Even with FDA chief Scott Gottlieb stepping down, the agency went ahead this week with its new rules regulating the sales of e-cig products — the big change being the banishment of most fruity flavours.
From now on, only menthol-flavoured cigarettes will be allowed.
Sales of e-cig products will also be restricted to “adult areas” in stores. I have no idea, and I think few people do, how exactly this would work. It sounds like it could literally be a storage closet in the back with a curtain. This was a huge step back from the proposal put forward by Gottlieb a few months ago. He originally proposed that e-cig sales would be restricted solely to tobacco shops, not convenience stores. I liked that idea, because there’s about 1/10th as many tobacco shops as convenience stores.
But, the convenience store industry balked at that and now we have this hybrid policy that no one knows how is going to work.
Unfortunately, with Gottlieb stepping down and a very pro-industry Trump administration in power at the moment, I remain cynical whether the FDA will actually go through with these regulations. Don’t be shocked if this all gets mysteriously dropped in the next few weeks. Gottlieb was a huge advocate (in the Trump administration, weird, huh) against teen smoking and teen vaping. Teen vaping has in particular skyrocketed the past five years, as the largely unregulated vaping industry was absolutely brazen about using friuity, kiddie flavours like bubble gum and Sprite and marketing their products to teens very much like the tobacco industry did 30 and 40 years ago.
FDA Administrator Scott Gottlieb announced this week that he is resigning his position to… get this … spend more time with his family.
Yup, that really actually is his excuse. And this came a couple of weeks after he insisted he wasn’t going anywhere … which was a pretty big clue that he was on his way out.
And he was totally not forced out by Republicans or by the tobacco industry because … he insists he was not forced out by Republicans or the tobacco industry. Repeatedly. So, that’s the end of discussion.
Gottlieb was a total anomaly in the Trump Administration, someone who actually was doing his job. Someone who wasn’t terribly controversial and who didn’t completely dismantle the agency he was put in charge of.
Honestly, for two years, I’ve been scratching my head at it. Trump has clearly put pro-industry, pro-business, anti-regulatory shills in charge of many federal agencies. And it’s clear that their role is to simply dismantle that agency.
Gottlieb was the outlier. He actually was fairly anti-tobacco industry and he was particularly anti-vaping industry (and I don’t differentiate much between the vaping and tobacco industry because the tobacco industry has a controlling interest about 75-80 percent of the vaping industry) was using the FDA to crack down pretty harshly on the vaping industry, mostly over the huge increase in recent years in teen vaping.
Gottlieb had gone so far as to threaten to completely ban vaping products completely. He didn’t follow through with that threat, but he did propose a bunch of new regulations toward vaping products, including rules that vaping products can only be sold in areas completely closed off to minors. He also proposed banning menthol cigarettes.
So, I wasn’t surprised when he suddenly announced this week he was resigning.
Hah, the kicker? He actually boldly announced two months ago he wasn’t going anywhere. That told me right there that there was political pressure coming down on him because he was too anti-industry for Republicans’ taste.
This New York Times article goes to great length to highlight Gottlieb and the Trump Administration’s denials that he was forced out by Big Tobacco and Republicans. He denies it a little too much, frankly. Yeah, because the Trump Administration ALWAYS tells the truth about these things, right? And the “I wanted to spend more time with my family” is the oldest excuse in the book.
Dr. Gottlieb has been subject to increasing pressure from some Republicans in Congress and his former associates in the conservative movement for his tough stance against youth vaping and traditional cigarettes. A coalition of influential conservative groups recently asked the White House to block some key parts of the F.D.A.’s strategy to prevent youths from vaping. Republican Senator Richard Burr blasted the commissioner on the Senate floor for his proposal to ban menthol cigarettes.
Dr. Gottlieb said these protests had no role in his departure.
“There’s no intrigue here,” he said in an interview. A senior White House official said Dr. Gottlieb was not pressured to leave and that the President was “very fond” of him.
Dr. Gottlieb said these protests had no role in his departure.
“There’s no intrigue here,” he said in an interview. A senior White House official said Dr. Gottlieb was not pressured to leave and that the President was “very fond” of him.
Gottlieb’s proposed regulations were in the “pending” stage. Expect them to remain there … or to be dropped entirely. From the article:
Dr. Gottlieb said he planned to advance the F.D.A.’s pending tobacco regulations before he leaves. And he was confident, he said, that the agency’s guidance on restricting flavored e-cigarettes would be issued before he left. He acknowledged, however, that he could not predict the fate of his proposals to ban menthol in cigarettes and reduce nicotine to nonaddictive levels in cigarettes.
Industry analysts expressed optimism that those initiatives would, in fact, now end.
“We think this major development will be broadly viewed as a positive for the tobacco industry, although this introduces some uncertainty,” Bonnie Herzog, a managing director of equity research at Wells Fargo Securities, wrote in an email to clients. “We believe his resignation calls into question whether or not the FDA will in fact enforce harsher regulations around youth e-cig usage/access, cig nicotine limits and a cig menthol ban given he was the champion behind these initiatives.”
So, I expect little or nothing to be done about vaping, teen vaping, menthol cigarettes for the next two years. Gottlieb was the wrong guy, in the wrong administration, to make it happen.
Well, this is progress, I wonder if it will have any effect.
The FDA announced that it will soon ban the sale of e-cig flavourings at minimarts. This is in response to the rapid rise of e-cig use by teenagers. The FDA warned a few weeks ago that it was cracking down on e-cigs because of the epidemic of teen e-cig use. So, this is apparently step one.
Also, cartridge-based e-cig products like Juuls will no longer be allowed to be sold at convenience stores. Sales will be limited to tobacco and vaping shops. Juuls are relatively news, they’ve only been around a year or two, but their use has exploded (not literally) among teens.
That seriously limits the venues that e-cig flavours and Juuls will be sold at — basically from millions of convenience stores around the country to about 10,000 estimated tobacco and vaping stores. It won’t stop kids from trying to buy them, but will make it harder. And tobacco and vaping stores are more regulated than convenience stores.
The FDA, and this is a big one I think, is also going to impose more rules and regulations on online sales of vaping products, requiring stricter standards for age verification. Today, any kid with their own debit card can just click on “yes, I’m 18” on most of these sites.
Will these be enough to stop the epidemic of kids using e-cigs? Only time will tell, but the FDA suggested this is just the beginning of the steps that it plans to crack down on the industry and its lax attitude toward teen vaping.
From an NBC News article on the FDA’s move:
The Centers for Disease Control and Prevention reported Thursday that adult smoking rates have dropped to their lowest level yet, at 14 percent. But the CDC found that 47.4 million U.S. adults , or 19 percent of the adult population, uses any tobacco product, including cigarettes, cigars, or e-cigarettes.
Public health experts have been complaining that the fruity, candy-like flavors found in e-cigarettes are targeted directly at children and teenagers, and rates of teen cigarette use have soared.
The FDA has also expressed concern about online sales to teens. In September, the FDA made an unannounced visit to Juul headquarters to look for evidence about the company’s marketing practices. In April, the agency launched what it called a “blitz” to stop retailers from selling vaping products to underage children. And it has warned several online sites about sales.
Next week, the FDA will do more, the official said.
“We’re also going to restrict online sales only to sites that put in place specific age verification measures and limit access to kids that we are going to specify in guidance,” the official said.
“This is just the first step. We will consider other steps if use doesn’t come down, and sharply.”
Tobacco advocates question if the FDA is going far enough.
Public health groups including the American Heart Association, American Lung Association, American Academy of Pediatrics, the Campaign for Tobacco-Free Kids, Truth Initiative and the American Cancer Society Cancer Action Network, have been urging the FDA to move faster and to remove Juul from the market until it undergoes an FDA review.
“To reverse the epidemic of youth e-cigarette use, the FDA needs to stop the sales of all flavored e-cigarette products that have not been subject to public health review by the FDA as the law requires,” the Campaign for Tobacco-Free Kids, American Academy of Pediatrics, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association and Truth Initiative said in a joint statement.
“There is nothing to prevent the number of vape shops from rapidly expanding and there is no solid evidence that vape shops do a good job of preventing illegal underage sales. In addition, youth use of e-cigarettes is not limited to Juul and other pod-type products. Even before the introduction of Juul, e-cigarettes had become the most commonly used tobacco product among kids and research found that 81 percent of youth who ever tried e-cigarettes started with a flavored product.”
Is this the beginning of the end for e-cigs in the U.S..?
It sounds like a hammer might be coming down very soon, one way or the other.
The FDA is really ratcheting up the rhetoric level against e-cigarettes this week, with FDA Chief Scott Gottlieb saying new data that is soon coming out is showing that the problem of e-cigarette use by teens has grown far worse.
They sound serious. I get a little jaded that the FDA will do anything about nicotine products, but I’ve never seen such strong governmental rhetoric against e-cigarettes before.
FDA Commissioner Scott Gottlieb said the agency will soon release data that show a “substantial increase” in youth vaping this year compared with 2017. He said the problem had reached “epidemic proportion.”
“I have grown increasingly concerned around what we see as rising youth use in these products, and I’m disappointed in the actions the companies have taken to try to address this,” Gottlieb said in an interview.
The FDA told five major e-cigarette manufacturers Wednesday to come up with ways to address youth use in 60 days or the agency could require them to stop selling flavored products that appeal to children. The products being targeted are: Juul, Altria Group Inc.’s MarkTen, Fontem Ventures’s blu, British American Tobacco’s Vuse and Logic.
Whoa, 60 days, so that will be mid-November.
And they’re going after the big boys. Blu, Vuse, MarkTen are about 75 percent of the e-cig market, not counting Juuls.
This new sense of urgency toward e-cigs appears to be driven somewhat by concerns over the exploding use of Juuls. Juuls are a relatively new kind of e-cig that look like a flash drive and are powered by actually plugging them into a laptop computer. They’re incredibly popular with kids.
From the Bloomberg article:
“This could result in a bullet through the head of Juul, the driver of youth initiation,” said Nico von Stackelberg, an analyst with Liberum in London.
To gain clearance to return to the market, the companies would have to prove that the benefits to adults who use e-cigarettes to stop smoking outweigh the risks associated with youth vaping.
“I certainly am in possession of evidence that warrants that,” Gottlieb said. He declined to disclose the evidence.
Of the 3.6 million middle- and high-school students who said in 2017 they are current tobacco-product users, 2.1 million used e-cigarettes, according to the Centers for Disease Control and Prevention.
“There is no question that a lot of the youth use is being driven by Juul,” Gottlieb said.
“Juul was a game changer,” said Matthew Myers of the Campaign for Tobacco-Free Kids. He listed three reasons the company became so successful: It figured out how to deliver high levels of nicotine in a way that wasn’t harsh; it packaged the product in a streamlined, clever way; and it developed a social media and advertising campaign that made a Juul e-cigarette “cool and hip.”
Keep in mind, this issue here isn’t that e-cigs are as bad as cigarettes. But,they are a nicotine-delivery system and they are effectively getting teenagers physically addicted to nicotine. And nicotine addiction is a bad thing in of itself, regardless of the delivery system. And the issue here is e-cig companies have been BRAZENLY marketing e-cig products to kids for years. I know I’ve been railing about it for years.
Oooh, I will DEFINITELY be keeping my eye on this one. The Food and Drug Administration is apparently mulling the possibility of banning vaping flavours and is reviewing any regulations that are needed for Juuls, as well.
Juuls are a fairly new type of e-cigarette that doesn’t look like an e-cig at all. It looks like a little flash drive that plugs into a laptop computer … and they DO plug into laptop computers in order to recharge.
Anyway, for now the FDA is doing anything, but will be starting an anti-teen vaping initiative in mid-September.
This month, the FDA asked four e-cigarette companies for information about the appeal of their products to youths and said it could take enforcement action against the companies based on what it learns.
In mid-September, the FDA will launch a vaping prevention campaign targeting 10 million youths who vape or are open to trying it, Scott Gottlieb said. It will continue enforcement against retailers that sell to minors.
“We are very concerned that we could be addicting a whole generation of young people,” Gottlieb said. “We only have a narrow window of opportunity to address it.”
Instead of committing to regulate flavor, the FDA solicited more research on flavor’s role. Robin Koval, CEO of the anti-tobacco group Truth Initiative, said there is ample evidence that flavors attract teens.
USA Today interviewed a bunch of young college students who vaped. The interview that really jumped out at me came from Kevin Kee.
From the article:
Kevin Kee, 22, took up vaping to give up smoking when he was starting college but found himself going back to smoking again when he noticed the Juul was “more ingrained in my life than cigarettes ever were.”
“With the Juul, you can vape anywhere, 24/7. I went through pods way quicker – I could go through a pod in one day,” Kee said. “My tolerance was higher, and I didn’t want that kind of life coming out of college.”
Kee said he thinks people who vape to quit smoking are a minority and most people “vape just to vape.” Out of college and working, he’s given up cigarettes and vaping but fears a flavor ban would really hurt others.
“It’s become so ingrained in our culture that banning flavored nicotine would be like the prohibition,” he said.
People vape just to vape, not to quit cigarettes. I’m all for people using ecigs to get off cigarettes. What I’m not all for is kids 14-, 15-, 16-year-olds becoming addicted to nicotine to begin with via ecigs or Juuls.
Gottlieb also said that the FDA is keeping an eye on Juuls and for its alleged marketing to teens.
Also from the USA TODAY article regarding the controversial and relatively new Juuls:
A class-action lawsuit filed at U.S. District Court in San Francisco by Juul users alleged that the vaping giant used a two-pronged approach to target adult smokers and teens.
One San Diego teen said she was introduced to Juul by eighth-grade classmates. When her device broke last November, she obtained a warranty replacement through Juul’s website even though she was only 14, the lawsuit says.
The lawsuit alleges Juul targeted youth and nonsmokers through ads and “social media blitzes” using “alluring imagery.” Adult smokers were wooed with the promise of a lower or equal amount of nicotine compared with a cigarette even though the product is designed to be more potent and addictive than cigarettes, the lawsuit says.
“On a puff-for-puff basis, this was designed to be more powerful than the gold standard – the cigarette,” said Esfand Nafisi, a San Francisco Bay Area attorney representing Juul users. “That potency was either not disclosed or misrepresented continuously from the time of the company’s inception.”
So, the moral of the story goes … teen smoking has been all but eliminated, but the struggle continues, and likely will always continue as long as nicotine is a legal product and companies are looking to make billions off of it by attracting new users … be it cigarettes, e-cigs or Juuls. I suspect it will be a never-ending battle.
San Francisco voters, by an extremely wide margin, voted during California’s Tuesday election to ban all flavoured tobacco products.
This include sugary cigars, menthol cigarettes and most importantly, sugary- or fruity-flavoured e-cig products. That is a HUGE deal because most e-cig flavours are fruity or sugary.
68 percent voted in favour of the measure. Just 31 percent voted against it.
San Francisco is notoriously one of the most stridently anti-tobacco cities in the country. And get this, RJ Reynolds spent $12 MILLION to try and defeat this measure. Why does RJ Reynolds care so much? In addition to owning Newport menthols, the No. 1 menthol cigarette (Lorillard originally bought out Vuse and then RJR merged with Lorillard), RJ also owns Vuse e-cigarettes, the No. 1 e-cig company in the U.S. (Somewhere along the line, Vuse must have passed Blu).
Anti-tobacco advocates have been trying to get menthol cigarettes banned for a few years, with little luck, no doubt because they’re a huge part of the overall market and are particularly popular with African-American smokers (My parents always smoked menthols when I was a kid). While menthols get a pass from the Food and Drug Administration, the feds a few years ago did ban candy-flavoured cigarettes because they were clearly being directed by tobacco companies toward teen smokers.
And this is the one of the issues with all these fruity and candy-flavoured e-cigarette flavours out there. It’s well-known that teen vaping is way up; more teens vape today than smoke, which is one of the reasons why teen smoking is way down.
This is a good thing … and it isn’t. Kids are still getting addicted to nicotine, they’re just finding a less obnoxious and cheaper delivery system than cigarettes. I’m fine with smokers using e-cigs to get off of cigarettes. I’m not fine with teenagers getting addicted to nicotine to begin with via e-cigs instead of cigarettes. And there’s no way you will convince me that c-cig flavours like strawberry shortcake, bubblegum or smurf grape are actually meant for adults.
“San Francisco’s youth are routinely bombarded with advertising for flavored tobacco and e-cigarettes every time they walk into a neighborhood convenience store. It’s clear that these products with candy themes and colorful packaging are geared towards teens,” the American Lung Association stated.
I love this quote, too from Patrick Reynolds, whose grandfather started RJ Reynolds. He’s now an avid anti-tobacco (and anti-vaping) advocate:
Patrick Reynolds, the executive director of Foundation for Smokefree America, said that R.J. Reynolds, the tobacco company that his grandfather started, had spent a lot of money fighting the ban because it’s concerned that if it passes in San Francisco, other cities will follow suit.
The company didn’t respond to messages from CNN.
“Big tobacco sees vaping as their future,” Reynolds, an anti-tobacco advocate said. “They are very afraid this is going to pass and if the voters make an informed decision to side with the health community, it will lead to hopefully a tidal wave of cities doing what SF did because the FDA did nothing. We will start to turn the tide against vaping.”
The FDA is warning e-cigarette companies in a letter sent out earlier this month to stop making their products look like candy.
This has been one of the big battles against the fledglinge-cig industry — candy-flavoured products. Candy-flavoured products marketed as candy-flavoured products. And most of all, candy-flavoured products that the industry insists are not designed for underaged users.
Some of these products have names like Smurf Sauce, Twirly Sour Patch kids and Nilla Wafers.
Are you seriously going to try to convince me that any product with the word “Smurf” in it is actually being marketed to adults?
The Food and Drug Administration and Federal Trade Commission sent 13 letters Tuesday to companies that make and sell the liquids used in e-cigarettes, warning them for using false and misleading labeling and advertising. The nicotine products resemble juice boxes, whip-cream canisters and well-known candy and cookie packages like Sour Patch Kids and Nilla Wafers.
The move follows an FDA sting operation that resulted in 40 warning letters last week to retailers that sold kids Juul e-cigarettes, the latest craze in underage tobacco use.
The FDA has given e-cigarette makers extra time to comply with certain e-cigarette regulations and is attempting to rein in youth use while it learns more about the products. Antismoking advocates have criticized the agency for not moving to ban flavors in tobacco products. FDA Commissioner Scott Gottlieb has said he wants to take a balanced approach to help adults who enjoy the flavors switch from regular cigarettes to vaping.
“Companies selling these products have a responsibility to ensure they aren’t putting children in harm’s way or enticing youth use, and we’ll continue to take action against those who sell tobacco products to youth and market products in this egregious fashion,” Gottlieb said in a statement.
The agency plans “a series of escalating actions” as part of a new plan to prevent youth tobacco use, Gottlieb said.
FDA commissioner Scott Gottlieb, in a telephone briefing with reporters, said that it would be hard for “any reasonable person” to examine the products and not conclude that “they are deliberately being packaged and marketed in a way that is designed to not only be appealing to kids” but also to confuse them by mimicking items they frequently consume.
So, something is supposed to hit the fan within three weeks. I’ll be keeping track of this.
I hate to say it. I try to avoid partisan politics on this page, but I am not a fan of Donald Trump and his administration, but I have to admit, this Scott Gottlieb *appears* to actually take his job seriously. I say “appears” because I am by nature a cynical person and I will await to see if the rubber meets the road with him, so to speak.
But, Jesus Christ on a cracker, e-cig flavours based on Oreo cookies, “Smurf sauce” and “Cookies & Milk” and you’re actually going to sit there with a straight face and try to convince me these are products designed for adults? C’mon!
Resembling a flash drive, Juul conveys a sense of industry — you’re Juuling into your MacBook Air while you are cramming for your test on Theodore Dreiser and thinking about trigonometry — and it is so easy to conceal that, as one mother explained to me, she failed to notice that her daughter was vaping in the back seat of the car as she was driving.
It’s basically just the latest “hip” e-cig. And this is one of the issues I have with e-cigs … is they keep trying to pass themselves off as “hip” and the “latest thing.” And kids love stuff that’s “hip” and the “latest thing.”
The company’s position that Juul is intended strictly for “adult” smokers as its website repeatedly indicates, is belied by the menu of flavors in which the nicotine pods are offered. These include Mango, Cool Mint, Fruit Medley and Creme Brulee. As Anthony Charuvastra, a child psychiatrist and assistant professor at New York University’s Medical Center put it, “Who over 25 is looking for creme brulee as part of a smoking experience?”
Like all modern tech companies that attract tens of millions of dollars in venture capital funding, Juul believes it is doing something globally valuable, acting as “part of the solution to end combustible smoking,’’ as its marketing material proclaims. A “Mission & Values” statement on the company’s website declares that no minor should be in possession of Juul and argues that the company is working to combat underage use. In August, it instituted an age-verification system on its e-commerce site to try and prevent anyone under 21 from buying Juul products.
“James and Adam recognized a groundbreaking opportunity to apply industrial design to the smoking industry, which had not materially evolved in over one hundred years,” the Juul website also declares, indicating how little Silicon Valley can distinguish between what needs to be disrupted and what simply needs to go away.
When asked about Juul’s use by teenagers, the company said in a statement, “We condemn the use of our product by minors. We are fully committed to dramatically reducing the incidence of young people using Juul.”
Yeah, the “we here at Juul are very concerned about teen vaping” sounds pretty lame and vapid (They gave a similar statement to Women’s Health), especially when it sounds EXACTLY like the Tobacco Industry excuses for their products being blatantly marketed to teens for decades. So, colour me seriously unimpressed with the owners of Juul and their milquetoast response about teens using their product.
This one is from the University of California, San Francisco (one of the leading anti-tobacco schools in the nation). It found that vapour from e-cigarettes not only contain carcinogenic chemicals, it also found that sweet, fruity-flavoured e-cig flavours are the worst for delivering carcinogenic chemicals into the lung.
These chemicals do not show up in the “ingredients” of e-cigarettes.
The chemicals are not listed on the ingredients of the vape liquid. They’re found under the catch-all description of “flavorings”, the researchers said.
Dr. Mark Rubinstein, of UCSF’s Division of Adolescent Medicine, and colleagues tested 67 teenagers who vape and compared them to 16 teens who both vape and smoke tobacco cigarettes and to 20 teens who do not use either type of cigarette.
They tested their urine and saliva and asked questions about cigarette use.
Those who used both types of cigarette had significantly higher levels of dangerous chemicals, including acrylonitrile, acrolein, propylene oxide, acrylamide and crotonaldehyde, the team reported. And those who used only e-cigarettes had much higher levels than those who used neither product.
“Among our e-cigarette–only participants, the use of fruit-flavored products produced significantly higher levels of the metabolites of acrylonitrile,” they wrote.
Glycerin and other flavorings in both tobacco and e-cigarettes can react with one another or break down into the potentially harmful chemicals.
“Acrylonitrile is a highly poisonous compound used widely in the manufacture of plastics, adhesives and synthetic rubber,” the National Center for Biotechnology Information says on its website.
Acrolein “is toxic to humans following inhalation, oral or dermal exposure,” the Environmental Protection Agency says. Some studies show it can play a part in bringing about lung cancer, although the EPA says there is not enough data to show whether it causes cancer in people.
This is just the latest in countless studies showing that e-cigarettes are — at BEST — not completely benign and really should be avoided by teens … and more should be done to dissuade teens from using them. They might be better than cigarettes, and might be a viable option for a smoker to quit cigarettes, but they should not be used by teens as an alternative delivery system for addictive nicotine. The best choice is to simply avoid nicotine in any form … period.
Another nail in the coffin on the idea that e-cigs are completely safe. Again, I’m a bit ambivalent on e-cigs, but it does bother me — a lot — to see them pretty blatantly marketed to teenagers. Like Medical News Today states … teenagers should not be using e-cigarettes at all.
The irony here is e-cigs were initially marketed long ago as a way to get around indoor smoking bans. I fully remember the Blu e-cig ads with Stephen Dorff and Jenny McCarthy smoking e-cigs at parties and clubs. Well not in New York. And not in a growing number of places.
The biggest issue with e-cigs indoors? Well, while that cloud of nicotine-laced steam might not smell and might not be irritating, it’s still got plenty of chemicals in it beside water vapour, including a potentially large amount of formaldehyde. (The e-cig industry has denounced these formaldeyde studies, but boy it sure sounds exactly like the cigarette companies trying to denounce the ties between smoking and lung cancer.)
I’m at the point where, absolutely e-cig steam does not bother me or irritate my eyes … but that doesn’t mean I personally want to inhale it. That doesn’t mean I want that formaldehyde coming into contact with my lung cells. I’ve found myself holding my breath or turning away from people vaping indoors.
So, yeah, sorry about those ads from three or four years ago, but vaping is being banned indoors. And I’m OK with that.