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FDA.gov: FDA takes significant steps to protect Americans from dangers of tobacco through new regulation

For Immediate Release: May 5, 2016

Today, the U.S. Food and Drug Administration finalized a rule extending its authority to all tobacco products, including e-cigarettes, cigars, hookah tobacco and pipe tobacco, among others. This historic rule helps implement the bipartisan Family Smoking Prevention and Tobacco Control Act of 2009 and allows the FDA to improve public health and protect future generations from the dangers of tobacco use through a variety of steps, including restricting the sale of these tobacco products to minors nationwide.

“We have more to do to help protect Americans from the dangers of tobacco and nicotine, especially our youth. As cigarette smoking among those under 18 has fallen, the use of other nicotine products, including e-cigarettes, has taken a drastic leap. All of this is creating a new generation of Americans who are at risk of addiction,” said HHS Secretary Sylvia Burwell. “Today’s announcement is an important step in the fight for a tobacco-free generation – it will help us catch up with changes in the marketplace, put into place rules that protect our kids and give adults information they need to make informed decisions.”

Tobacco use is a significant public health threat. In fact, smoking is the leading cause of preventable disease and death in the United States and responsible for 480,000 deaths per year. While there has been a significant decline in the use of traditional cigarettes among youth over the past decade, their use of other tobacco products continues to climb. A recent survey supported by the FDA and the Centers for Disease Control and Prevention shows current e-cigarette use among high school students has skyrocketed from 1.5 percent in 2011 to 16 percent in 2015 (an over 900 percent increase) and hookah use has risen significantly. In 2015, 3 million middle and high school students were current e-cigarette users, and data showed high school boys smoked cigars at about the same rate as cigarettes. Additionally, a joint study by the FDA and the National Institutes of Health shows that in 2013-2014, nearly 80 percent of current youth tobacco users reported using a flavored tobacco product in the past 30 days – with the availability of appealing flavors consistently cited as a reason for use.

Before today, there was no federal law prohibiting retailers from selling e-cigarettes, hookah tobacco or cigars to people under age 18. Today’s rule changes that with provisions aimed at restricting youth access, which go into effect in 90 days, including:

  • Not allowing products to be sold to persons under the age of 18 years (both in person and online);
  • Requiring age verification by photo ID;
  • Not allowing the selling of covered tobacco products in vending machines (unless in an adult-only facility); and
  • Not allowing the distribution of free samples.

The actions being taken today will help the FDA prevent misleading claims by tobacco product manufacturers, evaluate the ingredients of tobacco products and how they are made, as well as communicate their potential risks.

Today’s rule also requires manufacturers of all newly-regulated products, to show that the products meet the applicable public health standard set forth in the law and receive marketing authorization from the FDA, unless the product was on the market as of Feb. 15, 2007. The tobacco product review process gives the agency the ability to evaluate important factors such as ingredients, product design and health risks, as well as their appeal to youth and non-users.

Under staggered timelines, the FDA expects that manufacturers will continue selling their products for up to two years while they submit – and an additional year while the FDA reviews – a new tobacco product application. The FDA will issue an order granting marketing authorization where appropriate; otherwise, the product will face FDA enforcement.

For decades, the federal government and the public health community have fought to protect people from the dangers of tobacco use. Since the first Surgeon General’s report on Smoking and Health in 1964, which warned Americans about the risks associated with smoking, significant progress has been made to reduce smoking rates among Americans. In fact, tobacco prevention and control efforts have saved at least 8 million lives in the last 50 years, according to the 2014 Surgeon General’s Report on the Health Consequences of Smoking. In 2009, Congress took a historic step in the fight for public health by passing the bipartisan Family Smoking Prevention and Tobacco Control Act (TCA) giving the FDA authority to regulate the manufacturing, distribution and marketing of tobacco products to protect the public health.

Today’s action marks a new chapter in the FDA’s efforts to end preventable tobacco-related disease and death and is a milestone in consumer protection.

“As a physician, I’ve seen first-hand the devastating health effects of tobacco use,” said FDA Commissioner Robert M. Califf, M.D. “At the FDA, we must do our job under the Tobacco Control Act to reduce the harms caused by tobacco. That includes ensuring consumers have the information they need to make informed decisions about tobacco use and making sure that new tobacco products for purchase come under comprehensive FDA review.”

Today’s actions will subject all manufacturers, importers and/or retailers of newly- regulated tobacco products to any applicable provisions, bringing them in line with other tobacco products the FDA has regulated under the TCA since 2009.

These requirements include:

  • Registering manufacturing establishments and providing product listings to the FDA;
  • Reporting ingredients, and harmful and potentially harmful constituents;
  • Requiring premarket review and authorization of new tobacco products by the FDA;
  • Placing health warnings on product packages and advertisements; and
  • Not selling modified risk tobacco products (including those described as “light,” “low,” or “mild”) unless authorized by the FDA.

“This final rule is a foundational step that enables the FDA to regulate products young people were using at alarming rates, like e-cigarettes, cigars and hookah tobacco, that had gone largely unregulated,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “The agency considered a number of factors in developing the rule and believes our approach is reasonable and balanced. Ultimately our job is to assess what’s happening at the population level before figuring out how to use all of the regulatory tools Congress gave the FDA.”

To assist the newly-regulated tobacco industry in complying with the requirements being announced today, the FDA is also publishing several other regulatory documents that provide additional clarity, instructions and/or the FDA’s current thinking on issues specific to the newly-regulated products.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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The Washington Post: New, sweeping federal rules bar e-cigarette sales to teens younger than 18

By Laurie McGinley and Brady Dennis

The Obama administration on Thursday announced controversial new rules for electronic cigarettes, cigars, hookahs and pipe tobacco, including barring the sales of the products to teens under 18 years old.

The new requirements, which go into effect in 90 days, mark the first time the Food and Drug Administration has regulated any of the items.

The rules compel retailers to verify the age of purchasers by photo identification and bar sales of the products in vending machines that are accessible to minors. They also ban the distribution of free samples.

In addition, the FDA is generally requiring manufacturers whose products went on sale after Feb. 15, 2007, to get approval from the agency to continue selling their products. These product reviews will allow the FDA to scrutinize ingredients, product design and health risks, the agency said. It added that it will allow the companies to keep selling their products for two years while they submit their applications and then for an additional year while the FDA reviews the submissions.

The requirements, which have been the focus of intense lobbying from the industry on one side and tobacco-control advocates on the other, are likely to only intensify the debate over whether the devices are a dangerous gateway to traditional tar-laden, chemical-filled cigarettes or a helpful smoking-cessation tool.

“As cigarette smoking among those under 18 has fallen, the use of other nicotine products, including e-cigarettes, has taken a drastic leap,” said Sylvia Mathews Burwell, secretary of health and human services, in announcing the new rules. “All of this is creating a new generation of Americans who are at risk of addiction.”

She said the new regulations were an “important step in the fight for a tobacco-free generation — it will help us catch up with changes in the marketplace, put into place rules that protect our kids and give adults information they need to make informed decisions.”

E-cigarettes are battery-powered devices that heat flavored, nicotine-laced liquid, turning it into a vapor that the user inhales, or “vapes.” The flavors can come in a wide range, from mango to margarita to mocha.

The FDA’s authority to regulate the products stems from a 2009 law that gave the agency broad power over traditional cigarettes, as well as jurisdiction over other tobacco-related products.

In recent weeks, the e-cigarette industry has gotten support from some public health experts. In late April, a group of tobacco-control experts, writing in the journal Addiction, urged the FDA to be “open-minded” about e-cigarettes, saying that the products are more beneficial than harmful and can result in a reduction in traditional smoking.

“We’re concerned the FDA, which has asserted its right to regulate e-cigarettes, will focus solely on the possibility that e-cigarettes and other vapor nicotine products might act as a gateway to cigarette use,” David Levy, the lead author and a professor in the department of oncology at the Georgetown Lombardi Comprehensive Cancer Center, said at the time.

He added that the “big picture tells us that these products appear to be used mostly by people who already are or who are likely to become cigarette smokers.”

And recently, the Royal College of Physicians concluded that e-cigarettes were likely to be beneficial to public health in Britain.

But many anti-smoking advocates disagree. They say that e-cigarettes could be harmful, that the long-term health risks are unknown and that companies are marketing their products to younger and younger teens. They say the companies are using the same tactics and themes that the traditional cigarette makers used years ago.

The number of middle and high school students using electronic cigarettes tripled between 2013 and 2014, according to a study by the Centers for Disease Control and Prevention.

https://www.washingtonpost.com/news/to-your-health/wp/2016/05/05/obama-administration-announces-controversial-new-rules-for-e-cigarettes/

CBS News: New York teen badly injured by exploding e-cigarette

A teenage boy suffered serious injuries when an e-cigarette vaporizer he was holding blew up in his face.
The 14-year-old, who spent five days in the hospital, was left with permanent injuries after his attorney said he was maimed and blinded by an exploding e-cigarette or vape pen, CBS New York reports.
“I was shocked. I was bleeding out of my nose,” Leor Domatov said.
Domatov said he was at the Kings Plaza Shopping Center in Brooklyn with friends when they approached a kiosk called Plaza Vapes.
“The guy was showing me different products of the vaporizers. He connected one of the vaporizers to the battery at the store,” he said. “When he gave it to me to hold, it exploded in my hands and my face.”
Domatov now wears sunglasses after the explosion sent shrapnel flying into his eyes.
“My left eye, I can’t see anything right now cause I got a cut through my cornea, and in my right eye I have a little bit of vision,” he said.
At first, Domatov wasn’t sure what had happened. Then he realized he was bleeding.
“I see like red stuff on the floor, and I’m like, ‘Oh my God, is this blood?’ So I start crying, why does it hurt me in my hands?” he said.
Domatov’s attorney Marc Freund intends to sue both the shopping center and the kiosk.
“They don’t ask him for any ID, nothing, and they’re showing different types of products. There are no signs up that reflect the New York state and city law. It’s illegal to sell these products to anyone under the age of 21,” he said.
The kiosk now has a sign posted that reads, “Must be 21 to purchase any product, we ID all.”
Freund claims the notice went up after the incident.
The corporate management offices for Kings Plaza did not reply to a request for comment. The kiosk worker there on Thursday said he could not speak to the incident or provide a phone number for the manager.
This isn’t the first report of e-cigarettes malfunctioning and injuring people.
In January, an Orange County, California, teen suffered first- and second-degree burns when an e-cigarette exploded in his pocket.
A man from Colorado Springs was severely injured in November when an e-cigarette exploded in his face, leaving him with a broken neck, facial fractures, burns to his mouth, and shattered teeth.
And last spring, CBS Los Angeles reported that a Santa Ana man was injured after his e-cigarette blew up in his hands. The explosion sent half of the device into the ceiling, starting a fire at his apartment.
Last year, the federal government banned e-cigarettes from checked luggage on aircraft because of the potential fire hazard. The Department of Transportation said it had reports of least 26 incidents since 2009 in which e-cigarettes had caused explosions or fires.
http://www.cbsnews.com/news/new-york-teen-badly-injured-by-exploding-e-cigarette/?linkId=23480569

The New York Times: E-Cigarette Use by U.S. Teenagers Rose Last Year, Report Says

By SABRINA TAVERNISE

WASHINGTON — E-cigarette use continued to rise among young teenagers and preteens in the United States last year, according to new federal data, but cigarette smoking overall did not increase, suggesting that, at least so far, fears that the devices would hook a new generation on traditional cigarettes have not come to pass.

Experts said it was too soon to answer the essential question about e-cigarettes: Will they cause more or fewer people to smoke? But the broad trend in youth cigarette smoking has been down in recent years, and researchers have been taking note of that.

“We do not have any strong evidence that it is encouraging smoking among kids but neither do we have good evidence that it won’t over time,” said Kenneth E. Warner, a professor of public health at the University of Michigan.

About 5 percent of middle-school students reported using e-cigarettes in 2015, up from about 4 percent in 2014, according to data from the Centers for Disease Control and Prevention. That is a substantial increase from 2011, when less than 1 percent of middle schoolers used the devices.

Use for high-school students was also trending up, with 16 percent reporting using the devices in 2015, up from 13 percent in 2014. But the change was not statistically significant because of technical reasons having to do with the sizes and distributions of the samples. In 2011, the rate was just 1.5 percent for high schoolers.

Policy makers have worried that increased e-cigarette use could make it more likely young people would shift to traditional tobacco cigarettes, which are more toxic. But that does not seem to be happening yet. About 9 percent of high schoolers reported smoking cigarettes in 2015, unchanged from 2014, and down from 16 percent in 2011.

Among middle schoolers, about 2 percent reported smoking traditional cigarettes in 2015, statistically unchanged from 2014. In 2011, about 4 percent of middle schoolers smoked traditional cigarettes.

The popularity of electronic cigarettes has soared since they were introduced in the mid-2000s and the devices have swept through the market so quickly that they have outpaced the federal government’s intention to regulate them. (Final rules from the Food and Drug Administration, which regulates tobacco products, have been expected for months.) Bonnie Herzog, an analyst with Wells Fargo, estimates the total vapor market, including e-cigarettes and other related products, such as liquids and personal vaporizers, totaled about $3.3 billion in the United States 2015.

E-cigarettes, designed to deliver nicotine without the toxic tar of conventional cigarettes, have prompted a split among public health experts with some saying the devices will hook new generations of smokers and undo hard-won progress on smoking rates and others saying they will help older, addicted smokers quit.

The answer is not yet clear, in part because there is not enough data on use to tell. But it is important: Cigarette smoking is still the single largest cause of preventable death in the United States, killing about 480,000 people a year. While smoking rates have dropped drastically since the 1960s, there are still more than 40 million Americans who smoke.

Professor Warner said what stood out was the fact that the rate of e-cigarette use had slowed from its earlier more rapid rise, a shift that he said was too early to interpret and that smoking of traditional cigarettes, after many years of declines, had not gone down.

“I’m disappointed, and a bit surprised, not to see another decline in cigarette smoking, even if small,” he said. As for e-cigarettes, If anything, use seems to be flattening out.”

Young people are a particularly vulnerable bunch, and many public health experts agree that with so little known about the long-term effects of e-cigarettes, the fact that so many youths have started using them is worrying, even if they do not use them as a bridge to traditional cigarettes. Others argue that even nicotine can be harmful. In all, about three million middle and high school students used e-cigarettes in 2015, the data showed, up from 2.46 million in 2014.

“No form of youth tobacco use is safe,” said Dr. Thomas R. Frieden, the director of the C.D.C. in a statement. “Nicotine is an addictive drug and use during adolescence may cause lasting harm to brain development.”

The data, from the National Youth Tobacco Survey, which is a pencil-and-paper questionnaire administered to a large sample of middle- and high-school students across the country, had a bright spot: Hookah use declined for high school students, falling to about 7 percent from about 9 percent in 2014.

http://www.nytimes.com/2016/04/15/health/e-cigarettes-smoking-teenagers.html?_r=3

Reuters: No change in tobacco use among U.S. youth; e-cigarettes preferred

CHICAGO (Reuters) – Overall tobacco use among U.S. middle and high school students has not changed since 2011, a period in which use of electronic cigarettes increased dramatically, U.S. health officials said on Thursday.

Given that most adult smokers begin using tobacco before age 20, health officials are concerned over the lack of progress in reducing tobacco use among U.S. youth.

According to the latest data from the U.S. Centers for Disease Control and Prevention and the U.S. Food and Drug Administration’s Center for Tobacco Products, 3 million middle and high school students reported using e-cigarettes in 2015, compared with 2.46 million in 2014.

“E-cigarettes are now the most commonly used tobacco product among youth, and use continues to climb,” CDC Director Dr. Tom Frieden said in a statement.

“No form of youth tobacco use is safe. Nicotine is an addictive drug and use during adolescence may cause lasting harm to brain development.”

The FDA, which currently regulates most conventional tobacco products, is finalizing regulations that would bring e-cigarettes under its authority.

Mitch Zeller, of the FDA’s Center for Tobacco Products, said the agency “remains deeply concerned” about the overall high rate at tobacco use among youth and said finalizing those regulations “is one of FDA’s highest priorities.”

Increases in e-cigarette use in 2015 were largely driven by higher use among middle school students, a group in which use of the devices climbed to 5.3 percent in 2015 from 3.9 percent in 2014. There was no change in e-cigarette use among high school students between 2014 and 2015, following a dramatic 13.4 percent increase in 2014.

Overall, data from the 2015 survey show that 4.7 million middle and high school students used at least one tobacco product in the past 30 days, and more than 2.3 million of those students used two or more tobacco products.

There was no significant change in cigarette smoking habits among middle and high school students between 2014 and 2015, with 9.3 percent of high school students and 2.3 percent of middle school students saying they smoked cigarettes.

“Given that the use of e-cigarettes is on the rise among middle and high school students and nicotine exposure from any source is dangerous for youths, it is critical that comprehensive tobacco control and prevention strategies for youths address all tobacco products and not just cigarettes,” study authors wrote in the CDC’s weekly Morbidity and Mortality report.

(Reporting by Julie Steenhuysen; Editing by Dan Grebler)

http://newsdaily.com/2016/04/no-change-in-tobacco-use-among-u-s-youth-e-cigarettes-preferred/#yH3zqGy4RVGtYeVG.99