I am expecting the FDA to announce this afternoon that it plans to enforce a ban on the sale of all flavored e-cigarette pods and cartridges for closed vaping systems, with the exception of tobacco and menthol flavors, but that it is exempting e-liquids and vape juices sold for open systems. This means that the restriction will primarily affect the vaping products sold by convenience stores, but not all of the products sold by vape shops.The decision of the FDA not to ban all flavored e-cigarettes is a huge victory for public health. By allowing vape shops to continue selling flavored vape liquids, the FDA is preventing hundreds of thousands of ex-smokers from being forced to return to smoking. It also ensures that this important off-ramp from smoking remains available to adult smokers.However, the battle is not yet over because if the FDA implements the PMTA deadline in May of this year, it will wipe out most of the vaping industry, handing it over to the tobacco companies. The results would be devastating to the public’s health, as many ex-smokers would return to smoking and many more would turn to a new black market for these products.Hopefully, the FDA will re-think its overall approach to tobacco product regulation and announce a more sensible policy—one that regulates products based on their level of risk. Such a policy would remove the addictive nicotine from combustible cigarettes and restrict their sale to tobacco shops open only to adults. It would also directly regulate e-cigarette safety by issuing standards, including a maximum nicotine level for e-liquids that use nicotine salts, battery safety, and temperature regulation.This proposal is unlikely to curb the rise in underage vaping because teens who use JUUL can simply switch over to the menthol or tobacco flavors. Since the proposal does not restrict the nicotine level in these products—something I have been calling for since my Congressional testimony last fall—JUUL can continue to sell pods with more than 50 mg/mL of nicotine, a ridiculously high level that is contributing to youth addiction to this product.The FDA needs to stop focusing on the flavorings and for once, focus on the nicotine, which is the problem. The epidemic we have is not one of youth flavor use, but of youth addiction to the JUUL device, and that is occurring not because JUUL is flavored but because JUUL has more than 50 mg/mL of nicotine salts, compared to less than 25 mg/mL in most other products on the market, which use freebase nicotine rather than nicotine salts.All of the recent restrictions we have seen on the sale of flavored e-cigarettes are about politics rather than protecting the health of Americans. If policy makers were interested in protecting the health of Americans, the first thing they would do is to get the nicotine out of combustible cigarettes and restrict their sale to tobacco shops that are only open to adults. And the second thing they would do is limit the level of nicotine salts in electronic cigarettes, especially JUUL, because it’s the high levels of nicotine salts--not the flavors--that is causing the problem of youth addiction to vaping.All in all, the announced policy is a huge victory for the public’s health, compared to what would have happened had the FDA banned all flavored e-cigarettes. Now, attention must turn to the problem of the May 2020 PMTA deadline, which will decimate the vape shops, severely constrict the vaping market, and result in devastating health effects for hundreds of thousands of ex-smokers who will either be forced to return to smoking or forced to buy products from--ironically--a completely unregulated black market.Original author: Michael Siegel

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The American Academy of Family Physicians (AAFP) has released the results of a survey it commissioned to examine public attitudes regarding what CDC has incorrectly called the EVALI (e-cigarette, or vaping-associated lung illness) outbreak. The AAFP reports the results as follows:"In the online survey of 1,000 people aged 16 to 30 who vape, 93% of respondents said they were aware of the EVALI outbreak, and 65% said they were closely following news regarding the issue. More than 70% of respondents indicated they planned to be more careful about the products they buy and to reduce their use of vape products, and 86% were confident that they understood the health risks associated with vaping.""Survey results, however, showed a different reality regarding that understanding of risk. More than half of respondents said that only people who vape cannabis products were at risk of vaping-related illnesses and death. However, of 1,782 hospitalized patients with complete information in the CDC report, 20% reported not using cannabis products.""What's disturbing is that people aren't aware of their risks," Natasha Bhuyan, M.D., a family physician in Phoenix, told AAFP News. "They think that people are only at risk if they are using cannabis products or black-market products. They think, 'My apple-flavored vape juice is just fine.' But it could be just as dangerous as whatever else is out there."The Rest of the StoryWhat a depressing way to enter the holidays. The AAFP - the official national membership organization of the nation's family physicians - is upset because many people correctly link the EVALI outbreak with the use of THC vaping products! What this means is that the AAFP would rather that the public be misinformed about the cause of the EVALI outbreak. The AAFP would rather have people believe that e-cigarettes are causing the outbreak even though that is not true.This is deeply disturbing to me. It's also terribly scary. It basically means that the evidence-based practice of medicine is severely threatened. This is truly dangerous territory because what the AAFP is doing is allowing their pre-existing biases drive their clinical recommendations rather than the scientific evidence.As those who have followed the Rest of the Story well know, there is now nearly definitive evidence that the EVALI outbreak is caused by the inhalation of THC and CBD vaping products containing vitamin E acetate oil, which has been used as a thickening agent in some of these products and which is toxic to the lungs because it destroys surfactant, which is necessary to keep the alveoli open. It also may release a toxic chemical that causes direct lung injury, and the oil itself may impair the ability of the alveoli to function properly. In addition, the body's inflammatory response to the presence of this oil may further contribute to respiratory damage.There is absolutely no evidence that electronic cigarettes are playing a role in the outbreak. Vitamin E acetate oil is not used in any legal e-cigarettes. Moreover, if e-cigarettes were playing a role in the outbreak, we would not be seeing the drastic reduction in the number of cases that is occurring. After all, nothing has changed in the e-cigarette market, so why would the cases just disappear? Clearly, what is causing the outbreak to wane is the decreased production and distribution of vitamin E acetate oil-laden THC and CBD vape cartridges.The spokesperson for the AAFP is giving exactly the opposite advice of both the CDC and FDA. The CDC and FDA have explicitly warned people not to vape THC products, especially those purchased on the black market. The AAFP is directly refuting that, claiming that all e-cigarettes are involved in the outbreak and implying that people who use apple-flavored vape juice in their e-cigarettes are just as much at risk for respiratory failure as those who use black market THC vape carts like Dank Vapes, which alone is associated with 56% of the reported cases.Sadly, the AAFP has left the realm of evidence-based medicine. Compounding their irresponsible recommendations regarding the EVALI outbreak is the misinformation they are providing on their fact sheet about e-cigarettes, which contains two outright lies:First, the "fact" sheet informs the public that e-cigarettes are not safer than tobacco cigarettes. There is overwhelming evidence that although e-cigarettes are not safe in any absolute sense, they are certainly safer than smoking.Second, the "fact" sheet informs the public that e-cigarettes cannot be used to quit smoking. This completely ignores the fact that National Health Interview Survey data from 2018 revealed that more than 3 million adult smokers have quit smoking completely using e-cigarettes.The rest of the story is that the American Academy of Family Physicians has left the realm of evidence-based medicine and, at least with respect to e-cigarettes, is now being driven by ideology rather than science. We can only hope that the AAFP will take some time to reflect on this during the holidays and will return to an evidence-based approach in 2020.Original author: Michael Siegel

The CDC has released new data which almost definitively confirm that the respiratory disease outbreak was caused by vitamin E acetate oil in THC vaping products (and perhaps some CBD vaping products as well).I came to the same conclusion on August 25th, as did many experts from the cannabis industry who helped to inform my conclusion. Why it took the CDC four additional months of intensive investigation to discover something that cannabis industry experts had recognized much earlier is mystifying.Previously, CDC had tested lung fluids from 29 of the case patients. All 29 contained vitamin E acetate. This past Thursday, CDC reported the results of testing of 51 probable or confirmed case patients from 16 states. Vitamin E acetate was detected in 48 (94%) of the case patients.Importantly, the three cases in which vitamin E acetate was not detected were not confirmed cases, and each had other potential explanations for their illnesses. One had a multi-drug overdose, one had a fungal infection, and one may have had a bacterial lung infection.The most critical finding of the study was that 9 out of 11 patients who denied having used THC were found to have THC in their lung fluids.Overall, every single confirmed case patient (100%) had vitamin E acetate detected in their lung fluids.The investigators tested lung fluids from 99 healthy people, including 18 e-cigarette users, and none had vitamin E acetate detected. In addition, they did not find vitamin E acetate in any of the nicotine-containing e-liquids tested.The Rest of the StoryThese new data should pretty much put to rest the story that many state health departments and anti-nicotine groups have been telling for the past several months: that traditional e-cigarettes are causing severe lung injury and that getting these products off the market is necessary as an emergency response to the vaping-associated lung illness outbreak.On the contrary, the actions that would have been helpful in stemming the tide of this outbreak more quickly were: (1) explicitly warning the public about the dangers of vaping THC, especially black market products; and (2) taking steps to identify and dismantle the production and distribution channels that were disseminating the dangerous products.The federal agencies that appear to have done their job properly are the FDA and DEA, which have been investigating the distribution channels for black market THC vaping products and have closed down 44 web sites that were illegally selling THC vape carts. In contrast, CDC has done everything in its power to hide the truth from the public and to continually invoke electronic cigarettes as being involved in the outbreak. The very name that the CDC gave to the outbreak was a complete misnomer: "e-cigarette, or vaping-associated lung illness."While a few state health departments responded appropriately, most have been using the outbreak as an excuse to further demonize e-cigarettes, while downplaying the role of marijuana vaping and of black market THC vaping products. These actions have almost certainly resulted in more cases of the illness than would have occurred if these health agencies had simply told the public the truth and not allowed their bias against electronic cigarettes to have gotten in the way.Original author: Michael Siegel

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In response to an outbreak of multi-drug resistant Campylobacter infections associated with the purchase of puppies from pet stores, the Massachusetts Department of Public Health has issued a temporary, four-month ban on the sale of all animals by pet stores throughout the Commonwealth.The CDC concluded that the outbreak is being caused by puppies sold by pet stores based on the finding that 88% of the case patients reported contact with a puppy and 71% of these reported contact with a puppy from a pet store.The CDC conclusion is as follows: "Epidemiologic and laboratory evidence indicate that contact with puppies, especially those at pet stores, is the likely source of this outbreak."Nevertheless, the CDC has warned that: "No single strain of puppy has been identified that explains all cases of this outbreak. Therefore, the CDC recommends that anyone concerned about the illness avoid exposure to all animals." The CDC has termed the outbreak PAAGI - which stands for Puppy, or Animal-Associated Gastrointestinal Illness.Although the CDC has concluded that puppies purchased at pet stores are the likely cause of the illness, the Massachusetts Department of Public Health has issued an emergency order that immediately banned the sale or transfer of all animals. This includes the sale of all animals from Massachusetts pet stores as well as online sales of animals. In addition to not being able to sell animals, all pet stores had to clear their shelves of all inventory.Already, the ban has resulted in the closure of hundreds of pet stores in the state. Numerous store owners have explained that they spent tens of thousands of dollars on the inventory in their stores and having to clear this inventory and close their stores, even temporarily, is an economic impact that they simply cannot withstand. Some of the store owners had literally put their life savings into their small businesses, which has now all gone for naught.Asked why the state banned the sale of all animals, when the CDC concluded that the outbreak was linked to puppies, a spokesperson from the Massachusetts Department of Public Health stated: "Twelve percent of patients reported exclusively having contact with animals other than puppies. It was therefore necessary to ban the sale of all animals, not just puppies. Until we know the exact cause of the outbreak, people should refrain from contact with all animals." When asked why it was necessary to force hundreds of small businesses to shut down when the evidence clearly points to puppies alone as the cause of the illness, the spokesperson said: "The health of our children has to take precedence over economic interests."Several other states have followed the lead set by Massachusetts, except that instead of banning the sale of all animals, they have only banned the sale of cute animals. For example, a Montana official noted that: "Kids are attracted to animals because they are cute. Pet stores are clearly targeting youth by marketing cute animals. Cute animal ownership by youth has reached epidemic proportions and there is evidence that many youth have become addicted to their pets. It is now clear that owning a pet can cause severe illness or even death due to infection with multi-drug resistant bacteria."Health officials in Washington noted that "there is no such thing as a safe pet. Until the FDA has approved pets for sale, consumers should refrain from buying these animals."New York State declared a public health emergency because of the outbreak, but chose to ban only cute animals, not all animals. A Boston University animal researcher questioned this decision, saying that: "There is no evidence that this outbreak is only associated with the sale of cute animals. Thus, there is no public health justification for banning the sale of only cute animals. State health officials are simply taking advantage of this outbreak in order to get cute animals off the market."Early reports indicate that many families are now purchasing pets off the black market instead of at stores which are regulated. The animals sold on the black market are not tested for diseases, nor is it clear whether they have received the proper immunizations. As a result, families that buy pets off the black market are putting themselves at great risk. According to pet store owners in Washington State: "A new black market has emerged for cute pets. No one wants to purchase the non-cute breeds. We have lost 90% of our sales."In defending the ban, Washington health officials argued that anyone who wants a pet can simply switch over to a non-cute variety. A health department spokesperson stated: "We are not depriving people who want pets to have them. They can just switch over from the cute pets to the non-cute ones. Cute pets are only marketed to kids anyway. Adults who want pets should just buy the non-cute ones."A new study published earlier this week has linked the ownership of puppies to depression. The study found that people who experience sadness or depression are more likely to own a puppy. The investigators concluded that: "This is strong evidence that buying a puppy can lead to depression. Puppies have not been found by the FDA to be safe and effective."Critics of the study pointed out that it is very possible that people who are feeling sad or depressed buy a puppy specifically to cheer them up. Despite this possibility of reverse causation and a statement in the fine print of the paper stating that "Because of the cross-sectional nature of this study, causation cannot be proven," the investigators issued a press release with the headline: "New Study Demonstrates that Buying a Puppy Can Lead to Severe Depression." Although the FDA has had jurisdiction over the sale of animals for the past 10 years, the only regulations it has promulgated involve safety standards for puppies. Any store that wants to continue to sell puppies must submit a "Pre-Market Puppy Application," or PMPA, by May 2020 or it must take its puppies off the market. However, stores that sell pit bulls, boa constrictors, and alligators can continue to sell these more dangerous animals without submitting a single page of paperwork to the FDA.(Thanks to Michael S. Cox for the tip.)Original author: Michael Siegel

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Sometimes the most important evidence in a public health debate come from the most important informants: the people who are actually affected by public health policy and who know what is happening on the ground. This morning, WGBH reported that the Massachusetts e-cigarette ban is leading youth to substitute real cigarettes or illegal THC vapes for their flavored e-cigarettes.As the article reports: "Some students say the ban did little to stop use of e-cigarettes and they want to be part of the solution. Sullivan [a youth] says the temporary ban was actually harmful to students: “It’s forcing students to buy rip-off products, which are even worse for them, and can be laced.” She added that, with no flavored pods available for purchase, other students turned to combustible cigarettes, and even marijuana. “Even if it’s not safe, they'll still get their hands on it, just because they want to — or they need to, if they're addicted,” Sullivan said."The Rest of the StoryThis is one high school student who has a promising career in public health if she is interested. She demonstrates more wisdom than many policy makers who have taken on this issue. It is prescient of her to recognize that when you have a product that is under very high demand and particularly if it is addictive, banning it is not going to stop people from using it. But it is going to change the source of these products and the type of products they use. And in the case of banning flavored e-cigarettes, it is going to shift youth away from flavored nicotine e-liquids and towards either black market THC e-liquids or real cigarettes.While flavored e-cigarette bans may reduce use of these products among youth who only use e-cigarettes occasionally, it is unlikely to substantially reduce vaping among heavy e-cigarette users. However, it will likely create a shift towards more combustible cigarette consumption and more THC vaping, which is especially dangerous (and much more dangerous than e-cigarette use). After all, THC vaping is what has put more than 2,400 people in the hospital with respiratory failure and resulted in 52 deaths. E-cigarettes have not killed any youth or gotten them sick, although it has gotten many youth addicted.However, there are five key points to understand, related to the fact that among the youth who are heavy users of electronic cigarettes, the majority of them are also experimenting with real cigarettes and with THC vaping:1. Based on data from the 2018 National Youth Tobacco Survey, two-thirds (67%) of youth who are regular vapers (more than 19 days of use per month) have experimented with THC vaping. 2. Nearly half (48%) of youth who are regular vapers are current smokers. 3. Moreover, 76% of these youth have experimented with cigarette smoking.4. Among youth who are regular vapers, a whopping 88% have experimented with either THC or cigarettes. 5. Finally, among youth who are regular vapers, a whopping 93% have experimented with THC, cigarettes, cigars, cigarillos, or smokeless tobacco. What public policy makers who are supporting flavored e-cigarette bans apparently fail to realize is that the overwhelming majority of youth who are using e-cigarettes regularly are kids who are not only puffing on e-cigarettes, but also experimenting with more dangerous substances, including vaped marijuana and tobacco cigarettes.In this context, it is quite clear that the response to a ban on flavored e-cigarettes among these regular youth vapers is not going to be the total cessation of substance use. Instead, a flavor ban will merely shift what substance they experiment with and use. Most likely, these youth will simply shift toward greater use of THC vapes, real cigarettes, and other tobacco products.The great irony is that while many anti-tobacco groups claim that e-cigarettes have undermined decades of progress in reducing youth tobacco use, the reality is that bans on flavored e-cigarette use are what will actually undermine our progress in reducing youth tobacco use. And at the same time, they will result in more youth using black market products such as THC vape carts, putting them at a real risk of severe illness.Original author: Michael Siegel

A new study published in the American Journal of Preventive Medicine purports to show that the use of e-cigarettes causes long-term lung damage. The study found that adults who used e-cigarettes at baseline and had never been diagnosed with lung disease were more likely than non-vapers at baseline to be told that they have lung disease after three years of follow-up. The study controlled for whether or not a person reported smoking at baseline, but not for their lifetime history of cigarette consumption.Based on these findings, the authors concluded that: "Use of e-cigarettes is an independent risk factor for respiratory disease in addition to combustible tobacco smoking. Dual use, the most common use pattern, is riskier than using either product alone."National and international media headlines reported that e-cigarettes have now been recognized as causing long-term lung damage, including chronic lung disease (COPD).The Rest of the StoryThis study is deeply flawed because it fails to consider the most likely explanation for the study findings: that people who use e-cigarettes more likely have a history of more intense smoking than people who do not use e-cigarettes. For example, one study found that while only 21% of adult smokers who did not vape were heavy smokers, 68% of adult smokers who did vape were heavy smokers (or had been heavy smokers).This is critical because it shows that in order to control for smoking history properly in a study such as this one, you cannot merely control for whether or not someone was a current or ever smoker at baseline. You have to actually control for the person's overall smoking history including whether they were a heavy smoker and how many years they smoked.Importantly, this study did not control for a person's smoking history.Because smoking history is such a strong predictor of the development of chronic lung disease, the failure to control for smoking history invalidates the results of this study. In my view, it does not provide any evidence that e-cigarette use causes lung disease. What it does show, in contrast, is that smoking is a strong predictor of lung disease and that heavier intensity of smoking increases the risk.It is not even plausible that e-cigarette use could cause COPD within three years. Even with heavy smoking, it takes decades before a person develops COPD. If you walk into a respiratory intensive care unit, you're not going to find a lot of COPD patients in their 30s or even 40s. So if it takes at least three decades of smoking to develop COPD, how is a person supposed to develop COPD from e-cigarettes in only three years?The most telling aspect of the study is that it failed to report the risk of COPD associated with the use of e-cigarettes among people who never smoked. If e-cigarettes can cause lung disease within just three years, then one would expect to see many never smokers who started vaping to develop COPD within three years. This is simply not happening and this study doesn't even bother to test for it.Moreover, the study fails to examine the risk of COPD development among smokers who exclusively used e-cigarettes at baseline and those who continued to smoke. Such an analysis would show that switching to e-cigarettes actually reduces the risk of COPD among smokers. But if you don't test for such a relationship, you can't possibly find it. That's why you won't find these authors conducting any such analysis any time soon.Fortunately, numerous other studies have examined the risk of lung function and respiratory symptoms among smokers who switch to e-cigarettes compared to smokers who continue to smoke. These studies have reported dramatic improvements in lung function--both objectively and subjectively--among smokers who quit by switching completely to e-cigarettes.This evidence demonstrates that the truth is the opposite of what is being reported here. E-cigarette use is not a cause of chronic lung disease. On the contrary, it helps improve respiratory health among smokers who are able to quit completely using these products.Original author: Michael Siegel

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In court filings--both in state and federal court--the Massachusetts Department of Public Health strongly argued that allowing e-cigarettes to be sold in the Commonwealth, as it did by rescinding the emergency sales ban on December 11, will almost certainly lead to more cases of severe respiratory illness and possibly death.According to statements by both the governor and the Department of Public Health on December 11, the cause of the respiratory disease outbreak remains unknown and officials have not yet been able to pinpoint the specific source of the vaping-related illnesses. Therefore, according to the Department of Public Health's statement before a federal judge:"Until state and federal public health officials are able to pinpoint the specific source of the rapidly growing number of vaping-related illnesses, the continued sale of vaping products in Massachusetts will almost certainly lead to more cases of severe illness, and potentially deaths, among our residents. The Emergency Order is intended to prevent that tragic outcome." Well, DPH has now rescinded the emergency order and is allowing the continued sale of vaping products in Massachusetts. By its own argument, this will "almost certainly lead to more cases of severe illness, and potentially deaths, among Massachusetts residents." The Department of Public Health is no longer trying to prevent "that tragic outcome."Also in court filings, the state argued that until the cause of the outbreak is known, the reality is that people are becoming seriously ill and dying, which underscores the serious risks at stake at the current time:"vaping is at the center of public concern about serious illness, and event death, that has been linked to vaping. The linkage is, as yet, poorly understood and disputed. But the reality of people becoming seriously ill, and in some cases dying, after using certain vaping products, underscores the serious risks at stake while medical professionals unravel the mysteries."The state has made strong arguments that it is not just THC vape cartridges that are causing the outbreak, but also nicotine-containing products. According to Department of Public Health Court filings:"One person in Massachusetts—a woman in her 60s from Hampshire County who had vaped nicotine products—has died from the illness." "The Governor’s declaration determined that it is "necessary for DPH to take action immediately to address this public health emergency” of “severe lung disease associated with the use of vaping products.” Noting the explosion of reported cases nationwide and in Massachusetts, the declaration stressed that “the specific cause of this disease is unknown,” but that all cases “have a history of vaping and have indicated a history of using vaping products containing [THC], nicotine, or a combination of THC and nicotine.” "the data has shown that the majority of victims reported using nicotine and THC products; 13-17% of victims reported using only nicotine products; and 32-37% of victims reported using only THC products. The Emergency Order applies to nicotine and THC products because a significant percentage of victims used only nicotine products... ." "the most recent CDC data reflects that a significant percentage of affected patients vaped nicotine and THC products (41%) or nicotine products alone (16%), and it remains unknown how many cases of the illness are attributable to sales of vaping products in stores." [N.B. Updated CDC data show that 13% of affected patients reported vaping nicotine alone]Furthermore, the most recent data reported by DPH shows that 32% (nearly one-third) of confirmed and probable case patients in Massachusetts reported using nicotine only.The Department of Public Health has also admitted that by putting e-cigarettes back on the market, it is knowingly exposing the public to a product that it argued in court is no safer than traditional cigarettes and which it knows causes severe and potentially long-term health damage:"In line with that testimony, Dr. Raby emphasized that it “is simply untrue” to claim that e-cigarettes are “safer” than traditional cigarettes." The Department of Public Health is also admitting that preventing additional cases of vaping-related lung illnesses is apparently no longer paramount, since it acknowledged two months ago that:"the strong public interest in preventing additional vaping-related lung illnesses among Massachusetts residents, with attendant hospitalizations and potential deaths, is paramount.""numerous medical experts have recognized the severe and potentially long-term effects of vaping, although the full extent of the damage is yet to be known." DPH also acknowledges that its decision to return e-cigarettes to the market is against the public interest because medical and public health professionals have still not determined the cause of the illness:"the balance of equities and public interest weigh strongly in favor of keeping the Emergency Order in place while medical and public health professionals work to determine the cause of the illness." Importantly, the governor and DPH have made it clear that the outbreak is continuing, with more cases occurring weekly and that the cause of the outbreak remains unknown:"the underlying public health concerns associated with the use of vaping products and e-cigarettes and identified in my September 24, 2019 declaration remain...". "We don’t understand what is causing these illnesses. From a public health point of view, we cannot recommend that anybody use vaping or e-cigarette products at this time." "The cause of e-cigarette or vaping-associated lung injury (EVALI) remains unknown and under investigation at both the state and federal level. The Department of Public Health recommends that people not use e-cigarettes or vaping products." The Rest of the Story In summary, the state has argued the following points:Until the cause of the outbreak is known, it is imperative to ban the sale of all e-cigarettes in order to prevent more cases of severe and potentially fatal respiratory illness. Until it is known how many cases of the illness are due to vaping products sold in stores, failure to ban the sale of e-cigarettes will almost certainly lead to more cases of severe illness and possibly death, and the ban is necessary to protect the public's health. Until health officials are able to pinpoint the specific source of the vaping-related illnesses, it is necessary to prohibit the sale of electronic cigarettes to protect the public's health. As of December 11th, the cause of the outbreak was unknown. As of December 11th, the state did not know how many cases of the illness are due to vaping products sold in store. As of December 11th, the state is not able to pinpoint the specific source of the vaping-related illnesses. Synthesizing these six points, the state is acknowledging that by allowing electronic cigarettes to be introduced into the retail market on December 11th, there will almost certainly be more cases of severe illness and possibly death, that this action is putting the lives and health of Massachusetts residents at risk, and that the Department of Public Health is intentionally choosing not to continue a policy which it knows is necessary to protect the public's health.The rest of the story is that the state has acted irresponsibly, is knowingly putting residents at serious risk of health damage or even death, and they are content and comfortable doing so because the goal of banning flavored e-cigarettes has been achieved.Original author: Michael Siegel

In this post, I try to anticipate what Brexit means for the UK, for the Tobacco Products Directive and what that might mean for UK and European vapers. it’s in two parts because we need to speculate a little on how Brexit will play out and then how that will affect the TPD compliance in the UK as the TPD evolves from TPD2 to TPD3.

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by Carl V Phillips

The Massachusetts Department of Public Health (DPH), via a vote by the Public Health Council, has rescinded its emergency ban on the sale of electronic cigarettes which was issued on September 25. When the ban was implemented in September, the Department's rationale was that since we don't know what is causing the outbreak, there may be e-cigarettes that could be involved. Therefore, to protect the public's health, we need to ban the sale of e-cigarettes.In rescinding the emergency order, DPH stated that the cause of the outbreak remains unknown. So by its own rationale which it invoked on September 25, there could still be e-cigarettes causing the outbreak and therefore we need to continue to ban the sale of e-cigarettes to protect the public's health.By rescinding the ban, DPH is acknowledging that it wasn't actually necessary to ban the sale of electronic cigarettes back on September 25th because according to the Department, we still don't know what is causing the outbreak so we're in exactly the same position on December 11th as we were on September 25th. So how could banning electronic cigarettes be justified on September 25th but no longer appropriate on December 11th?What changed between September 25th and December 11th?What changed was that the Massachusetts legislature enacted a ban on flavored electronic cigarettes. However, this ban does not include tobacco-flavored e-cigarettes. There is absolutely no evidence to suggest that the e-cigarettes that may be associated with the outbreak are only the flavored varieties and not the tobacco-flavored ones. Therefore, allowing the continued sale of e-cigarettes, by the DPH's own rationale, is putting the lives of Massachusetts residents at risk.In other words, the Massachusetts Department of Public Health has chosen to knowingly put the public at risk of developing a potentially fatal respiratory illness that, even when not fatal, is often life-threatening and requires mechanical ventilation for several days.The Rest of the StoryI find this alarming. Frankly, it scares me to think that a state health department would knowingly put the public at risk of great harm from a potentially dangerous (and possibly fatal) product. Because the sale of electronic cigarettes was not allowed on December 10th, to suddenly allow the sale of e-cigarettes on December 11th is actively imposing a known risk upon the public. This is unethical by any standard. It is the last thing that any public health agency should do. It certainly violates the medical and public health code of ethical conduct: "to do not harm."The only way that DPH could justify rescinding the ban and knowingly exposing the public to a known health hazard would be if the Department had discovered the cause of the outbreak and therefore could determine that electronic cigarettes no longer posed a risk of respiratory illness. However, the Department has made it clear, through multiple public statements--made as recently as December 11th--that the cause of the outbreak remains "unknown."This has three important implications.1. The Department of Public Health Has Admitted that Its Emergency Order was Not Necessary to Protect the Public's Health The first implication of the rescinding of the emergency order is that it absolutely destroys the DPH's own justification for imposing the emergency ban on electronic cigarettes in the first place. By rescinding the emergency order on December 11th, the Department is acknowledging that the emergency order is not necessary. But if it is not necessary on December 11th - when DPH doesn't know the cause of the outbreak - then it was also not necessary on September 25th when DPH didn't know the cause of the outbreak. And if it was not necessary on September 25th, then DPH abused its power under chapter 17, section 2A of the Massachusetts General Laws because that section allows the Department of Public Health only to take actions that are "necessary" to protect the public's health.If it is not necessary to ban all e-cigarette sales on December 11th, then it was not necessary to ban all e-cigarette sales on September 25.In his letter declaring that the emergency is now over, the governor states very clearly that what he purported to be the emergency back on September 25th is actually not over. The letter states that: "the underlying public health concerns associated with the use of vaping products and e-cigarettes and identified in my September 24, 2019 declaration remain...".So the governor is admitting that the public health concern that led to his declaration of an emergency still remains! But he then goes on to declare that because the legislature has enacted a flavor ban, the need for addressing these concerns has "abated." Since the flavor ban does not prohibit the sale of either tobacco-flavored electronic cigarettes or flavored e-cigarettes, which can still be sold in smoking bars, the governor is admitting that the respiratory disease outbreak was not the emergency in the first place. Instead, the governor is admitting that the emergency justifying the original order was the problem of youth vaping, since that's what the new law addresses, not the disease outbreak.But here's the nail in the coffin of the Department's justification: DPH has already testified in Superior Court that the problem of youth vaping, while serious, is not an emergency.So if the respiratory outbreak is not an emergency and the problem of youth vaping is not an emergency, then what was the emergency? By the governor's and DPH's own admission, there was no emergency. And therefore, there was no justification for its September 24th declaration of an emergency and its order that banned the sale of electronic cigarettes throughout the Commonwealth.This confirms that what really occurred in Massachusetts is that the state used the respiratory disease outbreak as an excuse to impose a flavor ban. Once the flavor ban was imposed, the emergency no longer existed and the ban on e-cigarettes sales could be rescinded. Obviously, this had nothing to do with the respiratory disease outbreak because that outbreak is still occurring and both the governor and DPH admit that the public health concerns that justified the emergency declaration on September 24th still exist.Thus, what the governor and DPH are now admitting is that the emergency order was essentially a political move, not a public health necessity. The goal was to ban flavored e-cigarettes, not to protect the public from an outbreak of severe, acute respiratory failure.2. The Department of Public Health Has Unnecessarily Put Hundreds of Massachusetts Residents Out of Work and Destroyed their LivelihoodsAs anyone who has heard me testify against Big Tobacco knows, I believe that we sometimes must be willing to put people out of business if it is absolutely necessary to protect the public's health. Health must come before business. However, only if it is absolutely necessary. What the state is now admitting is that it was completely unnecessary to put hundreds of small businesses out of business. It was unnecessary to destroy the livelihoods of so many people. It was unnecessary to force many ex-smokers to return to smoking. It was unnecessary to force many vapers to turn to the black market to obtain their products to keep them smoke-free. It was unnecessary for the state to force hundreds of business owners to sustain losses of tens of thousands of dollars by requiring them to destroy their entire inventories of vaping liquids.3. The Department of Public Health is Apparently Willing to Knowingly Put People's Lives at Risk to Achieve a Legislative GoalBy its own admission, the Department of Public Health is putting the lives of the public at risk. They rescinded the ban on electronic cigarette sales when the governor and DPH have both acknowledged that the public health concerns regarding the outbreak of potentially fatal respiratory disease still remain. The state has also admitted that the cause of the outbreak remains unknown and that electronic cigarettes may be causing a substantial proportion of the cases. In its latest update, DPH reports that 32% of the cases in the state used only nicotine-containing products. In this light, how could DPH possibly allow the introduction of the sale of electronic cigarettes in the Commonwealth? How can they justify knowingly putting the lives of Massachusetts residents at risk?It is scary to me to think that a state health department would be willing to knowingly risk the lives of the state's residents in order to advance a legislative goal. No matter how important that legislative goal may be, it does not justify putting people's lives at risk. While my opinion is that the legislation is actually going to cause substantial public health harm, even if we stipulate that this legislation is necessary to protect the health of youth in the state, it still does not justify the Department of Public Health knowingly putting those very lives at risk of severe health damage, or even death.Original author: Michael Siegel

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Yesterday, the Massachusetts Department of Public Health (DPH) proclaimed to residents of the Commonwealth that it has no idea what is causing the outbreak of respiratory illness that has affected more than 2,000 people and killed 47 throughout the country.The proclamation came on a day when the Public Health Council voted to rescind the emergency order that banned the sale of all e-cigarettes in the state.According to an article in Boston Magazine, the Department of Public Health told reporters: "We don’t understand what is causing these illnesses. From a public health point of view, we cannot recommend that anybody use vaping or e-cigarette products at this time."In a press release issued by DPH yesterday, it stated: "The cause of e-cigarette or vaping-associated lung injury (EVALI) remains unknown and under investigation at both the state and federal level. The Department of Public Health recommends that people not use e-cigarettes or vaping products."The Rest of the StoryThis is the height of irresponsibility. Many people - especially youth and young adults - continue to develop life-threatening respiratory failure, primarily from the consumption of black market THC products that contain vitamin E acetate oil as a thickening agent, yet the Massachusetts Department of Public Health claims that it has no idea what is causing these illnesses.Both the CDC and the FDA have concluded that vaping THC products that contain vitamin E acetate oil is causing the bulk of cases of the outbreak, yet DPH is telling Massachusetts residents that the cause remains unknown.The CDC found that 100% of case patients whose lung fluids were tested revealed the presence of vitamin E acetate, yet the Department of Public Health claims that we have no idea what is going on -- it remains entirely a mystery what is causing this outbreak.Who, or what, is the Massachusetts Department of Public Health trying to protect? The black market marijuana industry? It is certainly not protecting the public health. On the contrary, it is putting the health of residents of the Commonwealth, especially young people, at great risk. After all, the public needs to understand that black market THC vape carts are--at the very least--playing a major role in the outbreak and must absolutely be avoided. Telling the public to avoid all e-cigarette, or vaping products is so vague a warning that it is essentially meaningless. Kids need to know that they absolutely should not be vaping THC vape carts. They need to be explicitly told that use of THC vape carts could be life-threatening.Even if there is a chance that some small proportion of the cases are being caused by something else, there is no justification for hiding from the public the fact that the majority of cases are being cause by THC vape cartridges. There is no justification for hiding from the public the fact that vitamin E acetate oil, a thickening agent that is a viscous oil, has been identified in the lungs of every outbreak patient tested so far.Ironically, the absolute height of irresponsibility was the Department of Public Health's decision - adopted by the Public Health Council - to rescind the emergency ban on the sale of e-cigarettes. Let me explain exactly what I mean because as readers know, I opposed the emergency order in the first place as it pertains to the sale of e-cigarettes at retail stores.I do not believe that there is any evidence that e-cigarettes are causing the outbreak. However, based on the Department of Public Health's statement that the cause of the outbreak remains unknown, how can it possibly rescind the emergency order? How can it possibly allow the sale of e-cigarettes in the Commonwealth if it does not know what is causing the outbreak?The entire justification for the emergency ban on e-cigarettes in the first place was that since DPH doesn't know the cause, it has to err on the side of caution and ban the sale of all e-cigarettes. Now, without having identified the cause, the DPH is suddenly throwing caution to the wind and allowing the sale of e-cigarettes. I can't think of anything more irresponsible than knowingly putting the public at risk.My point is not that the public is actually being put at risk because there is not one iota of solid evidence that e-cigarettes are contributing to the outbreak. My point is that based on the position of DPH - that the cause of the outbreak is unknown - they are knowingly putting the health of the public at risk by allowing the sale of e-cigarettes.In this context, the flavor issue is moot. There is certainly no evidence that the flavorings are what is causing the outbreak. Based on the DPH's justification for its ban on e-cigarette sales, there is no rational basis for it now to rescind that emergency order and allow the sale of any e-cigarettes, whether flavored or not.The rest of the story is that the premature cancellation of the e-cigarette sales ban demonstrates that what is really going on in Massachusetts is that the Department of Public Health apparently has used the respiratory disease outbreak to push through its desired agenda of banning the sale of flavored e-cigarettes. By conflating the respiratory disease outbreak with the general problem of youth vaping, the Department has successfully fooled both the public and policy makers into believing that e-cigarettes are causing youth to suffer severe respiratory failure. And that hysteria is what convinced the legislature to enact the ban on flavored e-cigarettes.It is scary to think that the Department of Public Health, which is entrusted with protecting the public health, would knowingly put the health and lives of residents of the Commonwealth at risk. But that is exactly what they are essentially doing by rescinding the emergency order. If the emergency order was justified on September 25 because we didn't know the cause of the outbreak, then the order is certainly still justified on December 11, when--according to DPH--we still don't know the cause of the outbreak.That DPH and the Public Health Council are willing to knowingly put lives at risk to advance a legislative agenda should give all of us pause.Original author: Michael Siegel

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Despite an outbreak of vegetable-associated Salmonella poisoning linked to products sold at Massachusetts restaurants that has affected 90 Massachusetts residents and resulted in three deaths, the Massachusetts Department of Public Health is refusing to release any information on the restaurants at which the patients ate or the exact products they consumed. The Department has revealed only that the outbreak is associated with "vegetable products" and that some of the patients reported having eaten vegetables at restaurants in the Commonwealth.The Department of Public Health is not even telling the restaurant owners themselves that their products may have been implicated in the outbreak. There have been 90 confirmed and probable cases of Salmonella poisoning. According to DPH, the only thing that links all the cases is that they all reported eating vegetables. However, DPH has not released information on how many of the patients reported eating vegetables at restaurants and how many purchased their vegetables off the unregulated black market, such as the many "farmers' markets" that are held weekly in cities across the Commonwealth.In response to the outbreak, the Department of Public Health issued emergency regulations that shut down all restaurants in Massachusetts for three months until the source of the outbreak could be identified. Of the 16 confirmed cases in which the patients were interviewed to determine what products they consumed, 14 of the 16 reported having purchased Romaine lettuce at farmers' markets. Only two of the patients denied having purchased vegetables from farmers' markets, although published studies have shown that patients in Massachusetts are reluctant to report that they frequent illicit farmers' markets because of the social stigma associated with that behavior.A recent study released by CDC found that 100% of the patients whose stool samples were tested were found to have consumed a strain of Romaine lettuce that is not sold at restaurants, but only at farmer's markets and black market produce stands. Nevertheless, it is possible that one or two restaurant chains may have cut corners and purchased this contaminated strain of Romaine lettuce from shady farmers. The Department of Public Health, however, will not release to the public any information on what restaurant chains were reported as having been frequented by case patients who denied buying from farmers' markets.Of the 16 confirmed cases, none were associated with the purchase of vegetables from restaurants. However, there are six probable cases who admitted to having purchased vegetables from restaurants; DPH has refused to release information on what restaurants those vegetables were purchased from or what the specific vegetables were.At a hearing last week, the Massachusetts Lettuce Commission, which is in charge of ensuring the safety of the lettuce supply at restaurants in the Commonwealth, complained about the lack of information being shared with it by DPH. Several commissioners told a DPH staff panel that the Department refused to provide them with any information on what vegetable products were reported being purchased at restaurants in the state and at which restaurants they were purchased.Fortunately, the Massachusetts Lettuce Commission was finally able to get DPH to enter into an agreement to release limited data on the vegetable products reported by case patients. However, the data will be released only to one person - the executive director of the Commission - and he will have to enter into a non-disclosure agreement, certifying that he will not share the information and under no circumstances will release it publicly, even if it becomes clear that a specific product at a specific restaurant is contaminated. In addition, the executive director of the Commission had to put up as collateral his David Ortiz, Bobby Orr, Tom Brady, and John Havlicek jerseys.Notably, DPH was not being asked to release any personally identifiable information or any information protected by patient confidentiality laws. The only data being sought was aggregated, de-identified product information, not linked to any particular patients but aggregated over the population of case patients.One piece of critical information that DPH refused to release was whether or not the six patients who reported consuming vegetables at restaurants had also eaten vegetables bought off the street. There is a suggestion that at least one of the patients who ate at a restaurant also ate vegetables that they purchased from an unnamed, makeshift corner farm stand, and it is possible that all six of the patients who reported having eaten vegetables at a restaurant also purchased from makeshift farm stands. Without that information, the Lettuce Commission is hard-pressed to figure out whether any of the products it regulates are involved and if so, where they are coming from and what specific lettuce strains are potentially contaminated.In what appears to be a possible step forward, DPH has posted the first information it shared in months on some of the products reported being consumed by case patients. Here are some of the data:First, although there were a total of 49 case patients interviewed, only 16 of these were confirmed cases and the other 33 were probably cases. Looking just at the confirmed cases, 14 of the 16 admitted to having eaten Romaine lettuce that was purchased at black market farm stands. There were only two patients who reported only eating vegetables from restaurants, but they purchased a non-lettuce product that is not regulated by the Commission. So none of the confirmed cases reported having purchased a lettuce product from a Massachusetts restaurant.Second, there were six of the probable cases who reported having consumed Romaine lettuce from a Massachusetts restaurant.Third, some of the products that were reported by patients included:Dank RomaineDr. BLTSweet LeafTossed SaladNaked SaladWettuceDespite the CDC's finding that a specific, contaminated strain of Romaine lettuce was detected in samples of 29 out of 29 case patients, the most recent communication from the DPH reports that the cause of the outbreak is "unknown." All that DPH is telling the public is that it is "vegetable-associated."Moreover, the product summary information sheet for providers states that the cause of the outbreak has not been determined. This despite the fact that both the FDA and CDC have concluded that contaminated black market Romaine lettuce is the predominant, if not only, cause of the outbreak. Due to an order by the Massachusetts Superior Court, all restaurants in Massachusetts will be allowed to re-open this Wednesday. However, on the same day, the Department of Public Health is expected to release regulations that will ban the sale of flavored Romaine lettuce as of next July. This is not expected to affected large chain restaurants because they sell a plethora of products. However, it is expected to put the state's specialized lettuce shops completely out of business.The Rest of the StoryCORRECTION: I apologize but I got the story slightly wrong. The numbers are all correct; however, the outbreak is not Salmonella poisoning but acute respiratory failure and the implicated product is not vegetables but e-cigarettes, or vaping products. The contaminant identified in 29 of 29 samples tested by CDC is vitamin E acetate oil, which is a thickening agent that is used only in black market THC vape cartridges and perhaps some shoddy CBD oil cartridges, as well as possibly a small number of legal THC vape cartridges sold by dispensaries, although it is not clear if any Massachusetts products are involved.It is inexplicable why the Massachusetts Department of Public Health has been so secretive about the products being used by outbreak cases, especially the confirmed cases. Not only does the Massachusetts Cannabis Commission need this information to determine whether any regulated THC vape products are involved, but the public needs this information to be able to make informed decisions about what products to avoid.For example, the fact that 14 of the 16 confirmed outbreak cases who provided information on the products used reported having vaped black market THC cartridges is game-changing. These data point strongly towards the recognized vitamin E acetate oil adulteration of black market THC vape cartridges as being the predominant, if not only, cause of the outbreak. This information is hidden on the web site, and not reported in summaries of the data that DPH is providing, which combine probable and confirmed cases, which is problematic because many probable cases will turn out not to be actual confirmed cases.This information casts serious doubt on the rationale behind the emergency order which closed down the state's vape shops, leading large numbers of former smokers to return to smoking. It also makes it inexcusable that the Department of Public Health is continuing to tell the public that it has no idea what is causing the outbreak and that DPH is doing absolutely nothing to try to curtail the outbreak by: (1) telling the public explicitly that black market THC vape cartridges should be avoided; and (2) identifying and shutting down the sources of black market THC vape carts being sold in the Commonwealth.The entire point of an outbreak investigation is to identify the cause of the outbreak so that this information can be communicated to the public in order to avoid further cases. Despite having shut down hundreds of small businesses, some permanently, DPH has done literally nothing to actually curtail the outbreak. If anything, its actions have resulted in more cases than would have occurred if DPH had shared, honestly, the information that it did have available rather than hide the truth from the public.In fact, it kind of has the appearance that the reason why DPH has been hiding this information is that it doesn't support its apparently pre-ordained conclusion that traditional e-cigarettes are causing respiratory disease.It is unconscionable that in order to obtain critical data to help ensure the safety of the THC vape product supply, the Massachusetts Cannabis Commission has to enter into a non-disclosure agreement with DPH.Original author: Michael Siegel

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