FDA, Juul, Tobacco Industry

N.Y. Times: Tobacco industry circling like vultures around FDA

Well, this was completely predictable. As predictable as FDA director Scott Gottlieb being forced out to begin with.

Here is a great story from the New York Times about how tobacco and vaping lobbyists are now “circling” the FDA with Gottlieb’s ouster (and yeah, I’m going to call it an ouster … if it walks like a duck …)

That’s circling as in circling like vultures.

From the New York Times article:

Dr. Gottlieb will depart at the end of this month, following his sudden announcement last week that he would resign, with his plans to toughen regulation of both vaping and smoking unfinished and powerful lobbying forces quietly celebrating the exit of a politically canny administrator who aggressively wielded his regulatory powers.

Opponents are already swooping in, making their case to Congress and reaching out to the White House. A coalition of conservative organizations that oppose government intervention in the marketplace has harshly criticized Dr. Gottlieb’s crackdown on e-cigarettes. Retailers, including convenience store and gas station owners, are on Capitol Hill lobbying against guidelines Dr. Gottlieb proposed on Wednesday to restrict sales of most flavored e-cigarettes to separate adult-only areas and to require age verification of customers.

And major tobacco companies are likely to seize on his departure to try to scuttle his long-term plans to lower nicotine levels in cigarettes to nonaddictive levels and to ban menthol cigarettes, which make up more than a third of the cigarette market and dominate sales to African-Americans. Some longtime officials inside the F.D.A. said privately that they fear these ideas could be delayed indefinitely.

“There have been well-intentioned commissioners before Gottlieb,” said Jonathan Havens, a former F.D.A. tobacco lawyer now in private practice. “But they were not as good at capturing the attention of the nation, of the stakeholders. I think that momentum could very well stall on some of these products, or be lost completely.”

It turns out Altria donated $500,000 to Trump’s inauguration committee and that both Altria and Juul, the largest e-cig brand on the market (which Altria just purchased a controlling share of months ago), have both donated thousands to right-wing lobbying firms  run by people like Grover Norquist and others. Juul spent $1.6 million in donations to lobbyists, according to the New York Times.

Gottlieb had also proposed banning menthol cigarettes and forcing cigarette makers to cut the amount of nicotine in their products. Sure enough, it turns out that when asked if the FDA planned to follow through with Gottlieb’s proposals, the response was “no comment.” (I shit you not).

e-cigarettes, e-cigarettes and kids, e-cigs, FDA

FDA releases new rules on e-cigarettes, banning fruity flavours

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.

e-cigs, FDA, Scott Gottlieb, Teen vaping

Scott Gottlieb was totally not forced out at the FDA or anything

Well, you could knock me down with a feather….

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.

From the article:

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.

Chantix, Ray Liotta

Great parody of really kind of weird Ray Liotta Chantix ad

OK, I immediately took an interest in this Ray Liotta Chantix ad that you see constantly on ESPN and during football games, just because of my interest in tobacco control.

It’s actually not a bad commercial. Ray sounds very sincere in his endorsement for this product and/or service. However, he just looks … weird. I really think he’s just had too much work done, like Kenny Rogers.

And for some reason, everything Ray is doing while endorsing Chantix is in slow motion. Playing with his dog. Slow motion. Drinking coffee. Slow motion. He even appears to give a Nazi salute … in slow motion. (Im sure Ray isn’t a Nazi … don’t beat me up Ray, I’ve seen  “Something Wild.” You tIt gives a certain gravitas to Ray … and Chantix. “Now, that I’m not going to die of smoking, I’m taking things slow and enjoying life…”

I also have to crack up because this is the same guy who does Vodka ads. “OK, I quit smoking, but I didn’t quit vodka, because I’m not some kind of pussy, OK?”

So, here’s the original Ray Liotta commercial, in all of his Botox glory

Here’s the parody

Here’s another parody, with scenes from Goodfellas

You have to laugh at it.

Uncategorized

More mixed bags for e-cigs … study suggests e-cigs increase risk of stroke

It’s been such a mixed week for e-cigs, with one study showing e-cigs are more successful than nicotine patches and gum for helping people quit, yet the American Lung Association ripping the FDA as a “failure” for doing nothing to stem the tide of teen vaping.

Well, this week another study came out that e-cigarettes, while perhaps safer than cigarettes, are still not completely harmless.

In what is admittadly a pretty limited study, a new survey by the American Stroke Association shows that e-cig use is associated with a higher risk of strokes and heart attacks.

From an NPR story:

“There’s a certain notion that e-cigarettes are harmless,” says Dr. Paul Ndunda, the study’s author and an assistant professor at the School of Medicine at the University of Kansas in Wichita. “But this study and previous other studies show that while they’re less harmful than normal cigarettes, their use still comes with risks.”

This study relied on a behavioral factor survey from the CDC and looked at 66,000 e-cig users. It found a 71 percent higher risk of stroke, 59 percent higher risk of heart attack and 40 percent higher risk of heart disease.

(OK, I’m going to be honest here … while I’m sure these figures are accurate, my first question is how many of these e-cig users are smokers and former smokers … the increased risk of stroke and heart disease could be from the smoking more than the e-cigs.)

The study does get into this to a degree, to be fair.

From NPR:

Ndunda found e-cigarette users are twice as likely to also smoke conventional cigarettes, compared with people who don’t use e-cigarettes.

To see the health effects of e-cigarette use alone, Ndunda and his colleague Dr. Tabitha Muutu compared people who had only used e-cigarettes — not conventional cigarettes — to nonsmokers.

“Even in that group there was a 29 percent higher risk of stroke and a 25 percent higher risk of heart attack,” Ndunda says. Taken together, these two analyses point to an additive effect of e-cigarette and conventional cigarette use.

So, Ndunda admits in the aritlce that the study has its limitations because there’s so many factors at play here — e-cigs, mixing e-cigs and cigarettes, and my point, the pre-existing damage experienced by former smokers from their decades of cigarette use.

Anyway, this survey strongly suggests it’s probably a really, really bad idea to mix e-cigs and cigarettes together. That if you’re going to use e-cigs, you really have to quit cigarettes to actually have any health benefit.

American Lung Association

And now for the other side of the coin … Harsh Lung Association report says FDA efforts to stop teen vaping a complete “failure”

In what NBC News is calling a “scathing” report, the American Lung Association rips the Food and Drug Administration for failing to take any action to stem the epidemic of teen vaping.

One of the proposals from the Lung Association is to raise the legal age of buying e-cig products to 21 and getting rid of fruity e-cig flavourings.

From the NBC News story:

“This year’s report finds a disturbing failure of the federal government and states to take action to prevent and reduce tobacco use in 2018, placing the health and lives of Americans at risk, including our youth,” the American Lung Association’s national president and CEO, Harold P. Wimmer, said in a statement.

Health

“The FDA’s failure to act has emboldened the tobacco industry, which has become increasingly aggressive in seeking to delay or oppose proven policies,” Wimmer said.

States need to raise their minimum age to purchase tobacco products to 21 and remove flavored e-cigarettes from the market, Erika Sward, national assistant vice president for advocacy for the American Lung Association, told NBC News.

“As a result of the failure by the federal and state governments to act, the tobacco industry is on a resurgence,” and therefore maneuvering “to addict our kids,” Sward said.

This final point is a really important to remember about the tobacco industry’s ties to e-cigs. The industry absolutely control the e-cig market, especially since Altria (formerly known as Philip Morris, makers of Marlboros) bought a stake in Juuls, the biggest e-cig brand on the market. Big Tobacco already owned Blu E-cigs, MarkTen and Vuse.

The industry sold people the disease — cigarettes. And is now selling people the cure — e-cigs. Pretty ingenious, huh?

So, cigarettes have become socially unacceptable, how is the tobacco industry recovering its costs? A wildly successful e-cig market and a 78 percent increase in teen vaping.

The report also grades states on their efforts toward tobacco control. The Lung Association doesn’t mince words. Most every state gets a failing grade. A handful get As, California gets a B.

The FDA is talking tough about e-cigs lately, but so far hasn’t taken any firm action. One proposal from the agency is to require that e-cigs be sold in areas cordoned off to teens, but no one has any idea how that could work. A proposal to restrict all sales to tobacco shops was dropped as quickly as it was raised.

It may be too little too late for the FDA to stem the epidemic of teen vaping. This epidemic grew and grew for four or five years before the FDA even acknowledged it.

Uncategorized

Study: E-cigs more effective than patches, gum for quitting cigarettes

Three studies came out in one day about e-cigarettes, two very, very negative and the third one with positive news.

It sort of sums up the mixed bag that are e-cigs, and sums up the quandary about them.

First, the good news. A recent study by Queen Mary University in London, published by the New England Journal of Medicine shows that e-cigarettes are far more effective than nicotine gum or patches in getting people to quit cigarettes.

The study involved 886 smokers, half were given the option to quit using e-cigs and the other half were given the option to quit through patches, gum or other nicotine replacement therapies.

After one full year, 18 percent of the e-cig group was able to quit smoking, while just 9.9 percent of the patches and gum group quit.

Those percentages may not sound good, but it’s widely known that nicotine replacement treatments have a pretty high failure rate. Most smokers, it takes four or five tries or more to actually quit.

From a CNBC article:

Doctors have been wary of recommending people use e-cigarettes as a way to wean themselves off conventional cigarettes, citing both the lack of evidence showing they work and lack of data on the long-term health effects of using the products. The new study may quell some of those concerns. However, the study is also likely to receive some pushback because it was conducted in the United Kingdom, which has embraced and even encouraged e-cigarettes as an alternative for adult smokers.

Here’s another flaw with the study, I think. The point of patches and gum is to eventually wean people off of addictive nicotine. However, that’s not how very many people really use e-cigs. They remain addicted to the nicotine, and in my opinion, as long as they remain addicted, they remain at risk at falling back onto cigarettes.

From the same article:

“While e-cigarettes are ‘safer’ than traditional cigarettes, they are not without risks,” Boston University professors Belinda Borrelli and George O’Connor said in a statement.

They also pointed to the finding that at the one-year mark, 80 percent of people in the e-cigarette group were still using the devices. So while people stopped smoking cigarettes, they were still using e-cigarettes. The study’s authors also noted this finding, saying it “can be seen as problematic if e-cigarette use for a year signals ongoing long-term use, which may pose as-yet unknown health risks.”

Huge numbers of teens using the products — particularly one brand, Juul — have soured perceptions about e-cigarettes in the U.S. Even Food and Drug Administration Commissioner Scott Gottlieb, who has championed the devices as a way to help adult smokers, says the industry is at a tipping point.

That final paragraph about Juuls explains the condundrum about e-cigarettes. While they appear to have a very valid and genuine value in helping some people quit smoking, the down side is their use among teens has exploded in the past five years … and these are kids who have never smoked a cigarette in their lives. They’re not using e-cigs to get off cigarettes, they’re using them to get addicted to nicotine to begin with.

The FDA has started talking tough about e-cigs the past couple of months, even going so far as saying it might just outright ban e-cigs. If 18 percent of the people who try e-cigs to get off cigarettes are successful, I think that’d be a terrible step in the wrong direction.

But, they gotta stop the teen epidemic of vaping. If that means banning fruity e-cig flavours, so be it. I personally would like to see e-cig marketing more strictly regulated. I liked the idea the FDA came up with a few weeks ago (and quickly dropped, unfortunately), of only allowing e-cig sales in tobacco shops, where you have to show an ID just to walk into the door. The FDA came up with some odd idea of only allowing e-cig sales in adult areas … but still allowing them to be sold in convenience stores. How could that even work?

Anyway, an interesting study showing the other side of the e-cig debate and showing that it’s not a black and white issue.

e-cig bans, FDA, Uncategorized

FDA chief threatens to completely remove e-cigs from the market

The war between FDA chief Scott Gottlieb and the e-cig industry continues to escalate with Gottlieb last week threatening to just say “Fuck it” and completely take e-cigs off the market.

To wit, the Food and Drug Administration has come out harshly against the e-cig industry beginning about six months ago because of the skyrocketing increase in teen vaping rates.

So, the FDA came out with a series of rules regarding e-cigs, including some restrictions on fruity flavours and the requirement that e-cig products only be sold in areas open to adults. The FDA didn’t get into marketing of e-cig products.

These rules weren’t as strong as what *I* had hoped for, at the very least, I liked an idea that was floated to restrict e-cig sales strictly to tobacco shops, but that got dropped, likely because of pressure from the industry.

Anyway, Gottlieb said he has met with industry representatives and he remains unimpressed with their response so far.

This is a quote from a Gottlieb tweet:

I still believe e-cigarettes present an opportunity for adult smokers to transition off cigarettes and onto nicotine delivery products that may not have the same level of risks. However, if the youth use continues to rise, the entire category will face an existential threat

Also, from an NBC News article:


“I’ll tell you this. If the youth use continues to rise, and we see significant increases in use in 2019, on top of the dramatic rise in 2018, the entire category will face an existential threat,” Gottlieb told a meeting.
“It will be game over for these products until they can successfully traverse the regulatory process.”

Gottlieb said he has met repeatedly with the vape industry. “I find myself debating with tobacco makers and retailers the merits of selling fruity flavors in ways that remain easily accessible to kids,” he said.

Last November, Gottlieb said he was starting the process to limit sales of flavored e-cigarettes, as well as to ban menthol in combustible cigarettes.

“I have questions about whether they are living up to the very modest promises that they made,” he said. “It matters if the e-cig makers can’t honor even modest, voluntary commitments that they made to the FDA.”

I’m curious if the industry is taking these threats seriously? Juul very quickly shut down its social media presence, but it might be too little, too late to slow down teen vaping use … or to satisfy the FDA.

Gottlieb said the dramatic rise in e-cigs is sabotaging the success public health advocates have had in cutting the teen smoking rate.

From a Yahoo article:

“This progress is being undercut — even eclipsed — by the recent, dramatic rise in youth vaping. A few years ago, it would have been incredible to me that we’d be here, discussing the potential for drug therapy to help addicted youth vapers quit nicotine,” he said Friday.

Gottlieb cited statistics about the large use of e-cigarettes by young people, saying that between 2017 and 2018 there was a 78 percent increase in e-cigarette use in high school students, and a 48 percent increase among middle schoolers. That means the total number of middle- and high-school students using e-cigarettes rose to 3.6 million — 1.5 million more than used the product the previous year. He added that more than a quarter (27.7 percent) of high-school-age e-cigarette users use the product regularly, and more than two-thirds (67.8 percent) are using flavored e-cigarettes. 

“Youth use of e-cigarettes has become an epidemic,” Gottlieb said, adding, “It could be ‘game over’ for some [of] these products until they can successfully traverse the regulatory process. I think the stakes are that high.” Gottlieb also noted that e-cigarettes can be a helpful tool for adults trying to quit smoking traditional cigarettes, and said he hopes to avoid removing e-cigarettes from the market because of the good they can serve in that regard. 

Stay tuned. Gonna be a rocky year on this issue likely.

Uncategorized

It’s official, Juul is now a subsidiary of Philip Morris, ie Altria

The tobacco industry will sell you the disease and now will sell you the cure.

This came out a couple of weeks ago and apparently this week it became official. Juul, those cutesey little e-cigs that plug into laptop computer and look just like a flash drive, came to completely dominate the e-cig industry incredibly quickly, eating up 75 percent of the market in less than two years.

Altria just invested $13.5 BILLION into Juul, taking ownership of 35 percent of the company.

Juuls sort of advertised themselves as an indie company against the tide of Big Tobacco. No more. Juul IS BIG TOBACCO now, baby. Altria, formerly known as Philip Morris, makers of Marlboro cigarettes.

Here’s the shit that actually pisses me off. From an AP story:

Juul will remain an independent company, but it gains access to Altria’s massive infrastructure and reach. Namely, Altria will help Juul secure space on store shelves beside traditional cigarettes. It will also help Juul reach smokers via cigarette pack inserts and mailings.

Yeah, fuck you, Juul. You’ve been one of the biggest guilty parties, if not THE biggest guilty party, in marketing e-cigs to kids. Now that you’ve got these teenagers hooked on nicotine, you get Altria’s [quote] “massive infrastructure and reach.”

Uncategorized

Surgeon general labels teen vaping an “epidemic”

More harsh rhetoric toward e-cigarettes and the explosion of e-cig use by teenagers over the past seven years.

U.S. Surgeon General Dr. Jerome Adams joined the head of the FDA this week in denouncing e-cigarettes, going so far as to call teenage e-cigarette use an “epidemic.”

From an NPR article:

“I am officially declaring e-cigarette use among youth an epidemic in the United States,” Adams said at a news conference. “Now is the time to take action. We need to protect our young people from all tobacco products, including e-cigarettes.”


“We have never seen use of any substance by America’s young people rise this rapidly,” Health and Human Services Secretary Alex Azar said at the briefing. “This is an unprecedented challenge.”

Officials at this press conference largely blamed Juul for the epidemic, though to be fair, the increase in teen vaping was already happening before Juuls hit the market about two years ago.

Less than 2 percent of teens were vaping in 2011. In 2018, that figure has increased to 21 percent.

At the same time, there’s been a big decrease in teens smoking, which is great.

Teens getting addicted to nicotine, not so great.

I debated with a few vaping advocates on this story. They keep harping on two really false and lame narratives.

One: Who cares if teens are vaping … would you rather they be doing crack or meth?

Well, no, of course, that’s just stupid. I’d rather they not do ANY addicting substances. It’s not an either/or situation. It’s not either they vape or they do meth. I’d rather they do NEITHER.

And the second lame point: “Well, e-cigs don’t have the toxins of cigarettes, and they’re much safer than cigarettes.”

Yes, probably. And I emphasize “probably,” big time. Because the jury is still out about that. No one is totally sure everything that is in e-cig vapour. Yes, e-cigs don’t contain the Polunium-210 and carbon monoxide and benzene that cigarette smoke does, but it still contains formaldehyde and most of all … nicotine, which is incredibly addictive. And studies have shown that a higher percentage of teens who vape eventually take up smoking to get their nicotine fixed filled, than teens who never vaped to begin with.

Anyway, I’m going to get into these weak-ass arguments in a little more in-depth in a later post about libertarian fake journalist and tobacco industry apologist stooge John Stossel (again … this isn’t my first go-around with Stossel, who seems to really have a thing about tobacco issues.).

Anyway, to try and combat the increase in teen vaping, the FDA has proposed putting limits on where e-cigarettes can be sold, ruling that they must be sold in an area closed off to minors. The FDA pulled up just short of flat out banning e-cigarette sales in minimarts and convenience stores, which was being proposed.

Strong language, for sure from the surgeon general. It’s going to be really interesting what will happen with the e-cigarette industry in the next two or three years.

Here’s a good article from the Verge about what Adams’ proclamation actually means. It means e-cigarettes are squarely in regulators’ sites:

From the Verge:

The Surgeon General’s power is more about influence, and less about enforcement: the real regulatory power over vaping comes from the Food and Drug Administration. So this advisory doesn’t have any legal force, Micah Berman, a professor of health services management and policy at The Ohio State University, tells The Verge in an email. “They are a tool used by the Surgeon General to call attention to an issue and to provide guidance to the public,” Berman says. “They are only issued rarely, when immediate action is called for — which is what makes them so noteworthy.”


That’s why it’s particularly significant that the Surgeon General is using the word “epidemic,” says Kathleen Hoke, a professor specializing in public health law at the University of Maryland: “Using the e-word, epidemic, takes it to a higher level. From a public health perspective, we try not to use that word unless it’s warranted — otherwise you have the boy cried wolf,” she says. But she says, according to these health officials, youth vaping has reached that level: “It’s broad, vast in its impacts, and of deep concern about its lasting effects.”