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Trick or Treat! Don’t Be Fooled by Industry Support of Tobacco 21

DUBLIN, OhioNov. 1, 2018 /PRNewswire/ — On Halloween the FDA issued a statement describing their ongoing conversations with the tobacco industry occurring as a result of the recent epidemic in youth use of electronic cigarettes.  Commissioner Scott Gottlieb reported that some tobacco manufacturers support “raising the minimum age to purchase tobacco to 21 years of age.”

We cannot be fooled by their words: the industry supports criminal sanctions on youth who fall prey to their predatory marketing tactics and addictive products, attached to legal provisions that shield retailers who profit from the sales of these deadly products.  The Preventing Tobacco Addiction Foundation and Tobacco 21 advocate for raising the minimum legal sales age of all nicotine and tobacco products to 21, coupled with reliable and robust enforcement that holds the industry and retailers responsible.

The tobacco industry’s statements to the FDA of their support for a policy that raises the access for tobacco products is a cynical distraction. The industry knows the FDA does not have the regulatory authority to raise the age to 21, but the FDA can and must respond to this epidemic through policy action within its regulatory authority.  This includes a ban on candy flavors, tight restriction of high dose nicotine salts and limits to where these products may be sold.

History has made clear that voluntary action by tobacco manufacturers always fails. The tobacco industry’s claims of cooperation can never be a substitute for effective regulation to protect public health and keep kids from lifelong nicotine addiction.

We call on the FDA to immediately implement the following:

A Complete Assessment of the Teen Nicotine Addiction Epidemic

  • The FDA and CDC must expedite the release of the 2018 Youth Tobacco Survey, completed 5 months ago, that demonstrates an epidemic surge in teen addiction.
  • The FDA and CDC must require robust, standardized annual surveys of youth and adult nicotine and tobacco use in all states and major metropolitan areas precedent to the release of federal monies for prevention. These studies must address perception and use of individual brands.

Require Investigational New Drug Applications and Restrict Nicotine Salts

  • Juul and other manufacturers have produced novel and patented drug formulations including nicotine benzoate and other nicotine salts in unique carrier solutions that deliver high dosages of addictive nicotine to the pulmonary and central nervous system of teen users. These salts reduce the usual irritant sensation of nicotine to the mouth and throat, thus promoting increased depth of inhalation and frequency.
  • The FDA must insist on required investigational new drug applications (IND) to be submitted to the Center for Drug Evaluation and Research (CDER).
  • Because these drugs are already in widespread use and their abrupt elimination might cause distress in adult users, an interim solution in advance of required CDER evaluation would be to remove them to “behind the counter,” sign-out security in pharmacies, similar to the treatment of pseudoephedrine. Clearly, nicotine salts are of equal or greater risk to public health. Suggestions by the FDA to restrict these product sales to newly-hatched and unregulated “vapor shops” as a means of public health protection is an egregious error that flies in the face of common sense.

Ban Characterizing Flavors

  • There is overwhelming evidence that adolescents are enticed into usage by candy, mint and other flavors, while there is no evidence that adult users committed to cessation of combustible tobacco require flavors to make that switch. Any small incentive for adult users is overwhelmed by the risk to teens.
  • All characterizing flavors should be immediately removed from products offered to the public. This is perhaps the most important step the FDA can take immediately to stem this tsunami of teen nicotine addiction.

Rob Crane, MD 
614-296-6666 
Rob.Crane@PTAF.org

The FDA Wakes Up to the Danger of E-Cigarettes

Like a parent who’s just caught the kids vaping in the backyard, the U.S. Food and Drug Administration has been jolted into realizing that electronic cigarettes are a problem. The agency’s wake-up call came in the form of startling early data from the National Youth Tobacco Survey indicating that e-cigarette use among high school students is up more than 75 percent since last year, and among middle-schoolers by 50 percent.

FDA Commissioner Scott Gottlieb has warned Juul and the other leading e-cigarette companies that he means business when he says they need to keep their devices out of teenagers’ hands. He accused the companies of so far treating the problem as a “public-relations challenge” rather than a serious legal and public-health concern.

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Like a parent who’s just caught the kids vaping in the backyard, the U.S. Food and Drug Administration has been jolted into realizing that electronic cigarettes are a problem. The agency’s wake-up call came in the form of startling early data from the National Youth Tobacco Survey indicating that e-cigarette use among high school students is up more than 75 percent since last year, and among middle-schoolers by 50 percent.

FDA Commissioner Scott Gottlieb has warned Juul and the other leading e-cigarette companies that he means business when he says they need to keep their devices out of teenagers’ hands. He accused the companies of so far treating the problem as a “public-relations challenge” rather than a serious legal and public-health concern.

The FDA is considering new limits on e-cigarette marketing, and threatens to take candy-flavored vapes off the market altogether. This is a most welcome change. But it still amounts to only a warning. The agency has to follow up with actions to regulate the manufacture, marketing and sales of electronic cigarettes as rigorously as it does the old-fashioned, combustible kind.

Until now, the FDA’s approach to e-cigarettes has been too lenient. Last year, Gottlieb gave manufacturers an extra four years — until August 2022 — to apply for FDA approval, allowing all e-cigarettes that had been on the market as of August 2016 to continue to be sold with no controls on how they are made or marketed. Explaining this decision, Gottlieb pointed to the “potential benefits” of e-cigarettes to help smokers quit — even though their ability to do that is not established. On the contrary, as the commissioner now acknowledges, the evidence shows that teens who vape are much more likely than others to become smokers.

The agency has so far declined to impose any meaningful restrictions on candy flavorings or even the common-sense restrictions that are in place in European countries, such as limits on nicotine content. (Juuls in the U.K. contain only about a third as much nicotine as American Juuls have.) In the U.S., e-cigarettes are not even subject to the same constraints on TV and radio advertising that apply to regular cigarettes.

Gottlieb has given e-cigarette makers until mid-November to lay out plans to keep their products away from minors, including by refusing to sell to lax retailers and by eliminating candy flavors. But it would be a mistake to assume that voluntary actions will be enough, or that children are the only people at risk from e-cigarettes. The long-term health effects of vaping are uncertain for all users. Much more research is needed.

. . .

Ban tobacco sales until age 21. It’s a bipartisan way to reduce addiction and death.

Patricia Garson was a smoker who died of lung cancer. Her husband inhaled second-hand smoke for over 20 years and died of lung cancer too. Their daughter smoked for 30 years and has lung cancer. And their son — a co-author of this column — smoked for three years. One thing uniting those Garsons: Their smoking began in their teenage years.

Unfortunately, this experience is far too familiar for many Americans. Tobacco is the leading cause of illness and death in the United States, claiming the lives of nearly half a million people each year. That is equivalent to three 747 planes crashing in this country every single day. However, we have the opportunity to prevent today’s teenagers from the harms experienced by the Garson family. The question is, are we willing to seize it?

There is an effective solution that can dramatically curb smoking — and one that has broad, bipartisan support. Across the country, several states and hundreds of cities have passed a law that can help ensure teenagers never start smoking — and therefore, never become addicted. These laws, known as “Tobacco 21 laws,” make it illegal to sell cigarettes and other tobacco products to anyone under the age of 21.
. . .

Nationally, 82 percent of Americans support preventing the sale of all tobacco products to those under age 21, according to a 2018 poll conducted by Texas Medical Center Health Policy Institute, to be released Wednesday.

Both Republicans and Democrats back these laws to keep tobacco out of the hands of teenagers. Support for the laws is high across different income and education levels. Support is high even among those under 21, who are most directly affected.

It’s important to enact these laws because teens are especially susceptible to the addictive effects of nicotine. Young people need less nicotine than adults to become addicted, and their impulsivity prevents them from recognizing the serious risks they face if they choose to become smokers. But if you prevent them from smoking when they’re under 21, many will choose not to take up smoking, even when they’re of legal age.

We killed the cigarette. What we got in return is mango-flavored nicotine in ‘party mode.’

This year, cryptic signs for something called Juul began appearing in the windows of the 7-Eleven on my block. On vacation in Miami, where smoking is still allowed in many clubs, I noticed a pretty young woman pull a Juul from her purse and lay it on the bar, next to her cocktail. This summer, I saw Juuls at a Fourth of July crab crack and Juuls on the city bus.

Juul, if you haven’t heard, has quietly become the most popular new way to smoke since the old coffin nail itself, claiming more than half of the booming market for electronic cigarettes.

Where early e-cigs tended to mimic cigarettes — and hilariously generated more smoke than a fog machine — the Juul is as far removed from a cigarette as you can get. A sleek little brick that looks like a USB flash drive, it flickers with colored light, puffs discreetly and smells like nothing at all. It is the iPhone of smoking, and the kids are wild for it.

. . .

But Juuling, health professionals say, also carries the dangers of the death stick of the past. It is raising alarms by hooking youth on nicotine at a time when old-fashioned smoking has been hitting a steep decline.

The secret to Juul’s controversial success may be a twist on the age-old story of smoking as an outlet for teenage rebellion. The popularity of Juul seems to grow in tandem with the uproar: Sales of Juul are up more than 700 percent from a year ago, according to Nielsen data.

Schools across the country say they are confiscating fistfuls of the things from their underage charges. Three lawsuits were recently filed against Juul Labs; each argues that users as young as 14 became addicted to Juul, and that the product was marketed as safe.

To Allan M. Brandt, a historian and author of “The Cigarette Century,” Juul is anything but new and different. “It represents the cultural norms and notions of the cigarette, which was very much youth-oriented,” he said. “It was kind of forbidden; it was extremely cool.” . . .
“I think the history of this tells me, don’t trust these industries,” said Brandt, the smoking historian. “Juul can say, ‘We’re not interested in kids; we’re going to fight the use of this in kids.’ But with flavors like mango, and cool cucumber. . . .”

“Cigarette makers have always said they didn’t want kids to smoke, he continued. But bad news about children lighting up on the schoolyard, he said, “was always great news for the tobacco companies.”

I think back on my own generation, which was in its teens when we watched Kurt Cobain on MTV, coolly dragging on a cigarette between strums of his acoustic guitar. And then, for a brief while, I smoked Parliaments on stoops in New York, too, till it became too expensive to continue. We straddled the time when all the fun kids loitered outside smoking, and the moment when, abruptly, the cigarette became social napalm.

Local student supports Tobacco 21

I’m looking forward to my last year of high school, but there’s something going on under the radar that our community needs to realize, and that’s the rising number of my classmates using tobacco products like e-cigarettes.

Many of my peers don’t even know they are inhaling nicotine when they vape – and it’s so easy to become addicted. E-cigarettes like JUUL are marketed to us constantly on social media, and tobacco companies target my age group with fun flavors and coupons to make their products cheaper. As a result, 1 in 5 Minnesota high school students uses e-cigarettes according to the latest Minnesota youth tobacco survey.

This month, the FDA starts requiring labels on e-cigarettes warning they contain nicotine and that nicotine is addictive. I hope these labels will make my peers think twice before using e-cigarettes and other tobacco products. But there is much more we can do in Otter Tail County to stop young people from ever trying tobacco.

One thing we can do is raise the tobacco sale age to 21. Right now, Otter Tail County is considering approving this policy. Tobacco 21 would be a big breakthrough because it would help widen the gap between people who can legally buy tobacco and younger students. Right now, it’s pretty easy for kids who are under 18 to get tobacco products from older friends, so Tobacco 21 would help limit this social access and stop the start of tobacco use.

I hope Otter Tail County commissioners will act for young people like me and support Tobacco 21. Healthier young people would mean a healthier future for all of us.