New Tobacco Rules

May 29, 2017

What does this new rule do?

The new tobacco rule establishes discourse taken over seven years ago concerning the regulation of cigarettes. As of  June 2009, The President and Congress passed the Family Smoking Prevention and Tobacco Control Act to give the FDA power to regulate the making, distribution, and selling of tobacco products (cigarettes, cigarette tobacco, smokeless tobacco ad roll-your-own tobacco).

This rule has several implications now.

This authority also applies to recent tobacco creations like e-cigarettes, ENDS (electronic nicotine delivery systems), cigars (even premium), hookah (also known as waterpipe tobacco), pipe tobacco, nicotine gels and dissolvables.

Health warnings are required on all tobacco-related products, and free samples are prohibited. Also, manufacturers of products that hit the market after February 15, 2007 must make sure their products meet FDA health standards to get FDA approval.

This act also prohibits the sale of all tobacco-related products to minors (people under age 18) and in vending machines not placed in adult-only locations. A government issued ID must be presented to verify age to purchase tobacco products.

What was the FDA’s point in doing this act?

Because of the detrimental effect of tobacco on public health, the FDA’s role in implementing the Family Smoking Prevention and Tobacco Control Act is to help reduce the risk of tobacco-related diseases and death.

FDA regulation does not equate to endorsing the products as being safe to use. However, it does stop the sale of products like hookah, cigars, and e-cigarettes to people under 18 years of age.  Although there is a significant decrease in traditional cigarette use among youth, there is a marked increase in the use of other tobacco-related products. The FDA and the Centers for Disease Control and Prevention. (CDC) report that over 16 percent of the high school population smokes e-cigarettes (up from 1.5% in 2011), and there is a great increase in the use of hookah.

But aren’t e-cigarettes safer than regular cigarettes?

The FDA realizes that not all tobacco-related products have the same level of potential harm. Therefore, the nature of tobacco regulation will change when the FDA has more information on the extent of harm all new tobacco-related products cause.

The FDA recognizes that some of these new technological tobacco products can be both beneficial and harmful. For example, e-cigarettes can reduce air pollution and encourage people to change from using real cigarettes. However, if products like these promote more youth encouragement to use tobacco and promote more encouragement for people to not stop using tobacco-related products, then their effect is negative on society.

The current goal of the FDA is to persuade manufacturers to consider new products that have a more beneficial impact on society than a negative one. The Family Smoking Prevention and Tobacco Control Act gives the FDA power to research the effect of these products on users and non-users and regulate how these products are marketed.

Smoking Prevention in Children

September 27, 2016

The number of children that smoke cigarettes is down, but the number using other tobacco products is up. The National Youth Tobacco Survey (NYTS) in 2014, claimed that this was the case. The Centers for Disease Control and Prevention (CDC as well as the FDA, co-conducted the survey.

Chief of epidemiology at FDA’s Center for Tobacco Products, Benjamin J. Apelberg, Ph.D said that this is the only nationally representative survey of high school and middle school students focused on tobacco use. The results of the survey provided a snapshot of what high school and middle school students are using and trends that are emerging over time.

The findings include:

  • In 2104, one in thirteen middle school students and one on four high school students said that they had been regular tobacco users, meaning that had used one or more tobacco products in the previous thirty days.
  • During the survey the then 4.6 million youth tobacco users, 2.4 million were using e-cigarettes.
  • The percentage of students using cigarettes decreased 15.8% to 9.2% between 2011 and 2014.
  • Hookah and e-cigarette use increased drastically between 2011 and 2014.
  • Around 2.2 million students reported using two or more tobacco products in 2014.

The survey started to collect e-cigarette use in 2011, but by 2014, their use surpassed every other tobacco product. This includes even regular cigarette use. High school and middle school children are using novel products like hookahs and e-cigarettes in larger numbers and many are using more than one tobacco product.

Epidemiologist Catherine Corey of the FDA say this is both good and bad. Cigarette smoking is decreasing, but hookah and e-cigarette use is increasing and it undermines the progress in the reduction of tobacco use.

Nicotine Can Impact the Developing Brain

Nicotine is highly addictive and it’s dangerous for children. It doesn’t matter if it comes from a hookah, cigarette, cigar or an e-cigarette. When the brain is still developing and adolescent is in a vulnerable position when it comes to nicotine use. Research shows that exposure to nicotine can be harmful because there are many other chemicals present in tobacco products that are linked to disease. Children and youth should not be using tobacco products in any form at all.

The FDA has regulatory authority over cigarette tobacco, cigarettes, smokeless tobacco, and roll-your own tobacco. The FDA is working on finalizing a rule that would extend its reach to other products that meet the legal definition of a tobacco product like cigars, hookahs, and electronic cigarettes. The FDA wants a minimum age of 18 for anyone looking to buy tobacco.

The new findings strengthen the evidence provided by science that novel tobacco products like hookahs and e-cigarettes have appeal to youth and that there needs to be prevention efforts to help stop smoking and cut down all use of tobacco products not just regular cigarettes.

‘Real Cost’ of Tobacco

February 19, 2015

The Food and Drug Administration (FDA) has launched its first public health education campaign—”The Real Cost”—to prevent and reduce tobacco use among at-risk young people ages 12-17. Mitch Zeller, J.D., director of FDA’s Center for Tobacco Products (CTP), explains why the agency is undertaking this effort and how it will work.

Q: Why has FDA launched a youth tobacco prevention campaign? 

A: Tobacco use is the leading preventable cause of disease, disability, and death in the United States, responsible for more than 480,000 deaths each year. But the consequences of tobacco use are not limited to adults. Tobacco use is almost always initiated and established during adolescence. More than 3,200 young people under age 18 smoke their first cigarette every day in the United States—and another 700 become daily smokers. FDA sees a critical need for targeted efforts to keep young people from starting on this path. Reducing the number of teens who start smoking will diminish the harmful consequences that tobacco use has on the future health of our country. “The Real Cost” campaign ads will run nationwide beginning on February 11.

Q: Tell us more about the campaign and its target audience.

A: As FDA’s first campaign to prevent youth tobacco use, “The Real Cost” targets the 10 million young people ages 12-17 who are open to trying smoking or who have already smoked between one puff and 99 cigarettes in their lifetime. These youths share important characteristics that put them at risk for tobacco use. They are more likely to live chaotic, stressful lives due to factors such as socioeconomic conditions; be exposed to smoking by friends and family; and use tobacco as a coping mechanism or a way to exert control or independence. Additionally, many at-risk youths who experiment with cigarettes do not consider themselves smokers, do not believe they will become addicted, and are not particularly interested in the topic of tobacco use. We want to make these teens hyperconscious of the risk from every cigarette by highlighting consequences that young people are concerned about, such as loss of control due to addiction and health effects like tooth loss and skin damage.

Q: How is FDA going to implement the campaign?

A: We’ll use paid advertising to surround teens with the “The Real Cost” message. This includes advertising on TV, radio and the Internet, as well as in print publications, movie theaters and outdoor locations like bus shelters. We plan to reach more than 9 million youths with our messages as many as 60 times a year.

Q: How will FDA know if the campaign is working?

A: FDA is going to evaluate the campaign over time to see if it’s effective. We’re going to conduct a longitudinal study, meaning that we are going to try to follow the same 8,000 youths over a two-year period. We will assess key changes in their tobacco-related knowledge, attitudes, beliefs and behaviors over several years to measure the impact and effectiveness of the campaign. In-person, baseline data collection started in November 2013 in 75 media markets across the country. Ultimately, we want to see if exposure to the campaign is associated with a decrease in smoking among youth.

Q: Is this campaign funded by U.S. tax dollars?

A: No. User fees collected from the tobacco industry fund all FDA’s tobacco-related activities, including educating the public about the harms of tobacco use.

Q. Is this FDA’s only youth tobacco prevention campaign?

A: This initial FDA effort is the first of several distinct youth-focused campaigns being launched in the next two to three years. Other youth tobacco prevention campaigns will target additional audiences such as African American, Hispanic, Asian/Pacific Islander and American Indian/Alaskan Native youths, rural youths, and lesbian, gay, bisexual and transgender youths.

Q: How can I get involved?

A: FDA’s goal is to keep “The Real Cost” campaign authentic through a peer-to-peer approach. The campaign website and social channels are intended for teens. We recommend that adults use and share the materials on FDA’s resource page, including campaign information and customizable resources such as posters, postcards and campaign flyers. All materials are available for free download and many will soon be available for ordering through the campaign’s clearinghouse. Stakeholders who work with youth audiences can help extend the campaign by encouraging teens to share campaign messages with their peers, or by sharing our resources with other youth-focused organizations.

Cigarette Health Warnings

December 18, 2011

Consumers are getting a glimpse of warnings images that will be alternating on all cigarette packages and advertisements within 15 months—an effort by health officials to discourage smoking by bringing Americans face to face with tobacco-related disease.

The Food and Drug Administration unveiled the nine, color images—including some of  bodies ravaged by disease—at a news conference. The images, which are paired with text health warnings, are required under the 2009 Family Smoking Prevention and Tobacco Control Act. They must appear on every cigarette pack, carton, and advertisement by September 2012.

FDA Commissioner Margaret A. Hamburg, M.D., says she’s hopeful the graphic images will give smokers the incentive to stop smoking and prevent potential smokers from ever starting. In fact, the phone number for the smoking cessation hotline—1-800-QUIT-NOW—will accompany each warning.

“The Tobacco Control Act requires FDA to provide current and potential smokers with clear and truthful information about the risks of smoking—these warnings do that,” she says.

The bold health warnings will cover the top 50 percent of the front and rear panels of all cigarette packages and at least 20 percent of each advertisement. They are expected to decrease the number of smokers, which will save lives and increase life expectancy.

The Centers for Disease Control and Prevention says tobacco use is the leading cause of premature and preventable death in the United States, responsible for 443,000 deaths each year. Tobacco addiction costs the U.S. economy nearly $200 billion every year in medical costs and lost productivity.