FDA, From a Distance

By: Claudia Heppner, Ph.D.

It is a great honor for me, as a European, to be working for FDA. I am one of the two Locally Employed Staff (Foreign Service nationals) currently working in FDA’s Europe Office in Brussels, Belgium.

Claudia HeppnerI came to this position after serving for 12 years in the European Food Safety Authority (EFSA), which is the European Union (EU) institution that provides independent scientific advice on existing and emerging food safety issues.

Before joining EFSA, I worked with the Secretariat of the EU’s Scientific Committee on Food. I’ve also worked for a multinational company in Belgium and the United Kingdom in the areas of pesticides product discovery and product development, including genetically-engineered plants.

With seven months at FDA under my belt, I enjoy and receive a great deal of satisfaction from my challenging new duties. Together with my colleagues, I am analyzing the range of science and policy issues under discussion in the EU’s decision-making framework. These EU issues span the breadth of FDA-regulated products and may sound familiar to some: updating and streamlining the food safety system; rapid access to innovative medicines; biotech, nanotech, novel foods, mobile and e-health; and, implementation of new legislation on tobacco and electronic cigarettes.

The EU has a complex environment for decision making, involving the “three pillars” (the European Commission, the European Parliament, and the Council of the EU) along with EU organizations that are counterparts to FDA such as the European Medicines Agency, EFSA, and various EU scientific committees.

In addition, each EU Member State (countries that are members of the EU) has its own national law-making bodies and regulatory organizations.

Only the European Commission can propose an EU law. The preparatory steps include: concept papers; a roadmap describing the timeline and significant events; impact assessments examining potential economic, social and environmental consequences; and public consultations.

I quickly learned that the European system is quite different from the legislative process and the notice-and-comment rule making system in the United States. In the Europe Office, we look at each step along the way in the EU decision-making process as a potential opportunity for strategic engagement.

Recently, I wrote a paper that analyzed what the EU is doing to strengthen food regulatory systems in Africa, China, and India. I was struck by the possibilities of what could be achieved through FDA and EU cooperation to help assure the safety of foods shipped to the United States and Europe and to improve public health around the world.

I feel fortunate to be working at FDA and to have the opportunity to broaden my professional horizons. I enjoy the dual focus on science and policy, working on medical product issues as well as foods issues, and observing how a non-EU organization like FDA works.

I look forward to continued learning and to the possibility of contributing to both the U.S. public health and – through FDA’s engagement with the EU – the EU public health.

Claudia Heppner, Ph.D., is a Senior Policy Analyst in FDA’s Europe Office

Find out more about FDA’s Europe Office

Need a Guidance Document? We’ve Got You Covered

By: Chris Mulieri, PMP

We all understand the frustration of searching online for something and not finding it. The Food and Drug Administration recently helped end this problem by making it faster and easier to find our guidance documents – some of the most requested items on our website.

Chris MulieriGuidance documents represent FDA’s current thinking on a particular subject. Currently, there are about 3,100 of them – and the list is growing.

FDA’s Web & Digital Media team and the Office of Information Management and Technology have created a dynamic search list on one site so you can go to just one page and find the guidance documents you need, no matter where they are on FDA.gov. This search tool is powerful and easy to use. Now you can go to just one search box to find what you need in moments, instead of the 10 different pages on FDA’s website where guidance documents are posted.

It doesn’t matter if it’s a guidance document on devices, drugs, biologics, tobacco, veterinary medicine, or foods – it’s all there.

We did this as part of FDA’s Transparency Initiative and in response to the feedback we got from our stakeholders via the American Customer Service Index (ACSI) online survey. They told us just how hard and time-consuming it was for them to find these important documents. So we decided to do something about it.

It’s not practical for us to put these documents all in one place. So, we assembled a working group with representatives from each of FDA’s Centers (which post the guidance documents on their own sites) and developed the search criteria.

In addition, we tagged the documents with metadata (search terms) needed to make search and filtering functions work as intended. Now, the list automatically populates as you enter search terms and filters. Each column is sortable.

You can narrow your search by filtering on different categories, including product, date issued, FDA organization, document type, and subject. Refine your search by draft guidance, final guidance, whether it’s open for comment, or by comment closing date.

How are we doing?

Since the launch of the guidance search in December 2014, page views have increased from about 22,000 to more than 136,000 for the first quarter of 2015. For the first time, the page is among the top visited on FDA’s website. And we’ve seen improved user satisfaction, reflected in the feedback in the ACSI responses.

We hope you’ll try the new guidance document search page soon and let us know what you think.

Chris Mulieri, PMP, is FDA’s Director, Web & Digital Media, Office of External Affairs.

FDA Science Forum 2015: Views of FDA

FDA’s 2015 Science Forum attracted more than 800 people from the scientific community. Here’s what some attendees said about the innovative research going on at the agency and why FDA can be a valuable collaborator in research aimed at transforming food safety and medical product development. If you couldn’t attend the FDA science forum, you can still see all the presentations on our web site.

FDA’s New Research Videos on E-Cigarettes, Nicotine and Cigarillos

By: Cathy L. Backinger, Ph.D., M.P.H. and Cindy Miner, Ph.D.

How dramatic is the increase in e-cigarette use? Why are flavored little cigars and cigarillos increasingly popular among ethnic minorities? What would happen if we reduced the amount of nicotine in cigarettes so that they were no longer addictive?

These are just some of the questions that FDA-funded scientists are answering. Often research is focused on innovation and discovery to expand the body of scientific knowledge. Regulatory science is different—and exciting in its own way. How often do scientists get to see their research findings used to improve people’s lives? Tobacco regulatory scientists are doing just that.

We Need a Strong Science Base to Address Issues that Matter Now

In 2009 Congress passed the Family Smoking Prevention and Tobacco Control Act, creating the Center for Tobacco Products (CTP) at FDA and giving us the responsibility to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco to protect public health.

Our challenge is to regulate effectively in a changing marketplace. The 2014 National Youth Tobacco Survey found that while cigarette smoking has continued to decline, a new trend emerged—more middle- and high-school students used e-cigarettes than traditional cigarettes and 2.2 million students reported using two or more types of tobacco products. In April 2014, FDA proposed a new rule to extend FDA’s authority to cover additional tobacco products, including e-cigarettes, little cigars, and cigarillos.

Data on these and other key topics—from harmful chemicals in tobacco to the effect of chewing tobacco on oral health to tobacco advertising—will help inform future regulatory actions and monitor the impact of those actions on public health.

Some of the Researchers Who Are Leading the Way

FDA is currently funding a broad range of important research, including the following via a partnership with the National Institutes of Health:


Andrew Hyland (Roswell Park Cancer Institute) is the lead investigator for the landmark Population Assessment of Tobacco and Health (PATH) Study, which will help us learn how and why people start using tobacco, switch from one tobacco product to another, quit using it, and start using it again after they’ve quit. The PATH Study collects information on new tobacco products like e-cigarettes and will give us many insights.

Watch Andrew Hyland’s “Tobacco Regulatory Science in Action” interview on FDA’s website.


Eric Donny (University of Pittsburgh) is studying how reduced levels of nicotine in cigarettes might affect the way people smoke. What are the benefits? Could there be adverse effects, such as people smoking more cigarettes to get the same amount of nicotine? Does it make a difference whether the levels are reduced gradually or at once?

Watch Eric Donny’s “Tobacco Regulatory Science in Action” interview on FDA’s website.


Kymberle Sterling (Georgia State University) is studying what people, especially ethnic minorities, think about little cigars and cigarillos. Little cigars and cigarillos are used by many people who are younger and in ethnic minority groups. Understanding what contributes to this behavior will help the nation begin to address some of the disparities that exist among vulnerable populations.

Watch Kymberle Sterling’s “Tobacco Regulatory Science in Action” interview on FDA’s website.


To learn more about the breadth of research we support, please look at all of our research videos* or look at the abstracts of research we’ve funded in our search tool. These projects are just a part of the work that FDA has undertaken to improve public health and inspire the next generation of researchers interested in tobacco regulatory science.

Cathy L. Backinger, Ph.D., M.P.H, is FDA’s Deputy Director for Research in CTP’s Office of Science

Cindy Miner, Ph.D., is FDA’s Director of the Division of Health, Regulatory and Scientific Communication in CTP’s Office of Health Communication and Education

*The opinions in these videos reflect the views of individual researchers, and not necessarily the official position of the FDA’s Center for Tobacco Products. These videos represent accurate information about the design of these CTP supported studies at the time the interviews were conducted (Spring, 2014).

FDA Science Forum to Focus on Emerging Technologies

Dr. Luciana Borio, FDA’s Acting Chief Scientist, invites you to the FDA 2015 Science Forum at our White Oak headquarters in Silver Spring, Maryland on May 27-28. We’ll be showcasing exciting, cutting-edge regulatory science research. For more information and how to register for the forum before the deadline of May 15, 2015, go to The FDA Science Forum.

FDA’s Keynote Address to the Annual Conference of the Food and Drug Law Institute

By Stephen Ostroff, M.D.

Today marks the start of my third week as Acting Commissioner of FDA and I “celebrated” by giving a keynote address to attendees at the annual conference of the Food and Drug Law Institute (FDLI). Few places offer a more appropriate stage for a newly designated leader of FDA. As our names suggest, our organizations have a lot in common.

Stephen OstroffFor decades, the FDA and FDLI have worked together to educate and inform the broad “food and drug” community about the latest developments in our field and FDA’s critical and complex role in promoting and protecting the public health.

It’s been an exciting, busy, and rewarding first three weeks since moving into my new office from the position of Chief Scientist. The FDLI annual meeting offered me the opportunity to highlight a number of FDA’s accomplishments over the last year. The credit for these achievements in no small measure goes to the immensely talented employees at FDA who are committed to assuring safe and nutritious foods, providing effective and high quality medical products, and reducing harm from tobacco products. Credit for these achievements also reflects the extraordinary leadership of my predecessor, Dr. Peggy Hamburg, over the last 6 years.

So today, I’m pleased and honored to present to this audience some of FDA’s accomplishments and challenges, and also to extend my sincere appreciation to FDA’s dedicated work force, who make my new job much easier. But much more importantly, our work force makes the lives of so many Americans safer and healthier. It is with great pride that I look forward to continuing to work with all of you in support of this noble goal.

Stephen Ostroff, M.D., is Acting Commissioner of the U.S. Food and Drug Administration

The Meaning of Wearing Red

By: Margaret A. Hamburg, M.D.

Last night I had the pleasure of attending the annual Woman’s Day Red Dress awards ceremony in New York City. The event is one of the highlights of American Heart Month, and it was created by that magazine to educate Americans about, and help fight, heart disease, which has become the number one killer of women. Many are surprised to learn that while breast cancer is the cause of death of one in every 31 American women, one of every three women dies of heart disease. So I found it particularly meaningful, both as a doctor and a woman, to be honored for FDA’s work to improve women’s cardiovascular health.

Commissioner Hamburg at Event

FDA Commissioner Margaret A. Hamburg, M.D., at the Woman’s Day Red Dress awards ceremony in New York City

One of our efforts toward this end that was cited by the magazine was the proposal to update the Nutrition Facts Label. The proposed updates would more prominently highlight calorie and serving size information, inform consumers about “added sugars,” update the daily values for nutrients, and ensure that the serving size requirements reflect the amounts of food people actually consume. They would encourage consumers to use the label to take note of foods high in sodium, saturated fat, and trans fat, which can increase the risk of coronary heart disease.

We also published final rules on restaurant menu and vending machine labeling. Calorie information is the key component of these requirements, and obesity is associated with a range of heart disease related problems. The new rules also require that other nutrition information, such as sodium, is provided upon the consumer’s request. High sodium intake can increase blood pressure, a major risk factor for heart disease. As with the nutrition facts label, these menu labeling requirements will give consumers nutrition information they need to be able to make healthy food choices for themselves and their families.

Another part of FDA that matters for cardiovascular health is our Center for Tobacco Products. Though its work is designed to protect the health of all Americans, it has special significance for women who, sadly, are catching up to men in the prevalence of tobacco-related diseases.

In the last 50 years, a woman’s risk of dying from smoking has more than tripled, and is now equal to that for men – not what we desire when we talk about equality. The more than 20 million women in the U.S. who smoke cigarettes are at risk not just for heart attacks, lung cancer, and strokes, but also emphysema and other serious chronic illnesses such as diabetes.

Our actions on smoking and nutrition have been complemented by the work of the Office of Women’s Health. Its outreach initiatives have helped provide women with tips and resources they can use to make better heart health decisions for themselves and their families. This Office has also supported research on treatment of heart disease in women.

FDA’s responsibilities also include reviewing, approving, and helping advance new and innovative medical products to diagnose, treat and prevent heart disease, including life-saving medical devices such as artificial hearts, stents, and heart valves, essential tests like echocardiograms, and important drugs for hypertension, lowering cholesterol and treating other aspects of cardiovascular disease.

Over the years, FDA’s support of women’s health has grown thanks to scientific advances, changes in society, and improvements in the agency itself. We will continue to promote these goals, not just in the area of cardiovascular health, but in women’s health more generally.

Of course, we can’t do it alone. And that’s why I sincerely welcome such events as the National Wear Red Day and Woman’s Day’s red dress awards. They help focus our nation’s attention and energy on the fight against women’s heart disease to which we, at FDA, are fully committed.

Margaret A. Hamburg, M.D., is the Commissioner of Food and Drugs

A Year of Significant Progress in Public Health

By: Margaret A. Hamburg, M.D.

Margaret Hamburg, M.D.A new year offers both an opportunity to look forward and an opportunity to reflect on the achievements of the previous year. And, in 2014, FDA’s accomplishments were substantial, touching on many of the agency’s broad responsibilities to protect and promote the public health.

Whether our achievements involved medical product safety and innovation, food safety and nutrition, tobacco control, or other areas of our important work, all were accomplished thanks in large part to our ability to respond to evolving needs and opportunities including the embrace of new approvals, technologies and cutting-edge science.

Consider these highlights:

Drug Approvals: This past calendar year, FDA approved 51 novel drugs and biologics (41 by CDER and 10 by CBER), the most in almost 20 years. Among CDER’s 2014 approvals are treatments for cancer, hepatitis C and type-2 diabetes, as well as the most new drugs for “orphan” diseases since Congress enacted the Orphan Drug Act over 30 years ago. Seventeen of these new approvals are “first in class” therapies, which represent new approaches in the treatment of disease. In addition, CBER approved many important biological products in 2014, including a number of groundbreaking vaccines for meningitis B, the flu, and certain types of Human Papillomavirus, the latter of which is expected to prevent approximately 90 percent of the cervical, vulvar, vaginal and anal cancers caused by HPV.

These developments are a testament not just to our expanding understanding of human biology, the biology of disease and the molecular mechanisms that drive the disease process, but also to FDA’s innovative approaches to help expedite development and review of medical products that target unmet medical needs, while adhering to the established standards for safety and efficacy. These include enhanced guidance to shape the research and development agenda, early input on clinical study needs and design, expedited review programs, targeted regulatory advice and other tools and incentives that spur investment and innovation in new medical products to address unmet medical needs.

Opioids: This past year FDA took several actions to address the abuse of opioid drugs. First, we approved abuse deterrent labeling for three opioid products that are designed to deter prescription drug abuse. These drugs used different technologies to combat the abuse problem in different ways, such as by making the product resistant to crushing or dissolving or using “aversive technology” to discourage users from taking more than the approved dosage of the drug. To help encourage the development of more drugs in abuse-deterrent forms, we are also working to provide additional advice to manufacturers. Although abuse-deterrent opioid drugs are not a silver bullet to prevent opioid abuse, we believe that our work in this area will give physicians effective new treatment options with less risk of abuse.

FDA also worked to improve the treatment of patients who overdose on opioids. We approved a new dosage form of naloxone, with an autoinjector to enable a caregiver to administer the drug in the emergency treatment of opioid overdose (as it rapidly reverses the effects of an overdose). While we continue to support development in this area, this approval offers a new valuable tool to help prevent the tragedy of opioid drug overdose.

Antibiotic Resistance: We made important strides in confronting the growing resistance of some bacteria to antimicrobial drugs. Our efforts, which are a critical part of the recently unveiled National Strategy on Combating Antibiotic Resistant Bacteria, offer a multi-pronged approach that recognizes that to effectively address this challenge means simultaneously addressing the many different causes for increasing antibiotic resistance. One important response has been efforts to expand the pipeline of new medical products, including therapeutics to treat and cure infection, diagnostics to aid in the identification of the cause of infection and of resistant infections, and vaccines to help prevent infection with bacteria in the first place.

These efforts are already having an impact. In 2014, FDA approved four novel systemic antibiotics. In contrast, only five new antibiotics had been approved in the previous ten year period.

In addition to working on the human medical product side, we also developed and, over the next two years will be implementing, an important complementary strategy to eliminate the use of medically important antibiotics for growth promotion in food-producing animals. This strategy, once fully implemented, also will bring the remaining uses of such drugs to treat, control or prevent disease in these animals under the oversight of veterinarians. All 26 animal health companies who produce those drugs have committed to participate, and 31 products already have been withdrawn from the market.

Pharmacy Compounding: We continued to respond effectively to the 2012 outbreak of fungal meningitis that was linked to contaminated compounded drugs. This included conducting more than 90 inspections of compounding facilities across the nation in the past year. As a result, numerous firms that engaged in poor sterile practices stopped making sterile drugs, and many firms recalled drugs that have been made under substandard conditions. Where appropriate, we have worked with the Department of Justice to pursue enforcement action against some of these facilities.

We also have continued to implement the compounding provisions of the Drug Quality and Security Act (DQSA), and to develop and implement policies to address compounding by state-licensed pharmacies and the new category of registered outsourcing facilities.

Food Safety: Over the past year, the Agency has made great strides in implementing the landmark FDA Food Safety Modernization Act (FSMA). Through our proposed rules for preventive controls requirements for both human and animal food, standards for produce safety, foreign supplier verification programs, third party auditor accreditation, focused mitigation strategies to prevent intentional adulteration of food aimed at causing large-scale public health harm, and requirements for sanitary transportation practices to ensure the safe transport of food, we are working to ensure the safety of American consumers related to the foods they eat.

Nutrition: Good health depends not just on food safety, but also on what we choose to eat. FDA plays an important role in promoting good nutrition and healthy food choices by helping consumers understand the importance and benefits of good nutrition – and of being able to make informed choices about what we eat.

New rules in 2014 to finalize requiring calorie information on restaurant menus and vending machines give our citizens information they need to make healthy food choices and hopefully help reduce the epidemic of obesity in the United States. We also proposed changes to the familiar “Nutrition Facts” label on packaged foods which, when finalized, will give our citizens updated nutrition information, reflecting the most current nutrition science, to help them make healthy choices when purchasing packaged foods.

Tobacco Control: There are few areas that have as profound an impact on public health as tobacco products, which is why, five years ago, Congress gave FDA the responsibility to oversee the manufacture, marketing, distribution, and sale of tobacco products.

Over the past year, we worked with state authorities to conduct more than 124,000 inspections of retailers to enforce the ban on the sale of tobacco products to children. We unveiled the first of its kind national public education campaign—The Real Cost—to reduce youth smoking. And we took the first steps towards extending the agency’s tobacco product authority over additional products such as electronic cigarettes (e-cigarettes), cigars, pipe tobacco, nicotine gels, waterpipe (hookah) tobacco, and dissolvables not already subject to such authority through our proposed “Deeming Rule.” In addition, as part of ongoing work on product review decisions, eleven tobacco products that were allowed to enter the market during a provisional period established by the Tobacco Control Act were found “not substantially equivalent” to a predicate tobacco product. As a result of this finding, these products can no longer be sold or distributed in interstate commerce or imported into the United States.

Ebola: The tragic Ebola epidemic in West Africa demonstrates that we do not have the luxury of closing our eyes – or our borders – to the public health problems that exist in the rest of the world. I’m proud that FDA has played an important role in the response to this disease, working closely with colleagues in our government as well as the scientific community, industry and a range of other organizations and nations. We have helped facilitate the development, testing, manufacture, and availability of investigational products for use in diagnosing, treating and preventing Ebola, and worked with sponsors and health care providers to facilitate access to these products as clinical circumstances warrant. In August 2014, FDA designated the drug Z-Mapp as an orphan drug for Ebola, with the hope that this would incentivize further development and study.

And I’m very pleased to report that FDA is represented on the ground in West Africa by dedicated officers of the Commissioned Corps of the Public Health Service who continue to staff and operate the Monrovia Medical Unit in Liberia that was built to treat the health workers who became ill responding to the outbreak. Like everything FDA does, both at home and abroad, our actions on Ebola represent our agency’s continuing commitment to health and safety, and the use of science to advance these important goals.

I am extremely proud of our accomplishments in 2014, and I am confident that FDA will have a successful 2015, as we continue our work to protect and promote the public health.

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

FDA’s FY 2016 Budget Request

By: Margaret A. Hamburg, M.D.

Margaret Hamburg, M.D.FDA oversees products that represent more than 20 cents of every dollar that American consumers spend. Today, FDA presented its FY 2016 budget to Congress.This sensible budget request will help ensure that FDA can continue to fulfill its vast responsibilities to protect the public health, safety, and quality of life of the American public.

I want to share the cover letter that I wrote to Congress outlining some of our specific proposals.

 

Letter from the Commissioner

I am pleased to present the FY 2016 Food and Drug Administration (FDA) Budget.

FDA fulfills its important mission to promote and protect health in an increasingly complex and globalized world in many ways.  The scope of our work includes assuring that foods are safe, wholesome, sanitary and properly labeled; ensuring that human and veterinary drugs, vaccines and other biological products, and medical devices intended for human use are safe and effective; and regulating tobacco products.  We also play a lead role in protecting the public from electronic product radiation and assuring that cosmetics and dietary supplements are safe and properly labeled.  Finally, we have devoted – and will continue to devote – substantial resources to advancing the public health by helping to speed product innovations.

FDA’s responsibilities continue to expand as we work to fulfill the mandates of groundbreaking legislation passed in recent years, including the Family Smoking Prevention and Tobacco Control Act of 2009, the Patient Protection and Affordable Care Act of 2010, the Food Safety Modernization Act (FSMA) of 2011, the FDA Safety and Innovation Act (FDASIA) of 2012, and the Drug Quality and Security Act of 2013.  Further, with so many FDA-regulated products manufactured in whole or in part outside of our borders, FDA is keenly focused on the complexities of regulating in a global marketplace.

In FY 2014, we took important steps to finalize a key set of proposed food safety rules; worked to improve the safety of compounded pharmaceutical products by conducting more than 90 inspections and implementing compounding legislation through proposed regulations, guidances, and other actions; published the “deeming rule” to extend FDA’s tobacco authority; and collaborated with federal, international, and industry partners to expedite the development and availability of medical products.  In addition, FDA has worked intensively to respond to the Ebola epidemic in West Africa by facilitating the development and availability of investigational diagnostics, therapeutics, and vaccines with the potential to help combat the epidemic.

FDA continues to seek new ways to obtain the most public health value for the federal dollar as we implement expanded authorities.  The products that FDA regulates are essential to public health, safety, and quality of life and represent over 20 cents of every consumer dollar spent on products in the United States.  Yet, in terms of our FDA budget, each American taxpayer contributes approximately $8 per year for the vast array of protections and services provided by FDA.

In FY 2016, we are requesting essential and timely resources to address critical food and medical product safety issues.  Mindful of the fiscal environment, we have identified targeted reductions where possible and identified long-term needs for additional user fees to balance budget authority growth.  FDA is requesting a total of $4.9 billion to support our various mandates to protect the American people.  This includes a $148 million budget authority increase to focus on the following:

  • delivering a farm-to-table system of prevention, including improved oversight of imported foods, through effectively implementing the final rules required by FSMA;
  • combating the growing threat of antibiotic resistance – in which drugs become less effective, or ineffective, against harmful bacteria;
  • promoting the development and appropriate use of reliable molecular and genetic diagnostics – precision medicine tools – to “personalize” the diagnosis, treatment, and prevention of disease;
  • implementing key FDASIA requirements to improve medical product review and inspections;
  • addressing the safety of compounded drugs;
  • continuing implementation of new requirements for review of sunscreen ingredients under the Sunscreen Innovation Act; and
  • supporting modern facilities to provide the laboratories and office space needed to meet FDA’s expanded legislative mandates.

As a science-based regulatory agency with a public health mission, FDA plays a unique and essential role in promoting and protecting public health and safety.  We are committed to meeting the needs and expectations of the American people.

Margaret A. Hamburg, M.D.

Commissioner of Food and Drugs

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