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FDA Regulations for Sales to Minors in Effect as of August 8

Original story by Dennis Thompson, HealthDay – August 8, 2016, 11:08 AM

The sale of electronic cigarettes to minors are banned nationwide as of this past Monday, August 8, 2016. This mandate is part of the U.S. Food and Drug Administration’s (FDA) long-overdue plan to extend the agency’s regulatory powers over all tobacco products. The new rule ensures electronic cigarettes and any other tobacco product (including hookah, cigars, and pipe tobacco) are not being sold to anyone younger than 18. The regulations also require photo IDs to buy e-cigarettes, and bans retailers from handing out free samples or selling them in all-ages vending machines.

Youth_Brain Development


Although Kansas has prohibited the sale of electronic cigarettes to minors since 2013, the state has not specified hookah as a tobacco product. Likewise, the City of Wichita’s youth access ordinance–which gives authority to the City’s Tobacco program to check retailers for compliance with sales restrictions to minors–includes tobacco products but does not currently allow for compliance checks for electronic cigarette or hookah retailers. TFW is anxious to help ensure these policy gaps are remedied in the near future.

Electronic cigarettes are battery-operated devices designed to create an aerosol that delivers nicotine, flavor and other chemicals when inhaled by the user. Manufacturers have marketed the products as a way to help smokers quit cigarettes, although these statements have not been verified by the FDA or trustworthy research studies. In addition to the youth access regulations, the new ruling forbids electronic cigarette manufacturers from promoting their products as a “healthier alternative to smoking”, until strong scientific evidence is provided to the FDA that supports the claim.

Tobacco control and other public health groups contend that electronic cigarettes actually encourage people — especially teens — to pick up the smoking habit. “Youth use e-cigarettes more than any other tobacco product on the market today, serving as an entry point to more traditional tobacco products,” Harold Wimmer, national president and CEO of the American Lung Association, said in May.

A recent survey of approximately 300 high school students discovered that teens in the United States who use electronic cigarettes are six times more likely to move on to traditional cigarettes compared to kids who never use the devices.  “The increase in electronic cigarette use, which may be followed by increases in cigarette use, could result in an erosion of the progress that has been made over the last several decades in tobacco control,” she added. This increase is amplified by the tobacco industry’s billion-dollar annual advertising budget, which targets ads at youth and other vulnerable populations.

Youth_Advertising_Ecig 2014

Until now, electronic cigarettes and other alternative tobacco products have gone unregulated by the FDA. Manufacturers are now required to submit new and existing products to the FDA for review and evaluation, unless the product was sold prior to Feb. 15, 2007. It is estimated that 99% of all electronic cigarette and “vaping” products that are now on the market will have to be submitted for review. The FDA anticipates that existing brands will have at least three more regulation-free years on the market — two of which allows manufacturers to prepare their product application and another year for FDA review.

For the full story, click HERE.

U.S. House Appropriations Committee Puts Tobacco Industry Before Health

Stakeholder groups strongly oppose a $110 million funding cut to the CDC’s Office on Smoking and Health (OSH), as presented in the FY 2017 House Appropriations bill.

In a July 12 Letter to leaders of the House Appropriations Committee, (spearheaded by the Campaign for Tobacco-Free Kids) 47 organizations called on legislators to restore that funding and allocate at least $210 million — the same amount Congress enacted for FY 2016 — to the OSH.”[This work] is critical to ending the tobacco epidemic that takes far too many lives and exacts an enormous financial toll on the nation’s economy,” the groups explain.

first-cigarette500Campaign for Tobacco-Free Kids’ President Matthew Myers also added in July 13 Press Release, “This funding cut makes no sense given the proven effectiveness of the CDC’s tobacco prevention and cessation programs and tobacco’s terrible toll in health, lives and health care dollars. It serves only the interests of the tobacco industry.” The July 12 letter adds, “Cuts to OSH funding would lead to more young people using tobacco products, fewer adult tobacco users quitting, more people with tobacco-caused diseases, more premature deaths and higher future health care costs for treating tobacco-caused disease,”.


How could cuts to OSH effect Tobacco Free Wichita Coalition?

  1. OSH provides funding and technical assistance to state health departments to help them maintain and enhance tobacco prevention and cessation programs at the state and community levels. 
  2. Essential OSH research programs on the prevalence of tobacco use are in jeopardy. This research is used to alert policymakers about related trends, such as the recent dramatic rise in e-cigarette use among adolescentstips-terrie-cancer-voice-sm-700x700
  3. One of the most high-profile activities OSH funds is the national Tips From Former Smokers media campaign. During a period of just over two months in 2014, 1.8 million Americans who smoke were motivated by the campaign to make a quit attempt, and 104,000 smokers actually quit. According to the stakeholder letter, the House’s proposed funding cut “would make it virtually impossible for CDC to continue this vital campaign,”. 
  4.  OSH also provides a considerable amount to states each year for tobacco quitlines, which have been shown to “greatly increase the chances that a smoker will quit successfully, the groups state.

Fortunately, the Senate Appropriations Committee has approved a bill that provides the current level of funding, $210 million, for the CDC’s tobacco control programs for FY 2017. TFW urges everyone to CONTACT YOUR LEGISLATORS and ask Congress to provide (at least) the current level of funding in final legislation.


August 01, 2016 04:02 pm  AAFP News Staff 

July 13, 2016 Statement of Matthew L. Myers, President, Campaign for Tobacco-Free Kids


Kansas Tobacco Quitline to Offer FREE Nicotine Replacement Therapy

WichitaArchEnemy -2016, KS – Kansas will start giving away nicotine gum, lozenges and patches next week to help tobacco users quit for good!

State health officials say nearly one in five Kansas adults smoke cigarettes and that nearly 70 percent of all cigarette smokers want to quit.

The Wichita Eagle reports that the Kansas Department of Health and Environment is distributing nicotine replacements from June 20 to July 1, or while supplies last. To participate, tobacco users can call the Kansas Tobacco Quitline (KanQuit) at 1-800-QUIT-NOW or go online at KSQUIT.org and must enroll with a professionally-trained coach, who will help them develop a quit plan. KanQuit coaches not only help smokers quit, they can help people addicted to smokeless tobacco and even electronic cigarettes. The program recently added the QuitNow! app and a Text2Quit program that provides participants with reminders for upcoming coaching sessions and encouraging messages between appointments.

KanQuit is part of a national tobacco education campaign through the U.S. Centers for Disease Control and Prevention.

ACTION ALERT! Attempts to Weaken FDA’s Final Ruling on Electronic Cigarettes and Cigars

May 13, 2016 – Campaign for Tobacco Free Kids Action Alert

Last week, the FDA finally issued rules to protect kids from e-cigarettes and cigars. But some in Congress are trying to Congress FDAundercut the new rules before they even take effect!

The House Appropriations Committee has approved an FDA funding bill with amendments that would prevent the FDA from conducting health and safety reviews of existing e-cigarettes – and exempt many cigars from the rules altogether!

Now, the Senate Appropriations Committee must decide whether to include the same damaging language in its version of the bill.

Your senator sits on that committee and will be key in determining the outcome.

Tell your senator to reject any attempts to weaken the new FDA rules protecting kids from e-cigarettes and cigars.

The need for strong oversight of these products couldn’t be clearer or more urgent. The most recent government survey found that youth use of e-cigarettes has skyrocketed: Three million U.S. kids used them last year. And cigars are now more popular than cigarettes among high school boys.

Yet somehow, many members of Congress still want to protect the tobacco industry instead of kids. They’ve already gotten too far in the House. It’s critical that we stop them in the Senate.

Make sure your senator knows you support strong oversight of e-cigarettes and cigars.

Again, the Senate Appropriations Committee will make this decision. Your senator is one of only 30 who sit on that committee. That’s why your voice is so important right now. Please don’t hesitate to send a message today.


Long-Awaited Ruling Brings Electronic Cigarettes Under Federal Authority

Washington (AP) – May 5, 2016


The U.S. Food and Drug Administration finalized a rule on Thursday, 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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