Tag Archives: FDA

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

March 15, 2019 Pepe Lepew

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

March 15, 2019 Pepe Lepew

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

March 6, 2019 Pepe Lepew

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.

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.

e-cig bans, FDA, Uncategorized

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

January 25, 2019 Pepe Lepew

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.

e-cig flavourings, e-cigarettes and kids, e-cigs, FDA, Juul, Teen vaping

FDA to ban flavoured e-cig products from minimarts

November 9, 2018 Pepe Lepew

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.

FDA, nicotine

FDA proposes reducing the amount of nicotine in cigarettes

March 16, 2018 Pepe Lepew

Got mixed feelings on this one and I definitely need to get more information to have a hard and fast opinion.

The FDA, which under the Trump Administration I seriously no longer trust at all, is taking public comment on its proposal to drop the level of nicotine to “minimally or non-addictive levels.”

Seriously, considering who is the president right now, I’m amazed the FDA is going after Big Tobacco at all. Which makes me paranoid that this is some kind of end run that will end up actually helping Big Tobacco. How, I’m not sure, but I cannot trust this administration. It doesn’t help my paranoia that the tobacco industry is weirdly applauding the measure.

From a Agence French Press article:

“Today’s advance notice is a request for information, not a proposed rule, and is the first step in a multi-year process that will require the agency to examine and resolve many complex issues,” said Murray Garnick, executive vice president and general counsel of Altria Group, Inc., which includes tobacco giant Philip Morris.

“As FDA has acknowledged, any proposed nicotine standard would need to be part of a comprehensive package,” he added.

“Altria has already been preparing for any reasonable potential standard, and we plan to participate in every step of this process.”

I’d feel more comfortable if the industry was openly freaking out about this.

Anyway, without getting into conspiracy theories, right off the bat, I have two thoughts.

If you simply reduce the level of nicotine, won’t that prompt smokers to smoke more in order to get the same level of nicotine they got prior? Remember, these are people already addicted to nicotine. I have no science to back this up, it’s just a thought on my part.

I CAN see a benefit that lowering nicotine drastically will make it much more difficult for young smokers to get addicted to nicotine to begin with.

There is some science to back up this point.

From a the Agence French Press article:

“We’re taking a pivotal step today that could ultimately bring us closer to our vision of a world where combustible cigarettes would no longer create or sustain addiction -– making it harder for future generations to become addicted in the first place and allowing more currently addicted smokers to quit or switch to potentially less harmful products,” said FDA commissioner Scott Gottlieb.

A study released Thursday in the New England Journal of Medicine projected that cutting nicotine to a non-addictive level could mean five million fewer smokers in the first year of implementation.

Within five years, another eight million fewer people would smoke, and by 2060, the smoking rate in the United States could drop to 1.4 percent, down from its present level of 15 percent, said the report.

Anyway, interesting times. I will definitely keep an eye on how this turns out. I expect it will be a while and I expect Trump will be long gone before it comes to any fruition.

Big Tobacco, e-cigarettes, e-cigs, FDA, Full Frontal

Samantha Bee: Big Tobacco and Little Vape — and a criticism of “Full Frontal”

July 31, 2016 Pepe Lepew

This is a really funny and fairly sympathetic piece done by Samantha Bee’s “Full Frontal” about the new Food and Drug Administration regulations and its effect on the vaping industry. The piece did miss one big point about the vaping industry, however.

The proposed regs, while missing a lot of important proposals anti-tobacco advocates wanted, like curbs on marketing and Internet sales, would require all vaping products to individually go through a lengthy approval process. Vaping advocates say this would cripple if not completely wipe out the vaping industry because the costs to go through this process would be so onerous. The FDA itself estimates that between 30 percent to 70 percent of e-cig businesses may be forced to go out of business due to the new regulations.

Full Frontal visited a vaping conference and did have a good time poking fun at vapers. For instance, Samantha Bee sends a correspondent to the conference rather than go herself because she doesn’t want to be around vapers, then the correspondent immediately runs out the door as soon as she encounters e-cigarette steam blown in her face. However, the show was fair to e-cigs and did acknowledge that some studies have shown that vaping is far less dangerous than smoking.

One thing I honestly learned from the segment is that there is a pretty distinct actual honest-to-goodness “vaping culture,” that at least according to the show, has a counter-culture edge. Sort of like cigar culture only with lots of piercings, I suppose. I never realized this culture existed, though, as I thought about it, some of the e-cig proponents I’ve dealt with online are almost messianic in their defence of e-cigarettes.

One thing the Full Frontal segment did get wrong, however, (and they got this like … really wrong), was that suggesting that Big Tobacco has “struggled to compete” in the e-cigarette market. That’s really not true. Vuse E-Cigs (35 percent market share, Blu E-Cigs (23 percent) and MarkTen (16 percent), the No. 1, No. 2 and No. 3 e-cig brands on the market, are actually wholly-owned subsidiaries of RJ Reynolds, Imperial Tobacco Group and Altria (Philip Morris). In fact, these three brands represent a combined 74 percent of the e-cig market. Seventy-four percent is hardly “struggling to compete.”

Yeah, maybe Big Tobacco wants to crush all the smaller makers through FDA regulations (Though, Altria has expressed its opposition to the FDA regulations), but if that’s the case, the real story is the tobacco industry is already deeply entrenched in and dominating the e-cig industry. Will these regulations help Big Tobacco dominate it even more? Full Frontal didn’t even mention that Big Tobacco owns the three most dominant e-cigarette brands and I really think the show either missed or ignored that dynamic between Big Tobacco and e-cigarettes.

e-cigarette advertising, e-cigarettes, e-cigs, FDA, Uncategorized

FDA finally issues ruling on e-cigarettes

May 6, 2016 Pepe Lepew

At long last, after TWO years of deliberations, the Food and Drug Administration earlier this week FINALLY issued a ruling on e-cigarette (and tobacco) regulation.

Unfortunately, this came at a time when I was really busy, plus I wanted to take a few days to digest the news.

My initial reaction to the news was disappointment that the FDA will do nothing to control e-cigarette marketing, online sales or candy flavourings. The biggest obvious change is the sale of e-cig products to minors will be banned. However, over 40 states already ban e-cig sales to minors, so this ruling is a bit cosmetic.

However, then I started reading comments from the e-cigarette industry absolutely FREAKING OUT over these regs, and I started thinking, “wow, if the e-cigarette industry is so pissed off, the regs can’t be that bad.”

It turns out the FDA ruling is pretty complex, and I’m personally still sifting through it to see what it means, and I fully expect to be writing more posts about this over the next several weeks and months. I saw several headlines that screamed, “E-cigarettes virtually banned.” Here’s what they’re talking about and what turns out might be the biggest effect of this ruling: The FDA will require that all tobacco products (which under the FDA definition includes e-cigs even though they don’t actually contain tobacco — they do contain nicotine) that hit the market since 2007 must be individually approved by the FDA. E-cigs were basically non-existent before 2007, so this affects nearly all e-cig products.

From a USA Today article:

That means nearly every e-cigarette on the market — and every different flavor and nicotine level — would require a separate application for federal approval. Each application could cost $1 million or more, says Jeff Stier, an e-cigarette advocate with the National Center for Public Policy Research and industry officials.

One million dolalrs each for every flavour? Holy cow, on the face of it, that would cripple the industry. Sure enough, industry leaders are incensed.

From a CNN story:

Ray Story, the founder and CEO of the Tobacco Vapor Electronic Cigarette Association, called the ruling “a complete disaster.” Since 2009, his association has advocated for a change in the law that would require age verification and restrict sales to minors.

“No children should have access to these products. Just like with alcohol, these are adult products,” he said.

What he takes issue with is the FDA requirement for approval on the products, down to the batteries. He said the rule “essentially bans the product across the land.”

Also, from a USA Today commentary, titled the “FDA went too far”:

E-cigarette shouldn’t be sold to minors, and government should restrict advertising so they aren’t marketed to kids. But the FDA’s drastic overstep today will require e-cigarettes not already on the market by February 2007 to undergo a costly and onerous Premarket Tobacco Application process that holds e-cigarettes to a standard nearly impossible to prove, and one that well-established actual cigarettes don’t have to face.

By the way, this commentary was actually written by Jeff Stier, who is from an organization called the National Center for Public Policy Research, which is described by Wikipedia as a “conservative think tank.” These are the same kind of “think tanks” that claimed for decades that there was no proof that smoking caused lung cancer or that secondhand smoke was completely harmless. If that wasn’t convincing enough … the National Center for Public Policy Research actually receives some of its funding from Big Tobacco and Big E-Cig (Which is rapidly becoming a wholly owned subsidiary of Big Tobacco). So take this hyperbole with as many grains of salt as you please. I take it was LOT of grains of salt.

Now, it could be these industry folks are being hyperbolic as hell. I remember back in the day everyone thought the 1998 Master Settlement Agreement was going to be the death of Big Tobacco. But, I love that the e-cig industry is freaking out. GOOD. They deserve to freak out.

Here’s why. I walk a fine line with e-cigs. I get it that e-cigs genuinely help some people get off cigarettes. There’s mixed data about the effectiveness of e-cigs as a tool for smoking cessation. But, I’ve seen enough anecdotal information online about people praising them for helping to get them off cigarettes to believe that they have a genuine value.

However, here is the problem with e-cigs. It has been painfully clear to people actually paying attention that e-cigs are blatantly marketing their products to kids … using actors dressed up as race car drivers, using women’s panties, even using Santa Clause … to sell e-cigs. Jesus …even Santa Clause? Big Tobacco did this kind of stuff 60 years ago, heck they were still using race car imagery with Joe Camel as recently as 20 years ago.

They’re using this hip, young, active, savvy, sexy imagery to addict teenagers to nicotine. For all of the benefits of e-cigs, and it appears there are some real benefits, it’s still a delivery system for nicotine. And nicotine is one of the most addictive substances on the planet. And people still don’t know what all is in e-cigarette steam. We know it contains formaldehyde and another chemical called diacetyl, which causes a disease known as “popcorn lung.”

From another very well-written USA Today editorial, this written by the USA Today editorial board of directors, appropriate titled “FDA takes e-cigs out of ‘wild West'”:

Once before, the nation let an addictive product get by with little regulation. By the time the surgeon general first warned of cigarettes’ deadly dangers in 1964, about four in 10 Americans were already hooked. It has taken more than 50 years and a costly war on smoking to cut that adult rate in half and to bring teen smoking down to about 9%.

No wonder the government and public health advocates are wary of these new “vaping” products, which also contain nicotine, and some of which are made by the same companies that brought the nation Joe Camel and the Marlboro Man.

While advocates for e-cigarettes talk about their potential upside in the future — getting smokers to quit — they seldom acknowledge the facts on the ground right now: E-cig use among teenagers is exploding. Last year, 16% of high school students used e-cigarettes at least once in the past month, making the devices more popular than traditional cigarettes among teens, according to a national survey by the federal government. That’s up from 1.5% in 2011 — an astounding rise.

Promoters argue that teens are switching to a safer product. Great if true. But some earlier data show that many teens who use e-cigarettes have not smoked traditional cigarettes before. Exactly how many fit that description now is a key question that researchers need to sort out.

Industry players also underscore that their products are only for adults. Their advertising says otherwise: The women who vape are sexy and glamorous, the men rugged and rebellious, the very themes that attracted generations of teens to traditional cigarettes. In stores, e-cigarettes are sold above ice cream freezers, next to candy and in flavors that include Cherry Crush and Gummy Bear. About 85% of youths who had used e-cigs in the past 30 days used ones that were flavored.

Game. Set. Match. Thank you, USA Today.

These rules will not go into effect immediately. I was initially deeply disappointed in the lack of regs over e-cig marketing (I believe the FDA was wary of going here because of fears over First Amendment lawsuits, and guess what, if the FDA loses a First Amendment lawsuit over e-cigs, that might affect the federal government’s ability to regulate marketing of cigarettes.). I don’t get as worked up about the candy flavouring because so many adult users have told me they like the sweet flavours, too, but I know a lot of anti-tobacco advocates hate that e-cigs are allowed to have sugary flavours.

But, this subtle little language about requiring all e-cig products to be approved by the FDA might reel in this out-of-control industry, which is selling a drug and is selling an addictive drug … to kids … with a wink and a nod … “Moi? Not us!”

Now, there is apparently legislation in Congress to push up this 2007 date and grandfather current e-cig products so they wouldn’t require individual review by the FDA. Golly wonder whose lobbyists might be behind that? I hope Obama and any other future Democratic president vetoes any such legislation that reaches his or her desk. The e-cig industry is a multi-billion dollar industry, about 40 percent of which is actually owned by Big Tobacco. It can damn well pony up to have its products approved fair and square.

I will be posting more on this, I promise, as the story develops.

centers for disease control, Congress, FDA, U.S. House

Bills would cut CDC funding for smoking prevention; limit FDA review of e-cigs, candy cigars

October 17, 2015 Pepe Lepew

I wasn’t even aware these bills were out there until I saw this recent editorial from The Hill.

There are two bills floating through Congress that would cut more than 50 percent of the funding for a Centers for Disease Control program to prevent kids from taking up smoking and for helping them to quit once they’ve started.

The second bill is even more heinous. It would restrict the Food and Drug Administration’s oversight over e-cigarettes and candy-flavoured cigars., including oversight over new tobacco products.

Gosh, I wonder who is lobbying for both of these bills?

Even though the editorial doesn’t get into partisanship, it’s also pretty obvious to me that these are likely both Republican-sponsored bills. Why they would want to cut funding for tobacco education and prevention is beyond me. I have no doubt the people behind these bills are receiving campaign contributions from Big Tobacco. It’s so cynical. And 77 percent of Big Tobacco’s political contributions go toward Republicans.

Fortunately, even though these provisions have been approved by the U.S. House Appropriations Committee, I doubt that either bill will become law, as long as a Democrat is in the White House. But, what a waste of time and energy to be even be proposed such ridiculous ideas.

The FDA is expected to release rules and regulations — eventually, one of these days — regarding e-cigarettes.

Big Tobacco, Camel Crush Bold, FDA, RJ Reynolds

FDA blocks four new RJ Reynolds brands, including Camel Crush Bold

September 18, 2015 Pepe Lepew 2 Comments

This is a really interesting story.

The Food and Drug Administration, which for the most part has taken a pretty milquetoast approach to administering tobacco products ever since the agency was given regulatory authority over nicotine, just banned four new RJ Reynolds brands.

RJ Reynolds, long known to tobacco control advocates as the truly sleaziest tobacco company out there, will be forced to pull the brands — Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13 — and to stop selling them because they are new “formulations.” (Camel Crush Bold is the only one I’m familiar with.).

One part of the problem with the new brands is that one of them had a new delivery system of adding menthol to the tobacco, while RJ Reynolds resisted the FDA on providing information on the sweeteners and formulations of the new brands. From the NBC News article:

The FDA said the Camel Crush product has a little capsule of menthol in the filter that’s new. After “considerable back and forth” R.J. Reynolds was unable to show that the menthol capsule didn’t change the product’s risk and didn’t change how consumer might view the brand. As for the Pall Mall products, the company wouldn’t give FDA enough information about sweeteners and other flavors added to the cigarettes, Mitch Zeller, director of the FDA’s Center for Tobacco Products, told reporters.

Retailers have 30 days to remove these brands from theirs shelves. After 30 days, the FDA has the power to simply seize them from the shelves.

From NBC News:

“Today’s decision sets an important precedent that almost certainly will apply to other brands. The FDA’s action is a critical step in preventing the introduction of tobacco products that may be more appealing to youth, more addictive or more harmful,” Matthew Myers, president of the Campaign for Tobacco-Free Kids, said in a statement.

“Tobacco manufacturers have a long history of continually modifying their products to make them more attractive and more addictive and introducing new brands and styles designed to appeal to specific segments of the market, including children. These tactics have been spectacularly successful in attracting new smokers, most of whom are children, and in discouraging current smokers from quitting.”

The FDA recently cracked down on RJ Reynolds for labeling its “American Spirit” brand of cigarettes as a “natural” cigarette. The agency is still holding off on regulations regarding e-cigarettes. Advocates have been waiting for months for the FDA to finally release final regs on e-cigs. So far, the agency has only proposed to disallow the sale of e-cigs to minors, which is already banned in most states. Tobacco control advocates want the FDA to ban Internet sales of e-cigs, crack down on e-cig marketing obviously directed at teens and ban sugary, fruity flavours of e-cigs.