Tuesday, July 28, 2015

Data from 2014 UK Youth Survey Show No Nonsmoking Youths Becoming Regular E-Cigarette Users

Newly released data from the Smoking, Drinking and Drug Use among Young People in England - 2014 survey show that although 22% of youth ages 11-15 have experimented with electronic cigarettes, only 3% are now regular vapers and none of these regular vapers are never smokers. In the survey, regular vaping was defined as using an e-cigarette at least once per week.

The Rest of the Story

While one cannot extrapolate from these data to the situation in the U.S., they do demonstrate that at least in England, e-cigarettes are not particularly addictive and they are not serving as a gateway to smoking among youth. Despite the high rate of e-cigarette experimentation, only a small proportion of these youth experimenters are going on to become regular vapers. And of these regular vapers, none are kids who never smoked cigarettes. Thus, there is little, if any, evidence that e-cigarette experimentation among youth in England is causing public health harm. If anything, e-cigarettes may be deterring some youth from continued smoking.

This hypothesis is further supported by the finding that youth smoking in England dropped to its lowest level since the survey began in 1982, despite the dramatic increase in e-cigarette experimentation in recent years.

Despite the definitive statements of CDC and other anti-smoking groups and advocates about e-cigarettes being a gateway to youth smoking, there remains no evidence to support that contention and a growing body of evidence refutes it.

Monday, July 27, 2015

American Chemical Society Grossly Misrepresents Scientific Study in Order to Demonize E-Cigarettes

The American Chemical Society (ACS) became yet the next organization to work a hatchet job on electronic cigarettes. This time, it was the ACS claiming publicly that based on a new study, e-cigarettes may be as addictive as traditional ones.

Last Wednesday, the ACS issued a press release to accompany the publication of a new article in its journal "Chemical Research in Toxicology." The press release headline warned that "E-cigarettes May Be As Addictive as Traditional Ones."

Responding to this press release, media outlets throughout the world published articles touting the extreme addictive dangers of e-cigarettes. For example, The Daily Mail article headline warned that "E-cigarettes are just as addictive as the real thing." The first sentence of the article read: "E-cigarettes are just as addictive as the real thing, researchers have found." The article goes on to cite the new study published in Chemical Research in Toxicology.

The Rest of the Story

After reading the press release and these articles and headlines, I fully expected to find in the actual study a comparison of the addictiveness of e-cigarettes and cigarettes. But the study did nothing of the sort. In fact, there was absolutely no study of cigarettes at all, and there was no comparison of nicotine levels produced from e-cigarettes compared to regular cigarettes.

In fact, all the study did was to demonstrate a new method for determining the fraction of nicotine in e-liquids and aerosols that is present in the free-base, rather than the protonated form. And it then used that method on several e-liquids and reported that most of the nicotine in these liquids and their aerosols was in the free-base form. This is important because the free-base form is the only form that is readily absorbed into the body.

That's it! That's all the study did. It did not make any comparisons with regular cigarettes. And most importantly, it did not compare the blood nicotine profile over time with e-cigarettes to that with tobacco cigarettes. So there is no way from this study that one can draw any conclusions about the relative addictiveness of e-cigarettes and regular cigarettes.

The truth is that multiple studies have compared the profile of blood nicotine levels over time between vaping and smoking. The result, unequivocally, has been that nicotine delivery is much more efficient with real cigarettes. Most important, real cigarettes, but not most e-cigarettes, deliver nicotine in such a fashion as to create a huge nicotine spike, resulting in what users experience as a "nicotine hit." E-cigarettes generally do not produce such an effect. Thus, the scientific evidence clearly shows that e-cigarettes are not nearly as addictive as tobacco cigarettes.

So how can the American Chemical Society conclude that based on this new study, e-cigarettes are just as addictive as tobacco cigarettes? The answer is: they can't. In other words, they are literally just making it up! And even worse, because the claim is not true, they are disseminating a blatant lie to the public.

This is how low the tactics of e-cigarette opponents have fallen. They now just make it up. They literally make up evidence to support their pre-determined conclusion that e-cigarettes are every bit as terrible as regular cigarettes. In the process, they lie.

I have long since realized that the reason for their need to make things up and tell lies to the public is that they just don't have any solid evidence to rely upon to support their anti-e-cigarette positions. All of the actual scientific evidence at present points to the tremendous benefits of e-cigarettes with only minimal harms. That's not convenient for advocates who have determined in advance to oppose e-cigarettes. So they have to start making things up and telling lies.

Today's is just another example in a long string of similar stories. But now you know the rest of the story behind these hysterical headlines about the extreme health risks of e-cigarettes.

Wednesday, July 22, 2015

Australian Therapeutic Goods Administration Acknowledges that Chantix Causes Suicide But Allows it On Market, While Banning E-Cigarettes with No Known Adverse Effects

The Therapeutic Goods Administration (TGA) in Australia has publicly acknowledged that Chantix causes suicide, and that the family members of patients taking this drug must carefully watch their loved ones to make sure that they don't kill themselves. Nevertheless, the TGA apparently has no problem allowing Chantix to stay on the market. Moreover, the Administration has not even required that a black box warning be placed on the drug's packaging.

At the same time, the TGA has banned electronic cigarettes, another effective smoking cessation tool, despite the absence of any evidence that it causes substantial adverse side effects.

According to an article on the web site of ABC News Australia: "The FDA in the US first implemented its so-called "black box" warning on Champix packets in 2009, and recently strengthened it, after a huge class action involving 3,000 litigants was settled by pharmaceutical manufacturer Pfizer. But Australia's Therapeutic Goods Administration (TGA) does not require a "black box" warning and Champix currently does not contain consumer medical information inside the box either. "We've been very concerned about the drug because it has so many more adverse reactions that have been reported than pretty much any other drug," Dr Zuckerman said."

"But the response to Champix in Australia by health professionals and the TGA has been markedly different. "The TGA continually reviews the adverse events and we believe that Champix PMI and CMI contains the appropriate information to assist in its safe and effective use," a TGA spokeswoman said. "This includes appropriate warnings on neuropsychiatric-adverse events, such as self-harm and suicidal tendencies. People taking this medicine [and their family or carer] need to pay special attention to your mood, behaviour and thinking while you are taking Champix." Champix was first introduced to the Australian market in 2007 and by 2010, 900,000 prescriptions had been filled. In that time, the TGA had more than 200 reports of suicide-related events for Champix patients."

The Rest of the Story

This is perhaps the most absurd policy rationale I have ever heard. We have a smoking cessation product that is so dangerous that it can cause suicide, so alarming that we need to warn the families of patients taking the drug to watch their loved ones carefully to be sure that they don't kill themselves, yet we don't take it off the market. On the other hand, we have another smoking cessation product with no evidence of any significant clinical harms, yet we ban that product because of uncertainty over the possibility of potential adverse effects if people were to vape regularly for 20 or 30 years.

I am not necessarily arguing that Chantix should be taken off the market. The risks need to be weighed against the benefits. However, if it is justified for Chantix to remain on the market despite its known association with suicide, then it makes absolutely no sense to take electronic cigarettes off the market, despite the lack of any evidence that it causes significant adverse side effects.

Why does the TGA even need to wait for studies to see if e-cigarettes have serious side effects? The Administration has already admitted that Chantix has life-threatening side effects but allowed that drug to stay on the market without even a black box warning. Does this mean that the TGA will finally approve electronic cigarettes once they are shown to have a serious side effect, like possible sudden death? Apparently, unknown risks are of far greater concern to the Administration than known risks.

I find it rather comical (but really, sad) that the TGA believes that it is appropriate to allow a drug that it thinks causes suicide on the market, as long as you warn family members to look out for suicide attempts.

But the worst part of this story is the argument by Professor Renee Bittoun for why a black box warning should not be included on the Chantix labeling. According to the article: "Respiratory physiologist Renee Bittoun started one of the world's first "quit smoking" clinics in Sydney. "The risk you take by putting a big warning on [Champix] is that people will not take it and smokers die from it. From smoking," Associate Professor Bittoun said."

This is not a good justification for failing to require a black box warning. The fact that a black box warning might scare people away from taking a drug is no reason to not require such a warning if it is otherwise justified. After all, one could make the same argument about any drug, and so this argument is tantamount to saying that no black box warning should ever be placed on a drug because it would discourage many people from using the drug. So it's actually quite scary reasoning. The only reason to not require a black box warning is if the warning is not justified based on the scientific studies of the side effects of the drug.

The rest of the story is that Australia's TGA is taking a completely nonsensical approach to the regulation of smoking cessation products. Apparently, they would rather that smokers use products with known, serious risks than products that are probably quite safe, but whose risks are not definitively characterized. Unknown risks can't be tolerated, but serious, life-threatening risks are fine, as long as they are known.

Tuesday, July 21, 2015

Tobacco Control Journal Makes Fun of Vapers, Calling them Idiots

A cartoon appearing in this month's issue of Tobacco Control makes fun of vapers, calling them "idiots." The cartoon features a man vaping and a woman next to him. The man says: "With vaping, I get all the nicotine, none of the smoke and it makes me look cool." The woman responds: "You look like an idiot smoking a laser pointer."

The Rest of the Story

Why is Tobacco Control making fun of vapers and calling them idiots?

Imagine that the journal ran a similar cartoon about nicotine patch users. In it, the man says: With NRT, I get all the nicotine and none of the smoke." And the woman responds: "You look like an idiot putting a cream patch on your chest."

I think most readers could appreciate that a cartoon which makes fun of smokers who are using a nicotine patch to try to quit smoking, improve their health, and save their lives so that they are around longer to enjoy life and time with their families would be quite insensitive and inappropriate, especially coming from a journal that is supposed to be promoting health.

But there is no qualitative difference between such an NRT cartoon and the e-cigarette cartoon that is featured in the July issue of Tobacco Control. Both are making out smokers who are using various forms of nicotine to try to quit as looking like (and being) idiots.

Sadly, this is an accurate reflection of how so many tobacco control groups and advocates see vapers. While the nicotine patch is an acceptable way to quit smoking, the e-cigarette is not. Why? For one reason: it looks like smoking. And smoking is idiotic. And people who smoke are therefore idiots. Apparently, smokers who sincerely try to quit smoking using e-cigarettes are even worse idiots because they aren't even really smoking.

While that logic might sound stupid, it is precisely the thinking that characterizes the bulk of the "anti-smoking" movement today. That Tobacco Control saw fit to publish this cartoon demonstrates that they apparently see things in this way.

Now I recognize that a journal is not necessarily promoting the opinions expressed in a work that it publishes. For example, if a journal publishes an article which presents data suggesting that smoking in cars should be banned, the journal is not necessarily taking that position and promoting it. The journal is simply publishing an article that offers such a view. However, this is different because it is not a research article. The journal's purpose is not to provide cartoons. It made a deliberate choice to include this cartoon.

I also recognize that humor should be given a little more leeway than a scholarly piece. We all need to have a sense of humor in our work. However, dying from smoking is not a laughing matter. Neither is being addicted to cigarette smoking and being unable to quit. Nor is being fearful of dying prematurely because of an addiction that you cannot easily overcome. When smokers try to quit by switching to e-cigarettes, it is a very serious matter. It's about their health and their lives. I don't find it something to joke about. Nor do I think it is appropriate to call those people idiots because they are forced to go to such extremes to try to break the smoking addiction.

Should we call heroin addicts who try to overcome their addiction by switching to methadone idiots because they have to pop opiate pills everyday?

On the contrary, these are people who should be praised for taking control of their health and their lives and making a wise decision to switch from the most toxic form of nicotine to a much safer alternative form of nicotine. Vapers should be congratulated, not made fun of and called idiots. Does the journal prefer that these people continue smoking so as not to make fools of themselves?

It continues to baffle me why the tobacco control movement views vaping and vapers with such venomous disdain. If we had the same disdain for smokers who slop on patches or use nicotine inhalers or chewing gum, we would be writing ourselves out of the public health field. I'm afraid that's exactly what we're doing with our attitude about e-cigarettes and the people who are using these devices to try to improve their health and save their lives.

Monday, July 20, 2015

California State Senator is Fooling the Public About Hazards of Smoking Just Like the Tobacco Industry Used to Do Decades Ago

A California state Senator has accused the tobacco industry of fooling the public by asserting that electronic cigarettes are less harmful than tobacco cigarettes.

According to an article in the Daily Caller, state Senator Mark Leno stated:

"Decades ago, the tobacco industry tried to fool us into believing that filtered cigarettes were a healthier alternative to traditional cigarettes, and now they’re making the same claims about e-cigarettes."

The Rest of the Story

The only problem with this accusation is that it is not true. The tobacco industry is not fooling the public by suggesting that e-cigarettes are safer than tobacco cigarettes. Far from it. The tobacco industry is telling the truth. And so is the e-cigarette industry. Electronic cigarettes are far safer than tobacco cigarettes. There is simply no comparison. Smoking kills more than 400,000 Americans each year, while vaping is not known to have caused any deaths. In fact, unlike smoking, vaping appears to have no major acute risks.

The rest of the story is that it is actually Senator Leno who is trying to fool the public. He is trying to fool the public into believing that electronic cigarettes are no safer than the real ones. But that is equivalent to telling the public that smoking is no more hazardous than vaping.

Not only is Senator Leno lying to the public, but he is causing public health damage. First, he is undermining the public's appreciation of the hazards of smoking by telling us that smoking is only as hazardous as vaping. This truly minimizes the risks of smoking since electronic cigarettes do not contain any tobacco, do not involve combustion, and only expose users to a small number of chemicals of concern, most at very low levels.

Second, his statements are doing actual public health damage. By equating the health hazards of vaping with those of smoking, he is almost certainly discouraging many smokers from quitting (via e-cigarettes) and encouraging many former smokers (who quit via e-cigarettes) to return to smoking.

Before attacking the tobacco industry for lying about electronic cigarettes, Senator Leno should look in the mirror and check his facts. He would find that he is the one who is lying, trying to fool the public, falsely and irresponsibly minimizing the health hazards of smoking, and causing substantial public health damage by discouraging smoking cessation and encouraging many former smokers to return to smoking. 

Thursday, July 16, 2015

Study on Potential Toxicity of E-Cigarette Flavorings Produces Unwarranted Scare

A study published in the journal Tobacco Control this past April has produced an unwarranted scare about the potential toxicity of the flavorings in electronic cigarettes.

(See: Tierney PA, et al. Flavour chemicals in electronic cigarette fluids. Tobacco Control. Published online ahead of print on April 15, 2015. DOI: 0.1136/tobaccocontrol-2014-052175.)

The study used gas chromatography/mass spectrometry to analyze the chemical constituents in e-liquids of various flavors. It appears that 30 different e-liquid flavors were tested. Multiple flavors of two brands of disposable e-cigarettes (Blu and NJOY) were tested along with a convenience sample of e-liquids obtained from vape shops.

The results were reported as follows: "In many liquids, total flavour chemicals were found to be in the∼1–4% range (10–40 mg/mL); labelled levels of nicotine were in the range of 0.6–2.4% (6 to 24 mg/mL). A significant number of the flavour chemicals were aldehydes, a compound class recognised as 'primary irritants’ of mucosal tissue of the respiratory tract. Many of the products contained the same flavour chemicals: vanillin and/or ethyl vanillin was found in 17 of the liquids as one of the top three flavour chemicals, and/or at ≥ 0.5 mg/mL."

The study concludes as follows: "The concentrations of some flavour chemicals in e-cigarette fluids are sufficiently high for inhalation exposure by vaping to be of toxicological concern. Regulatory limits should be contemplated for levels of some of the more worrisome chemicals as well as for total flavour chemical levels. Ingredient labeling should also be required."

The reporting of the results of this study in the media has resulted in a health scare about the potential dangers of electronic cigarettes, with some policy makers calling for a complete ban on e-cigarette flavorings.

The Rest of the Story

Here are the chemicals that were found in the e-cigarettes:

Benzalkonium chloride: may cause rapid onset bronchoconstriction

Oleic acid: may cause respiratory irritation

Chlorofluorocarbons: destroys the ozone layer

Soya lecithin: may cause respiratory irritation

Sorbitan trioleate: may cause respiratory irritation

Sulfites: may cause life-threatening respiratory reactions

Methylparaben: possible link to breast cancer at high concentrations

Propylparaben: possible link to breast cancer at high concentrations

SORRY - that was a mistake. The above is NOT a list of the inactive chemical ingredients in e-liquids. It is a list of the inactive ingredients that have been detected in pharmaceutical inhalers, approved by the FDA.

Let's try again. Here are the chemicals that were found in the e-cigarettes:

Acetanisole, · Acetic Acid, · Acetoin, · Acetophenone, · 6-Acetoxydihydrotheaspirane, · 2-Acetyl-3- Ethylpyrazine, · 2-Acetyl-5-Methylfuran, · Acetylpyrazine, · 2-Acetylpyridine, · 3-Acetylpyridine, · 2-Acetylthiazole, · Aconitic Acid, · dl-Alanine, · Alfalfa Extract, · Allspice Extract, · Oleoresin, · And Oil, · Allyl Hexanoate, · Allyl Ionone, · Almond Bitter Oil, · Ambergris Tincture, · Ammonia, · Ammonium Bicarbonate, · Ammonium Hydroxide, · Ammonium Phosphate Dibasic, · Ammonium Sulfide, · Amyl Alcohol, · Amyl Butyrate, · Amyl Formate, · Amyl Octanoate, · alpha-Amylcinnamaldehyde, · Amyris Oil, · trans-Anethole, · Angelica Root Extract, Oil and Seed Oil, · Anise, · Anise Star, Extract and Oils, · Anisyl Acetate, · Anisyl Alcohol, · Anisyl Formate, · Anisyl Phenylacetate, · Apple Juice Concentrate, Extract, and Skins, · Apricot Extract and Juice Concentrate, · 1-Arginine, · Asafetida Fluid Extract And Oil, · Ascorbic Acid, · 1-Asparagine Monohydrate, · 1-Aspartic Acid, · Balsam Peru and Oil, · Basil Oil, · Bay Leaf, Oil and Sweet Oil, · Beeswax White, · Beet Juice Concentrate, · Benzaldehyde, · Benzaldehyde Glyceryl Acetal, · Benzoic Acid, Benzoin, · Benzoin Resin, · Benzophenone, · Benzyl Alcohol, · Benzyl Benzoate, · Benzyl Butyrate, · Benzyl Cinnamate, · Benzyl Propionate, · Benzyl Salicylate, · Bergamot Oil, · Bisabolene, · Black Currant Buds Absolute, · Borneol, · Bornyl Acetate, · Buchu Leaf Oil, · 1,3-Butanediol, · 2,3-Butanedione, · 1-Butanol, · 2-Butanone, · 4(2-Butenylidene)-3,5,5-Trimethyl-2-Cyclohexen-1-One, · Butter, Butter Esters, and Butter Oil, · Butyl Acetate, · Butyl Butyrate, · Butyl Butyryl Lactate, · Butyl Isovalerate, · Butyl Phenylacetate, · Butyl Undecylenate, · 3-Butylidenephthalide, · Butyric Acid, · Cadinene, · Caffeine, · Calcium Carbonate, · Camphene, · Cananga Oil, · Capsicum Oleoresin, · Caramel Color, · Caraway Oil, · Carbon Dioxide, · Cardamom Oleoresin, Extract, Seed Oil, and Powder, · Carob Bean and Extract, · beta-Carotene, · Carrot Oil, · Carvacrol, · 4-Carvomenthenol, · 1-Carvone, · beta-Caryophyllene, · beta-Caryophyllene Oxide, · Cascarilla Oil and Bark Extract, · Cassia Bark Oil, · Cassie Absolute and Oil, · Castoreum Extract, Tincture and Absolute, · Cedar Leaf Oil, · Cedarwood Oil Terpenes and Virginiana, · Cedrol, · Celery Seed Extract, Solid, Oil, And Oleoresin, · Cellulose Fiber, · Chamomile Flower Oil And Extract, · Chicory Extract, · Chocolate, · Cinnamaldehyde, · Cinnamic Acid, · Cinnamon Leaf Oil, Bark Oil, and Extract, · Cinnamyl Acetate, · Cinnamyl Alcohol, · Cinnamyl Cinnamate, · Cinnamyl Isovalerate, · Cinnamyl Propionate, · Citral, · Citric Acid, · Citronella Oil, · dl-Citronellol, · Citronellyl Butyrate, · Citronellyl Isobutyrate, · Civet Absolute, · Clary Oil, · Clover Tops, Red Solid Extract, · Cocoa, · Cocoa Shells, Extract, Distillate And Powder, · Coconut Oil, · Coffee, · Cognac White and Green Oil, · Copaiba Oil, · Coriander Extract and Oil, · Corn Oil, · Corn Silk, · Costus Root Oil, · Cubeb Oil, · Cuminaldehyde, · para-Cymene, · 1-Cysteine, · Dandelion Root Solid Extract, · Davana Oil, · 2-trans, 4-trans-Decadienal, · delta-Decalactone, · gamma-Decalactone, · Decanal, · Decanoic Acid, · 1-Decanol, · 2-Decenal, · Dehydromenthofurolactone, · Diethyl Malonate, · Diethyl Sebacate, · 2,3-Diethylpyrazine, · Dihydro Anethole, · 5,7-Dihydro-2-Methylthieno(3,4-D) Pyrimidine, · Dill Seed Oil and Extract, · meta-Dimethoxybenzene, · para-Dimethoxybenzene, · 2,6-Dimethoxyphenol, · Dimethyl Succinate, · 3,4-Dimethyl-1,2-Cyclopentanedione, · 3,5- Dimethyl-1,2-Cyclopentanedione, · 3,7-Dimethyl-1,3,6-Octatriene, · 4,5-Dimethyl-3-Hydroxy-2,5-Dihydrofuran-2-One, · 6,10-Dimethyl-5,9-Undecadien-2-One, · 3,7-Dimethyl-6-Octenoic Acid, · 2,4-Dimethylacetophenone, · alpha,para-Dimethylbenzyl Alcohol, · alpha,alpha-Dimethylphenethyl Acetate, · alpha,alpha Dimethylphenethyl Butyrate, · 2,3-Dimethylpyrazine, · 2,5-Dimethylpyrazine, · 2,6-Dimethylpyrazine, · Dimethyltetrahydrobenzofuranone, · delta-Dodecalactone, · gamma-Dodecalactone, · para-Ethoxybenzaldehyde, · Ethyl 10-Undecenoate, · Ethyl 2-Methylbutyrate, · Ethyl Acetate, · Ethyl Acetoacetate, · Ethyl Alcohol, · Ethyl Benzoate, · Ethyl Butyrate, · Ethyl Cinnamate, · Ethyl Decanoate, · Ethyl Fenchol, · Ethyl Furoate, · Ethyl Heptanoate, · Ethyl Hexanoate, · Ethyl Isovalerate, · Ethyl Lactate, · Ethyl Laurate, · Ethyl Levulinate, · Ethyl Maltol, · Ethyl Methyl Phenylglycidate, · Ethyl Myristate, · Ethyl Nonanoate, · Ethyl Octadecanoate, · Ethyl Octanoate, · Ethyl Oleate, · Ethyl Palmitate, · Ethyl Phenylacetate, · Ethyl Propionate, · Ethyl Salicylate, · Ethyl trans-2-Butenoate, · Ethyl Valerate, · Ethyl Vanillin, · 2-Ethyl (or Methyl)-(3,5 and 6)-Methoxypyrazine, · 2-Ethyl-1-Hexanol, 3-Ethyl -2 -Hydroxy-2-Cyclopenten-1-One, · 2-Ethyl-3, (5 or 6)-Dimethylpyrazine, · 5-Ethyl-3-Hydroxy-4-Methyl-2(5H)-Furanone, · 2-Ethyl-3-Methylpyrazine, · 4-Ethylbenzaldehyde, · 4-Ethylguaiacol, · para-Ethylphenol, · 3-Ethylpyridine, · Eucalyptol, · Farnesol, · D-Fenchone, · Fennel Sweet Oil, · Fenugreek, Extract, Resin, and Absolute, · Fig Juice Concentrate, · Food Starch Modified, · Furfuryl Mercaptan, · 4-(2-Furyl)-3-Buten-2-One, · Galbanum Oil, · Genet Absolute, · Gentian Root Extract, · Geraniol, · Geranium Rose Oil, · Geranyl Acetate, · Geranyl Butyrate, · Geranyl Formate, · Geranyl Isovalerate, · Geranyl Phenylacetate, · Ginger Oil and Oleoresin, · 1-Glutamic Acid, · 1-Glutamine, · Glycerol, · Glycyrrhizin Ammoniated, · Grape Juice Concentrate, · Guaiac Wood Oil, · Guaiacol, · Guar Gum, · 2,4-Heptadienal, · gamma-Heptalactone, · Heptanoic Acid, · 2-Heptanone, · 3-Hepten-2-One, · 2-Hepten-4-One, · 4-Heptenal, · trans -2-Heptenal, · Heptyl Acetate, · omega-6-Hexadecenlactone, · gamma-Hexalactone, · Hexanal, · Hexanoic Acid, · 2-Hexen-1-Ol, · 3-Hexen-1-Ol, · cis-3-Hexen-1-Yl Acetate, · 2-Hexenal, · 3-Hexenoic Acid, · trans-2-Hexenoic Acid, · cis-3-Hexenyl Formate, · Hexyl 2-Methylbutyrate, · Hexyl Acetate, · Hexyl Alcohol, · Hexyl Phenylacetate, · 1-Histidine, · Honey, · Hops Oil, · Hydrolyzed Milk Solids, · Hydrolyzed Plant Proteins, · 5-Hydroxy-2,4-Decadienoic Acid delta- Lactone, · 4-Hydroxy-2,5-Dimethyl-3(2H)-Furanone, · 2-Hydroxy-3,5,5-Trimethyl-2-Cyclohexen-1-One, · 4-Hydroxy -3-Pentenoic Acid Lactone, · 2-Hydroxy-4-Methylbenzaldehyde, · 4-Hydroxybutanoic Acid Lactone, · Hydroxycitronellal, · 6-Hydroxydihydrotheaspirane, · 4-(para-Hydroxyphenyl)-2-Butanone, · Hyssop Oil, · Immortelle Absolute and Extract, · alpha-Ionone, · beta-Ionone, · alpha-Irone, · Isoamyl Acetate, · Isoamyl Benzoate, · Isoamyl Butyrate, · Isoamyl Cinnamate, · Isoamyl Formate, Isoamyl Hexanoate, · Isoamyl Isovalerate, · Isoamyl Octanoate, · Isoamyl Phenylacetate, · Isobornyl Acetate, · Isobutyl Acetate, · Isobutyl Alcohol, · Isobutyl Cinnamate, · Isobutyl Phenylacetate, · Isobutyl Salicylate, · 2-Isobutyl-3-Methoxypyrazine, · alpha-Isobutylphenethyl Alcohol, · Isobutyraldehyde, · Isobutyric Acid, · d,l-Isoleucine, · alpha-Isomethylionone, · 2-Isopropylphenol, · Isovaleric Acid, · Jasmine Absolute, Concrete and Oil, · Kola Nut Extract, · Labdanum Absolute and Oleoresin, · Lactic Acid, · Lauric Acid, · Lauric Aldehyde, · Lavandin Oil, · Lavender Oil, · Lemon Oil and Extract, · Lemongrass Oil, · 1-Leucine, · Levulinic Acid, · Licorice Root, Fluid, Extract and Powder, · Lime Oil , · Linalool, · Linalool Oxide, · Linalyl Acetate, · Linden Flowers, · Lovage Oil And Extract, · 1-Lysine, · Mace Powder, Extract and Oil , · Magnesium Carbonate, · Malic Acid, · Malt and Malt Extract, · Maltodextrin, · Maltol, · Maltyl Isobutyrate, · Mandarin Oil, · Maple Syrup and Concentrate, · Mate Leaf, Absolute and Oil, · para-Mentha-8-Thiol-3-One, · Menthol, · Menthone, · Menthyl Acetate, · dl-Methionine, · Methoprene, · 2-Methoxy-4-Methylphenol, · 2-Methoxy-4-Vinylphenol, · para-Methoxybenzaldehyde, · 1-(para-Methoxyphenyl)-1-Penten-3-One, · 4-(para-Methoxyphenyl)-2-Butanone, · 1-(para-Methoxyphenyl)-2-Propanone, · Methoxypyrazine, · Methyl 2-Furoate, · Methyl 2-Octynoate, · Methyl 2-Pyrrolyl Ketone, · Methyl Anisate, · Methyl Anthranilate, · Methyl Benzoate, · Methyl Cinnamate, · Methyl Dihydrojasmonate, · Methyl Ester of Rosin, Partially Hydrogenated, · Methyl Isovalerate, · Methyl Linoleate (48%), · Methyl Linolenate (52%) Mixture, · Methyl Naphthyl Ketone, · Methyl Nicotinate, · Methyl Phenylacetate, · Methyl Salicylate, · Methyl Sulfide, · 3-Methyl-1-Cyclopentadecanone, · 4-Methyl-1-Phenyl-2-Pentanone, · 5-Methyl-2-Phenyl-2-Hexenal, · 5-Methyl-2-Thiophenecarboxaldehyde, · 6-Methyl-3,-5-Heptadien-2-One, · 2-Methyl-3-(para-Isopropylphenyl) Propionaldehyde, · 5-Methyl-3-Hexen-2-One, · 1-Methyl-3Methoxy-4-Isopropylbenzene, · 4-Methyl-3-Pentene-2-One, · 2-Methyl-4-Phenylbutyraldehyde, · 6-Methyl-5-Hepten-2-One, · 4-Methyl-5-Thiazoleethanol, · 4-Methyl-5-Vinylthiazole, · Methyl-alpha-Ionone, · Methyl-trans-2-Butenoic Acid, · 4-Methylacetophenone, · para-Methylanisole, · alpha-Methylbenzyl Acetate, · alpha-Methylbenzyl Alcohol, · 2-Methylbutyraldehyde, · 3-Methylbutyraldehyde, · 2-Methylbutyric Acid, · alpha-Methylcinnamaldehyde, · Methylcyclopentenolone, · 2-Methylheptanoic Acid, · 2-Methylhexanoic Acid, · 3-Methylpentanoic Acid, · 4-Methylpentanoic Acid, · 2-Methylpyrazine, · 5-Methylquinoxaline, · 2-Methyltetrahydrofuran-3-One * (Methylthio)Methylpyrazine (Mixture Of Isomers), · 3-Methylthiopropionaldehyde, · Methyl 3-Methylthiopropionate, · 2-Methylvaleric Acid, · Mimosa Absolute and Extract, · Molasses Extract and Tincture, · Mountain Maple Solid Extract, · Mullein Flowers, · Myristaldehyde, · Myristic Acid, · Myrrh Oil, · beta-Napthyl Ethyl Ether, · Nerol, · Neroli Bigarde Oil, · Nerolidol, · Nona-2-trans,6-cis-Dienal, · 2,6-Nonadien-1-Ol, · gamma-Nonalactone, · Nonanal, · Nonanoic Acid, · Nonanone, · trans-2-Nonen-1-Ol, · 2-Nonenal, · Nonyl Acetate, · Nutmeg Powder and Oil, · Oak Chips Extract and Oil, · Oak Moss Absolute, · 9,12-Octadecadienoic Acid (48%) And 9,12,15-Octadecatrienoic Acid (52%), · delta-Octalactone, · gamma-Octalactone, · Octanal, · Octanoic Acid, · 1-Octanol, · 2-Octanone, · 3-Octen-2-One, · 1-Octen-3-Ol, · 1-Octen-3-Yl Acetate, · 2-Octenal, · Octyl Isobutyrate, · Oleic Acid , · Olibanum Oil, · Opoponax Oil And Gum, · Orange Blossoms Water, Absolute, and Leaf Absolute, · Orange Oil and Extract, · Origanum Oil, · Orris Concrete Oil and Root Extract, · Palmarosa Oil, · Palmitic Acid, · Parsley Seed Oil, · Patchouli Oil, · omega-Pentadecalactone, · 2,3-Pentanedione, · 2-Pentanone, · 4-Pentenoic Acid, · 2-Pentylpyridine, · Pepper Oil, Black And White, · Peppermint Oil, · Peruvian (Bois De Rose) Oil, · Petitgrain Absolute, Mandarin Oil and Terpeneless Oil, · alpha-Phellandrene, · 2-Phenenthyl Acetate, · Phenenthyl Alcohol, · Phenethyl Butyrate, · Phenethyl Cinnamate, · Phenethyl Isobutyrate, · Phenethyl Isovalerate, · Phenethyl Phenylacetate, · Phenethyl Salicylate, · 1-Phenyl-1-Propanol, · 3-Phenyl-1-Propanol, · 2-Phenyl-2-Butenal, · 4-Phenyl-3-Buten-2-Ol, · 4-Phenyl-3-Buten-2-One, · Phenylacetaldehyde, · Phenylacetic Acid, · 1-Phenylalanine, · 3-Phenylpropionaldehyde, · 3-Phenylpropionic Acid, · 3-Phenylpropyl Acetate, · 3-Phenylpropyl Cinnamate, · 2-(3-Phenylpropyl)Tetrahydrofuran, · Phosphoric Acid, · Pimenta Leaf Oil, · Pine Needle Oil, Pine Oil, Scotch, · Pineapple Juice Concentrate, · alpha-Pinene, beta-Pinene, · D-Piperitone, · Piperonal, · Pipsissewa Leaf Extract, · Plum Juice, · Potassium Sorbate, · 1-Proline, · Propenylguaethol, · Propionic Acid, · Propyl Acetate, · Propyl para-Hydroxybenzoate, · Propylene Glycol, · 3-Propylidenephthalide, · Prune Juice and Concentrate, · Pyridine, · Pyroligneous Acid And Extract, * * Pyrrole, * Pyruvic Acid, * Raisin Juice Concentrate, * Rhodinol, * Rose Absolute and Oil, * Rosemary Oil, * Rum, * Rum Ether, * Rye Extract, * Sage, Sage Oil, and Sage Oleoresin, * Salicylaldehyde, * Sandalwood Oil, Yellow, * Sclareolide, * Skatole, * Smoke Flavor, * Snakeroot Oil, * Sodium Acetate, * Sodium Benzoate, * Sodium Bicarbonate, * Sodium Carbonate, * Sodium Chloride, * Sodium Citrate, * Sodium Hydroxide, * Solanone, * Spearmint Oil, * Styrax Extract, Gum and Oil, * Sucrose Octaacetate, * Sugar Alcohols, * Sugars, * Tagetes Oil, * Tannic Acid, * Tartaric Acid, * Tea Leaf and Absolute, * alpha-Terpineol, * Terpinolene, * Terpinyl Acetate, * 5,6,7,8-Tetrahydroquinoxaline, * 1,5,5,9-Tetramethyl-13-Oxatricyclo(8.3.0.0(4,9))Tridecane, * 2,3,4,5, and 3,4,5,6-Tetramethylethyl-Cyclohexanone, * 2,3,5,6-Tetramethylpyrazine, * Thiamine Hydrochloride, * Thiazole, * 1-Threonine, * Thyme Oil, White and Red, * Thymol, * Tobacco Extracts, * Tochopherols (mixed), * Tolu Balsam Gum and Extract, * Tolualdehydes, * para-Tolyl 3-Methylbutyrate, * para-Tolyl Acetaldehyde, * para-Tolyl Acetate, * para-Tolyl Isobutyrate, * para-Tolyl Phenylacetate, * Triacetin, * 2-Tridecanone, * 2-Tridecenal, * Triethyl Citrate, * 3,5,5-Trimethyl -1-Hexanol, * para,alpha,alpha-Trimethylbenzyl Alcohol, * 4-(2,6,6-Trimethylcyclohex-1-Enyl)But-2-En-4-One, * 2,6,6-Trimethylcyclohex-2-Ene-1,4-Dione, * 2,6,6-Trimethylcyclohexa-1,3-Dienyl Methan, * 4-(2,6,6-Trimethylcyclohexa-1,3-Dienyl)But-2-En-4-One, * 2,2,6-Trimethylcyclohexanone, * 2,3,5-Trimethylpyrazine, * 1-Tyrosine, * delta-Undercalactone, * gamma-Undecalactone, * Undecanal, * 2-Undecanone, 1 * 0-Undecenal, * Urea, * Valencene, * Valeraldehyde, * Valerian Root Extract, Oil and Powder, * Valeric Acid, * gamma-Valerolactone, * Valine, * Vanilla Extract And Oleoresin, * Vanillin, * Veratraldehyde, * Vetiver Oil, * Vinegar, * Violet Leaf Absolute, * Walnut Hull Extract, * Water, * Wheat Extract And Flour, * Wild Cherry Bark Extract, * Wine and Wine Sherry, * Xanthan Gum, * 3,4-Xylenol, * Yeast Benzene 2-Napthylamine 4-Aminobiphenyl Nickel Polonium 210 (radioactive) Nitrogen oxides N-Nitrosodimethylamine N-Nitrosodiethylamine N-Nitrosopyrrolidine 1,3-Butadiene Analine Formaldehyde Hydrazine N-Nitrodiethanolamine Cadmium Benzo[a]pyrene Benz[a]anthracene Y-Butyrolactone Particulate matter N-Nitrosonornicotine NNK Carbon monoxide Carbon dioxide Carbonyl sulfide Toluene Acrolein Acetone Pyridine 3-Methylpyridine 3-Vinylpyridine Hydrogen cyanide Ammonia Methylamine Dimethylamine Nicotine Anatabine Phenol Catechol Hydorquinone Cholesterol Quinoline Harman Zinc Benzoic acid Lactic acid Glycolic acid Succinic acit PCDDs and PCDFs (Dioxins, Dibenzofurans) Formic acid Acetic acid Methyl chloride Dimethylnitrosamine Ethylmethylnitrosamine Nitrosopyrrolidine Hydrazine Vinyl Chloride Urethane Formaldehyde Carbon Monoxide Hydrogen Cyanide Acrolein Acetadehyde Nitrogen oxides Ammonia Pyridine Nitric acid Mathylamine Hydrogen cyanide Indole 3-hydroxypyridine 3-vinylpyridine Acetone Acetonitrile Acrolein 1,3-Butadiene, mg Nitrous acid isoquioline Isoamylamine 3-Cyanopyridine Carbonyls Formaldehyde, Acetaldehyde, Acetone, Acrolein, Propionaldehyde, Crotonaldehyde, Methyl-Ethyl-Ketone, Butyraldehyde Phenolics Hydroquinone, Resorcinol, Catechol, Phenol, Cresol (m+p and o) Benzo[a]pyrene BaP (HPLC) Aromatic Amines 3- and 4-aminobiphenyl, 1- and 2- aminonapthlene, o-toluidine, o-anisidine Oxides of Nitrogen NO, NOx Hydrogen Cyanide HCN (gas and particulate phases) Ammonia NH3 by ion chromatography Volatiles Benzene, Toluene, 1,3-butadiene, Isoprene, Acrylonitrile Semi-Volatiles Pyridine, Quinoline, Styrene Trace Metals Nickel (Ni) Cadmium (Cd) Lead (Pb) Chromium (Cr) Arsenic (As) Selenium (Se) Mercury Mercury (Hg) Smoke pH Integrated Puff Profile Tobacco Specific Nitrosamines N-Nitrosonornicotine (NNN) N-Nitrosoanabasine (NAB) N-Nitrosoanatabine (NAT) 4-(N-nitrosomethylamino)-1-(3-pyridyl)-1-butanone (NNK) Volatile Nitrosamines N,N-Nitrosodimethylamine (NDMA) N-Nitrosopyrrolidine (NPYR) N,N-Nitrosodiethylamine (NDEA) N,N-Nitrosoethylmethylamine (NEMA) N,N-Nitrosodipropylamine (NDPA) N,N-Nitrosodibuthylamine (NDBA) N-Nitrosopiperidine (NPIP) Polycyclic Aromatic Hydrocarbons Naphthalene 1-Methylnaphthalene 2-methylnaphthalene Acenaphthylene Acenaphthene Fluorene Phenanthrene Anthracene Fluoranthene Pyrene Benzo(a)anthracene Chrysene Benzo(b)fluoranthene Benzo(k)fluoranthene Benzo(j)fluoranthene Benzo(g,h,l)perylene Benzo(e)pyrene Benzo(a)pyrene Perylene Indeno(1,2,3,-cd)pyrene Dibenzo(a,h)anthracene Dibenz(a,j)acridine Dibenz(a,h)acridine Dibenz(a,e)pyrene Dibenz(a,h)pyrene Dibenz(a,i)pyrene Dibenz(a,l)pyrene 7H-Dibenzo(c,g)carbazole Heterocyclic Aromatic Amines 2-Amino-3-methylimidaszo(4,5-f)quinoline (IQ) 2-Amino-3,4-dimethylimidazo(4,5-f)quinoline (MeIQ) 2-Amino-3-methyl-9H-pyrido(2,3-b)indole (MeAaC) 2-Amino-9H-pyrido(2,3-b)indole (AaC) 1-Methyl-9H-pyridol(3,4-b)indole (Harman) 9H-Pyrido(3,4-b)indole (Norharman) Nitrogen 280-320 mg (56-64%b) Oxygen 50-70 mg (11-14%b) Carbon dioxide 45-65 mg (9-13%b) Carbon monoxide 14-23 mg (2.8-4.6%b) Water 7-12 mg (1.4-2.4%b) Argon 5mg (1.0%b) Hydrogen 0.5-1.0 mg Ammonia 10-130 μg Nitrogen oxides (NOx) 100-600 μg Hydrogen cyanide 400-500 μg Hydrogen sulfide 20-90 μg Methane 1.0-2.0 mg Other volatile alkanes (20) 1.0-.16 mgc Volatile alkenes (16) 0.4-0.5mg Isoprene 0.2-0.4mg Butadiene 25-40μg Acetylene 20-35μg Benzene 12-50μg Toluene 20-60μg Styrene 10μg Other volatile aromatic hydrocarbons (29) 15-30μg Formic acid 200-600 μg Acetic acid 300-1,700 μg Propionic acid 100-300 μg Methyl formate 20-30 μg Other volatile acids (6) 5-10 μgc Formaldehyde 20-100 μg Acetaldehyde 400-1,400 μg Acrolein 60-140 μg Other volatile aldehydes (6) Acetone Other volatile ketones (3) Methanol Other volatile alcohols (7) Acetonitrile Other volatile nitriles (I0) Furan Other volatile furans (4) Pyridine Picolines (3) 3-Vinylpyridine Other volatile pyridines (25) Pyrrole Pyrrolidine N-Methylpyrrolidine Volatile pyrazines (18) Methylamine Other aliphatic amines (32) Nornicotine Anatabine Anabasine Other tobacco alkaloids (17) Bipyridyls (4) n-Hentriacontane (n-C31H64) Total nonvolatile hydrocarbons (45)b Naphthalene Other naphthalenes (23) Phenanthrenes (7) Anthracenes (5) Fluorenes (7) Pyrenes (6) Fluoranthenes (5) Carcinogenic polynuclear aromatic hydrocarbons (11)c Phenol Other phenols (45)b Catechol Other catechols (4) Other dihydroxybenzenes (10) Scopoletin Other polyphenols (8)b Cyclotenes (10)b Quinones (7) Solanesol Neophytadienes (4) 200-350 Limonene 30-60 Other terpenes (200-250)b NA Palmitic acid 100-150 Stearic acid 50-75 Oleic acid 40-110 Linoleic acid 60-150 Linolenic acid 150-250 Lactic acid 60-80 Indole 10-15 Skatole 12-16 Other indoles (13) NA Quinolines (7) 2-4 Other N-heterocyclic hydrocarbons (55) NA Benzofurans (4) 200-300 Other O-heterocyclic hydrocarbons (42) NA Stigmasterol 40-70 Sitosterol 30-40 Campesterol 20-30 Cholesterol 10-20 Aniline 0.36 Toluidines 0.23 Other aromatic amines (12) 0.25 Tobacco-specific N-nitrosamines (4)c 0.34-2.7 Glycerol PAH Benz(a)anthracene Benzo(b)fluoranthene Benzo(j)fluoranthene Benzo(k)fluoranthene Benzo(a)pyrene Chrysene Dibenz(a,h)anthracene Dibenzo(a,1)pyrene Dibenzo(a,1)pyrene Indeno(1,2,3-c,d)pyrene 5-Methylchrysene Aza-arenes Quinoline Dibenz(a,h)acridine Dibenz(aj)acridine 7H-Dibenzo(c,g)carbazole N-Nitrosamines N-Nitrosodimethylamine N-Nitrosoethyl methylamine N-Nitrosodiethylamine N-Nitrosopyrrolidine N-Nitrosodiethanolamine N’-Nitrosonomicotine 4-(Methylnitrosamino)-1- (3-pyridyl)-1-butanone N’-Nitrosoanabasine N-Nitrosomorpholine 2-Toluidine 2-Naphthylamine 4-Aminobiphenyl Aldehydes Formaldehyde Acetaldehyde Crotonaldehyde Miscellaneous organic compounds Benzene Acrylonitrile 1,1-Dimethylhydrazine 2-Nitropropane Ethylcarbamate Vinylchloride Inorganic compounds Hydrazine Arsenic Nickel Chromium Cadmium Lead Polonium-210 Asbestos Plutonium

SORRY - that was also a mistake. The above is NOT a list of the inactive chemical ingredients in e-liquids. It is a list of the inactive ingredients that have been detected in the smoke from cigarettes, also approved for sale, marketing, and inhalation by the FDA.

Here is the actual list of chemicals in the flavoring components found in e-liquids, which have not yet been approved for sale by the FDA:

Vanillin, maltol, ethyl maltol, ethyl vanillin, benzaldehyde, p-tolualdehyde, benzyl alcohol, limonene, ethyl butyrate, ethyl acetate, gamma-undecalactone, menthol, eugenol, 2-methylbutyl acetate, cinnemaldehyde, ethyl hexanoate, menthone, piperanal,  carvone, methyl anthranilate, ethyl isovalerate, hexyl acetate, hexenol.

My point is four-fold:

1. The chemicals in electronic cigarettes - the "inactive" ingredients if you will - are not dissimilar to inactive ingredients in many pharmaceutical inhalers that are approved by the FDA. The chemicals in those inhalers are known to cause respiratory irritation. Yes, it is true that some of the chemicals in the e-liquids, especially the aldehydes, could cause some mild respiratory irritation. However, there is no reason to believe at present that the degree of respiratory irritation is substantially different than what occurs with the inhalation of approved FDA drugs.

2. The chemicals detected in e-cigarette flavorings present an extremely low level of risk when compared to the chemicals in tobacco smoke. The difference is essentially between a behavior that results in destruction of the lungs and a behavior that may cause, at the worst, mild respiratory irritation. Let's keep a sense of perspective here. Most of the individuals who are regular users of e-cigarettes are former smokers who have quit or current smokers. In either case, switching to vaping is the most important thing they can do to protect their health, assuming they are unable to quit nicotine use completely, which is probably the case for most vapers (that is why they tried vaping in the first place; had they been able to quit cold turkey, they would have).

3. One cannot necessarily draw conclusions about human health risks based solely on looking at a list of ingredients. The dose of exposure is critical. We do not know enough at this point for anyone to conclude that the flavorings in electronic cigarettes pose a significant risk of substantial adverse health effects. Moreover, there has been enough short-term use of these products for us to feel somewhat confident that we are not observing acute toxicity due to these products. Any potential risks would likely be very long-term. And we don't even know yet whether it is possible to sustain vaping for the 20 or 30 years that would be necessary before any respiratory irritant effect would translate into clinical lung disease, or if anyone would want to do that.

4. Remember that e-cigarettes are recreational products, not pharmaceutical products. The critical concern is not their absolute level of safety, but their relative level of safety compared to real cigarettes. The analysis presented in this paper is actually reassuring, because it provides irrefutable evidence that e-cigarettes are much, much safer than real ones.

Before closing, let me make three important points.

First, although I don't think a health scare over the flavorings in e-cigarettes is warranted, I do support reasonable regulations and safety standards to minimize any health risks from e-cigarettes. And I do support full disclosure of ingredients. So I actually agree with the article's ultimate recommendation that the ingredients of e-cigarettes should be listed for the consumer and that the FDA exercise some reasonable degree of regulation over the flavorings. But clearly, a ban on e-cigarette flavorings is completely unwarranted.

Second, there may be a few select flavorings that absolutely should not be used in e-cigarettes. Dr. Farasalinos has made a compelling case that diacetyl should not be used as a flavoring because of its known potential for severe respiratory effects. It would not be unreasonable for the FDA to promulgate a list of a few select flavorings that should not be used in these products, nor would it be unreasonable to restrict the total percentage of flavorings to some reasonable proportion of the overall e-liquid.

Third, it is worth noting that two of the authors of this paper are co-authors on the paper which concluded that vaping is more hazardous than smoking based on high levels of formaldehyde, levels that resulting from the severe overheating of the e-liquid producing dry puff conditions under which no vaper would continue vaping. The apparent bias of these researchers against e-cigarettes should be considered in interpreting the results of the study.

Wednesday, July 15, 2015

New Study Finds that E-Cigarettes Have No Adverse Effect on Respiratory Epithelial Cells, While Tobacco Smoke Kills the Cells

A new study conducted by British American Tobacco and published in the journal Toxicology in Vitro reports that e-cigarette aerosol from two conventional products had no adverse effect on human respiratory epithelial cells (in cell culture), while tobacco smoke caused almost complete cell death.

The methods and results are summarized as follows: "EpiAirway™ tissues [in vitro respiratory epithelial cells in culture] were exposed to cigarette smoke and aerosol generated from two commercial e-cigarettes for up to 6 h. Cigarette smoke reduced cell viability in a time dependent manner to 12% at 6 h. E-cigarette aerosol showed no such decrease in cell viability and displayed similar results to that of the untreated air controls. Applicability of the EpiAirway™ model and exposure system was demonstrated, showing little cytotoxicity from e-cigarette aerosol and different aerosol formulations when compared directly with reference cigarette smoke, over the same exposure time."

According to a British American Tobacco press release: "Until now, there have been no aerosol studies of potential adverse effects of e-cigarette vapour on in vitro models that so closely mimic the structure, function and exposure of normal human airway tissue. The researchers combined a commercially available 3D model of respiratory epithelial tissue and the popular VITROCELL smoking robot, an aerosol exposure system, to assess the irritant potential of e-cigarette vapour from two commercially available e-cigarettes on human airway tissue. The results show that, despite hours of aggressive and continuous exposure, the impact of the e-cigarette vapour on the airway tissue is similar to that of air."

The overall conclusion of the study was as follows: "Further studies will need to be conducted to compare between different commercially available products, formats,and formulations, but our data suggest that e-cigarette aerosols have significantly less impact than cigarette smoke over the duration of a 6 h exposure in vitro using organotypic tissue constructs."

The two products tested were NJOY Bold and NJOY Menthol.

The Rest of the Story

While one cannot necessarily extrapolate from this study to all e-cigarette products, at least we now know that one major brand of electronic cigarettes appears to have relatively benign effects on the cells lining the respiratory tract, in contrast to cigarette smoke which exhibits very high levels of cytotoxicity. This finding is consistent with earlier studies showing that the aerosol produced by NJOY e-cigarettes did not contain measurable quantities of most of the chemicals of concern that have been detected in the aerosol produced by some e-cigarette brands.

A major contribution of this research is that it sets out a procedure that could be used to test the cytotoxicity of various brands of electronic cigarettes, providing some assessment of the potential for respiratory irritation or inflammation that could be associated with these products. It could also help the FDA identify manufacturing procedures and/or quality control measures that prevent the formation of the unwanted chemicals in e-cigarette vapor, which could aid the agency in crafting quality standards to ensure that e-cigarettes on the market are as safe as they can be.

Despite the limitations of the research, it adds additional evidence to support the contention that vaping is a lot safer than smoking. Moreover, it suggests that it is possible to produce an e-cigarette that has little cytotoxicity to respiratory epithelial cells.

I am by no means an expert on e-cigarette design, but I can't help but think that the careful voltage and temperature regulation that the tobacco companies and the large independent e-cigarette companies have built into their products have a great deal to do with the fact that the aerosol produced by these products appears to present few concerns about the chemicals present or about the aerosol's cytotoxicity. Overheating is likely a major reason why some products have been found to produce an aerosol that does contain a number of toxins, such as various aldehydes.

This research adds to the evidence suggesting that with proper regulation, the FDA could maximize the potential benefits of e-cigarettes while minimizing their potential harms. If embraced by the agency, e-cigarettes have the potential to transform the nicotine market and produce a dramatic shift away from combustible tobacco products (i.e., cigarettes) and toward non-combusted, non-tobacco-containing e-cigarettes. Such a phenomenon would result in the greatest public health miracle of our lifetimes.

Unfortunately, I do not believe that the anti-tobacco groups or major health agencies, including the CDC or the FDA, are aiming to try to transform the nicotine market and achieve this huge public health victory. Instead, they are taking a zero-risk, zero-addiction approach that is ideal in a fantasy world, but destructive to the public's health in the real world.

Tuesday, July 14, 2015

Minneapolis City Council Supports Continued Addiction of Kids to Flavored Tobacco Products

In a move of striking hypocrisy and cowardice, the Minneapolis City Council has decided to continue supporting the addiction of its kids to flavored tobacco products. What makes the move hypocritical, however, is that the Council has claimed to ban the sale of flavored tobacco products in the city, with the only exception being specialty tobacco shops limited to adults, citing the urgent need to protect the health of future generations by preventing youth from becoming addicted to nicotine.

According to an article in the Southwest Journal: "The City Council has unanimously voted to approve new restrictions on the sale of flavored tobacco products — a policy change designed to prevent young people from smoking. The sale of flavored tobacco products will be limited to specialty tobacco shops, which are required to restrict people under age 18 from entering. ... “We heard loud and clear from Minneapolis youth that flavored tobacco products are what most kids use when they start smoking,” said Gordon, chair of the Health, Environment and Community Engagement Committee. “We believe that limiting access to these products will help prevent youth from becoming addicted to nicotine and dramatically improve the health of future generations.”"

The Rest of the Story

What policy makers in Minneapolis are not telling the public is that the new law exempts the one flavor that is most popular among kids in their jurisdiction and which most contributes to youth addiction to tobacco products: menthol.

In fact, about 50% of youth smokers in middle school prefer menthol flavored cigarettes. And about 81% of African American middle school smokers prefer menthol flavored cigarettes. There are 1.3 million youth menthol smokers in the U.S., making menthol the single and overwhelmingly most popular flavored tobacco product among our nation's youth, including those in Minneapolis.

So while politicians in Minneapolis can boast that youth in that city will not have access to chocolate, vanilla, honey, and cocoa tobacco products, the ordinance does nothing to actually address the most popular flavored tobacco product that Minneapolis youth are actually using: menthol cigarettes. 

One might ask why it is that if policy makers in Minneapolis aimed to "help prevent youth from becoming addicted to nicotine and dramatically improve the health of future generations," they chose to exempt the primary flavored tobacco products that youth are actually using.

The answer is quite simple: the true aim was not to "help prevent youth from becoming addicted to nicotine and dramatically improve the health of future generations," but to score a political victory without having to actually put a dent in tobacco sales and thus alienate tobacco companies or engender any serious political opposition.

The rest of the story is that the primary aim of these policy makers appears to be protecting the sales of the most popular and important flavored tobacco products among youth tobacco users, so as not to threaten the profits of cigarette companies.

It is difficult to find a sincere desire to "help prevent youth from becoming addicted to nicotine and dramatically improve the health of future generations" when one reads the fine print of the ordinance and considers the rest of the story.  

Rather than close the loophole which exempted menthol cigarettes from the FDA's flavored cigarette "ban," the Minneapolis City Council chose to look the other way, while distracting attention from its decision to ignore the problem by praising itself for eliminating youth access to chocolate cigars and cigarillos. 

The rest of the story is that the Council's claim to want to "help prevent youth from becoming addicted to nicotine and dramatically improve the health of future generations" is complete crap. If it were truly sincere, the Council would not have exempted menthol cigarettes, which is overwhelmingly the most popular flavored tobacco product among youth in Minneapolis and which contributes most to harming the health of future generations.

Monday, July 13, 2015

Congressional Democrats Protect Cigarette Company Profits, then Attack Republicans for Aiding Tobacco Industry

In an ironic and hypocritical action, Congressional Democrats last week attempted to aid cigarette companies by protecting them from competition and then proceeded to attack Republicans for siding with the tobacco industry.

Congressional Republicans, concerned that the soon to be released FDA deeming regulations for electronic cigarettes would devastate the electronic cigarette industry and force hundreds of e-cigarette products off the market, putting many e-cigarette shops and small companies out of business, inserted language in an appropriations bill that would prevent the FDA from requiring new product applications for e-cigarettes already on the market as of the effective date of the deeming regulations. In the proposed regulations, only products already on the market in February 2007 would be relieved from the need to file a new product application. According to an article in the Washington Post, Congressional Democrats tried to strip that language from the bill, at the same time attacking Republicans for siding with the tobacco industry on this issue.

According to the article: "This week, Democrats accused Republicans of “tucking a special interest giveaway to the tobacco industry” in an agriculture appropriations bill. The White House scolded them that spending bills should be “free of ideological provisions.” Public health groups warned they’re putting children at risk. But Republicans stood fast Wednesday to vote down a Democratic amendment to strip out language exempting tobacco products, like e-cigarettes, which are already on the market, from a retroactive review by the federal government."

The Rest of the Story

Things are not always as they appear, and that's why there is a need to tell the rest of the story. In this case, things are actually the opposite of how the Democrats are trying to make them look.

The deeming regulations, if unchanged from the FDA's initial proposal, would not protect the public's health in any way. The major effect of the regulations would be to protect cigarettes from competition from electronic cigarettes which are much, much safer. By requiring expensive and resource-intensive new product applications for every electronic cigarette product on the market, the FDA's proposed regulations would put virtually every small e-cigarette and vaping company or store out of business, leaving the entire vapor product market to the tobacco companies and a small number of independent electronic cigarette companies. A vape shop that carries 100 flavors, for example, would have to submit 100 separate applications, and each one would have to demonstrate that the particular flavored product described in the application is beneficial to the public's health, considering not only the impact on product users, but also the potential for youth and adult nonsmokers to start using the product. The FDA itself acknowledged that each application would cost about $300,000 in human resources and laboratory and clinical research, a sum that would put virtually every vape shop out of business even if it only had to submit only a single application.

By removing most flavored electronic cigarette products from the market, the regulations would do a huge favor to cigarette companies by protecting cigarettes from competition from the much safer electronic ones. While some brands of electronic cigarettes would remain on the market, there would be a loss of many flavored products that thousands of vapers are already using, forcing many of them - realistically - to return to cigarette smoking. Innovation in the industry would also be stifled. In short, market growth would be halted and the prediction that e-cigarette consumption will surpass cigarette consumption within a decade would be brought to a screeching halt.

This means that the major impact of the regulations would be to greatly increase cigarette consumption, leading to a higher incidence of disease, disability, and death. Such an action would protect cigarette sales at the expense of the public's health.

Congressional Republicans tried to undo this favor to cigarette companies by removing the requirement for all e-cigarette products to have to submit these expensive new product applications. Ironically, Congressional Democrats, by trying to strip out this provision, are acting to protect cigarette companies at the expense of the public's health.

Yet the Democrats had the gall to attack the Republicans for aiding the tobacco industry.

It is not even clear that the tobacco companies support the rider. To the best of my knowledge, they have not taken any definitive position on the issue, and it would clearly be in their best interests to let the rider pass since it would make it much more difficult for a multitude of third-generation vapor products to compete with them for the vaping market.

Contrary to the claims of those who oppose the appropriations rider, it would not affect the FDA's ability to protect children from the potential harms of electronic cigarettes, nor would it exempt any product from FDA regulatory control. The agency could still ban the sale of e-cigarettes to minors, regulate e-cigarette marketing directed at minors, and apply an unlimited set of safety standards to all electronic cigarettes (including a ban on all flavorings if the agency wanted to do that).

In fact, the rider would speed up the protection of the public's health by saving the agency from having to spend the next five or six years tied up with the tens of thousands of new product applications that could be submitted. Instead, the agency could actually step up to protect the public's health immediately by simply promulgating a set of safety and manufacturing standards for electronic cigarette devices and e-liquids.

While I don't generally find myself siding with Congressional Republicans, it is important to analyze every individual issue thoroughly from a public health perspective and not jump to conclusions solely on a political partisan basis. In this case, it is the Republicans who are acting to protect the public's health by allowing a much safer product to seriously compete with the most toxic consumer product on the market (real cigarettes), a market dynamic that could potentially cut cigarette sales in half and save millions of lives. Ironically, it is the Congressional Democrats whose actions would protect the cigarette companies and threaten the health and lives of millions of Americans.

Friday, July 10, 2015

Another Youth E-Cigarette Survey Fails to Ask the Right Questions and Compromises Study Conclusions

An article just published in the journal Addictive Behaviors presented data from the 2014 Texas Youth Tobacco Survey. It reported that 14% of middle and high school students in Texas used electronic cigarettes in the past 30 days. The prevalence of past 30-day e-cigarette use among nonsmokers who had never used any type of tobacco product was 7.3%.

(See: Cooper M, Case KR, Loukas A. E-cigarette use among Texas youth: Results from the 2014 Texas Youth Tobacco Survey. Addictive Behaviors 2015; 50:173-177.)

Despite putting out alarming conclusions about the high rate of electronic cigarette use among youth and bemoaning the fact that the prevalence of past 30-day e-cigarette use (14.0%) was higher than that for smoking (11.7%), the paper fails to mention two very important facts: (1) that electronic cigarettes are much safer than regular cigarettes; and (2) that electronic cigarettes do not contain any tobacco. In fact, the study classifies e-cigarettes as tobacco products. Moreover, in the survey instrument itself, e-cigarettes are referred to as tobacco products, thus suggesting to youth that these products contain tobacco and are therefore probably just as hazardous as real cigarettes.

The Rest of the Story

This is yet another example of how current tobacco control research is failing to ask the proper questions regarding e-cigarette use. Instead of merely asking about past 30-day e-cigarette use, these types of surveys should ascertain the number of days in the past 30 that the subject used e-cigarettes. It is possible that many of the respondents were only experimenting with e-cigarettes and that they only used these products once or twice in the past month. Some may have just tried an e-cigarette once and not used it again. Moreover, previous data suggest that although e-cigarette experimentation among nonsmokers is significant, very few of these nonsmokers are becoming regular vapers. They tend to try or use e-cigarettes in social situations but not to progress beyond that. Without asking the key question, the Texas Youth Tobacco Survey is unable to provide any sense of whether e-cigarette use among nonsmoking youth is really a problem or not.

Furthermore, by omitting from the paper the facts that e-cigarettes are much safer than real cigarettes and that they contain no tobacco and involve no combustion, the article suggests that e-cigarette experimentation among smokers is a much larger problem than it actually is.

Given that most anti-tobacco organizations are obsessed with making sure that e-cigarettes are treated no differently than cigarettes, it is surprising that they are consistently treating these products differently in terms of the questions asked in surveys. These surveys only inquire about past 30-day use of e-cigarettes, but they ask about the actual frequency of use within the past 30 days for real cigarettes.

Why the discrepancy? I believe it is because they don't want to compare daily and weekly use of e-cigarettes to daily and weekly use of e-cigarettes. They know this will destroy the story they want to tell, and it will reveal that e-cigarettes are much less addictive than the real ones. This truth is simply not a part of the story line.

Thursday, July 09, 2015

Wall Street Journal Article Predicts that FDA Deeming Regulations Could Decimate the E-Cigarette Industry

According to an article by Tripp Mickle which appeared in Tuesday's Wall Street Journal, the FDA deeming regulations, which are expected to be released later this summer, could decimate the e-cigarette industry by forcing thousands of small companies and shops out of business.

According to the article: "Within the next two months, the Food and Drug Administration is expected to complete rules that would require federal approval for nearly all flavored liquid nicotine juices and e-cig devices sold in vape shops ... The approval process could cost anywhere from $2 million to $10 million to collect data and put forward an application for each item, according to the regulatory consulting company SciLucent LLC. ... After the FDA finalizes its rule, the association [Smoke-Free Alternatives Trade Association] estimates that 99% of the industry will go out of business."

The Rest of the Story

While I think the estimated cost of application development may be exaggerated, even if the cost is closer to $400,000, that is enough to put most small e-cigarette vendors out of business. If promulgated as initially proposed last year, the regulations would require every e-cigarette product on the market (including devices and liquids) to file a new product application. An application would be required for every flavor. Thus, a vape shop might have to file hundreds of applications if it carries hundreds of flavors. Even if the cost is not prohibitive, the resource requirement will be.

These applications are not just a matter of filling out a bunch of forms and providing information. Instead, the company must demonstrate that the product in question will benefit the public's health, while taking into account not only benefits to the user, but also the possibility that nonsmokers (including youth) will start using the product. The applications need to demonstrate that the benefits of the product outweigh the risks.

Clearly, to meet the statutory requirements for new product approval, the applications will need to provide data showing that the product is effective in helping smokers quit or greatly cut down on their tobacco consumption, that the product is much safer than tobacco cigarettes, and that any costs associated with the uptake of vaping the product among youth and nonsmoking adults will not outweigh the benefits.

This is not straightforward research. It would require some rigorous studies, including clinical trials, for example, just to answer the question of how effective the product is in helping smokers quit. It seems that some sort of survey, perhaps even a longitudinal study, would be required to estimate the potential costs related to uptake of the product among youth. And it is unlikely that the FDA will accept simple chemical analysis studies to demonstrate the relative safety of e-cigarettes over real cigarettes, because the agency has stated that based on such studies that have already been conducted, it is not convinced that smoking is any more hazardous than vaping.

Moreover, separate safety studies would be required for every flavor, since the flavorings could potentially have health effects.

As I have argued before, this is not an appropriate way to regulate e-cigarettes, and I hope that the FDA regulations have not gone in this direction. Instead of creating this huge bureaucracy that will decimate the industry while doing nothing to protect the public's health, the FDA should instead simply promulgate a set of safety standards for e-cigarettes that all products must meet. Then, the companies would have to simply submit information to verify that they are in compliance with these standards. It would be a much simpler, less expensive, and reasonable process that would actually serve to protect the public's health by minimizing the costs of the product while maximizing its benefits.

There is at least some hope for a resolution of this problem even if the FDA promulgates a rule that relies on the new product application approach. Congress is considering legislation that would automatically remove any requirement for a new product application for all products already on the market at the time of the rule's effective date.

Unfortunately, this is not enough because new products introduced after the effective date of the regulations would have to submit new product applications. This would completely stifle the market, discouraging innovation that would otherwise result in safer and more effective products. It would significantly impede progress in protecting and promoting the public's health.

Congress may need to force the FDA to scrap the pre-approval requirements entirely, requiring the agency to simply promulgate a set of uniform safety standards.

Hopefully, there will not be a need for this legislation. However, based on the approach that the FDA has initially proposed, I am not hopeful that the agency is going to take the path that I recommend. It seems that the FDA is headed towards treating e-cigarettes similarly to real cigarettes. Instead, I think that the agency needs to carve out a separate and distinct regulatory framework for electronic cigarettes.

Tuesday, July 07, 2015

E-Cigarette Opponents' Campaign of Deception is Working: Only 11% of Adults Believe E-Cigs are Much Safer than Real Ones

Based on a new study published in the Harm Reduction Journal, the campaign of deception being waged by the CDC, FDA, California Department of Public Health, and other groups which oppose e-cigarettes is working. Only 11% of U.S. adults believe that electronic cigarettes are much safer than real ones. Nearly half of all adults (49%) believe that e-cigarettes are as hazardous (46%) or more hazardous (3%) than real cigarettes.

(See: Kiviniemi MT, Kozlowski LT. Deficiencies in public understanding about tobacco harm reduction: results from a United States national survey. Harm Reduction Journal 2015, 12:21.)

The study concludes that: "Clearly, the public does not show an expert understanding of tobacco/nicotine harm reduction. These limitations in the public’s understanding have the potential to lead to both individual and public health harms."

Importantly, the study notes that the proposed FDA deeming regulations represent a significant barrier to the accurate communication of health risks to the public: "There are some barriers to accurate and effective messaging on this topic. Currently the FDA regulations present significant barriers for manufacturers to make cross-product risk comparisons. The value of these barriers need to be weighed against the possible ill effects of beliefs that are currently held by the public and that can influence behavior. Note the FDA regulations have concerns about promoting reduced-risk products that might increase the population level of use of this safer product. Consumers themselves, however, can be interested in their own levels of toxicological risk—no matter the effects on population health. When some products, like e-cigarettes and snus, are so much less dangerous than cigarettes, it becomes unlikely that increased levels of use could ever produce a net population health loss in comparison to cigarettes."

Ultimately, the authors conclude that: "Given the potential benefits of tobacco risk reduction strategies, public health education efforts to increase understanding of basic harm reduction principles are needed to address these misperceptions."

The Rest of the Story

I agree that the proposed FDA regulations represent a significant barrier to the accurate communication of risk to the public. Making e-cigarettes subject to section 911 of the Tobacco Act (the modified risk provisions) would be a public health disaster. It would prevent companies from telling consumers the truth about their products. In fact, it would force companies to hide from the public the two most important facts about e-cigarettes: (1) that they are much safer than regular cigarettes; and (2) that they do not contain tobacco.

I would add that another significant barrier to an accurate public understanding of the risk of smoking compared to vaping is that so many anti-smoking groups and health agencies, including prominent ones like the FDA and CDC, are waging a campaign of deception that has contributed significantly to the public's misunderstanding of the relative risks of using these products. It is not just that these groups need to heed the authors' advice and start communicating the truth to consumers. First, they must stop lying to consumers by telling them that e-cigarettes are more hazardous than, or equally hazardous as tobacco cigarettes.

Monday, July 06, 2015

U.S. Senator Lies About Tobacco Companies' Role in "Peddling" E-Cigarettes to Children

In a recent op-ed column printed in the Daily Record (Wooster, OH), U.S. Senator Sherrod Brown (D-OH) claims that the tobacco companies are peddling e-cigarettes to children, offering them flavors that include gummi bears, fruit loops, and sweet tarts. Further, he claims that the tobacco companies' goal in marketing e-cigarettes to kids is to get them hooked on tobacco. Finally, he claims that e-cigarettes are a gateway to smoking.

Senator Brown writes:

"Protecting our children from the dangers of tobacco products has always been a challenge—and now Big Tobacco has a new product it is actively peddling to children and teens. E-cigarettes are the new frontier in tobacco companies’ quest to get kids addicted while they are young. ... Now that they are no longer allowed to advertise traditional tobacco products to children, these tobacco companies are taking advantage of the new, unregulated world of e-cigarettes to advertise their products directly to kids. ... And they’re using new advertising platforms on social media to get to kids where parents often aren’t looking. E-cigarettes and their refill liquids come in thousands of different flavors, like gummi bears, sweet tarts, and fruit loops.  Gummi Bears?  Fruit Loops?  Sweet Tarts?  These are candies that young children – not just teens – receive at Halloween. The shameful e-cigarette marketing tactics employed by tobacco companies are aimed at encouraging a new generation to use tobacco. And as the CDC’s study shows – their tactics are working. It is past time for the FDA to regulate these dangerous products before more children and teens get hooked on e-cigarettes. ... E-cigarettes are still tobacco products. Right now they’re being used by the tobacco industry as a gateway cigarette for our children, and that has to stop."

The Rest of the Story

Actually, it's not so clear that the tobacco companies are peddling electronic cigarettes to children. If they were, how does Senator Brown explain why both of the U.S. tobacco companies that sell electronic cigarettes have employed age verification on the web sites for their products which prevents minors from gaining access to these sites? Despite the absence of any requirement that the companies limit access to their sites and despite the absence of any specific requirement that the companies achieve this using third-party age verification services, both of the U.S. tobacco companies have chosen to use third-party age verification, thus making it extremely difficult for minors to access their e-cigarette sites.

Moreover, blu has chosen not to make most of its flavored cigarettes available to minors as disposables. With just one exception, all of blu's potentially youth-enticing flavors are only available for the rechargeable devices, which come at a minimum price of $35.

What is undeniable is that Big Tobacco is not marketing e-cigarettes in the flavors gummi bears, fruit loops, or sweet tarts. None of these flavors are offered by any of the tobacco companies which produce electronic cigarettes. They are being marketed by independent cigarette companies, which obviously do not have any incentive to hook children on tobacco. If anything, they might potentially have an incentive to hook kids on e-cigarettes, but definitely not on tobacco. In fact, the value proposition for virtually every independent electronic cigarette company is to make smoking and tobacco use obsolete.

It is also untrue that e-cigarettes are a gateway to smoking. There is no evidence to support this contention, while a growing body of evidence supports the opposite: e-cigarettes appear to be a gateway away from cigarettes. If the tobacco companies truly wanted to addict more children to smoking, the last thing they would do is actively market flavored e-cigarettes, like sweet tarts-flavored e-cigs, to children. Why? Because once a kid gets used to vaping a sweet tarts flavor, it is going to be virtually impossible to entice that kid to switch to a Marlboro. With evidence that youth smoking rates are plummeting at the same time as e-cigarette experimentation among youth skyrockets, the tobacco companies have no incentive to hook kids on electronic cigarettes.

The marketing of electronic cigarettes is not designed to encourage a new generation of youth to use tobacco. At worst, this marketing may result in a generation of youth which heavily experiments with electronic cigarettes. But most likely, the end result if going to be a diversion away from smoking for many kids who might otherwise have chosen smoking as their method of nicotine inhalation.

I actually agree with Senator Brown's call for regulation of electronic cigarettes and for restrictions on the sale and marketing of these products to minors. However, why is it necessary to lie to the public in order to support the need for such regulations? I've been able to make a strong argument for such regulations while relying on the facts. There's no need to massively deceive the public.

Senator Brown lies again when he states that:

"the U.S. House of Representatives is moving forward with a plan to exempt most e-cigarettes already on the market from any oversight."

The House plan would grandfather existing e-cigarettes from the requirement to submit new product applications in order to stay on the market. However, the plan would not remove all oversight of these products. The products would still be subject to any other rules that the FDA sets for electronic cigarettes, include age of sale restrictions, marketing restrictions, childproof packaging requirements, and any other safety or quality control standards.

It continues to baffle me why electronic cigarette opponents need to lie to the public in order to support what in some cases are sensible restrictions on the sale and marketing of e-cigarettes and on the safety of these products. Why is the truth not enough?

The only explanation that makes sense to me is that the actual facts simply don't support the position of these e-cigarette opponents on the most critical issues, including the relative safety of e-cigarettes, the usefulness of these products for smoking cessation, and the lack of any evidence that e-cigarettes are a gateway to youth smoking.

It seems that not a day goes by without at least one example of an electronic cigarette opponent disseminating a lie to the public about e-cigarettes. The collective result of these actions is a national campaign of deception that is obscuring the public's understanding of the relative safety of e-cigarettes and undermining the public's appreciation of the severe hazards of smoking. Thus, this campaign of deception is not only unethical but it is actually damaging the public's health.

Thursday, July 02, 2015

Public Health Law Center Lies to Public About Tobacco Companies Marketing of Flavored E-Cigarettes

According to a new legal update from the Public Health Law Center, tobacco companies are marketing electronic cigarettes to kids with kid-friendly flavors that include watermelon, Son of a Beach, vanilla malt, popcorn, s’mores, kettle corn, colas, Pizza Pia, chocolate ice cream, and pink lemonade.

The document claims as follows:

"Summer is finally upon us. If you don’t have time to picnic, visit the beach, or go camping, no problem. You can buy your fill of vacation flavors at your nearest tobacco or e-cigarette store — either at a brick and mortar establishment or online. In fact, no matter the season, tobacco product and e-cigarette manufacturers continue to produce seasonally inspired flavors such as watermelon, Son of a Beach, vanilla malt, popcorn, s’mores, kettle corn, colas, Pizza Pia, chocolate ice cream, and pink lemonade in what are euphemistically described as “kid-friendly flavors."

Clearly, the document is claiming that tobacco companies are marketing electronic cigarettes in flavors that include watermelon, Son of a Beach, vanilla malt, popcorn, s’mores, kettle corn, colas, Pizza Pia, chocolate ice cream, and pink lemonade.

The Rest of the Story

The rest of the story is that this claim is not true. None of the tobacco companies are marketing e-cigarettes in any of the above flavors.

Here is a complete list of all the flavors offered by tobacco companies (this list does not include Chinese tobacco companies, whose products are not marketed in the U.S.; it is complete to the best of my knowledge):


Reynolds American (Vuse)
Original
Menthol
Crema
Chai

Altria (Mark Ten)
Classic
Menthol
Fusion
Winter Mint

Imperial (blu)
Classic
Menthol
Cherry Crush
Vivid Vanilla
Pina Colada
Peach Schnapps
Carolina Bold


Green Smoke (owned by Altria)
Tobacco
Menthol
Mocha Mist
Smooth Cream
Mountain Clove

E-Lites (owned by Japan Tobacco)
Tobacco
Menthol

Skycig (acquired by Blu, which was acquired by Imperial)
Tobacco
Menthol
Crown Vanilla
Crown Cherry
Cinnamon

British American Tobacco (Vype)
Tobacco
Crisp Mint
Dark Cherry
Infused Vanilla
Fresh Apple
vPure

Imperial (Puritane)
Original
Menthol

Imperial (Jai)
Original
Intense
Rich
Fresh

Nicolites (owned by Nicocigs, acquired by Philip Morris International)
Tobacco
Menthol

Intellicig (I believe owned by British American Tobacco) (RiZe and ECO e-liquids)
Tobacco
Menthol
Reds
Turkish Gold
Apple
Cherry
French Vanilla
Chocolate
Caramel
Cigar Aficianado
Coffee
Peach
Whiskey

None of the flavors that the Public Health Law Center claims are being marketed to kids by tobacco companies are actually being marketed by tobacco companies. All of the flavors they mention are being marketed by independent electronic cigarette companies.

To be clear, I completely support the work that the Public Health Law Center is doing in tobacco control, and this is not a criticism of their mission or work. However, I just don't see why it is necessary to lie to the public in order to make its point about how electronic cigarettes are being made in a large variety of what seem to be "kid-friendly" flavors. Why not just point out that electronic cigarettes are being marketed in these flavors without claiming that it is the tobacco companies which are producing these flavored products?

The truth is that the major U.S. tobacco companies (and Imperial, which acquired blu e-cigs from Lorillard) are offering very few "kid-friendly" flavors. The two biggest U.S. tobacco companies (Altria and Reynolds American) are marketing their e-cigarettes only in tobacco/original, menthol, crema, chai, fusion, and winter mint flavors. And while blu e-cigarettes are available in kid-friendly flavors such as pina colada and peach schnapps, these two flavors are only available for the rechargeable kits (which start at $35), not as disposable products, which are likely to be more popular among kids because of the price of the starter kits.

I am not arguing here that flavored electronic cigarettes do not appeal to children, that measures to reduce youth access to e-cigarettes are unwarranted, or that restriction of marketing of e-cigarettes to minors is not needed. However, it seems to me that the basic point could have been made without resorting to lying to the public.

I don't mean to pick on the Public Health Law Center. Readers of this blog know that there are numerous tobacco control organizations and health agencies that are lying to the public about electronic cigarettes. What I don't understand is why electronic cigarette opponents need to resort to misleading and deceiving te public to make their points. The only logical explanation appears to be that the truth simply does not support their position, so they have to resort to lies.

Tuesday, June 30, 2015

Why are So Many Anti-Tobacco Groups and Advocates Throwing Vapers Under the Bus?

There is no evidence that electronic cigarettes are a gateway to smoking, that they are attracting nonsmokers to become regular vapers, or that they are impeding smoking cessation. Nevertheless, even if all three of these were the case, one thing would remain true: smokers who succeed in quitting smoking by switching to electronic cigarettes ought to be congratulated rather than scorned. However, the anti-tobacco community has shown nothing but scorn for the vaping community.

Vapers who have quit smoking have greatly improved their health. In fact, they have taken the single most important action to improve their health. They have literally saved their lives. This is a tremendous accomplishment that should be praised. Yet many anti-tobacco groups and advocates will not publicly acknowledge that these thousands of vapers have saved their lives and have shown scorn for the vaping community rather than congratulating vapers on their accomplishment.

Even those vapers who have not quit smoking completely but have cut down substantially on their cigarette consumption have taken an action that is improving their health. In addition to helping slow the progression of respiratory disease and improving respiratory symptoms, this accomplishment has significantly reduced their level of addiction to smoking and will likely make it easier for them to quit smoking in the future. These vapers, too, deserve congratulations and encouragement. But the anti-tobacco community has shown nothing but discouragement for anyone and everyone who is using electronic cigarettes.

The Rest of the Story

Let me take this opportunity to publicly congratulate the vaping community, including all the vapers who are helping to de-normalize smoking by switching to this much safer alternative. I also congratulate all the electronic cigarette companies which are contributing to the public's health by making available this safer alternative that has the potential to reduce cigarette consumption in half in the next decade, according to tobacco financial experts, including Bonnie Herzog at Wells Fargo. For all independent electronic cigarette companies, their value proposition is to make smoking obsolete, as Craig Weiss of NJOY has clearly expressed.

While anti-tobacco groups have attacked and condemned electronic cigarette companies and vapers, I want to take this opportunity to congratulate them and praise them for what they are doing to de-normalize smoking and promote a shift from combustible tobacco products to a much safer non-tobacco-containing product.

The current smoking cessation products on the market are dismal in their effectiveness, with long-term success rates of only about 10%. Clearly, there is a need for an alternative strategy for harm reduction for the 90% of smokers who are unable to quit using nicotine replacement or other drugs. The electronic cigarette companies have provided that alternative strategy, and thanks to their continued innovation, the safety and effectiveness of this strategy are improving every day. Moreover, every smoker who has become a vaper has helped pave the way for a public health revolution.

It is time that anti-tobacco groups and advocates show some respect for the many thousands of vapers who have greatly improved their health by successfully using electronic cigarettes to quit smoking or greatly reduce their tobacco cigarette consumption.

I hope that my publicly calling out the vaping community and pulling them out from under the bus, where they have been thrown by the anti-tobacco community will help reverse the damage that anti-tobacco groups have done by discouraging quit attempts using e-cigarettes and encouraging vaping ex-smokers to return to cigarette smoking.

Monday, June 29, 2015

IN MY VIEW: Anti-Tobacco Advocates are OK With Letting Smokers Die at the Current Rate

In what to me is a shocking admission, two anti-tobacco advocates have argued that there is no need for e-cigarettes - a new and promising smoking cessation tool - because current progress in reducing smoking is sufficient and more smokers each year are trying to quit.

In other words, what they are saying is that they are content with letting smokers die at the current rate. There is no need to expand the smoking cessation alternatives available to smokers, they argue. This means that they are OK with letting smokers die at the current rate and not pursuing a wider range of alternative cessation strategies. They are apparently content with the status quo; that is, the current anti-smoking interventions and cessation treatments (and the current rate of decline in cigarette smoking).

This is shocking to me because it runs counter to not only public health, but to any concept of humanity. How can we possibly be content with letting smokers die at the current rate? How could we possibly not want to accelerate the rate of decline in smoking by making a new smoking cessation tool available to smokers? How can we possibly be content with the current slow rate of decline in smoking prevalence? How can we simply accept the more than 400,000 deaths from smoking each year, and not want to drastically reduce that by pursuing a new, alternative, and potentially much more effective tool for smoking cessation?

This argument is presented in a press release appearing on Stan Glantz's blog and is based on a new article by Kulik and Glantz which appears in the journal Tobacco Control.

According to the press release, Dr. Glantz argues as follows:

"Smokeless tobacco and, more recently, e-cigarettes have been promoted as a harm reduction strategy for smokers who are “unable or unwilling to quit.” The strategy, embraced by both industry and some public health advocates, is based on the assumption that as smoking declines overall, only those who cannot quit will remain.  A new study by researchers at UC San Francisco has found just the opposite.  

The researchers analyzed survey data spanning 18 years in the United States and six years in the European Union. They found that, contrary to the prevailing assumptions, as the fraction of the population that smoked declined, the remaining smokers actually smoked less and were more likely to quit than to stick with it. The authors said their findings challenge the need to promote new forms of nicotine delivery, such as e-cigarettes, since the smoking population continues to quit smoking as a result of proven policies and interventions."


According to Glantz:

"“The fact that the smoking population is softening has important implications for public health policy. These results suggest that current tobacco control policies have been leading to softening of the smoking population without the need to promote new recreational nicotine products like e-cigarettes.”"

Later in the press release, Dr. Kulik echoes this argument:

"We show that there is no real need to distribute e-cigarettes as part of a tobacco policy package because the smoking population is softening."

The Rest of the Story

Whether the smoking population is softening or not is irrelevant to the question of whether we should pursue new and potentially more effective alternative treatments or strategies for smoking cessation. The reason to promote the search for these more effective treatments or alternative strategies is that we are not content with watching more than 400,000 people die from smoking each year and we want to decrease the number of smoking-related deaths as much and as quickly as humanly possible. Smoking prevalence is declining, but it is declining quite slowly. The rapid rates of decline in smoking prevalence that were observed in past decades have plateaued and started to drop off. This should lead us to be open to alternative cessation strategies, not to close the door on them and be content with the current rate of progress.

The authors of this article set up a straw man by arguing that the reason for the promotion of electronic cigarettes is that the smoking population is hardening. Then, if they can show that the smoking population is actually softening, they can argue that e-cigarettes are not needed. However, this is a straw man argument because the reason why advocates like myself are promoting electronic cigarettes has nothing to do with whether the smoking population is hardening or softening.

Even if it were true that the smoking population is softening (and I'll show below that it is not), I would still be promoting electronic cigarettes because there are so many smokers (the overwhelming majority) who fail to quit with existing therapies. We cannot be content to just let these smokers die. Instead, we need to find more effective or at least equally effective alternative strategies that they can use, rather than have them give up on quitting. Electronic cigarettes are just such an alternative and they have helped thousands of smokers to quit who could not and would not have quit using existing treatments.

This reason for promoting electronic cigarettes as an alternative cessation strategy that should be made available to smokers has nothing to do with whether the smoking population is hardening or softening. Even if it were shown convincingly that there was a huge amount of softening of the smoking population, I would never use that as an argument that the status quo is acceptable and that we should be content with the current slow decline in smoking progress and smoking-related disease, disability, and death.

The Rest of the Rest of the Story

Although the potential value of electronic cigarettes is not conditioned on whether the smoking population is hardening or softening, this article misinterprets its own data to incorrectly conclude that the smoking population is softening.

The evidence presented by the article and used to argue that the smoking population is softening is that, according to the article, as smoking prevalence decreases, quit attempts and quit ratio increase. However, the data involve a panel of 50 states with annual measurements over time. Each data point represents the smoking prevalence, quit attempts, and quit ratio in a given state in a given year. So a good deal of the variation in quit attempts and quit ratios is due to differences in smoking prevalence between states, not to differences in smoking prevalence over time.

The study did attempt to make some inferences about the degree to which there were differences in the relationship between smoking prevalence and quit attempts or quit ratios over time by including two time-dependent variables. However, neither of these variables were significant in the models. Thus, there was no change in the relationship between smoking prevalence and either quit attempts or quit ratios over time. In other words, the observed relationship could be explained simply by the fact that states with a lower smoking prevalence tend to have smokers with higher quit attempts and a higher quit ratio. The analysis conducted in the paper is not answering the correct question. It is largely answering the question of whether states with higher smoking prevalence have higher smokers with more quit attempts. In fact, it could be that the reason the smoking prevalence is lower in these states is precisely because the smokers in that state are more likely to try to quit and are more likely to quit successfully.

To examine the question of hardening vs. softening, what really needs to be examined is the relationship not between smoking prevalence and quit ratios and attempts across states, but the relationship between quit attempts and quit ratios over time. What we really want to know is what percentage of quit attempts made each year are successful and how that changes over time across the United States. A state-by-state analysis is of less interest than a national analysis. But most importantly, what we need to know is what proportion of smokers made quit attempts and what proportion succeeded in quitting each year, and then how those proportions changed over time. This is what will tell us whether the percentage of successful quit attempts has been increasing or decreasing over time.

This article confirms that the proportion of smokers making quit attempts in the United States has increased over time. However, trends in smoking prevalence during the same time period confirm that the decline in prevalence has declined over the past decade and a half. And since the number of quit attempts has gone way up, this means that the proportion of quit attempts that are successful has dropped. In other words, smokers are finding it more difficult, not easier, to quit. This actually suggests that the smoking population is hardening.

Dick Puddlecote has provided an excellent explanation of this phenomenon and does a fine job of showing why the conclusions of this study are inconsistent with the very data that it presents. He summarizes his argument as follows:

"Glantz has ... proven that more people are embarking on quit attempts. However, since there is no steepening decline in prevalence from real life data - in fact it is the opposite - this can only mean one thing; that a smaller percentage of smokers are successful with their quit attempts than in the past and making people quit is therefore getting harder."

Interestingly, data from the UK (the Smoking Toolkit Study) quite ironically show that while the proportion of successful quit attempts was stable prior to the dramatic rise in e-cigarette use, this proportion has increased as e-cigarette use has proliferated in the UK. Moreover, the advent of e-cigarettes was associated with large increases in the number of quit attempts being made. Furthermore, the most common aid now used in quit attempts is e-cigarettes.

To be clear, whether the smoking population is hardening or softening is irrelevant to the issue of whether e-cigarettes should be promoted or not. If e-cigarettes are a bona fide smoking cessation aid for many smokers who could not or would not quit using existing therapies, then e-cigarettes should be promoted as an alternative for this sub-population of smokers (which is, in fact, the vast majority - about 90% to 97%). Even if smokers were making ever more quit attempts and becoming more successful, that is no reason to deny the large proportion of smokers who are not successful quitting using traditional drugs the opportunity to try e-cigarettes as an alternative approach.

The rest of the story is that in this new article, the study sets up an irrelevant straw man argument, misconstrues the reasons why e-cigarettes are being promoted, misinterprets the data analysis, and draws an invalid conclusion about the "irrelevant" research question which it set out to answer. But the worst part of the story is that the article, or at least the statements accompanying the article, essentially argue that we should not pursue e-cigarettes because we should be content with the status quo, as smokers are making more quit attempts each year.

But that status quo is actually the death of more than 400,000 smokers each year. That status quo is a decreasing rate of decline in smoking prevalence. How any anti-tobacco activist could be content with the status quo is not clear to me. I honestly believe that it is Dr. Glantz's extreme hatred for e-cigarettes that has led him to express this inane (and rather inhumane) argument.

Current projections suggest that the U.S. is not going to reach the Healthy People 2020 goal of reducing adult smoking prevalence to 12% in the next five years. Why Glantz and Kulik seem to be content with that failure is not clear to me. I would argue that we should not accept the slow rate of progress and we should not be content to rely on current interventions. We need to expand these interventions, not sit on them. Most importantly, we need to pursue alternative smoking cessation treatments for the vast majority of smokers who are unsuccessful using current approaches. Why are Glantz and Kulik throwing these smokers under the bus?