Category Archives: Tobacco Products

Celebrating American Heart Month—Making Heart Healthy Choices in 2013

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By: Janelle Derbis, PharmD

Each year, nearly half of all Americans make New Year’s resolutions. They often include losing weight, starting an exercise program, quitting smoking, and making healthier food choices—all of which contribute to a heart-healthy lifestyle. February is American Heart Month, and the timing couldn’t be better to make these lifestyle changes, especially since heart disease is the leading cause of death in the U.S.

FDA joins in the commemoration of American Heart Month by highlighting agency initiatives to help Americans reduce their risk of heart disease.

Achieve a healthy weight. Obesity contributes to a number of health conditions, including high blood pressure and high cholesterol. To help obese and overweight Americans who have been unsuccessful in getting their weight under control with diet and exercise alone, FDA approved two long-term weight management medications in 2012—Belviq and Qsymia. These are the first medications the agency has approved for the treatment of chronic weight management in 13 years.

Quit smoking. Smoking and tobacco use contribute to many health hazards, including heart disease. Nearly half of adult Americans are at risk for heart disease and stroke, and over 20% are at risk due to cigarette smoking. To address the huge public health problem of tobacco use, FDA is building a national tobacco product regulation program to reduce the impact of tobacco use on the nation’s health. Using powerful new regulatory tools provided by the law, FDA’s work supports the objective of the Department of Health and Human Services to end the epidemic of tobacco-related death and disease in America. In November 2012, HHS announced the availability of a new comprehensive tobacco website, BeTobaccoFree.gov, a providing one-stop access to the best and most up-to-date tobacco-related information from across its agencies. This consolidated resource includes general information on tobacco, federal and state laws and policies, health statistics, and evidence-based methods on how to quit.

Eat right. Consumers can eat for a healthy heart and choose foods that are lower in salt, cholesterol, and trans-fat by reading the Nutrition Facts label on food and beverage packages.  In January 2013, the agency announced it is planning to update the Nutrition Facts label based on the latest science-based nutrition recommendations. The updates are still being formulated, and public input will be sought when they are proposed.

Lower cholesterol levels.  Making lifestyle modifications can help reduce cholesterol levels. However, hereditary issues can make some people more likely to have high cholesterol levels regardless of diet and exercise. The good news is there are treatment options for people who are unable to lower their cholesterol levels. There are several FDA-approved cholesterol lowering medications on the U.S. market.

In December 2012, FDA approved Juxtapid for a rare cholesterol disorder called homozygous familial hypercholesterolemia (HoFH), an inherited condition that makes the body unable to remove the “bad” cholesterol (LDL cholesterol) from the blood, which  can lead to heart attacks and death before age 30. The approval of Juxtapid is an example of how FDA provides the scientific and regulatory advice needed to bring new treatment options to market.

Control high blood pressure.  Adopting a healthy lifestyle can help prevent high blood pressure. If lifestyle modifications are not enough to lower your blood pressure so that it is within the normal limit (less than 120 over 80), medications are often prescribed. There are many FDA-approved medications to treat high blood pressure so talk with your health care provider to determine which is best for you.

In April 2012, FDA approved the first generic versions of Avapro (Irbesartan) and Avalide (Irbesartan and Hydrochlorothiazide) for the treatment of high blood pressure.  Generic drugs such as these provide safe and effective alternatives to brand-name drugs. 

Exercise. And lastly, physical activity is an essential component of a healthy lifestyle and when done in combination with healthy eating can help prevent heart disease. In 2013, make a commitment to exercising on a routine basis and keep your heart strong!

To receive up-to-date information on heart-related drug and device approvals, safety announcements, and notices of upcoming meetings, subscribe to FDA’s CardioBeat or visit FDA’s cardiovascular webpage.

Janelle Derbis, PharmD, co-manages the Cardiovascular and Endocrine Liaison Program (CELP), at FDA’s Office of Special Health Issues.

National Conference on Tobacco or Health: Convening for a Healthier Future

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By: Lawrence R. Deyton, M.S.P.H., M.D.

As director of FDA’s Center for Tobacco Products (CTP), I am delighted that representatives from many areas within CTP will be participating in the National Conference on Tobacco or Health (NCTOH). NCTOH is one of the oldest and largest meetings on tobacco education and action, bringing together more than 2,500 national, state, territorial and local tobacco control scientists, program managers, communicators and other professionals in the field every three years. The mission of the conference is to improve the reach and effectiveness of tobacco control programs and activities throughout the United States.

This is the first time that CTP has participated in this meeting. The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) which gave the FDA the authority to regulate tobacco products, was actually passed by Congress during the last NCTOH meeting in 2009. When the vote was announced, it drew large cheers from the participants.

Some of the staff from the FDA’s Center for Tobacco Products attending NCTOH stand in the FDA exhibit. (from left to right): Tarsha McCrae, David Ashley, Les Weinstein, Laura Shay, Sarah Landry, Andrea Frydl, Greta Tessman, and Gail Cherry-Peppers.

FDA’s participation in this year’s conference comes at a critically important point in our history. Since CTP was established we have achieved success in moving science-based regulation forward with historic advances in public health.

Key accomplishments include:

  • enforcing the ban on candy-like characterizing flavors in cigarettes;
  • restricting youth access to cigarettes and smokeless tobacco;
  • enforcing requirements for larger smokeless tobacco health warnings;
  • enforcing prohibition of misleading advertising claims;
  • restricting cigarette and smokeless tobacco marketing to youth;
  • awarding nearly $43 million in contracts to 37 states and the District of Columbia for conducting inspections of retail establishments. So far they have conducted more than 86,000 inspections to determine whether the establishments are complying with regulatory requirements which, among other things, forbid selling cigarettes and smokeless tobacco products to minors;
  • issuing more than 3,500 warning letters and 290 fines to retailers for violating the law.

Sharing what we’ve learned and accomplished will be an important part of CTP’s participation in the NCTOH conference. I will be giving remarks during the opening and closing plenaries as well as presenting during a panel session. Many other CTP staff members will be moderating or presenting during the conference on critical tobacco-related issues including:

  • key elements of FDA’s regulatory authorities;
  • consumer perceptions of dissolvable tobacco products;
  • the development of data systems to support tobacco regulation;
  • national tobacco education campaigns; and
  • strategic partnerships for retail tobacco enforcement.

If you are participating in the meeting, we encourage you to engage with us by attending our sessions and visiting our booth. CTP experts will be looking forward to taking your questions, sharing information and hearing about the activities in your community that are helping to reduce tobacco use and keeping young people from starting to smoke. 

Lawrence R. Deyton, M.S.P.H., M.D., is the Director of FDA’s Center for Tobacco Products

Information Technology, Tools, Tobacco Products and Public Health

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By:  Cindy Miner, Ph.D.

Providing stakeholders with easy to find information that they need to know on FDA’s web site is paramount.

Cindy Miner, Ph.D.Today, I am pleased to announce a new tobacco product section on FDA’s website that organizes important information on tobacco product regulation. This new section brings together information on the three pathways available to legally market new tobacco products under the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act (TCA).

We created this section, called Tobacco Product Review and Evaluation, to centralize information on the pathways for review and evaluation of new tobacco products, before they are marketed. This information does not replace the TCA or any other legal document – it simply guides the user through the key elements of each of the three pathways to market.

Using a creative new interactive tool, users can determine which of the three pathways is most appropriate when seeking to market a new tobacco product. To legally market a new tobacco product in the United States, manufacturers must seek and receive permission from FDA by either:

Although FDA may issue a marketing order for a tobacco product to be marketed, that order does not indicate the tobacco product is either safe or “approved.” The marketing order means the manufacturer has complied with the requirements under the law to bring its product to market. With the passage of the TCA, manufacturers of tobacco products are now required to submit scientific information and seek permission from FDA prior to marketing a new tobacco product, including when making changes to existing products. Learn more about how FDA is protecting public health through tobacco regulation.

This section will also serve as a building block for more information as we develop it. We have already added additional content on modified risk tobacco products and guidance on how to request a meeting with FDA’s Center for Tobacco Products Office Science.

Three years after the Tobacco Control Act was signed into law, we have taken great strides in implementing its provisions. Making sure stakeholders can get the information they need quickly and in a user-friendly manner is a critical aspect of our overall mission.

Cindy Miner is the Associate Director for Scientific Communication, Office of Science, at FDA’s Center for Tobacco Products

Youth and Tobacco Town Hall: Involving Young People in Preventing the Use of Tobacco

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By: Jenny Haliski, M.A.

This morning, FDA’s Center for Tobacco Products Director Lawrence Deyton, M.D., M.S.P.H., is participating in a Youth and Tobacco Town Hall Meeting in Seattle, Washington. He’ll be joining U.S. Surgeon General Regina M. Benjamin, M.D., M.B.A., other public health leaders, and youth from across the Pacific Northwest to discuss FDA’s action agenda for tobacco product regulation.

VADM Regina M. Benjamin, MD, MBA, Surgeon General, USPHS greeting (from left to right) Dr. Lawrence Deyton, director of the FDA Center for Tobacco Products; Howard Frumkin, DrPH, MPH, MD, AB, Dean of the University of Washington School of Public Health, Seattle, Washington, and moderator of the panel on Tobacco Free Campuses; and Kate Cole, MPH, coordinator of the Tobacco Studies Program at the University of Washington, Seattle, Washington, and moderator and panel chair for the conversation with the Surgeon General, “Young People’s Thoughts on Reducing Tobacco Use.”

View photos from the event on FDA’s Flickr
View archived webcast of the Youth and Tobacco Town Hall Meeting

Tobacco use is the leading cause of preventable death in the U.S., responsible for more than 443,000 deaths each year. Nearly all tobacco use begins during youth and young adulthood. The day-long event brings together tobacco prevention leaders, policy makers, advocates and—most importantly—young people from around the region.  Participants will be sharing tools and best practices in tobacco use prevention, discussing existing efforts, and devising new strategies to help youth resist pressures to start using tobacco.

This town hall is part of the broader effort on the part of the Federal Department of Health and Human Services to prevent children from starting to use tobacco and to help current tobacco users quit. The goals for the town hall meeting are to:

  • Help spread the word about the Surgeon General’s Report, Preventing Tobacco Use among Youth and Young Adults;
  • Learn about new initiatives at the FDA to reduce the public health burden of tobacco products;
  • Increase the already-considerable regional energy around efforts to prevent tobacco initiation and reduce tobacco use among young people; and
  • Provide an opportunity for advocates and experts working in this field to share experiences, solutions, and ideas for further reducing tobacco initiation and use among young people.

Watch the live webcast and follow along on Twitter!

  • Beginning at 12 p.m. EDT on June 14, join the live webcast of two plenary sessions with Dr. Deyton and other public health officials, and a conversation between the Surgeon General and youth.
  • Follow @FDAtobacco on Twitter and participate using the hashtag #PNWtobacco

Find out more about the event and view the agenda. Help spread the word!

Jenny Haliski, M.A., is a Press Officer in the Office of the Commissioner, Office of Public Affairs, who works with the Center for Tobacco Products.

National Women’s Health Week: The Dangers of Using Tobacco Products

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By: Lawrence R. Deyton, M.S.P.H., M.D.

The health of every American is of the utmost importance to the Food and Drug Administration, which regulates the manufacture, marketing, and distribution of tobacco products.  Our Center for Tobacco Products works to improve public health, with the goal of making sure that tobacco-related death and disease is part of America’s past, not its future. Lawrence R. Deyton, M.S.P.H., M.D.National Women’s Health Week, May 13-19, provides an opportunity for us to reach out and remind the women in our lives about the dangers of tobacco use and exposure to second-hand smoke — which claims the lives of nearly 200,000 women every year.

Never starting to use tobacco products and quitting tobacco use – for those who do use tobacco – is proven to lead to longer and healthier lives for everyone.

There is no question that tobacco use is dangerous to women. Just consider a few of the facts:

  • An estimated 173,940 women die every year due to cigarette smoking
  • An estimated 18,000 non-smoking women die every year from exposure to second-hand smoke
  • Smoking causes almost 80% of lung cancer deaths in women
  • Smoking causes cervical cancer and eight other cancers
  • Smoking causes infertility and poor pregnancy outcomes
  • Smoking causes low bone density and hip fractures in women

National Women’s Health Week is the perfect time for you — or one of the important women in your life — to break a dangerous addiction to tobacco, and for those who do not use tobacco, it is a time to be empowered to never start. Need help? Here are some great resources:

When we spend countless hours taking care of our families and friends, it’s far too easy to forget to look after our own health. This coming week, make an investment in yourself and the women who are close to you by committing to a life that’s free of tobacco-related disease and death.

Lawrence R. Deyton, M.S.P.H., M.D., is the Director of FDA’s Center for Tobacco Products

Talk With Your Kids About Tobacco

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By: Margaret A. Hamburg, M.D.

The next time you’re out with your kids, take a moment to pause and look at the adult smokers you pass on the street.  Research shows that many of them took up the addictive habit when they were kids — and too young to truly understand the very real risks and dangers of tobacco use.

Margaret Hamburg, M.D.By law, a person has to be at least 18 years old to purchase tobacco products, yet more than 80 percent of adult smokers began before they were 18.  Each day in the United States more than 3,800 youth smoke their first cigarette.  It’s estimated that more than 1,000 youth become daily smokers each day.

As a mother and a doctor, I know that this is something that must change.  And, one of the best ways to help our kids grow into healthy, happy adults is to teach them about the dangers of smoking and tobacco use. And, just as you do with your family, you can play an important role in your community when it comes to getting the word out about the dangers of tobacco. FDA is working to ensure retailers are fully aware of regulations that help protect kids from the dangers of tobacco.  Everyone — from moms (and dads!) to retailers and community leaders — can help protect kids from tobacco.

We all know that our nation’s youth hold the key to our future.  This Mother’s Day, let’s make sure it’s a healthy one.

Margaret Hamburg, M.D., is Commissioner of the U.S. Food and Drug Administration

Getting More Accurate Tobacco Information to Consumers

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By: Margaret Hamburg, M.D.

Tobacco use is the leading preventable cause of disease and death in our country. And this Administration is committed to implementing strategies that will stop our nation’s youth from starting to use tobacco and also help adults to quit. Today we’re taking two critical steps forward that will help reduce harm from tobacco and tobacco products.

Margaret Hamburg, M.D.Americans will soon have more information on the chemicals found in certain tobacco products, reflecting FDA’s commitment to inform and protect the public. For the first time ever, tobacco companies will be required to report the quantity of harmful and potentially harmful constituents – HPHCs – that are in their products to the FDA.

The detailed information that we receive will help FDA determine how best to make science-based decisions to reduce the terrible toll of tobacco-related disease and death. We also hope that by having to disclose this information, industry will voluntarily start to make their products substantially less addictive and harmful.

We are also forging new territory as we seek to ensure that tobacco companies provide accurate information and will not be able to mislead American consumers, especially by making it sound like certain products are less risky than they are. The landmark Family Smoking Prevention and Tobacco Control Act signed by President Obama gives FDA the authority to ensure the claims for tobacco products marketed to reduce risk or exposure, such as “low tar” or “light,” are truthful and demonstrated by sound science.

So today we issued a draft guidance that provides direction for tobacco companies when they submit applications for modified risk tobacco products – MRTPs – tobacco products that are sold, distributed, or marketed to the public for use to reduce harm or the risk of tobacco-related disease.

We want to make sure consumers and the public have an accurate understanding of the health risks of tobacco products—so mistaken beliefs don’t cause them to start or continue using products that lead to preventable disease and death.

We are doing everything that we can to protect all Americans – especially our youth – from the dangers of tobacco, and we’re hopeful these two additional steps will accelerate our goal to make tobacco-related disease and death part of America’s past – not its future.

Margaret Hamburg, M.D., is Commissioner of the U.S. Food and Drug Administration

FDA Voice Interviews Lawrence R. Deyton, M.S.P.H., M.D.

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FDA Voice: What is your current position at FDA and, briefly, what is the mission of the Center for Tobacco Products?

Dr. Deyton: I joined FDA in the fall of 2009 as Director of FDA’s Center for Tobacco Products. CTP has a clear-cut mission: to help make tobacco-related death and disease part of America’s past, not America’s future, and, by doing so, ensure a healthier life for every person and every family.  That means putting programs and regulations in place that will help people, especially children, to not start using tobacco products, help current users to quit, and educate Americans about the risks of tobacco use. 

Lawrence R. Deyton, M.S.P.H., M.D. FDA Voice: Can you tell us in basic terms about the Family Smoking Prevention and Tobacco Control Act?

Dr. Deyton: Sure. When the Tobacco Control Act was enacted in 2009, FDA was given a series of important new responsibilities and authorities to protect the public from the dangers of tobacco use. And we’re implementing and enforcing the law’s provisions as they take effect.

For example, we’re helping to reduce access and the attractiveness of tobacco to kids by restricting advertising, marketing and retail practices related to cigarettes and smokeless tobacco products. We’ll be educating Americans about the contents of tobacco products and smoke and, as we do, we’ll be helping families understand the health effects of tobacco use.

The law is also requiring tobacco manufacturers to register with us and submit information about their products and product ingredients, including additives. As incredible as it sounds, consumers of cigarettes, a mass-consumed product, currently don’t know the chemicals they’re inhaling that cause or have the potential to cause harm to them.  And, FDA now has the authority to set standards that can make tobacco products less addictive and harmful.

I should add that FDA has clear authority to enforce all these provisions. Take the case of retailers. Most retailers are happy to take on their new responsibilities under the Tobacco Control Act to make sure kids don’t buy cigarettes or smokeless tobacco products. But some are not.  And FDA has not been shy about using our authority to enforce penalties against them.

FDA Voice: Can you tell us how CTP is unique and how it differs from other Centers at FDA?

At CTP we’re regulating a product which, if you look at what is available today, is fundamentally unsafe. So, we employ a different regulatory standard than other centers: a public health/population health standard that focuses on reducing the health threat tobacco use poses to all of us, not just the individual consumer. That’s a different strategy than other FDA Centers use, but CTP is regulating a very different product.

FDA Voice:  If you could tell the American public one thing that they might not know about what CTP does to directly benefit them, what would it be?

Dr. Deyton: I think Americans ought to know that, even though we’re a new part of FDA, CTP is really grounded in values that have guided FDA since its inception: the belief that government has a responsibility to take action when people’s lives are needlessly put in danger.

You know, I’ve yet to meet anyone anywhere in this country who wants kids to start to use tobacco. Current smokers tell us, “Help keep this stuff out of kids’ hands.” They want them to grow up healthy. And I should add that those smokers also tell us how badly they’d like to quit. That’s why this law doesn’t only help to prevent initiation; it also promotes cessation and includes provisions for reducing the addictiveness and toxicity of future tobacco products. If we achieve these goals, we will accomplish our mission of making the harm caused by tobacco use part of America’s past, not America’s future.

Lawrence R. Deyton, M.S.P.H., M.D., is the Director of FDA’s Center for Tobacco Products

FDA Voice Interviews Stephen Spielberg, MD, PhD

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FDA Voice: Dr. Spielberg, thank you for agreeing to let us interview you for FDA Voice.  Can you tell us about your position at FDA and what that entails?

Dr. Spielberg: I am the Deputy Commissioner for Medical Products and Tobacco. In creating this new position, Commissioner Hamburg envisioned that it would “provide high-level coordination and leadership across the Centers for drug, biologics, medical devices, and tobacco products, and support, coordinate and advocate for the work and needs of the Centers.”  In my short time at FDA, I have been working with the Center Directors and their staff to understand shared challenges and opportunities to advance regulatory science and practice across all “human products”.  Together, we have begun to define areas of mutual interest and synergy where we can work together and with external partners in the public and private sectors to bring the best of science to bear on our public health responsibilities, to advance managerial and operations support to optimize our core tasks, and to assure in everything we do that FDA is at the cutting edge of promoting and protecting the public health.

 Stephen Spielberg, MD, PhDFDA Voice: Why did you join FDA?

Dr. Spielberg: Throughout my career, I have been involved with FDA.  In fact, my MD-PhD training at the University of Chicago, particularly in the Department of Pharmacology, was in the context of former UC faculty (Drs. E.M.K. Geiling and Francis Kelsey) who were intimately involved with creation of FDA by their work on elixir of sulfanilamide (Federal Food, Drug, and Cosmetic Act of 1938) and thalidomide (Drug Amendments of 1962). So, in retrospect, I suppose I “grew up” with knowledge and appreciation of FDA.  Over the years, I have served as a member of the Pediatric Subcommittee, the Science Board, rapporteur for ICH E-11, and helped get BPCA and PREA through Congress. At this stage of my career, it is a true honor for me to be able to serve the Agency at a critical time in biomedical science and therapeutics.

FDA Voice: What did you do before joining FDA?

Dr. Spielberg: I have had a 35 year career as a pediatrician and clinical pharmacologist, including in academic settings in the US and Canada, as well as in the pharmaceutical industry. My research career has focused on human pharmacogenetics and pharmacogenomics, mechanisms of adverse drug reactions, and pediatric/development pharmacology and pediatric clinical trials. In the years prior to coming to FDA, I was Dean of Dartmouth Medical School, and subsequently headed a new personalized medicine program at Children’s Mercy Hospital in Kansas City, MO, as well as working with the Institute for Pediatric Innovation, a non-profit organization focused on advancing therapeutics for children.

FDA Voice:  What is the favorite part of your job here at FDA?

Dr. Spielberg: This is a remarkable time to be at FDA. Biomedical science is advancing at an incredible rate. We are now beginning to see the impact of genomic and other science in defining the causes of disease, and in the discovery and development of new therapies. Medicine now is at a place that I could barely have imagined when I began my career, but we have the age old challenges of how to skillfully and wisely use the knowledge we have at any time to advance the health of individual patients and of all patients we serve. At such a time, what could be more challenging and satisfying than being here at FDA and having the opportunity to advance the promotion and protection of the public health.

FDA Voice:  If you could tell the American public one thing that you think they don’t know about what your office does to directly benefit them, what would it be?

Dr. Spielberg: Every day, I am impressed by the outstanding, dedicated, hard working people here at FDA. Their focus on our public health mission is remarkable, and it is an honor to work with them.

FDA Voice: Dr. Spielberg, thank you so much for your time!

Stephen Spielberg, MD, PhD, is Deputy Commissioner for Medical Products and Tobacco

FDA: Reflection on 2011 and Looking Forward to 2012

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By: Margaret A. Hamburg, M.D.

The beginning of a New Year is a wonderful time to reflect on the past year and to think about what lies ahead. While 2011 had its share of challenges for us at FDA, it was also a time of significant accomplishment. We are excited about the many opportunities that 2012 will bring to the Agency.

2011 began with the most sweeping reform of our food laws in more than 70 years. FSMA promises an even safer food supply than we enjoy today and a wonderful opportunity to help promote public health.  We also continued the hard work of implementing the Family Smoking Prevention and Tobacco Control Act.

Margaret Hamburg On the medical product front, there were a multitude of outstanding activities and advances.  Importantly, we renewed our focus on the importance of innovation, in our own work and in the products we are tasked to review.  This was also a remarkable year for innovative drug approvals.  During Fiscal Year 2011, the FDA approved 35 novel drugs, targeting diseases such as late-stage lung cancer, metastatic breast cancer, and hepatitis C.

We also worked to continually strengthen the science that guides our policies, including many important collaborations with key partners and stakeholders.  Even with all of our ongoing work, when crises came in 2011, we acted swiftly to protect the American people.  We also continued to strengthen our capacity to address one of the greatest challenges in this new century – our increasingly globalized world.  “Pathway to Global Product Safety and Quality”

In 2012, FDA will meet new and complex challenges and continue our work in implementing FSMA and the Tobacco Act, promoting advancements and innovation in medical products, and broadening our strategic globalization and regulatory science initiatives. We will be working closely with Congress and stakeholders to support the reauthorization of user fees for pharmaceutical products (PDUFA), and medical devices (MDUFA), as well as to authorize new user fees for generic drugs (GDUFA) and biosimilars.

I am confident, thanks to the dedication of the employees of the FDA, that we will continue to make invaluable contributions to the lives of you, the American people.

I wish you and your family a healthy and happy 2012.

Margaret Hamburg, M.D., is Commissioner of the U. S. Food and Drug Administration.