SILVER SPRING, Md., May 5, 2016 /PRNewswire-HISPANIC PR WIRE/ — 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.

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“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.

For more information:

• Final Rule: https://federalregister.gov/a/2016-10685 
• Deeming – Extending Authorities to All Tobacco Products, Including E-Cigarettes, Cigars, and Hookah: http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm388395.htm

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.

Media Inquiries: Michael Felberbaum, 240-402-9548, [email protected]; Tara Goodin, 240-402-3157, [email protected]
Consumer Inquiries: 888-INFO-FDA

ATLANTA, May 3, 2016 /PRNewswire-HISPANIC PR WIRE/ — More young children 2 to 5 years of age receiving care for attention-deficit/hyperactivity disorder (ADHD) could benefit from psychological services – including the recommended treatment of behavior therapy. The Centers for Disease Control and Prevention’s (CDC) latest Vital Signs report urges healthcare providers to refer parents of young children with ADHD for training in behavior therapy before prescribing medicine to treat the disorder.

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ADHD is a biological disorder that causes hyperactivity, impulsiveness, and attention problems. About 2 million of the more than 6 million children with ADHD were diagnosed before age 6. Children diagnosed with ADHD at an early age tend to have the most severe symptoms and benefit from early treatment. The American Academy of Pediatrics recommends that before prescribing medicine to a young child, healthcare providers refer parents to training in behavior therapy. However, according to the Vital Signs report, about 75% of young children being treated for ADHD received medicine, and only about half received any form of psychological services, which might have included behavior therapy.

“Parents may feel overwhelmed with decisions about their child’s treatment for ADHD, but healthcare providers, therapists, and families can all work together to help the child thrive,” said Anne Schuchat, MD (RADM, USPHS), Principal Deputy Director, CDC.  “Parents of young children with ADHD may need support, and behavior therapy is an important first step.  It has been shown to be as effective as medicine, but without the risk of side effects. We are still learning about the potential unintended effects of long-term use of ADHD medicine on young children. Until we know more, the recommendation is to first refer parents of children under 6 years of age with ADHD for training in behavior therapy before prescribing medicine.”

The report looks at healthcare claims data from at least 5 million young children (2-5 years of age) each year insured by Medicaid (2008-2011) and about 1 million young children insured each year through employer-sponsored insurance (ESI) (2008-2014). In both groups, just over 75% of young children diagnosed with ADHD received ADHD medicine. Only 54% of young children with Medicaid and 45% of young children with ESI (2011) received any form of psychological services annually, which might have included parent training in behavior therapy. The percentage of children with ADHD receiving psychological services has not increased over time.

“Many families will benefit from behavior therapy. However, in some cases medicine may be appropriate,” said Georgina Peacock, MD, director of the Division of Human Development and Disability in CDC’s National Center on Birth Defects and Developmental Disabilities. “When healthcare providers and families know the benefits and risks of all available treatments, they are best prepared to make the most appropriate treatment choice for young children with ADHD.”

Parents do not cause their child’s ADHD, but parents can play a key role in the treatment of ADHD.  In behavior therapy, parents are trained by a therapist during eight or more sessions, learning strategies to encourage positive behavior, discourage negative behaviors, improve communication, and strengthen their relationship with their child. When applied, these skills can help the child at school, at home, and in relationships by improving behavior, self-control, and self-esteem. Learning and practicing behavior therapy requires more time, effort, and resources than treating ADHD with medicine, yet research shows that there are lasting benefits making it worth the investment.

In behavior therapy, therapists help parents build skills in guiding their child’s behavior. Skills may include, but are not limited to:

• Positive communication:  When parents give children their full attention and reflect their words back to them, your child knows you are listening and care about what he has to say.
• Positive reinforcement: Praise the child when she does something right. The more parents praise a behavior, the more likely it is the child will behave the same way again.
• Structure and discipline: Children do better when their world is predictable. Set up routines and daily schedules to help the child know what to expect each day.  Respond to the child’s behavior the same way every time to help her learn more quickly. 

CDC message to healthcare providers

CDC is calling on doctors, nurses, and allied health professionals who treat young children with ADHD to support parents by explaining the benefits of behavior therapy and referring parents for training in behavior therapy. This report recommends that healthcare providers:

• Follow clinical guidelines (American Academy of Pediatrics, American Academy of Child and Adolescent Psychiatry) for diagnosis and treatment of ADHD in young children.
• Discuss with parents the benefits of behavior therapy and why they should get training.
• Identify parent training providers in the area and refer parents of young children with ADHD for training in behavior therapy first, before prescribing medicine.

The report highlights missed opportunities for young children with ADHD to benefit from behavior therapy. Increasing referrals and the availability of appropriate services could help many families with young children who have ADHD.

“We recognize that these are not easy treatment decisions for parents to make,” said Dr. Schuchat. “We know that behavior therapy is effective, and the skills parents learn can help the whole family be successful. Building these skills in parents and children empowers families and helps young children with ADHD live up to their full potential.”

For more information, visit www.cdc.gov/ADHD or www.cdc.gov/vitalsigns.

U.S. Department of Health and Human Services

CDC works 24/7 protecting America’s health, safety and security. Whether diseases start at home or abroad, are curable or preventable, chronic or acute, stem from human error or deliberate attack, CDC is committed to respond to America’s most pressing health challenges.

Preventive health care can help Americans stay healthier throughout their lives. Those enrolled in health insurance coverage can use the “Roadmap to Better Care and a Healthier You” (English and Spanish) to learn about their benefits, including how to connect to primary care and the preventive services that are right for them, so that they can live a long and healthy life.

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