FDA Now Collects Data for Tobacco User Fee Calculations

By: Bryan Walsh

The Family Smoking Prevention and Tobacco Control Act (FSPTCA) granted FDA the authority to regulate tobacco products and to collect user fees from tobacco manufacturers and importers to support FDA tobacco regulation activities. These fees provide the FDA with resources for building a regulation framework to reduce the impact of tobacco use on the nation’s health.

Bryan WalshOn July 10, 2014, FDA issued a final rule that changed some administrative aspects of the tobacco product user fee process. In the past, U.S. Department of Agriculture (USDA), under a separate tobacco assessment program, collected information from tobacco product manufacturers and importers and shared that information with FDA. FDA then used that information to calculate tobacco product user fees. However, the USDA program ended in September 2014, and FDA’s authority to collect the information directly from tobacco product manufacturers and importers began on October 1, 2014.

This change does not have a large impact on tobacco manufacturers and importers. The July rule applies only to domestic manufacturers and importers of four classes of tobacco products – cigarettes, snuff, chewing tobacco, and roll-your-own tobacco. They will submit essentially the same information to FDA as they did to USDA. The new Form FDA 3852 is very similar to the form manufacturers and importers have been sending to USDA. Thus, the new rule does not add additional administrative burdens to required data submissions.

The rule also addresses other issues related to tobacco product user fees. For example, it advises how manufacturers and importers might submit a dispute, explains FDA notification procedures and how to pay user fee assessments, and describes penalties for failure to report information or pay user fees.

The final rule will help ensure that FDA continues to have the information needed to assess and collect tobacco product user fees. You can find more information on our User Fees page, including the form FDA 3852 (which includes submission information).

If you are interested in learning more about user fees, please join us for a webinar on Nov. 5, 2014 at 2 p.m. EST.

Bryan Walsh is a Program Analyst, Office of Management, at FDA’s Center for Tobacco Products

FDA Invites Students to Sharpen their Research Skills

By: Nysia George, Ph.D., and Tom Powers

NCTR Intern Claire Boyle, a graduate student from Florida State University

NCTR Intern Claire Boyle, is a graduate student from Florida State University. Get this and other NCTR photos on Flickr.

Biology. Chemistry. Bioinformatics. Toxicology.

Practical, hands-on laboratory work is important for all college students who want to become scientists—but, for many of them, such experiences are out of reach.

That’s one of the reasons why every summer, our National Center for Toxicological Research (NCTR)—FDA’s internationally acclaimed toxicological research center in Jefferson, Arkansas—hosts a special internship program for science students interested in toxicology research.

The 2014 program was exceptionally successful for both the students and the Center.

Applications poured in from more than 200 students pursuing a variety of majors in universities from coast-to-coast. The competition was intense, and the 21 selected students came from schools in 13 states. But they were all alike in two fundamental ways: they were top students, and were eager to hone their scientific skills in real FDA laboratories.

NCTR Intern Luis Valencia, a senior from Texas A&M University

NCTR Intern Luis Valencia, is a senior from Texas A&M University. Get this and other NCTR photos on Flickr.

During their 10 weeks at NCTR, the students worked on projects varying from the development of bioinformatics and statistical methods for RNA sequencing data, to evaluating effects of silver nanoparticles in plastic food containers. They conducted in-vitro experiments; examined effects of nicotine treatment; gained lab experience in cell culture; and were trained in computational modeling or statistical programming.

Each student’s experience was unique and addressed the student’s interests.

The interns gave the program top grades. For example Claire Boyle, a graduate student from Florida State University, said about the lab work: “I like it a lot more than classes. There they tell you that you can do research once you get into the real world. I’ve never had an opportunity to do that before coming here [to NCTR], and that’s the aspect of the program I like best. It’s given me insight into what I want to do for the rest of my life!”

Luis Valencia, a senior from Texas A&M University, echoed similar praise. “This isn’t some pointless classroom assignment; this is the FDA. Something you discover [in this lab] could save a life.” He continued, “I’m having a great experience at NCTR. [My NCTR mentor] let me design my own experiment and helps me a lot. I’m already on my second trial and we’re getting good results.”

The internship program, which was partly funded by the FDA’s Office of Minority Health, is one of the many ways NCTR reaches far and wide to strengthen the scientific foundations of our agency. We engage with scientists within FDA and across other government agencies, industry, and academia to develop scientific information that is vital for sound regulatory policy. We cooperate with colleagues abroad to advance international standardization of regulatory science. And we’re mindful that all quest for knowledge starts with education.

If you are a science student interested in toxicology research, or if you know someone who is, it’s not too early to consider the NCTR’s 2015 internship program. To qualify for admission, a candidate must meet the GPA requirements and provide evidence of success in science courses. He or she will also need letters of recommendation and a personal statement describing his or her research interests.

If you believe you have what it takes, you could be among the select few chosen to join us in the summer of 2015. Applications are accepted throughout the month of February. We look forward to your application!

For more information about the program go to: Summer Student Research Program (NCTR)

For more information about the FDA Office of Minority Health go to: Minority Health

Nysia George, Ph.D., is the National Center for Toxicological Research’s Intern Program Coordinator.

Tom Powers is the National Center for Toxicological Research’s Communication Officer.

FDA’s Program Alignment Addresses New Regulatory Challenges

By: Margaret A. Hamburg, M.D.

Over the last year, a group of senior FDA leaders, under my direction, were tasked to develop plans to modify FDA’s functions and processes in order to address new regulatory challenges. Among these challenges are: the increasing breadth and complexity of FDA’s mandate; the impact of globalization on the food and medical product supply chains; and the ongoing trend of rapid scientific innovation and increased biomedical discovery.

Margaret Hamburg, M.D.The Directorates, Centers and the Office of Regulatory Affairs (ORA) have collaborated closely to define the changes needed to align ourselves more strategically and operationally and meet the greater demands placed on the agency. As a result, each regulatory program has established detailed action plans. Specifically, each plan describes the steps in transitioning to commodity-based and vertically-integrated regulatory programs in the following areas: human and veterinary drugs; biological products; medical devices and radiological health; bioresearch monitoring (BIMO); food and feed; and tobacco.

These action plans focus on what will be accomplished in FY 2015 and outline the need to develop detailed future plans for the next five years in some cases. The plans represent what each Center and ORA have agreed are the critical actions to jointly fulfill FDA’s mission in the key areas of specialization, training, work planning, compliance policy and enforcement strategy, imports, laboratory optimization, and information technology.

Because each Center has a unique regulatory program to manage, there are understandably variations among the plans. However, there are also common features across most of the plans: the need to define specialization across our inspection and compliance functions; to identify competencies in these areas of specialization and develop appropriate training curricula; to develop risk-based work planning that is aligned with program priorities and improves accountability; and to develop clear and current compliance policies and enforcement strategies.

Below are some highlights from the plans that illustrate these features:

  • Establish Senior Executive Program Directors in ORA. In the past, for example, the Center for Drug Evaluation and Research (CDER) would work with several ORA units responsible for the pharmaceutical program. Now, the Centers will have a single Senior Executive in ORA responsible for each commodity program, allowing ORA and the Centers to resolve matters more efficiently.
  • Jointly develop new inspection approaches. The Center for Devices and Radiological Health (CDRH) and ORA plan, for example, will begin to focus some inspections on characteristics and features of medical devices most critical to patient safety and device effectiveness. ORA investigators will perform these inspections utilizing jointly developed training.
  • Invest in expanded training across ORA and the Centers. The Center for Biologics Evaluation and Research (CBER) and ORA will jointly develop a biologics training curriculum, redesign investigator certification, and cross-train Center and ORA investigators, compliance officers and managers.
  • Expand compliance tools. Field investigators will be teamed with subject matter experts from the Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine to make decisions in real time, working with firms to achieve prompt correction of food safety deficiencies and to help implement the preventive approaches outlined by the FDA Food Safety Modernization Act (FSMA). If industry does not quickly and adequately correct critical areas of noncompliance that could ultimately result in food borne outbreaks, we will use our enforcement tools, including those provided under FSMA, as appropriate.
  • Optimize FDA laboratories. ORA and the various Centers will establish a multi-year strategic plan for ORA scientific laboratory work, including hiring and training analysts, purchasing and using equipment, and allocating resources and facilities. At the same time, ORA is committed to conducting an ongoing review of its labs to ensure that they are properly managed and operating as efficiently as possible.
  • Create specialized investigators, compliance officers, and first-line managers. A bioresearch monitoring (BIMO) working group is developing a plan for a dedicated corps of ORA investigators to conduct BIMO inspections, and a dedicated cadre of tobacco investigators is being established.

Working together to implement these action plans will take time, commitment, and continued investment and we’ll need to monitor and evaluate our efforts. These plans will help us implement the new FSMA rules announced in September, as well as the Agency’s new medical product quality initiatives under the FDA Safety and Innovation Act and Drug Quality and Security Act.

FDA’s Program Alignment is a well-thought out approach that responds to the needs of a changing world. I look forward to the ways in which these action plans will ultimately enhance the FDA’s public health and regulatory mission.

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

FDA’s New Roadmap for Progress: Strategic Priorities 2014-2018

By: Margaret A. Hamburg, M.D

The U.S. Food and Drug Administration regulates products that represent about 20 cents of every dollar American consumers spend on products. This includes the safety and effectiveness of drugs, medical devices, and vaccines, the safety of blood supply to food supply, cosmetics, dietary supplements, products that emit radiation, and more recently, tobacco. This fact can be easy to gloss over, but if one pauses for a moment to reflect on this fact, it is clear that the FDA’s regulatory role is large and truly meaningful to all of our everyday lives.

Margaret Hamburg, M.D.When the FDA was first established, our regulated industries were predominantly local, the volume of imported products was low, and even the movement of goods across country was minimal. But times have changed, and so have the strategies we employ to address those changes. Over the last five years alone, the FDA’s regulatory portfolio has increased to now include regulating tobacco products, developing a new global system for protecting food safety, and addressing challenges created by the global expansion of research, commerce and trade.

In fact, more often than not today, a drug or medical product that ends up on the shelves of an American drugstore or in our hospitals will come, at least in part, from some foreign source. Nearly 40 percent of finished medicines that Americans now take are made elsewhere, as are about 50 percent of all medical devices. Approximately 80 percent of the manufacturers of active pharmaceutical ingredients used in the United States are located outside our borders.

These and other new challenges and transformative developments in global science, technology and trade are rapidly altering the environment in which we work to fulfill our broad public health mission. In order to continue to carry out that mission, we need a set of clearly defined priorities and goals, as well as the strategies for reaching them. Therefore, I am pleased to announce the release of a revised set of FDA Strategic Priorities which will guide the agency in how we continue to promote and protect the health of the American public.

The new Strategic Priorities document sets the path for our Agency over the next four years. It establishes a framework for integrating our five strategic priorities – regulatory science, globalization, safety and quality, smart regulation, and stewardship.

Although each priority is significant in and of itself, the priorities are also interconnected and must not be addressed in isolation. In addition, this new roadmap sets forth FDA’s core mission goals and objectives, such as improving and safeguarding access to the products FDA regulates – and promoting better informed decisions about their use.

The Strategic Plan has been in development for more than a year and was created by a hard-working team of talented and knowledgeable FDA employees representing programs from across the agency. While this team drove the Plan’s creation, it is backed by the commitment of all of us at the FDA. My hope is that these priorities, which will be repeatedly cited in our speeches, policies and writings, will serve as our foundational guidepost, providing the strategic direction to help the agency continue to provide the level of service and protection the American people deserve.

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

20 Years of Improving Women’s Health: 1994 – 2014

By: Margaret A. Hamburg, M.D.

Margaret Hamburg, M.D.As we celebrate the 20th anniversary of the FDA’s Office of Women’s Health, I would like to highlight some of the work we’ve done to help improve women’s health, both looking across FDA and within the office. Whether it is approving new treatments for chronic conditions like heart disease, conducting research or helping to protect pregnant women from foodborne illnesses, the work we do at FDA makes a difference throughout a woman’s life.

Consider our product approvals. In 1996, for example, our agency approved a product for use in Pap smears that revolutionized the detection of cervical cancer; ten years later we approved the first vaccine for the prevention of this cancer. We have also approved advances in breast imaging, including 3D breast tomosynthesis and automated screening ultrasound.

We have encouraged innovation in lupus treatment and approved the first new lupus drug in 50 years. And we approved the latest generation of cardiac synchronization therapy devices which our own FDA scientists have shown particularly benefit women with heart failure.

FDA has also supported research to help us better understand how medical products affect women. Since 1994, the Office of Women’s Health research program has provided $30 million to support over 300 research projects, workshops, and trainings on a wide range of topics including cancer, HIV and osteoporosis. More than 25 percent of these research dollars have been directed at cardiovascular disease, the number one killer of women, with studies examining such issues as QT interval prolongation (a disorder of the heart’s electrical activity), how breast cancer drugs can affect the heart, and sex differences in various cardiac interventional therapies. FDA’s medical product centers have also sponsored women’s health research and initiatives such as the Health of Women Program that promote a better understanding of sex differences.

The results have been impressive: OWH’s research alone has been published in over 290 articles in peer-reviewed journals and has made impact on the regulatory decision-making process, including guidance documents, label changes, and standards development. Indeed, FDA’s guidance to industry is an important way that the agency has been helping to address important issues in women’s health.

Over the years, FDA guidance has encouraged greater inclusion of women in clinical trials and the evaluation of sex differences. Our own analysis last year found that women make up about half of the representation in these studies, but the numbers are lower for medical devices. So we have more to do and recently issued guidance to medical device developers to address this concern.

We have also made great strides in our communication and outreach to women during the past two decades. OWH’s Take Time to Care Program has built partnerships with other government agencies, retailers, and national organizations that provide millions of women with FDA safety information. Over the years, we have launched other educational initiatives like the Food Safety for Moms-to-Be and expanded the women’s health resources available via our “For Women” website and social media to make sure that women have tools to help them make informed decisions about the use of FDA-regulated products.

I am pleased at how much we have done to promote and protect women’s health since 1994. At the center of much of this change has been the consistent, driving force of the Office of Women’s Health and its determined leader, Marsha Henderson. I encourage you to check out OWH’s 20th Anniversary brochure to learn more about the progress that has been made. And I hope that you will collaborate with us on the work that still needs to be done.

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

FDA and Health Professionals, Safeguarding the Public’s Health

By: Anna M. Fine, Pharm.D.

At our recent third annual Health Professional Organizations Conference, some of FDA’s most senior leaders exchanged views and discussed issues of mutual interest with senior representatives from key health professional organizations.

Anna FineHeld on FDA’s White Oak campus in Silver Spring, Md., and organized by the FDA’s Office of Health & Constituent Affairs (OHCA), the event was attended by 30 professional organizations representing physicians, nurses, physician assistants, dentists, optometrists, nurse practitioners, pharmacists, and others.

An open and ongoing dialogue between these professionals and FDA is a vital part of addressing many important public health issues. In her opening remarks, FDA Commissioner Margaret Hamburg offered a few examples, such as health professionals’ contributions to the FDA’s MedWatch and Adverse Event Reporting programs and their work in interpreting and addressing medical products’ safety signals. A drug’s safety profile is continually evaluated after FDA approval, and health professionals are encouraged to report suspected adverse events to FDA which allows FDA to conduct comprehensive safety evaluations. Dr. Hamburg also emphasized the importance of health professionals’ engagement in regulatory science research, which provides essential support for the agency’s decisions and ability to bring innovative products to market.

Mitch Zeller, the Director of FDA’s Center for Tobacco Products, speaking at the third annual Health Professional Organizations Conference, on May 14, 2014

Mitch Zeller, Director of FDA’s Center for Tobacco Products, speaking at the agency’s third annual Health Professional Organizations Conference. See more photos of this event on Flickr.

Key FDA leaders who gave presentations throughout the day included Mitch Zeller, the Director of FDA’s Center for Tobacco Products; Dr. Stephen Ostroff, Acting Chief FDA Scientist; and Dr. Peter Lurie, Acting Associate Commissioner of FDA’s Office of Planning and Policy.

In addition, senior scientists from FDA’s centers for drugs, medical devices and food discussed FDA’s priorities and answered questions from the audience. The robust dialogue between the panel members and our stakeholders covered many public health issues including youth and tobacco and FDA’s proposed changes to the food label.

Feedback from the audience highlights the need for such a conference.

“It’s great to have this dialogue with FDA officials. It demonstrates that they respect our organizations and want our feedback,” said one stakeholder representative.

“I love coming to these annual meetings, not only to meet FDA personnel but to talk with colleagues in other professions. This is a one-of-a-kind forum,” said another.

As a pharmacist and team leader within OHCA, I can attest to the fact that my FDA colleagues and I benefited as well. We learned a lot about our stakeholders’ concerns and established new connections with health professional organizations—contacts that we plan to follow-up on to explore new opportunities for mutual cooperation and collaboration in the interest of the public health.

Anna M. Fine, Pharm.D., is Director of the Health Professional Liaison Program in FDA’s Office of Health and Constituent Affairs.

For National Women’s Health Week, FDA Resources Help Women Make Informed Health Choices

By: Marsha B. Henderson, M.C.R.P.

“Ask your mother.” In households throughout the country, women often make decisions about foods and medical products for themselves and their loved ones.

8547850411_6e188c4b11_o-1As we celebrate National Women’s Health Week (May 11-17), I want to highlight some of the many ways in which FDA is working to make sure that women have the resources they need to make informed health choices.

FDA’s Office of Women’s Health (OWH) offers educational resources to help women at every stage of their adult lives—covering topics that range from college health to healthy aging. We develop and disseminate easy-to-read health materials and educational videos for women. We also connect women to these resources and other safety information on the FDA’s For Women website.

Throughout this week, OWH will be conducting special health promotions to connect women to resources on how to stay healthy. Starting today, women can order a free kit of OWH health materials on topics including mammograms, sleep problems, pregnancy, and contact-lens care. OWH is also collaborating with FDA’s Office of Communications to share tips for new mothers and other resources.

Lastly, we’re using social media to challenge women to take better care of their health. Encourage the women in your networks to follow us on Pinterest for a special challenge and health tips each day of the week. Use #1wk4health to participate.  In addition, follow @fdawomen and join us on May 13 at 1 pm for a Twitter chat we are co-hosting with the National Institute of Health’s National Heart, Lung, and Blood Institute and Office of Research on Women’s Health; the Department of Health and Human Services’ Office of Minority Health; and Everyday Health.

Once the week is over, I hope you will continue to look to FDA for women’s health resources. Encourage the women in your community to read our health materials, watch a video or participate in one of our social media activities.

Marsha B. Henderson, M.C.R.P., is FDA’s Assistant Commissioner for Women’s Health

Building Expertise and Crossing Boundaries to Improve Oversight

By: Howard Sklamberg, J.D.

To keep the food supply safe, have safe, effective, and high quality medical products, and decrease the harms of tobacco product use, we have to work with the rest of the world.

Howard SklambergAs FDA’s Deputy Commissioner for Global Regulatory Operations and Policy (GO), I oversee FDA’s efforts to further advance its thinking and strategies from a primarily domestic to a globally focused regulator.

GO coordinates the efforts of FDA’s Office of Regulatory Affairs (ORA) and the Office of International Programs (OIP), and works with all of FDA’s product centers on scientific, manufacturing or other regulatory challenges. The highly skilled and dedicated workforce in ORA and OIP is responsible for conducting domestic and foreign inspections, deepening collaborations with local, state and foreign regulatory partners, helping these regulatory partners to strengthen their regulatory systems, and fostering the use of science-based standards and regulatory coherence around the globe to promote the public health of our citizens.

We have to be able to share information with our regulatory partners. We need their help to implement new regulations that have worldwide impact on the oversight of food under the Food Safety Modernization Act and medical products under the Food and Drug Administration Safety and Innovation Act. Working together with these partners, we can ensure an effective public health safety net for our citizens and communities.

An important new priority for FDA is to make fundamental changes in the way we operate in today’s world by aligning our efforts across the agency to keep pace with the acceleration of scientific innovation and the global expansion of the markets. So much of FDA’s work cuts across multiple product areas. How do we make that work as a large and complex agency?

Commissioner Hamburg and senior leaders across the Agency are committed to strengthening our ability to do just that and are collaborating to achieve greater operational and program alignment across the Centers and ORA.

A key part of this process is to enhance specialization across FDA. For ORA, enhanced specialization means that investigators, compliance officers, import reviewers, laboratory personnel, managers and others will have increased technical expertise in a specific commodity area and will work closely with subject matter experts in FDA’s centers. Over time, ORA’s geographic-based model will evolve to a commodity-specific, program-based model that will provide ORA staff the opportunity to gain increased expertise in specific product areas, such as pharmaceuticals, food, animal feed, medical devices, biologics, and tobacco. They will work as part of a team with the staff from other centers, collaborating, for example, with the Center for Drug Evaluation and Research on pharmaceutical oversight or with the Center for Food Safety and Applied Nutrition on food safety issues.

It is especially important that experts in the centers and ORA be engaged in helping to develop compliance policies and priorities. Working with the centers on these broader concerns puts ORA investigators and compliance officers in a better position to implement the preventive approaches contained in new statutes and work together more seamlessly with the centers.

These and other changes that are part of the agency’s focus on program alignment will deepen our knowledge and make us more effective and efficient, with more clarity and coherence in our communications and actions.

This process is still in its early stages. There is a lot of planning still to be done, and we will work to ensure a transparent and inclusive process. Nevertheless, change is coming and I am excited and proud to be part of a transformation that can only strengthen our efforts to safeguard the foods and medical products that are so important in the lives of people all over the world.

Howard Sklamberg, J.D., is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy

Compliance with the Tobacco Control Act: A Key Part of Reaching the Law’s Potential

By: Margaret A. Hamburg, M.D.

The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) gave FDA the authority to regulate tobacco products, marking a groundbreaking advancement in protecting public health. One vital way in which FDA works to realize the potential of this important law is by making sure it’s followed. This is where a rigorous compliance and enforcement program comes into play.

Margaret Hamburg, M.D.FDA’s tobacco compliance and enforcement efforts run the gamut – from training and education, to monitoring compliance with the law, to initiating advisory and enforcement actions. And some key highlights and accomplishments are contained in FDA’s new comprehensive Compliance and Enforcement Report, which covers activities from June 22, 2009 through September 30, 2013.

While it’s clear that we’ve made progress in reducing the burden of tobacco use on the nation, it’s imperative that we end youth access to tobacco products. Each day in the U.S. more than 3,200 youth under age 18 smoke their first cigarette, and more than 700 become daily cigarette smokers. In order to combat this reality, FDA inspects tobacco retailers to ensure, among other things, that retailers are checking IDs and not selling regulated tobacco products to anyone under the age of 18.

Most tobacco retail establishments FDA inspects are in compliance with the law. In fact, as of May 1, 2014, more than 289,000 inspections show that retailers in 51 states and territories are keeping regulated tobacco products away from kids. However, when violations are found during an inspection, FDA is ready to take action. In a significant milestone this past summer, FDA issued its 10,000th Warning Letter for observed violations of federal laws found during tobacco retailer inspections. In addition, FDA has brought over 1430 civil money-penalty actions against tobacco retailers for violations found during follow-up inspections.

Notably, through its monitoring and surveillance efforts, as of May 1, 2014, FDA has issued over 150 Warning Letters for violations of Tobacco Control Act requirements related to tobacco product promotion, advertising and labeling found online or in print publications.

FDA also regularly inspects registered establishments involved in the manufacture or processing of a tobacco product to determine compliance with existing laws and regulations. Additionally, FDA performs investigations at sites that distribute free samples of smokeless tobacco to monitor for compliance with relevant restrictions, including age verification by photo ID.

These achievements signify the impact of our compliance and enforcement program and its contribution towards assisting FDA in meeting its goal of protecting Americans, especially young people, from the dangers of tobacco use.

FDA understands that it is important to educate the regulated tobacco industry about their obligations under the law, and how they can best comply. As part of a broad compliance and training initiative, FDA recently developed the Sales to Minors: Age and ID Requirements for Sales of Regulated Tobacco video as a new tool to assist industry and retailers in protecting America’s youth. FDA also provides additional education and training opportunities, including guidance for industry publications and online webinars that aim to provide easily accessible educational opportunities.

The laws around tobacco control form the cornerstone of our efforts. And we are dedicated to providing compliance training and education to regulated industry; monitoring regulated industry’s compliance with the law through surveillance, inspections, and investigations; and initiating advisory and enforcement actions against non-compliant industry as appropriate. This way, FDA is better able to protect the health of tobacco users and non-users, and in turn, improve the lives of every American.

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

Proposed Rule Would Expand FDA’s Tobacco Control Authority

By: Margaret A. Hamburg, M.D.

Today we usher in a new chapter in FDA’s role in tobacco control, which began nearly five years ago when the Family Smoking Prevention and Tobacco Control Act enabled us to regulate certain tobacco products, including cigarettes and smokeless tobacco. Now, FDA has proposed a rule that would extend our authority to additional products meeting the legal definition of a tobacco product. This would include electronic cigarettes, some or all cigars, pipe tobacco, nicotine gels, waterpipe (hookah) tobacco and dissolvables not already under the FDA’s authority, as well as future tobacco products.

Margaret Hamburg, M.D.The tobacco product marketplace is evolving at a dizzying pace with many unanswered questions about the health effects of novel products. Especially in the shadow of alarming increases in the number of youths using unregulated products like electronic cigarettes and cigars, it’s more crucial than ever to help prevent early tobacco use that could lead to a lifetime of nicotine addiction. The proposed rule—which would “deem” other tobacco products to be subject to FDA authority—is poised to help make that happen.

FDA is committed to protecting public health. Expanding our authority over tobacco products gives FDA additional tools to help reduce the number of illnesses and premature deaths associated with the use of tobacco products. Under FDA’s proposal, these powerful regulatory tools would include age restrictions, rigorous review of new tobacco products and claims, and health warnings.

“Deeming” – and the new health warning requirements included in the proposed rule – would also help to correct a misperception by consumers that tobacco products not regulated by FDA are safe alternatives to currently regulated tobacco products. Equally important, “deeming” would allow FDA to issue future regulations regarding these products, including regulations to reduce their harmfulness, if we determine that would be appropriate to protect public health.

As we work to finalize the proposed rule, we welcome comments and will consider all that are submitted, as well as any data, research and other information submitted to the docket for this proposed rule.

For more information:

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