why it is not appropriate or legal:

"Agencies may clarify existing obligations through non binding guidance documents, which the APA [Administrative Procedures Act] exempts from notice-and-comment requirements.  Yet agencies have sometimes used this authority inappropriately in attempts to regulate the public without following the rulemaking procedures of the APA.  Even when accompanied by a disclaimer that it is non-binding, a guidance document issued by an agency may carry the implicit threat of enforcement action if the regulated public does not comply.  Moreover, the public frequently has insufficient notice of guidance documents, which are not always published in the Federal Register or distributed to all regulated parties.

Americans deserve an open and fair regulatory process that imposes new obligations on the public only when consistent with applicable law and after an agency follows appropriate procedures.  Therefore, it is the policy of the executive branch, to the extent consistent with applicable law, to require that agencies treat guidance documents as non-binding both in law and in practice, except as incorporated into a contract, take public input into account when appropriate in formulating guidance documents, and make guidance documents readily available to the public.  Agencies may impose legally binding requirements on the public only through regulations and on parties on a case-by-case basis through adjudications, and only after appropriate process, except as authorized by law or as incorporated into a contract."

An "enforcement authority"-imposed ban on flavored e-cigarettes also appears to violate a second emergency order, also issued on October 9 of this year.

That executive order states that:

"When an agency uses a guidance document to state the legal applicability of a statute or regulation, that document can do no more, with respect to prohibition of conduct, than articulate the agency’s understanding of how a statute or regulation applies to particular circumstances.  An agency may cite a guidance document to convey that understanding in an administrative enforcement action or adjudication only if it has notified the public of such document in advance through publication, either in full or by citation if publicly available, in the Federal Register (or on the portion of the agency’s website that contains a single, searchable, indexed database of all guidance documents in effect)."

Since I do not believe that the FDA notified the public of this new enforcement approach through publication, it seems that it would violate this executive order.

2. Such a guidance and/or new policy on enforcement action would violate the Congressional Review Act.

The Congressional Review Act (5 U.S. Code 801-808) requires that a federal agency submit any rule to Congress prior to its issuance. Congress has an opportunity to disapprove the rule via a joint resolution. While it may seem that a guidance or a new policy on enforcement action is not a "rule," the definition of "rule" in the Congressional Review Act is quite broad, being defined as:

"the whole or a part of an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy."

In addition, this past April the Office on Management and Budget issued a memorandum explaining that in its view:

"The CRA applies to more than just notice-and-comment rules; it also encompasses a wide range of other regulatory actions, including, inter alia, guidance documents, general statements of policy, and interpretive rules."

The imminent ban on flavored e-cigarettes would appear to fit under this definition.

3. Such a guidance and/or new policy on enforcement action would violate the Administrative Procedures Act because it represents "Rule-making by enforcement."

I believe there is a legitimate argument that what the FDA is attempting to do represents rule-making by enforcement action. It is generally held that rule-making by enforcement is not permissible because it circumvents due process.

Finally, even if it were lawful for the FDA to promulgate a rule banning flavored e-cigarettes merely by announcing a new enforcement action policy, I do not think it is an appropriate action. A policy of this magnitude, which is going to affect the national economy in a major way, is going to shut down almost an entire industry, is going to create new black markets, and is going to cause severe public health consequences, should not be implemented by enforcement action, but by a formal rule-making process.

I Expect FDA to Announce Flavor Ban This Week, But Vapers Save Mint and Menthol E-Cigarettes

Due to the outcry from the vaping community, it appears that mint and menthol will be excluded from a ban on flavored e-cigarettes that I expect the FDA to announce this week. I also do not expect menthol cigarettes to be included, since that would actually cause a decline in cigarette consumption (while a flavored e-cigarette ban will increase cigarette consumption, and therefore, federal government revenue). Moreover, it is easy to take a stand against the weak vaping industry but takes actual political courage to stand up to the large cigarette companies.

The only reason why I think mint and menthol will be excluded from the ban is that vapers have loudly made their voices heard, shared their experiences, and let politicians know that e-cigarettes have saved their lives and that they rely upon flavored e-liquids to stay off real tobacco cigarettes. This has apparently convinced the Trump administration that a more comprehensive flavor ban would alienate the vaping community and could give him problems in the 2020 election. The votes of the vaping community are widely acknowledged to have played a role in the close 2016 election victory of Senator Ron Johnson in Wisconsin.

The Rest of the Story

While this would be a victory for public health, it would only be a small victory. There are still hundreds of flavored e-cigarettes that would have to be taken off the market, and the public health consequences of even this "watered down" flavor ban would be devastating.

The ban would still:
  1. Cause many ex-smokers to return to smoking;
  2. Deter many current smokers from trying to quit in the future;
  3. Create a new, unregulated black market for flavored e-liquids; and
  4. Create a shift in youth use of vaping products towards the use of black market THC oils (the precise ones that are causing the current outbreak of severe respiratory illness).
Allowing mint and menthol e-cigarettes to remain on the market is better than banning all flavors other than tobacco, but it is only marginally better.

Why is the FDA interested in creating an unregulated black market for e-liquids, rather than simply directly regulating the safety of these products. If the current outbreak teaches us anything, it is that when you have a large black market, you can expect much more dangerous products being consumed and if a dangerous product does enter the market, it becomes almost impossible to control its manufacture, distribution, and use.