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

Technology Transfer—Transforming Food Safety with the GenomeTrakr Collaboration

By: Alice Welch

In my last blog post I discussed how FDA’s Technology Transfer program helps drive innovation by building collaborations that can solve today’s public health challenges using leading-edge science. This blog post describes one of those FDA collaborations—a pathogen detection network that is transforming food safety.

Alice WelchAccording to the Centers for Disease Control and Prevention (CDC), foodborne disease outbreaks are responsible for about 48 million illnesses, 325,000 hospitalizations, and 3,000 deaths every year in the United States. The annual toll for Salmonella poisoning alone in this country is 1 million illnesses, 19,000 hospitalizations, and nearly 400 deaths. As the world becomes even more interconnected, FDA has recognized the urgency of creating new approaches and better tools to detect food contamination and stop outbreaks in their tracks.

The FDA-established GenomeTrakr is an innovative response to this global public health challenge. Using a cutting-edge technology called Whole Genome Sequencing (WGS), FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and Office of Regulatory Affairs (ORA) are collaborating with federal and state public health laboratories to build a publicly accessible genomic database called GenomeTrakr. GenomeTrakr enables us to compare some of the bacterial pathogens that cause foodborne diseases and trace them back to their sources faster and more precisely than traditional methods.

WGS is a laboratory process that identifies the complete DNA sequence of an organism’s genetic material at a single time. The process is being used together with GenomeTrakr to identify pathogens isolated from food or environmental samples and compare them to pathogens isolated from sick patients. If the isolates from food or environmental samples match the pathogens taken from the sick patients, scientists can establish a reliable link that helps characterize the size and location of the foodborne disease outbreak. It can even help public health officials determine which ingredient in a multi-ingredient food is causing the outbreak—so that we can get contaminated food out of the food supply. Used by epidemiologists in combination with traditional methods, WGS is advancing our understanding of contaminations in the food supply.

Pathogens evolve very quickly and have thousands of genetic variations. After spending time in a particular geographic location, a pathogen like Salmonella begins to acquire unique genetic signatures that identify it as coming from that location. Until recently, some strains of Salmonella have looked much the same to us, no matter where we found them, because some of the older methods of testing have been unable to distinguish between certain strains of pathogens. But WGS can detect unique signatures within and between species with far greater precision than previous methods, which makes it one of our biggest secret weapons in tackling foodborne illness outbreaks.

FDA scientists and our collaborators in federal and state public health laboratories are using WGS and the GenomeTrakr database to identify those unique signatures. The signatures can often tell us, for example, if a Salmonella that has contaminated a certain part of the food supply is from the U.S. West Coast, New England, or even Germany. FDA and state lab scientists upload the entire genome sequence for a pathogen into the GenomeTrakr database at the National Center for Biotechnology Information, where it’s available for further use. As the database continues to grow, it’s becoming an increasingly powerful tool to help investigations home in faster on the root causes of outbreaks and track their location.

The potential of technologies like WGS to enhance food safety could not be realized without the development of a powerful database like GenomeTrakr. But to build that kind of database FDA needed to form a web of collaborations. Enter FDA’s Technology Transfer team. It plays a critical role in working with our researchers to create the successful relationships that make huge databases like GenomeTrakr work.

To achieve CFSAN’s vision, FDA’s Technology Transfer team worked with CFSAN researchers to create agreements tailored to the project’s needs. The team drafted collaboration agreements that included provisions for establishing relationships between FDA and state laboratories to perform WGS and upload genome sequences into GenomeTrakr. Once CFSAN’s project concept and goals were established, Technology Transfer experts negotiated and put agreements in place so FDA could begin linking federal and state partners to advance the use of WGS across public health.

Since the first state public health lab collaboration was established in February 2012, FDA, along with other international, federal, and state laboratories have added genome sequences for more than 11,000 isolates to the GenomeTrakr database, and we are already seeing impressive results! In early 2014, through a partnership with CDC, FDA and state department of health laboratories used GenomeTrakr to match environmental and food samples with human biological samples, which helped FDA confirm the source of Listeria in an outbreak.

This collaboration is just one of many that our Technology Transfer team has helped create to support FDA efforts to speed innovation in public health. Stay tuned for my next post, where I’ll discuss an FDA invention that is preventing hundreds of thousands of Africans from contracting the debilitating disease of Meningitis.

Learn more:  Whole Genome Sequencing: The Future of Food Safety

HHS Innovates Award Paves Way for the Future of Food Safety and PulseNet

Alice Welch, Ph.D., is Director of FDA’s Technology Transfer Program

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

Making the Case for Critical FSMA Funding

By: Michael R. Taylor

Over the past two years, my colleagues and I have written here about what FDA is doing to create the preventive, risk-based food safety system mandated by the FDA Food Safety Modernization Act (FSMA). We’ve taken you along on our visits to farms and food facilities to get input on the FSMA rules we have proposed. We’ve described the changes we’re making within FDA and the framework we’re building to implement those rules after they become final in late 2015 and early 2016.

Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine.Now we’re at a critical juncture as Congress considers the funding that will help transform all the plans and preparations we’ve shared with you into protections that will greatly reduce the number of illnesses caused by contaminated foods and greatly increase consumer confidence in the safety of our food supply. President Obama’s FY 2016 budget request, released to Congress yesterday, would provide an additional $109 million for FSMA implementation. In the current fiscal year, FDA received an additional $27.5 million.

Why do we need this money? Because a lot of work must be done right now to ensure that the FSMA rules are implemented smoothly and effectively in late 2016 and 2017. Let me give you a few examples of areas in need of additional funding that, through FSMA, will transform the food safety system into one that prevents hazards instead of just responding to them.

Under FSMA, our approach to food safety inspections and compliance will be fundamentally different. FDA will deploy inspectors who are specialized in specific food commodities, rather than covering a broad range of FDA-regulated products. Backed by technical experts, they will assess the soundness and performance of a facility’s overall food safety system. Achieving this will require a major reorientation and retraining of more than 2,000 FDA inspectors, compliance officers and other staff involved in food safety activities.

While FSMA has given us new enforcement tools to use against those who flout safety requirements, the vast majority of food producers want to comply and keep their products safe. FDA will be issuing guidance documents that will be essential to helping industry meet FSMA requirements. Funds are needed now for FDA to recruit additional experts who can ensure that guidance development is based on the best science and knowledge of industry practices. These experts will also collaborate with industry, academia, and state extension services to ensure that their concerns are heard, that their advice is sought and used, and that the guidance documents reflect the most cost-effective solutions.

I cannot say enough about the importance of education and technical assistance to help farmers, processors and importers—especially small businesses—implement the new standards. Approximately 300,000 entities could be subject to the final FSMA rules. FDA wants to make a substantial investment in providing such assistance and making training materials widely available. In addition to direct technical assistance, FDA would use a large portion of these resources to provide financial support to state agencies and public-private-academic collaborative entities, such as the Produce Safety Alliance and the Preventive Controls Alliance. FDA has also joined with the U.S. Department of Agriculture’s National Institute of Food and Agriculture (NIFA) in providing grants that will fund food safety training for small, sustainable and organic farm owners and food processors.

We cannot make FSMA a reality without our state partnerships. There are more than 3,000 state, local and tribal government agencies involved in food safety. To align state programs with FDA’s new facility inspection and compliance approach, the agency will provide states with funds for inspector training, information sharing capacity with FDA and other states, state laboratory coordination, and inspector certification programs. These preparations have already begun but they must be accelerated in 2016 if the states are to be prepared to conduct sound, consistent inspections when industry must comply with the new prevention standards starting in late 2016. In addition, to successfully implement the produce safety rule, FDA must build state partnerships and capacity in 2016 to provide education and technical assistance to growers.

About 50 percent of fresh fruits, 20 percent of fresh vegetables, and 80 percent of seafood consumed by Americans comes from other countries, so it is clearly essential to modernize how we ensure the safety of imported foods. The Foreign Supplier Verification Program (FSVP) mandated by FSMA, will require importers to implement supplier verification plans to help ensure food produced overseas meets U.S food safety standards. This shift presents an enormous challenge for both FDA and food importers, given that last year there were approximately 88,000 consignees receiving food shipments and, in 2013, 12 million entries for FDA to oversee. FSVP will require a substantial regulatory development process, increased staffing and the training of more than 400 investigative and compliance personnel within FDA to enforce the regulation. It will also require extensive training and technical assistance for importers.

Those are just the highlights; there’s much more to be done. The bottom line is that without investment now, and sustained funding afterwards, there is the risk that the implementation of FSMA will be uneven or even delayed. This would be bad for everyone, including those who must meet the new standards and those who must enforce them. Most importantly, it would be bad for consumers, who want to be sure that the foods they are eating and serving their families are safe.

Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine

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

Protecting Susceptible Populations from Chemical Contaminants in Food

By: Suzanne Fitzpatrick, Ph.D., DABT

Anyone who regularly eats food containing low levels of certain chemical contaminants may be adversely affected over time. But some groups of people are more sensitive to chemical contaminants than others and thus are more likely to be harmed by long-term exposure. We call these groups “susceptible populations.”

Suzanne FitzpatrickThe FDA’s charge to ensure the safety of the food supply is not limited to the protection of the general public. We also have a responsibility to protect susceptible populations.

Pregnant women, infants, young children, and older adults have long been recognized as susceptible populations by the scientific community. In addition, people with cancer, diabetes, HIV/AIDS and transplant recipients may have weakened immune systems and thus may also be more vulnerable. In short, these groups may be at greater risk from a given amount of a chemical contaminant because of their age, genetics, sex, or health status.

Committed to protect susceptible populations as best we can, the FDA convened its Food Advisory Committee on December 16-17, 2014 to help shape our efforts to understand when and how risk assessments should integrate concern for susceptible populations.

Conducted and used by regulators, risk assessments are one of the most objective and scientific ways to understand the potential adverse health effects of chemical contaminants in the food we eat. They help regulators apply science in policy and decision-making. Think of them as a foundation for risk management, a bridge between data and decisions.

At times, however, susceptible populations may require special consideration. They may even warrant separate risk assessments under certain circumstances. If we evaluate their risk with the same broad brush that we apply to the general population, we might miss certain realities. In pregnant women, for example, metals like cadmium, lead and arsenic can cross the placenta and may harm the fetus while its neurological and immune systems are in their earliest stages of development. Similarly, senior citizens may have nutritional deficiencies or cardiovascular problems that make them more susceptible to certain contaminants.

We asked difficult questions of the Food Advisory Committee. To paraphrase a few, we asked what factors the FDA should use to define a susceptible population, what data and level of confidence are needed to initiate a separate assessment for any given susceptible population, and whether there are subpopulations or life stages of particular concern. We also asked several technical questions.

My colleagues and I hope to make meaningful inroads toward better understanding the risks faced by susceptible populations through our risk assessments, in part with the committee’s help. We are confident that we are on the right track. In fact, our effort aligns with a recent report by the National Academy of Sciences (on inorganic arsenic), which suggests that, depending on the chemical, separate risk assessments may be warranted for certain susceptible populations.

We will study the committee’s advice to consider how we can best incorporate susceptible populations into our risk assessments. Ultimately, we know that it might not always make sense to take a “one-size-fits-all” approach when it comes to food safety.

Suzanne Fitzpatrick, Ph.D., DABT, is the Senior Advisor for Toxicology in FDA’s Center for Food Safety and Applied Nutrition.

Food Safety Together

By: Mary Lou Valdez and Julie Moss Ph.D., R.D.

In early December, we represented the FDA in Cape Town, South Africa, at the third annual conference of the Global Food Safety Partnership (GFSP). FDA has been a strong supporter of the GFSP since 2012, when it was launched by the World Bank and Commissioner Margaret A. Hamburg, M.D., gave the keynote address at the first conference. FDA provides the Partnership with financial support and technical expertise.

Julie Moss (left) and Mary Lou Valdez (right)

Julie Moss (left) and Mary Lou Valdez (right)

The World Bank is uniquely positioned to facilitate the GFSP and create a “big tent” where all parties in the global supply chain can work together to help ensure that all food products are safe for consumers. While government agencies like FDA develop standards and regulations, and provide regulatory oversight, it is the food industry, not the government, which produces safe food for consumers. To be successful in improving global food safety, we need to create partnerships across nations and sectors. The unique role of GFSP is to enable and catalyze a clear strategic direction to strengthen food safety systems and supply chains globally in ways that can only be achieved or enhanced collectively.  The GFSP brings together government, industry, academic, consumer and international organizations, providing a unique and valuable opportunity for all of these parties to cooperate in new and creative ways to improve food safety. This requires coordination to focus our efforts and avoid duplicating each other’s work.

Attendees at the 2014 Food Safety Global Conference.

Attendees at the 2014 Food Safety Global Conference.

During the conference, we acknowledged progress on many ongoing food safety activities (e.g., needs assessment progress in Zambia and Good Aquaculture Practices training in Malaysia, among others) and we moved forward in building a framework for a long-term strategy to collectively support and sustain investment in food safety systems. Yet, there is still much work ahead for 2015, which will be a critical year for the GFSP, as we will further refine our strategy and look forward to making great strides in key GFSP initiatives, including work to strengthen food safety systems in China and Zambia. Success in protecting the safety of the world’s food requires a new paradigm with new partnerships across nations and sectors. Moving forward, we intend to work to expand and promote this valuable partnership in the coming year to continue to strengthen the global food safety net for all consumers.

At FDA, we recognize that today’s food supply chain is global, complex, and interconnected. Because the U.S. imports half of its fresh fruits and 80 percent of its seafood, our efforts to protect the U.S. food supply must be global, and we must build strong partnerships to create a world-wide product safety net to protect public health. GFSP is an example of our ongoing efforts to build partnerships as we aim to prevent unsafe products from entering the market, no matter where the products come from or where they are consumed.

Mary Lou Valdez is FDA’s Associate Commissioner for International Programs

Julie Moss, Ph.D., R.D., is Deputy Director, International Affairs Staff in FDA’s Center for Food Safety and Applied Nutrition

Together: A Food Safe America

By: Michael R. Taylor

I recently had the pleasure of speaking at the Consumer Food Safety Education Conference convened by the Partnership for Food Safety Education (PFSE). The conference brought together food safety educators from across the country – people in state and local health departments, universities, extension services, and food businesses who are working every day on the front line, with consumers, to reduce food safety risks by improving consumer food handling practices.

Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine.The theme of the conference was “Together: A Food Safe America” – a theme that captures so well the sense of community, high purpose and energy that were present so abundantly at the conference. I shared the podium with two good friends and colleagues representing key FDA partners on food safety – USDA’s Acting Under Secretary for Food Safety Brian Ronholm, and Joe Corby, the Executive Director of the Association of Food and Drug Officials, which represents state and local food safety officials.

We regulators have a responsibility, through our oversight of the food industry, to do everything we reasonably can to make sure that the foods consumers bring into their homes are as safe as they can be. We are doing this by building into our food safety standards and compliance programs modern concepts and techniques for preventing the contamination that can make people sick.

Under the FDA Food Safety Modernization Act (FSMA), we at FDA have a new mandate to build a farm-to-table system of prevention, encompassing work that must be done to make food safe at four major stages of the commercial food system. These pillars of prevention include:

  • Production of produce on the farm,
  • Practices in food processing and storage facilities,
  • Transportation of food, and
  • Practices in grocery stores and restaurants.

But there’s a fifth pillar of prevention, and that’s the consumer. We all know that, even with the best of efforts by commercial food producers and handlers, consumers still must play a crucial role in preventing the introduction and spread of contamination – by keeping their hands and food surfaces clean, by keeping raw meat and produce separate, and by being sure to cook food to proper temperatures and chill food through prompt refrigeration.

It seems like common sense – and the basic ideas are – but food safety educators know that it’s far from simple to provide consumers the information, tools, and motivation they need to turn common sense into sustained behavior change. But they are out there, every day, doing the hard work.

We in government and the food industry need to better support our food safety educators.  FDA, USDA, and the Centers for Disease Control and Prevention (CDC) do some good work on food safety education. For example, at FDA, our current programs include targeting groups and individuals who are especially vulnerable to foodborne illness and partnering with the National Science Teachers Association to incorporate food safety into the science curriculum at the middle and high school levels. But there is more we can do to support food safety educators at the front line, in their daily work with consumers in clinics, in schools and in communities – where most of the food safety education, and all of the behavior change, takes place.

At FDA, we will be building food safety education into our risk-based priority setting paradigm, which means documenting better the contribution that education makes to reducing risk, evaluating what works to sustainably improve consumer practices, and targeting resources where they will make a real difference. Federal food safety agencies – and their finite resources – are overwhelmingly focused on the congressional mandate to prevent hazards arising from the commercial supply chain, which makes sense: that’s what we regulate. But, backed up by the right analysis, we can effectively target and increase our investment in consumer education in ways that will make a real difference for public health.

But the federal government can only do so much. And that’s where PFSE comes in. The Partnership brings together government, industry and consumer leaders to pool their expertise, share their perspectives, and collaborate on the hard work of food safety education. I applaud and thank the consumer groups, food companies, and trade and professional associations that are contributing their time, creative energy and resources to the work of the Partnership. And I salute the PFSE’s Executive Director Shelley Feist for her leadership and her sustained commitment to food safety and consumer education.

Working hard, and working together, we can have a Food Safe America.

Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine

Tragic Deaths Highlight the Dangers of Powdered Pure Caffeine

By Michael M. Landa

On Tuesday, Dec. 9, my colleagues and I met with the parents of two young men who died after using powdered pure caffeine.

Michael M. LandaLogan James Stiner, an 18-year-old high school senior, prom king and athlete just days away from graduation, died on May 27, 2014 at his Ohio home after taking powdered pure caffeine. On June 24, 24-year-old James Wade Sweatt of Georgia, newly married and a recent graduate of the University of Alabama at Birmingham, died after being in a coma caused by his use of powdered pure caffeine.

Their parents spoke with us about how both young men were healthy, intelligent, and careful about what they put in their bodies.

They learned, and shared with us, that Logan and Wade both thought this form of caffeine would be a safe way to get an energy boost. Both were able to obtain it cheaply and easily. Wade had sought out the product as a way to avoid the added sugar and sodium associated with soda or energy drinks. He had even downloaded a conversion chart to try to calculate the right dose to take.

Katie and Dennis Stiner, and Julie and James Sweatt, came to the FDA in hopes of sparing other families this terrible loss.

We share that goal. That’s why, after learning of Logan’s death, the FDA posted a consumer advisory warning of the dangers of consuming powdered pure caffeine.  Symptoms of caffeine overdose include rapid or erratic heartbeat and seizures.

We are working right now on our next steps. In the meantime, I cannot say strongly enough how important it is to avoid using powdered pure caffeine. The people most drawn to it are our children, teenagers, and young adults, especially students who want to work longer to study, athletes who want to improve their performance, and others who want to lose weight.

The powdered pure caffeine that the Stiners and Sweatts brought to show us—readily available for purchase online—was packaged in the same way as protein powder and marketed as a source of energy, rather than a stimulant. The reality is that these products are 100 percent caffeine, with a single teaspoon roughly the equivalent to the amount in 25 cups of coffee. Pure caffeine is a powerful stimulant and even very small amounts may cause an accidental overdose.

Our hearts go out to the Stiner and Sweatt families, and we appreciate their efforts to protect others from harm. As regulators, and parents ourselves, we take this threat to public health very seriously and are committed to protecting young people like Logan and Wade, and all consumers, from the dangers inherent in the use of powdered pure caffeine.

Michael M. Landa is the Director of FDA’s Center for Food Safety and Applied Nutrition

Regulators Caught in the Act of Protecting Public Health

By: Melinda K. Plaisier and Michael M. Landa

We were ready to head out to observe the inspection of a Miami seafood warehouse, but another team of investigators asked that we first look at evidence from their last job. They showed us a video of a huge quantity of rice contaminated with live insects.

Melinda K. Plaisier is FDA’s Associate Commissioner for Regulatory Affairs.

Melinda K. Plaisier, FDA’s Associate Commissioner for Regulatory Affairs

Their work, they knew, would prevent that shipment from reaching consumers, and they were justifiably proud.

“Government regulation” is a term often used with derision. During a recent tour to observe investigators in FDA’s Office of Regulatory Affairs (ORA), however, the value of regulations was clear. So were the dedication, skill, experience, physical stamina, and pride investigators bring to one of the major steps in enforcing regulations. Those qualities appeared again and again–at a blood bank inspection in Boston, a juice facility in Philadelphia, an egg farm in Iowa, a smoked seafood plant in Seattle and at the Miami warehouse.

About 91 percent of the seafood sold in the U.S. is imported; 80 percent of that comes through Miami. ORA inspector Michael McCoy offered us winter parkas for the inspection in the cold storage warehouse.

McCoy, a marine biologist, formerly specialized in aqua farming and helped develop the process for farming shrimp, including the means to artificially inseminate them. He has worked for ORA for seven years. When he walked in the warehouse to sample yellowfin tuna from Surinam, someone announced, “It’s the meticulous one.”

From an even colder section of the warehouse, forklifts carried tuna-filled boxes called coffins, due to their size and shape. McCoy randomly selected 18 fish and from each one cut, from fin to belly, a sample. Then he weighed each piece before bagging and freezing it in dry ice for shipping to ORA labs in Atlanta. Inspection procedures call for one-pound samples. McCoy weighs each piece, but it turns out that in every case, he’s cut exactly one pound.

Just 24 hours after McCoy cuts the samples, the shipper learns the fish passed all tests and can be put on a plane to its buyer in Jericho, New York.

Michael M. Landa

Michael M. Landa, Director of FDA’s Center for Food Safety and Applied Nutrition

The cold warehouse inspection in Miami contrasts with the heat of an Iowa farm where 480,000 hens produce 144 million eggs yearly. FDA’s “Egg Rule,” or Title 21 of the Code of Federal Regulations, Part 118, is aimed at keeping the deadly bacteria Salmonella Enteritidis from the egg supply.

We travel deep into the countryside and up a long gravel road. In a “safe area,” we put on disposable Tyvek suits, including booties, hairnets, gloves and respirators. The suits are to ensure we don’t bring in anything to contaminate the area. At the door of the first of six henhouses, lead FDA investigator Katie Jo Close, a biologist, makes sure everyone walks through a box of powdered disinfectant—part of the farm’s biosecurity plan.

Sample collection requirements are exacting: for example, each swab for bacteria must be collected on a 4×4 inch, 12-ply gauze square that has been moistened with evaporated milk poured from a can whose lid has been disinfected with 70% ethanol. The protocols for where samples must be collected and how they are handled are even more exacting.

Before coming to ORA nearly six years ago, Close worked for a seed company, researching ways to make higher-yield, drought-resistant corn. Currently, in addition to inspecting egg farms, Close inspects facilities producing juice, canned goods and animal feed products, to name a few.

“I like the fact that each day is different,” Close says. “I feel like I’m protecting my family, my friends, my neighbors, everyone. I’m educating firms and farmers on how to follow the regulations that will prevent illness and death. I’m making a difference in people’s lives.”

From our desks in FDA headquarters, we see important work going on. Going into the field, though, is both humbling and inspiring. These men and women around the country, every day, are giving government regulations a good name.

Melinda K. Plaisier is FDA’s Associate Commissioner for Regulatory Affairs

Michael M. Landa is Director of FDA’s Center for Food Safety and Applied Nutrition