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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.

. . .

‘Tobacco 21’ policy contemplated in Niagara County

Niagara County legislators are contemplating a local law that would ban sales of tobacco products to people younger than 21 years old.

At the legislature’s business meeting earlier this month, Lockport High School students, school nurses and local physicians urged lawmakers to adopt a “tobacco 21″ policy, arguing it would drastically reduce smoking rates and associated illness.

Dr. Andrew Hyland, head of Roswell Park Comprehensive Cancer Center’s tobacco control program, told legislators that one-third of cancer deaths result from cigarette smoking. According to the center, which strongly supports the proposed policy, over 95 percent of current adult smokers began smoking before age 21.

“Younger people are more susceptible to nicotine and more likely to get hooked when they try it,” Hyland said. “The tobacco 21 policy pushes that age a little bit further, (so that) fewer young people will get hooked.”

Lockport High School nurses and students argued that a tobacco 21 policy would leave teens with fewer social sources for tobacco.

According to a 2015 Institute of Medicine report, raising the age for tobacco sales to 21 would reduce youth smoking by 12 percent.

“We know that passing tobacco 21 will not completely erase the issue of tobacco use by young people, but we know it’s a huge step in the right direction,” said Nick Doxey, a junior at LHS and member of the Reality Check program.

Legislature Chairman Keith McNall said lawmakers will discuss a tobacco 21 policy in the coming weeks, calling it “very possible” the legislature could vote on such a resolution by its next monthly meeting Nov. 20.

“This is certainly a health concern. Smoking does hurt people, some tremendously,” McNall said. “I think our county will make the right decision.”

McNall would not say whether he personally supports a tobacco 21 policy, saying he wanted to do more research on the topic. However, he added, “I’m not opposed to anything that protects the people’s health.”

Niagara County Public Health Director Daniel Stapleton said he supports the proposal, saying research shows the average age of new smokers is just 13 in New York.

“The data shows if you can prevent someone from smoking while they’re a teenager, it significantly reduces the chances they’ll become a smoker,” Stapleton said.

Should it adopt a tobacco 21 policy, Niagara County would be far from alone. Twenty-three counties and cities across the state, including New York City, Cattaraugus and Chautauqua counties, have raised the age for tobacco sales.

The policy has proven popular beyond New York. Hyland said that over 350 localities and six states have raised the minimum age for tobacco purchases to 21. And in those that have, he argued, retailers that sell tobacco have seen little impact.

. . .

Brooklyn Center City Council weighs raising tobacco sales age to 21

Brooklyn Center is poised to become the latest Minnesota city to raise the tobacco sales age to 21.

The City Council this month approved the first reading of the rule change and is expected to take a final vote on Nov. 13. If approved, the changes will take effect Dec. 21.

The measure would restrict the number of licensed tobacco retailers in the city to 15. There are now 22 tobacco retailers in town, according to City Clerk Barb Suciu.

“If someone does not renew [a license], then we are not going to open up another one,” she said. “The eventual goal is to get down to 15.”

In 2014, Brooklyn Center became the first city in Minnesota to set a minimum price for cigars in an effort to curb their appeal among young people.

. . .

Hartford Acts to Protect Kids, Save Lives by Raising Tobacco Age to 21

Statement of Matthew L. Myers, President, Campaign for Tobacco-Free Kids
October 23, 2018

WASHINGTON, D.C. – The Hartford City Council took bold action last night to protect kids from tobacco addiction and save lives by voting to raise the sale age of tobacco products in the city to 21. As the first city in Connecticut to raise the tobacco age to 21, Hartford is providing strong leadership in the fight against tobacco – the No. 1 preventable cause of death – and setting a terrific example for Connecticut and the nation. Increasing the tobacco age to 21 will help prevent young people from using tobacco, save lives and help make the next generation tobacco-free.

The Hartford vote adds momentum to the growing movement across the nation to raise the tobacco age to 21. Six states – California, New Jersey, Massachusetts, Oregon, Hawaii and Maine – have enacted Tobacco 21 laws, along with at least 350 localities, including New York City, Chicago, San Antonio, Boston, Cleveland, Minneapolis, both Kansas Cities and Washington, D.C. Many other states, counties and cities are considering such measures.

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