Wednesday, November 20, 2019

Massachusetts State Senate Votes to Ban Almost All E-Cigarettes, But to Leave the Real Deadly Ones on the Shelves

In a move that defies public health logic, the Massachusetts Senate today voted for a bill that would ban the sale of virtually all e-cigarettes, but would allow non-mentholated real cigarette brands to remain on the shelves of all stores, including convenience stores and gas stations where youth have easy access to these products.

There is simply no public health justification for taking e-cigarettes off the market but allowing youth to continue to have unfettered access to real tobacco products. The average annual death toll of these products is starkly different:

Flavored e-cigarettes: 0
Real cigarettes: 480,000

Given the morbidity and mortality burden differential between these two products, how can the state Senate ban the former, but leave the latter free to addict and eventually kill the youth of the Commonwealth?

The Rest of the Story

I'm sorry, but there is simply no justification for banning the sale of most electronic cigarettes but allowing real cigarettes, which kill more than 400,000 Americans each year, to remain on the shelves, almost completely unregulated.

One of the major arguments that supporters of the bill offered to support their call for a ban on all flavored e-cigarettes is that when JUUL pulled its flavors other than mint and menthol from store shelves, youth simply switched to mint and menthol flavors. But if that's true, then shouldn't we be concerned that if flavored e-cigarettes are banned, youth will simply switch to tobacco-flavored e-cigarettes?

If the Senate is genuinely concerned about youth vaping, then there is no justification for it failing to call for a ban on all e-cigarettes. By its own logic, leaving tobacco-flavored e-cigarettes will simply result in youth switching to tobacco-flavored e-cigarettes.

OK, so you're thinking that kids are not going to switch from a candy- or fruit-flavored e-liquid to a tobacco-flavored one? Fine, but if that's the case, then it's even less logical to argue that kids are going to switch from fruit-flavored e-cigarettes to the harsh, tobacco-flavored real ones. You can't credibly make the argument that youth will avoid the tobacco flavor of e-cigarettes, but get hooked on the tobacco flavor of real cigarettes.

The truth, of course, is that kids are not getting hooked on flavored e-cigarettes and then progressing to tobacco-flavored real cigarettes. They are using flavored e-cigarettes specifically because they want to avoid the health consequences that they all know are associated with the tobacco-flavored real cigarettes.

So if youth are not going to switch from flavored e-liquids to tobacco-flavored e-liquids, what are they going to switch to?

The answer is THC e-liquids, many of which are packaged in kid-friendly brands like "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."

These are precisely the black market products that have led to more than 2,000 cases of severe respiratory failure, most among young people, with 42 fatalities.

The Senate's proposal to ban all flavored e-cigarettes would result in a shift from flavored e-liquids to the increased use of flavored e-joints, and it would make the current respiratory disease outbreak much worse, potentially resulting in more deaths. Does the Senate really want those severe illnesses and deaths on its hands?

This is before we even get to talking about the effects that a flavored e-cigarette ban would have on adults, which include a mass return to cigarette smoking or entrance into a new black market for flavored e-liquids, which might eventually result in an even worse disease outbreak in the future, since the number of adults using these products and thus subject to any contaminant that may arise in these black market products will be immense.

The Senate has apparently written off adult smokers completely. This is a complete betrayal of the Commonwealth's stated objective of reducing tobacco use by increasing successful quit rates and reducing disparities in access to prevention and cessation services.

The rest of the story is that the state Senate has steered away from its mission to protect the health of the public, and this bill to ban flavored e-cigarettes would severely harm the health of both youth and adults across the Commonwealth.

Massachusetts Senate Uses a Big Tobacco Tactic: Votes Not to Allocate Master Settlement Agreement Money to Smoking Prevention and Cessation; In that Light, the Flavor Ban is Disingenuous

Anyone who thought the Massachusetts state Senate's probable passage of a bill tonight that will ban the sale of flavored e-cigarettes and menthol tobacco cigarettes is motivated by a pure desire to protect kids and reduce tobacco-related diseases is mistaken. The supporters of this legislation showed their true colors tonight by rejecting an amendment that would have required that the state allocate a mere 10% of the money it receives from the Master Settlement Agreement to smoking prevention and cessation programs.

It was quite a sight to witness. Senator after senator got up and spoke about how terrible smoking is and how we have to protect kids from tobacco and nicotine and fight Big Tobacco and their devious tactics.

And then, they used a classic Big Tobacco tactic themselves from voting to continue the diversion of nearly 100% of the Master Settlement Agreement money to non-tobacco-related causes.

It seems disingenuous to me to put on a grand political show about how much you care about the problem of tobacco use and smoking and nicotine addiction and how much we need to protect kids from Big Tobacco and its deceptive tactics and then to follow that up by immediately using a classic Big Tobacco strategy yourself and by refusing to put your money where your mouth is by adequately funding smoking prevention and cessation programs in the state.

To be honest, I stood motionless and in shock as I watched the roll called and senator after senator voted to continue the diversion of MSA funding. Ironically, it was mostly Democratic senators who voted against the amendment and Republican senators who voted for the amendment, which was sponsored by Senator Bruce Tarr (R - First Essex and Middlesex).

The Rest of the Story

In 1992, Massachusetts voters approved an initiative measure (Question 1) that increased the cigarette tax by 25 cents per pack and allocated the money to tobacco prevention and cessation programs. The program was funded at a level of more than $100 million for the first year and approximately $96 million the second year. However, Governor Jane Swift slashed the budget by 95%, diverting funds away from tobacco prevention and cessation and towards the general budget, violating the will of the voters.

In fact, getting states to divert cigarette tax revenue funding away from tobacco control was a favored tactic of the tobacco industry. They succeeded in convincing Governor Pete Wilson to do this in California prior to Governors Swift and Weld doing this in Massachusetts.

In 1998, the state of Massachusetts entered into a settlement of its lawsuit against Big Tobacco, under which the tobacco companies agreed to make an annual payment of funds to the state. This was called the Master Settlement Agreement (MSA). Although the intent of the MSA funding was to provide money for smoking prevention and cessation (since that was the topic of the lawsuit), the state has diverted most of these funds away from tobacco-related purposes.

So between the Question 1 revenue and the MSA revenue, the state is bringing in millions of dollars each year that are supposed to go to tobacco prevention and cessation, but which instead have been diverted to the general budget, violating the will of the people and the intent of the state's lawsuit against Big Tobacco and its subsequent settlement of the lawsuit.

Senator Tarr's proposal would have re-allocated merely 10% of the MSA revenue to tobacco prevention and cessation. As he said on the Senate floor, theoretically 100% of this revenue should be spent on tobacco-related programs, but at least approving a 10% allocation would demonstrate that the Senate views tobacco use prevention and cessation as a priority, as senators had said throughout the entire first part of the session, prior to the amendment being introduced.

Well, right after the amendment was introduced, they suddenly changed their tune. All of a sudden, everything they had said previously was thrown out the window. They voted to continue the unconscionable diversion of almost all the MSA funding away from tobacco prevention and cessation programs.

In 2019, Massachusetts received $236.6 million from the MSA. However, it allocated only $4.2 million to tobacco prevention and cessation. This represents a measly 1.8% of the MSA funds.

According to CDC best practice recommendations, Massachusetts should be spending a minimum of $46 million a year on tobacco prevention. An allocation of 10% of MSA funds to tobacco control would represent an expenditure of $24 million, which is still only about half of the CDC recommended funding level.

The rest of the story is that the hypocrisy of the state Senate's actions tonight is striking. After talking about how much they care about reducing tobacco-related disease and death, the Senate adopted a Big Tobacco tactic and voted to continue the diversion of MSA funding away from tobacco prevention. Tonight was a great display of politics, but not of public health.

Tuesday, November 19, 2019

American Medical Association Calls for Removal of the Main Competitors to Cigarettes from the Market

In a resolution that is the most dangerous health-related policy proposal from a medical or health organization that I have seen in my career, the American Medical Association (AMA) today called for the complete removal from the market of the #1 competitor to Big Tobacco profits. The resolution also calls for hundreds of thousands of ex-smokers to return to smoking and for the removal from the market of a critical off-ramp that has helped 2.5 million American smokers to quit for good. In addition, the resolution calls for the creation of a dangerous new black market for e-cigarettes and e-liquids.

If this sounds crazy, let me assure you that this is not a re-publication of an Onion article.

In fact, it is true that today, the American Medical Association called for the complete and immediate removal of all electronic cigarettes from the market. Since e-cigarettes are the #1 threat to the consumption of real tobacco cigarettes, this recommendation would remove the greatest competitor to cigarette sales and would therefore represent a huge gift to Big Tobacco.

In calling for an e-cigarette ban, the AMA is also calling for hundreds of thousands of ex-smokers to return to smoking since that is the effect that such a policy would have on a large proportion of the 2.5 million ex-smokers who currently rely upon e-cigarettes to stay off of the real ones.

In addition, the AMA is calling for the creation of a new, dangerous black market for e-cigarettes and e-liquids because the overwhelming majority of those vapers who do not return to cigarette smoking will turn instead to the black market in an act of desperation to avoid having to go back to smoking.

The Rest of the Story

I'm sorry to have to say this, but right now the AMA is a great threat to the health of the public. Don't let this organization fool you. This has nothing to do with protecting the public's health. It is all about gaining publicity and political advantage for the organization. 

How do we know that the AMA is not being sincere?

Because the AMA president gave the following as the justification for the recommendation:

"It’s simple – we must keep nicotine products out of the hands of young people."

If it is imperative that we keep nicotine products out of the hands of young people, then why in the world did the AMA not call for a ban on the sale of all real cigarettes as well?

There is absolutely no way in which the AMA can justify calling for a ban on e-cigarettes while allowing real tobacco cigarettes to stay on the market. While e-cigarettes have not killed anyone, tobacco cigarettes kill more than 400,000 people each year. It is therefore ludicrous that the AMA is calling for a ban on the fake cigarettes while allowing the real ones to remain!

I defy anyone who is an AMA member to provide a public health justification for banning e-cigarettes but not cigarettes.

There simply is none.

This is a misguided resolution that has no public health justification, would do immense public health damage, and would substantially increase cigarette consumption in this country. It is a huge gift to Big Tobacco.

The AMA has a long and sordid history of promoting tobacco use through the help it has provided to Big Tobacco, but this resolution takes the cake. It takes the cake because it is now 2019, and we should be long past the point of cowing down to Big Tobacco. But the AMA has done exactly that.

The AMA should be ashamed of itself for being willing to call for a ban on e-cigarettes, but not touching the real cigarettes that are killing hundreds of thousands of Americans each year and which are still the number one cause of preventable death.

Saturday, November 16, 2019

American Heart Association Urges Parents to Lie to Their Kids About E-Cigarettes and Not to Answer their Questions

It has been well established that using e-cigarettes is far safer than smoking. Clinical studies show that smokers who switch to e-cigarettes experience immediate and dramatic improvement in both their lung function and in their cardiovascular function. They also experience a dramatic reduction in levels of chemical toxins. Any parent who suggests to their kids that e-cigarettes are as dangerous as real cigarettes is lying.

However, this fact has not stopped the American Heart Association from urging parents to hide from their kids this important factual information. The American Heart Association actually recommends that if your kid asks you whether e-cigarettes are any safer than tobacco cigarettes, you not answer the question directly but immediately divert attention to the fact that nicotine will harm their brain and that their e-cigarette battery might explode and kill them.

Here is an excerpt from a fact sheet that the American Heart Association recommends parents use to answer this question from their kids:

"Aren’t e-cigarettes safer than conventional cigarettes?• Because your brain is still developing, scientific studies show that it isn’t safe for you to use any tobacco product that contains nicotine, including e-cigarettes.
• Whether you get nicotine from an e-cigarette or a cigarette, it’s still risky.
• Some e-cigarette batteries have even exploded and hurt people."


The Rest of the Story

I find it disturbing that the American Heart Association is recommending that parents essentially lie to their kids by deceiving them into thinking that e-cigarettes are as hazardous as real cigarettes. But it is even more disturbing that the American Heart Association is recommending that parents refuse to directly answer the questions that their kids may ask about the relative harms of e-cigarettes vs. tobacco cigarettes.

The rest of the story is that the American Heart Association is so obsessed with disseminating hysterical claims about the health effects of e-cigarettes that they are willing to stoop to the level of recommending that parents risk their entire relationship with their kids by lying to them and not directly answering their questions.

Frankly, I don't think there is a kid in America who would fall for this crap and not realize that their parent is spewing out nonsense. This will most likely result in their kid wanting to immediately get together with their friends and vape up a storm.

I have my own recommendation for the American Heart Association: Stop telling parents how to talk to their own children, especially if you are going to recommend that they use lies, misinformation, question avoidance, and deception. Both the parents and their children, and the quality of their relationships, will be far better off without your inane advice.

NOTE: In fairness to the American Heart Association, the "fact sheet" to which they link is not their own. It was apparently produced by the U.S. Department of Health and Human Services. Nevertheless, by choosing to refer parents to this fact sheet, they are essentially providing this advice.

While American Heart Association Claims E-Cigarettes are as Harmful as Smoking, a Clinical Trial Shows Immediate Cardiovascular Improvement After Smokers Switched to E-Cigarettes

Last week, the American Heart Association issued a press release whose headline read: "E-cigarettes take serious toll on heart health, not safer than traditional cigarettes."

But while the American Heart Association was busy disseminating this message throughout the world, the results of an actual clinical trial of this very research question demonstrated the almost immediate improvement in cardiovascular health that occurs when smokers switch to e-cigarettes.


The study compared smokers who switched to e-cigarettes to those who continued to smoke. Endothelial function (a measure of damage to the lining of arteries) and blood vessel stiffness were measured at baseline and after one month. The study reported that: "TC [tobacco cigarette] smokers, particularly females, demonstrate significant improvement in vascular health within 1 month of switching from TC [tobacco cigarettes] to EC [e-cigarettes]. Switching from TC to EC may be considered a harms reduction measure."

The investigators concluded that: "The main findings from this present study are that within 1 month of switching from TC to EC, smokers demonstrate a significant improvement in vascular function. ...
there is an early benefit to vascular function from switching from TC to EC. Within the switching time frame of 1 month, chronic smokers demonstrated significant improvements in vascular endothelial function."

The Rest of the Story

The difference between the hysterical propaganda from the American Heart Association and the hard evidence from this randomized clinical trial is striking. While the American Heart Association is trying to convince the public that there is no difference in cardiovascular health effects between vaping and smoking, this paper provides solid clinical evidence that smokers who switch to e-cigarettes experience an immediate improvement in cardiovascular health.

Why the American Heart Association would want to deter smokers from quitting is beyond my comprehension. And to do that while spreading false information about health risks is irresponsible.

Friday, November 15, 2019

Bill Passed by Massachusetts House Would Allow Police to Seize Cars from Vapers who Possess DIY or Black Market E-Liquids

But You Can Drive With Marijuana or Cartons of Marlboros in Your Car To Your Heart's Content

Jacob Sullum, a senior editor at Reason, has revealed a striking set of provisions in the bill (H4183) passed by the Massachusetts House of Representatives on Wednesday. These provisions would allow the police to seize your vehicle if you possess any DIY or black market e-liquids in your car.

The relevant provision in the bill reads as follows:

"When the commissioner or a police officer discovers an untaxed electronic nicotine delivery system in the possession of a person who is not a licensed or commissioner-authorized electronic nicotine delivery system distributor, the commissioner or police officer may seize and take possession of the electronic nicotine delivery systems and any vending machine or other receptacle including, but not limited to, a motor vehicle, boat or airplane in which the electronic nicotine delivery systems are contained or transported."

Because a DIY e-liquid or a black market e-liquid would meet the definition of an "untaxed electronic nicotine delivery system," possessing either in your car would make your vehicle subject to seizure. 

Moreover, if you merely possess a DIY or black market e-liquid (in any location), you are subject to a potential $5,000 fine for the first offense and up to $25,000 for subsequent offenses.

Youth are also subject to the penalties in H4183. So if a youth were caught possessing a black market CBD, THC, or nicotine cartridge, they would be subject to a $5,000 fine; $25,000 if they are caught twice.
 
Even worse, the bill essentially requires you to have a receipt for your e-cigarette or e-liquid purchase to prove that you paid the excise tax. The bill contains a provision that presumes your e-cigarette was not taxed unless you can prove it. So even if you possess a legal e-cigarette (meaning one you purchased from a licensed smoking bar), if you don't have the receipt that e-cigarette could cost you an extra $5,000 above its purchase price. If you're caught twice possessing a JUUL pod without a receipt, that pod four-pack will cost you $25,019.99.

The Rest of the Story

Today, I reveal that if this law is enacted, it will be illegal for any person in Massachusetts to possess any electronic cigarette, vaping device, e-liquid, e-cigarette battery, cartridges, or even e-liquid vials that you obtained prior to the effective date of the law. In other words, you have to discard every single e-cigarette device, component, or e-liquid that you possess on the day the law goes into effect. Otherwise, you are subject to a fine of up to $5,000 for the first offense and up to $25,000 for subsequent offenses.

The relevant provision in HB4183 reads as follows:
  "A person who knowingly purchases or possesses an electronic nicotine delivery system not manufactured, purchased or imported by a licensed electronic nicotine delivery system distributor or licensed electronic nicotine delivery system retailer shall, in addition to any other penalties provided by this chapter or chapter 62C, be subject to a civil penalty of not more than $5,000 for the first offense and not more than $25,000 for a second or subsequent offense."

So for example, suppose you bought a JUUL device at Walgreen's in 2018. Walgreen's was not a licensed electronic nicotine delivery system retailer at the time you made the purchase. You could therefore be considered to be in a possession of an e-cigarette that was not obtained from a licensed dealer. What you thought was a cheap $14.99 expenditure may actually be an expenditure of $5,014.99.

What is so striking about this legislation is how severely it treats e-cigarettes, while treating much more hazardous Marlboro cigarettes leniently. In fact, this bill has absolutely no implications for the sale, purchase, or possession of the product responsible for the most preventable deaths in Massachusetts. But it levies a potential $25,000 fine and forfeiture of your car if you are caught twice with a DIY e-cigarette device or liquid in your vehicle.

I just don't understand the extent of this hysteria around e-cigarettes. There is no doubt that youth addiction to e-cigarettes, which essentially translates into youth use of JUUL, is a major problem. But you don't have to shut down the entire e-cigarette market, criminalize people who are trying to save their lives, create a new black market, and push youth towards THC vaping in order to solve this problem. You can do it with one simple law: limit the nicotine level in e-cigarettes.

In the UK, there isn't a problem with youth addiction to JUUL. But in the UK, JUUL does not contain 54 mg/mL of nicotine. It contains only 17 mg/mL because there is a legal nicotine limit. In fact, H4183 contains a provision that limits e-liquid nicotine levels to 20 mg/mL, except those sold at smoking bars. If the legislature merely enacted that one provision, but including all e-cigarettes (not just those sold at smoking bars), it could significantly curtail the youth vaping epidemic without all of the severe negative health consequences.


Thursday, November 14, 2019

Massachusetts House Passes Bill that Promotes Marlboro Cigarettes; Why are They Doing This Huge Favor for Philip Morris?

Yesterday was a dream come true at the Massachusetts State House for Philip Morris USA - the nation's largest domestic cigarette manufacturer. The House voted to approve a bill that bans the sale of all e-cigarettes except those with tobacco flavoring, bans the sale of menthol cigarettes, and imposes a 75% excise tax on all e-cigarettes. According to an article in the Boston Globe, the aim of the legislation is "to protect young people from the harmful effects of tobacco."

The Rest of the Story

If the purpose of this legislation is to protect young people from the harmful effects of tobacco, then it is an utter failure. It makes it much easier for a youth in Massachusetts to get their hands on a Marlboro cigarette than a cherry vape. In addition, since proponents of the law argue that e-cigarettes are a gateway to smoking, there are now thousands of youth vapers in Massachusetts who would no longer be able to vape, so by the proponents' own reasoning, there is going to be a large increase in youth smoking in the state if this bill is enacted.

But that's not the worst of it.

If policy makers think that by banning flavored e-cigarettes they are going to put an end to youth vaping, they are deceiving themselves. Youth are not vaping because the products are flavored. They are vaping because vaping is now viewed as cool. The phenomenon that is cool is vaping, not the use of flavors. If flavored, nicotine-containing e-liquids are no longer available, youth are not simply going to stop vaping. What they are going to do is to change what they are vaping. And instead of vaping flavored nicotine e-liquids, they are going to shift towards the use of black market THC e-liquids. Those are precisely the products that are causing this terrible outbreak of severe respiratory failure.

In other words, what this legislation would do is to create a shift in youth vaping from the vaping of nicotine to the vaping of marijuana (and perhaps CBD as well). Youth who use drugs tend to use whatever is most available. Whatever e-liquids are being supplied by the school suppliers is what kids will vape. The overwhelming majority of youth vapers are not buying the e-liquids themselves from retail stores. They are purchasing them from friends, classmates, or school dealers who serve as the distribution channel for these products. Whatever e-liquids they have available are the e-liquids that kids will use. And if this law goes into effect, what the kids who are distributing these drugs will have available is THC carts instead of flavored nicotine-containing pods.

The damage doesn't end there.

If enacted, this ban is going to cause many ex-smokers to return to cigarette smoking. Ex-smokers who rely upon flavored e-liquids to stay off cigarettes are going to return to smoking in large numbers. The majority of those who don't will turn to black market e-liquids, and we all now understand the dangers of an unregulated black market. In addition, this legislation removes a major off-ramp for adult cigarette smokers who are trying to quit smoking.

In the short time that the emergency ban on the sale of e-cigarettes has been in place in Massachusetts, the state has already experienced significantly higher rates of cigarette consumption than would have occurred without the ban -- this is based on actual sales data, not self-reports of smoking behavior.

On top of all of this, the legislation imposes a whopping tax on electronic cigarettes, which essentially removes any incentive for smokers to switch to tobacco-flavored vapes, the only ones which will remain on the legal market.

So the end result of this legislation will be a significant increase in the level of cigarette consumption in Massachusetts. That's a victory for Big Tobacco. But not all the companies will benefit equally. Most sub-brands of Newport, Kool, and Salem are menthol-flavored, while most sub-brands of Marlboro are non-mentholated. What this legislation essentially does is ban the sale of Newport, Kool, and Salem while allowing the sale of Marlboro cigarettes to remain unfettered.

There is simply no public health justification for banning some brands of cigarettes, but leaving others on the market.

The big question this raises is this: If the legislature is willing to ban menthol cigarettes, then why isn't it willing to ban the sale of all cigarettes? There is no evidence that menthol cigarettes are any more dangerous than other cigarettes. Thus, there is ultimately no justification for singling them out and allowing other brands to reaming on the market to continue to kill thousands of Massachusetts residents each year.

This bill is a dream come true for Philip Morris USA because it essentially removes all of its major competition. First, the bill eliminates the overwhelming majority of the e-cigarette market in Massachusetts, so Philip Morris no longer has to worry about competition from much safer alternative products. Now all its competition will come from products that are equally deadly.

However, even many of those products are being removed from the market. The main competitors to Marlboro, such as Newport, Kool, and Salem are largely being removed from the market. Philip Morris couldn't have hoped for a more favorable piece of legislation had they written the bill themselves.

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.

Wednesday, October 30, 2019

Sales Data Show that Massachusetts Vaping Product Ban Has Already Caused Severe Harm as Vapers Migrate to Smoking in Large Numbers

Sales data reported by PiperJaffray for the four weeks ending October 20 (when the Massachusetts emergency ban was in effect for 25 of the 28 days) and the four previous weeks (mostly before the ban went into effect) were compared to sales data for the previous year. The PiperJaffray analysis revealed that there has been a substantial shift from vaping to smoking in the state. This indicates that as I predicted, ex-smokers in Massachusetts who were reliant on e-cigarettes to stay smoke-free are now returning to smoking in large numbers.

Nationally, there was very little difference in the rate of decline in cigarette sales between these two time periods from 2018 to 2019. The rate of decline decelerated by 0.3 percentage points (from -7.8% to -7.5%). However, in Massachusetts, the rate of decline decelerated by a massive 5.7 percentage points (from -9.8% to -4.1%).

Another way of expressing this is that in September 2019, national cigarette sales were 92.5% of what they were in September 2018, and in October 2019, they were 92.2% of what they were in October, 2018. Thus, there was little change in the rate of decline.

However, in Massachusetts, while cigarette sales in September 2019 were 90.2% of what they were in September 2018, in October 2019, they were 95.9% of what they were in October 2018, a substantial lowering of the rate of decline in cigarette sales.

The Rest of the Story

What these sales figures mean is that the emergency ban on the sale of all vaping products in Massachusetts has resulted in an increase in cigarette consumption, most likely due to large numbers of vapers going back to smoking.

Because cigarette consumption is roughly linearly related to smoking-related disease and death, this means that unless the state reverses course, the vaping products sales ban is going to result in a substantial increase in disease and death.

The state is justifying causing this known harm to the public's health based solely on pure speculation that although 90% of outbreak cases admit to vaping THC purchased off the black market, store-bought e-cigarettes are causing a substantial proportion of these cases. This assumes that the 10% of case patients who didn't report using THC: (1) know exactly what the ingredients were in the products they used even though the vapes may have been given to them by friends or purchased off the street or the internet; (2) know that the products are not counterfeit or tampered with; and (3) are not under-reporting their THC use even though we know that a huge proportion of youth who present in emergency rooms do under-report their THC use to physicians.

These known negative health consequences are also occurring in the absence of any documentation that a substantial proportion of confirmed case patients who reported using nicotine-only products tested negative for THC in a urine drug screen.

And furthermore, these known adverse health outcomes are occurring without any finding that a single nicotine-containing e-liquid sold by a retail store was contaminated with a chemical that could be causing the respiratory failure observed in outbreak case patients.

The principle tenet of all public health practice is "Do no harm." As a central principle, we try to avoid doing known harm to the public's health. In this case, states that are banning e-cigarettes (or flavored e-cigarettes) are violating this principle because they are knowingly causing substantial harm to the public's health while producing no known benefits in terms of helping to curtail the outbreak. And, on top of this, they are likely going to make the outbreak worse.

Thursday, October 24, 2019

Analysis Reveals that 44% of State Health Departments are Not Explicitly Warning Youth Not to Vape THC and Three States are Committing Public Health Malpractice

This is part 1 of an analysis of the health warnings that state health departments are issuing to the public regarding the outbreak of vaping-associated respiratory illness. Here, I analyze the warnings issued by the first 25 states (Alabama through Montana).

For each state, after briefly summarizing the warning, I categorize the warning based on three criteria:
  1. Is there an explicit warning not to vape THC?
  2. Does the warning inform the public that THC vape cartridges are playing a major role in the outbreak?
  3. Does the warning mention THC at all?
Based on the warning and these three criteria, I then classify the state health department warnings into six rating levels:
  1. Excellent: There is an explicit warning not to vape THC, the state informs the public that THC is playing a major role in the outbreak, and the state goes beyond CDC by not undermining its warning about vaping THC
  2. Good: There is an explicit warning not to vape THC and the state goes beyond CDC by not undermining this warning, but the state either fails to inform the public that THC is playing a major role in the outbreak or issues too vague a warning.
  3. Fair: There is an explicit warning not to vape THC but the state undermines that warning by emphasizing that no single product has been associated with all cases.
  4. Poor: There is an explicit warning not to vape THC but it is undermined by a vague warning or the failure to acknowledge that THC plays a major role in the outbreak.
  5. Very poor: There is no explicit warning not to vape THC.
  6. Public health malpractice: There is no mention of THC in the warning.
My rationale for this classification is that at this point, it is very clear that THC vape cartridges are playing a major role in the outbreak and both CDC and the FDA have now acknowledged that. Given that fact, it is imperative that state health departments issue an explicit warning to the public, and especially to youth, not to vape THC (at least black market THC products). Finally, this message should not be undermined by other statements in the warning.

Here are the results of my analysis:

The Rest of the Story

The most striking finding of this analysis is that 3 states - Alabama, Illinois, and Kentucky - are committing public health malpractice by not even mentioning THC at all in their warnings. This is inexcusable and puts the lives and health of residents, especially youth, at risk.

The second most striking finding is that 11 of the 25 states (44%) are not explicitly warning the public not to vape black market THC cartridges. These states are (in addition to the 3 states above): California, Georgia, Idaho, Indiana, Kansas, Louisiana, Massachusetts, and Montana.

In only 3 states are the warnings rated as excellent: Connecticut, Maine, and Minnesota.

Links to the warnings for each state that I used in the analysis are provided below:


Alabama
Arizona
Arkansas
California
Connecticut
Colorado
Delaware
Florida
Georgia
Hawaii
Idaho
Illinois
Indiana
Iowa
Kansas
Kentucky
Louisiana
Maine
Maryland
Massachusetts
Michigan
Minnesota
Mississippi
Missouri
Montana