Unveiling the New Nutrition Facts Label

By: Robert M. Califf, M.D., and Susan Mayne, Ph.D.

Today, the FDA has finalized the new Nutrition Facts label on packaged foods with changes that will make it easier for consumers to make informed choices about what they’re eating.

Robert Califf

Robert M. Califf, M.D., Commissioner of the U.S. Food and Drug Administration

Our goal is to help people make better informed food choices that support a healthy diet. The changes are based on updated science that reinforces the link between diet and chronic conditions such as obesity, heart disease and diabetes.

This is not about telling people what they should eat. It’s about making sure that they know what they’re eating. With that knowledge, they can make more healthful choices. For example, the new Nutrition Facts label includes the addition of information about added sugars. Studies have shown that healthy dietary patterns that include lower amounts of sugar-sweetened foods and beverages are strongly associated with reduced cardiovascular disease.

Obesity continues to be an epidemic in this country, and excess weight can lead to a host of health problems. People who want make healthier food choices will really benefit from the more prominent display of calories and updated information about serving sizes that more accurately reflects what people are likely to eat in one serving.

Susan Mayne

Susan Mayne, Ph.D., FDA’s Director of the Center for Food Safety and Applied Nutrition

We all play many different roles in life. In addition to taking care of ourselves, we’re parents and grandparents who want to take good care of our families. We have busy lives, and we need ready access to information about the nutritional value of the foods we eat. That’s why design changes to the label will make it easier to see essential information at a glance; including calories and information about serving sizes and servings per container.

The label also reflects new or updated Daily Values (DVs), which are the reference amounts of nutrients to consume or not to exceed and the basis of the percent Daily Value (% DV) on the nutrition label. In addition to added sugars, new nutrients that must be declared include Vitamin D, which is important in bone development, and potassium, which is good for controlling blood pressure; both nutrients of which people aren’t getting enough.

Across the board, this is a better label for all of us. And you can have confidence in the science on which it is based, including evidence used to support the Dietary Guidelines for Americans, nutrition intake recommendations from the Institute of Medicine, and nutrition intake information from the National Health and Nutrition Examination Survey (NHANES).

We’ve reached an important milestone, but our work is not yet done. Our next step is to reach out to the larger community to provide education and outreach on the new label and what it means for consumers and families.

The Nutrition Facts label can make a real difference in helping consumers have the information they need to make dietary choices that support a healthy diet.

Robert M. Califf, M.D., is Commissioner of the U.S. Food and Drug Administration

Susan Mayne, Ph.D., is FDA’s Director of the Center for Food Safety and Applied Nutrition

Protecting Trade in Safe Food is a Global Concern

By: Sharon Mayl and Debbie Subera-Wiggin

Protecting consumers from contaminated foods is a global concern—as well as a key FDA priority. This was clear to us when we attended a World Trade Organization (WTO) conference in Geneva earlier this spring to provide outreach on FDA’s new food safety regulations.

Debbie Subera-Wiggin, left, and Sharon Mayl at the World Trade Organization meeting in Geneva.

Debbie Subera-Wiggin, left, and Sharon Mayl at the World Trade Organization meeting in Geneva.

This was the 65th meeting of the WTO’s Committee for Sanitary and Phytosanitary Measures (SPS), an important body that provides a forum for the discussion of food safety and animal and plant health issues that affect the international food trade. While enhancing free trade is WTO’s focus, members understand the importance of facilitating trade in safe food products.

Working with the WTO Secretariat, the U.S. Mission in Geneva and the Office of the United States Trade Representative, we shared information about the FDA Food Safety Modernization Act (FSMA) rules that aim to help ensure the safety of foods exported to the United States. It was exciting to look out at the audience and see public health and trade officials from more than 33 countries and international organizations seeking to learn more about the new food safety regulations.

The United States has been a member of the WTO, which has 162 member nations and observer organizations, since 1995. Under the auspices of this SPS Committee, U.S. trade and regulatory agencies, including FDA, work with governments worldwide on trade issues related to food safety. Their work includes ensuring that the regulations of each nation support the rights and obligations of WTO agreements.

FDA incorporates these obligations into our regulatory process, specifically to ensure that our regulations are risk- and science-based, are created through a transparent process, and are equitable to both domestic and foreign producers, while protecting public health. The WTO SPS Committee is an ideal international venue for sharing information on FDA’s food safety rules.

Our job during this meeting was to share insights on three of the new FSMA rules — in particular, produce safety, foreign supplier verification programs, and accredited third-party certification.

We were very impressed by the interest that the countries’ representatives had in these rules. More than 50 representatives even skipped their lunch to participate in the outreach session and many returned that evening, after the main session closed, to continue the discussion!

WTO members are interested in understanding and meeting the regulatory requirements in FSMA rules so that they can continue to ship safe products to the U.S. Several of the participants expressed their government’s support for working cooperatively with us to strengthen food safety controls.

We left the outreach session with a better understanding that our trading partners are highly motivated to put mechanisms in place that will help their producers and manufacturers comply with the FSMA rules and contribute to robust trade partnerships.

Sharon Mayl, J.D., is a Senior Advisor for Policy in FDA’s Office of Food and Veterinary Medicine; Debbie Subera-Wiggin is a Consumer Safety Officer on the International Affairs Staff in FDA’s Center for Food Safety and Applied Nutrition.

Engagement and Collaborative Problem Solving: Two Ingredients for FSMA Success

By: Michael R. Taylor and Stephen Ostroff

As we’ve developed the rules needed to implement the FDA Food Safety Modernization Act, we’ve done a great deal of outreach to explain the new requirements and obtain feedback from stakeholders.

group touring Florida citrus grove

Tim Dooley (top of photo, center right), vice president of Blue Goose Growers in Fort Pierce, Florida, leads a tour of the company’s citrus groves.

We’ve got to continue doing this with the people working on the nation’s farms–since the produce safety rule issued in late 2015 primarily involves them.

This was a lesson learned in our recent trip to southern Florida, where we toured citrus farmlands and took part in a public meeting on the final FSMA rules at the University of Florida’s Institute of Food and Agricultural Sciences (UF/IFAS). We found that growers want to meet the new standards in the produce safety rule but need greater clarity and understanding about how the rule can be applied to their specific farm setting.

Florida farmers are under a lot of pressure that has nothing to do with the FSMA rules. The citrus groves there have been hard hit in recent years by a disease called citrus greening that results in stunted, bitter, green fruit and drastically reduced harvests. The stark backdrop to our conversations is that these growers are fighting for survival–and every cost counts.

That makes it especially important that they, and all farmers covered by the produce rule, understand what will be required. And, just as important, what won’t be required.

For example, we talked to growers who have dozens of wells on their farms and are worried about the rule’s water testing requirements and associated costs. But in many cases, only a fraction of those wells are used to apply water in a way that is intended or likely to contact crops during growing, or for other uses that are  subject to the microbial water quality criteria in the produce rule.

Some growers pull surface water out of extensive canal systems where the water from any one canal may deliver water to many farmers. Other growers use seep irrigation systems in which the water seeps from a surface water source through the soil. The growers told us that the soil filters the water, which comes in contact with root vegetables like carrots, beets and radishes.

Their questions were: How are we covered by the produce safety rule and how do we achieve compliance? One of the growers produces beets and our answer to him was that beets are not covered because the produce rule exempts specific crops that FDA identified as rarely consumed raw, such as garden beets and sugar beets. We explained that water used in seep irrigation that contacts root crops covered by the rule does have to meet the applicable microbial standard. But farms have the option of establishing and using alternatives for certain agricultural water requirements if they have scientific evidence to support them.

Each region of the country has its own complexities, and Florida has a dramatically diverse landscape of crops, settings, and soils. The soil around Lake Okeechobee transitions from sandy at one end to densely dark muck at the other. Within the citrus industry, agricultural water can come from completely different sources, surface and ground water that have different testing requirements. We at FDA are constantly learning about the complexities that are part of everyday life for our nation’s food producers.

This trip highlighted how important it will be for us to be continually engaged at the local, state and federal levels in collaborative problem solving with growers and others in the food industry as we implement the FSMA rules.

We value the leadership of Florida Commissioner of Agriculture Adam Putnam, Deputy Commissioner Lisa Conti and others on their team. We have long been partners with Martha Roberts of UF/IFAS, an authority on food safety issues. And Florida itself is a pioneer in food safety, in 2008 establishing the first mandatory state regulatory program for produce with provisions for inspections and audits for tomato handling, production and packing.

Susan Turcovski, the director of FDA’s Florida District, and her team accompanied us on this visit. They are also on the front lines of implementation and their role will be critical in the months and years ahead. We were joined by Leanne Skelton, the U.S. Department of Agriculture’s liaison to FDA on FSMA issues, and spent time at USDA’s Horticultural Research Lab in Fort Pierce.

Education is an important part of our FSMA efforts. Another member of our group was Dr. Michelle Danyluk, one of the leads for the Southern Training, Education, Extension, Outreach, and Technical Assistance Center at the University of Florida. The center is one of four regional centers funded by USDA and FDA that will coordinate and implement FSMA-related training.

We’ve got our work cut out for us but every conversation brings us closer to the food safety system envisioned by FSMA that systematically takes steps to prevent the causes of foodborne illness. Working together, we’ll get there.

Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine; Stephen Ostroff, M.D., formerly FDA’s Acting Commissioner, will be succeeding Mr. Taylor as Deputy Commissioner on June 1, 2016.

FDA-State Partnership Propels FSMA Implementation

By: Michael R. Taylor and Stephen Ostroff, M.D.

Ever since the FDA Food Safety Modernization Act (FSMA) was enacted in 2011, we’ve said that successful implementation is not possible without a meaningful partnership between FDA and its counterparts in state government. This is especially critical in the new area of produce safety regulation.

Michael R. Taylor

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

After years of rulemaking – of planning, discussing and revising – this partnership is no longer just an aspiration. Instead, it’s evolving into a real union of public health and regulatory colleagues at the state and federal levels who together are taking concrete steps to make the produce safety protections envisioned by FSMA a reality.

An example of this forward movement is a conference we both attended on March 22 in Orlando, Florida, where the National Association of State Departments of Agriculture (NASDA) unveiled its proposed framework for state participation in the implementation of FDA’s new produce safety rule. This rule—for the first time—establishes enforceable federal safety standards for the production and harvesting of produce on farms.

In 2014, FDA entered into a five-year cooperative agreement with NASDA to work with state partners to collaboratively plan implementation of the produce rule. The NASDA framework will help guide and inform states that are working to develop a state produce safety regulatory program that is aligned with the FSMA rule.

The NASDA framework was developed with the active involvement of 24 state departments of agriculture and five national public health organizations. Key areas addressed include education and compliance, information sharing, regulator training, accessing laboratory resources, technical assistance, and infrastructure.

Stephen Ostroff, M.D.

Stephen Ostroff, M.D., formerly FDA’s Acting Commissioner, will be succeeding Mr. Taylor as Deputy Commissioner on June 1

All 50 states were represented at the Orlando meeting to review and discuss the proposed framework, which is intended by NASDA to be a living document that can be refined and improved over time as experience is gained with implementation of the produce safety rule. The level of alignment and energy among participants at the conference – which included 46 agriculture departments and 19 public health departments – was inspiring and demonstrates that we are very much on the right path toward a sustained partnership with our state colleagues.

The states have always been clear in conversations with us, and we have been clear in conversations with Congress, that federal funding is necessary for the work ahead. State agriculture and public health personnel are the ones who have built relationships with and knowledge of local farming communities and practices and can often deliver oversight most efficiently. But almost all states will have to build produce safety programs largely or completely from scratch. We want to rely on them, not only to deliver education and technical assistance, but also to provide ongoing compliance support and oversight.

But this requires resources.

The President’s Fiscal Year 2017 budget request includes $11.3 million in new funds for the National Integrated Food Safety System. We have been building this system to fully integrate the more than 3,000 state, local and tribal government agencies involved in food safety in FDA’s work to meet the FSMA mandate. The FY 2017 funding, which Congress is considering, will be used primarily to support state produce safety programs through cooperative agreements and grants.

The FY 2017 funding builds upon resources for states that Congress provided for FSMA implementation in FY 2016. Earlier this month we took an important step toward distributing these funds – $19 million – to support state produce safety programs by soliciting applications for cooperative agreements with state regulatory agencies. These funds will make an important down payment on the capacity states need to be our full FSMA partners in produce safety. The FY 2017 funding request recognizes that more will be needed – both next year and beyond — to realize this goal.

There is a great diversity in where states are right now in planning and developing their produce safety programs. Some may already have developed multi-tiered plans and are ready to begin implementing. Others may just be starting to consider what’s ahead. This program is designed to give states the support they need at whatever stage they’re in.

Our goal is to get the initial funding to a number of states before the end of this fiscal year.

This has been a long road. But we are gaining real momentum toward the ultimate goal of having a food safety system in place in which government agencies at all levels are working in partnership with each other – and collaboratively with farmers – to ensure that we are doing everything we can to prevent or reduce the risk of foodborne illness. Safe and widely available produce is good for consumers, good for public health, and good for growers. That’s why we’re all in this together.

Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine; Stephen Ostroff, M.D., formerly FDA’s Acting Commissioner, will be succeeding Mr. Taylor as Deputy Commissioner on June 1.

Priorities – Teamwork to Achieve Common Goals

By: Robert M. Califf, M.D.

With my appointment as Commissioner of Food and Drugs comes a rare and humbling opportunity—to make a positive difference at an institution that does vitally important work for the nation and its citizens. During my vetting process I received hundreds of emails and had almost as many conversations with a large and diverse group of stakeholders. Over the course of these discussions, a recurring theme emerged: namely, that setting priorities would be critical to success.

Robert M. Califf, M.D., Commissioner of the U.S. Food and Drug AdministrationThis is hardly surprising. FDA regulates about 20 percent of the nation’s economy and, given the vast number of options, it would be easy to get lost in an overwhelming swirl of activity. In fact, at times I have been (rightfully) accused of having an excessively lengthy to-do list! But my interactions with so many of the knowledgeable, dedicated, and mission-driven people here at FDA have helped foster a clear, realistic, and focused sense of priorities and have further heightened an already strong enthusiasm for helping this awesome organization reach these ambitious goals.

FDA makes decisions in a remarkably effective and responsible way. Guided by the lodestone of our mission to protect and promote the public health, and supported by the concerted efforts of dedicated and talented professionals who examine issues within team-based systems, FDA’s Centers that form the core of our organization are able to make an enormous number of decisions every day. The vast majority of these decisions, many of which are vital to the well-being of all Americans, are made possible by a system sustained by professionalism and a well-earned reputation for high-quality and impartial judgments—despite the fact that many decisions must ultimately disappoint (or at least not fully satisfy) one or more constituencies.

I strongly believe my most important responsibility during my time at FDA is to encourage and support a professional environment that enables our remarkably dedicated workforce to thrive and to reach its fullest potential. Dramatic advances in biotechnology and information sciences, as well as continuously accelerating trends toward globalization, are ushering in an era of rapid change. But amid this change, the key to success for the Agency in accomplishing its mission remains constant—sustaining and expanding our talented workforce and ensuring that we both hire the people we need for the future while we continue to enhance our environment to ensure that we retain existing staff. To that end, I will pursue a workforce initiative designed to 1) improve the hiring system, 2) ensure that the Agency has the best possible working conditions for staff, and 3) foster professional homes for the diverse professions that make up our teams so that we are able to recruit and retain them in a very competitive market.

My top programmatic priority will likely come as no surprise, given the astonishing changes that are currently rippling through society: we must do everything possible to rapidly adapt our national and global systems of evidence generation to meet the challenges and opportunities presented by technological advances. What does this mean? I’ve noticed that when high-quality evidence is available, FDA’s scientific decision making is often straightforward. But it can be particularly challenging for the Agency when it must make scientific decisions in the absence of optimal information. In such cases, opinions may carry greater weight, and there can be an increased likelihood of dissension both inside and outside of FDA, as well as a greater risk that we may fail to most fully protect or advance the welfare of patients and the public.

FDA is a science-based, science-led organization that focuses on the needs of patients and consumers; protecting their well-being is our charge as a public health agency. The state of the art as it pertains to understanding the needs and choices of patients and the public is progressing rapidly, and we must continue to keep pace by incorporating the best methods for taking patient preferences, experiences, and outcomes into account in every part of our work.

Biomedical science is nearing a tipping point where the amount of high-quality evidence available to support our decisions is likely to increase exponentially. As a nation, we have invested over $50 billion to provide an electronic health record (EHR) for almost every American. Further, computational storage capacity and analytical power are increasing by orders of magnitude from year to year. At the same time, the advent and wide diffusion of social media are enabling direct communication with patients and consumers on an unprecedented scale. When projects such as Sentinel and the National Medical Device Evaluation System are linked with the many complementary initiatives under way at our sister agencies and at organizations outside of the government, we can (and I believe in short order will!) build a robust foundation for a system in which both private and public sectors can produce much more useful knowledge at a fraction of the cost such efforts have previously required. Indeed, a major function of FDA is to support the continued development of an effective system for evidence generation, so that the private and academic sectors can make it happen.

Accordingly, FDA is thoroughly committed to working with the many partners in our ecosystem to help build and sustain an infrastructure that produces the high-quality scientific evidence needed to guide FDA’s decisions about the drugs, medical devices, tobacco products, and food products it’s charged with regulating, as well as the decisions that healthcare providers, patients, and consumers make about their health and well-being.

In addition to this overarching priority, a number of specific critical issues are on my front burner this morning and will remain there for the foreseeable future:

  • Pain. The present epidemic of opioid overdose deaths now exceeds deaths from automobile crashes. FDA cannot solve this problem on its own—and indeed, no single entity can—but we have a critical role to play, as described in our FDA Opioids Action Plan.
  • Tobacco product deeming. Much effort has gone into developing the framework for the approach to the regulation of the broad array of tobacco products. FDA is working hard to finalize the deeming rule, which in its proposed form would extend FDA regulation over virtually all tobacco products, including electronic cigarettes, either all cigars or all but premium cigars, pipe tobacco, certain dissolvables that are not “smokeless tobacco,” gels, and waterpipe tobacco.
  • Implementation of the FDA Food Safety Modernization Act (FSMA). This statutory directive to transform the food safety system is well on its way to being implemented, with critical regulations issued and more to come. The effort involves the complex development of a new control and risk-based system that includes the entire chain of food safety. Effective implementation of this system will require the application of cutting-edge analytical and biological science, as well as the most modern approaches to human systems management.
  • Antimicrobial resistance. Concerns about the proliferation of multidrug-resistant pathogens, as well as the sustainability of the product pipeline needed to meet this threat, continue to grow. We have a major responsibility in the federal plan, one that will involve many parts of the Agency and require that we work with the broad ecosystem, both to ensure that appropriate antimicrobials are used appropriately on farms, and that novel antimicrobials are developed, approved, and used responsibly within a framework of effective stewardship.
  • Interagency effectiveness. When we consider our mission to protect and advance the public health, as well as our duty to balance benefit and risk for patients and consumers of medical products, much of our success can be enhanced by coordinated effort across government. We have therefore continued the FDA-NIH Joint Leadership Council and the FDA-CDC meetings, and also initiated similar discussions with CMS. The Biomarkers, Endpoints and other Tools (BEST) Resource offers a powerful example of the ability of FDA and NIH to contribute to solving scientific and regulatory issues together.
  • Precision Medicine. President Obama’s Precision Medicine Initiative represents more than just a project. Rather, it is a window that provides a clear view of the future for biomedicine and agriculture, a future in which powerful new technologies and methods allow the precise targeting of interventions using an array of genetic, genomic, biological, clinical, social, and environmental data according to the scale needed to achieve improved health outcomes.
  • Cross-Cutting Issues. There are a great many other issues (truthfully, the number reaches triple digits) on my list of concerns. But those issues that cut across the Agency, including optimizing our approach to combination products, medical countermeasures, and improving product labeling, will benefit most from my attention and support.

A single introductory blog post is not suited for giving details about priorities or individual programs. However, I hope I’ve conveyed my enthusiasm for the work at hand, as well as my confidence that we will be able to make real and lasting improvements in many critical areas. I promise that we will follow up with frequent updates, as fostering effective communication is itself an overarching priority of immense importance to me. So expect to hear from me again soon!

Robert M. Califf, M.D., is Commissioner of the U.S. Food and Drug Administration

Border Crossings: Working With Partners to Verify the Safety of Imported Produce

By: Michael R. Taylor

One of the vivid images that sticks with me from my tenure at FDA is of the port of entry at Nogales, Arizona. There, I saw large trucks from Mexico lined up as far as the eye could see, awaiting entry into the United States‎, many loaded full with fresh produce. I was told by our FDA team that, during the busy season, as many as 1,500 produce trucks enter the United States there daily, and Nogales isn’t even the busiest port of entry on the 2,000-mile U.S.-Mexico border.

Michael R. TaylorThat visit to Nogales was in the early phase of our food safety modernization initiative at FDA‎, but it had a lasting effect on me. It drove home the degree of difficulty we would face in fulfilling the produce safety vision embodied in the FDA Food Safety Modernization Act (FSMA).

With 50 percent of our fresh fruit and 20 percent of our vegetables coming from growers in other countries, the challenge was not only to establish produce safety rules that would be effective and workable across the hugely diverse produce sector, but also to verify with reasonable confidence that those standards are being met consistently, every day, regardless of where the produce is grown.

‎The FSMA produce ‎safety rule is now on the books, but implementation and the task of achieving and verifying compliance is just getting started. We know that success will take an enormous amount of education, training, and technical assistance to support the vast majority of farmers who will want to comply.

It will take a concerted effort by government and industry alike to verify that compliance is happening. And all of that demands active public-private collaboration and partnership to meet high consumer expectations.

‎‎Within the United States, this means working with our state government partners to build state produce safety programs that will provide our primary interface with U.S. growers on all aspects of produce safety. We will also work with growers and their customers to strengthen the reliability of private audits as a source of verification that can complement, but never replace, the essential role of government inspection.

‎But what about those 1,500 truckloads coming into Nogales daily from Mexican farms? How do we verify their compliance?

‎The answer is this: only by using every tool in our import tool kit‎, and, of course, by building partnerships.

‎I’m writing this while en route to Tubac, Arizona, for the annual Spring Policy Summit of the Fresh Produce Association of the Americas (FPAA). FPAA represents those producing and trading fresh produce across the U.S.-Mexico border. For good business reasons, FPAA and its members focus heavily on ensuring the safety of that huge volume of food.

At this meeting, my colleagues and I will be discussing implementation of the foreign supplier verification program (FSVP) final rule, which places new responsibility on importers to ensure the safety of the food they import. This responsibility includes ensuring and verifying that their foreign suppliers use processes and procedures that meet U.S. safety standards. The result is that importers’ private verification efforts will help ensure the public health. At the same time, they are accountable to FDA.

FSVP is the regulatory linchpin of FSMA’s historic paradigm‎ shift for imported food from reaction at the border to accountability for prevention at the point of production. But Congress recognized that FSVP alone is not enough. FSMA also mandates that FDA conduct more foreign inspections and work more closely with foreign governments to ensure the safety of imported food.

‎So‎ also gathering in Tubac are our regulatory colleagues from the two Mexican agencies responsible for produce safety on the farm (SENASICA) and after the produce leaves the farm (COFEPRIS).

In 2014, we formed the US -Mexico Produce Safety Partnership, through which we are collaborating with our Mexican colleagues – much the way we do with our state partners – on education and technical assistance, inspection and compliance, and response to outbreaks. We’ll be reviewing our progress and discussing our challenges in a partnership working group meeting and sharing our government perspectives with FPAA, which has formed its own working group to collaborate with the government effort.‎

‎This degree of collaboration on food safety is unprecedented‎. But it is necessary because neither government nor industry alone can provide the level of verification FSMA envisions and consumers demand.

And it is possible because of the deep alignment of strategic interests ‎on food safety that exists among industry, government and consumers. We all have a huge stake in seeing that modern preventive practices are being used consistently to make produce safe. That is the foundation for real partnership. We all have different roles to play, but we all have the same goal.

‎That’s why we are gathering in Tubac. And, that’s why I’ll be traveling to Mexico City in April with Dr. Stephen Ostroff, my successor at FDA when I leave the agency in June, to work with our Mexican colleagues and the Mexican industry on FSMA implementation. That’s why we’re holding a public meeting in Washington today to discuss import safety with consumer, industry, and foreign stakeholders.

‎And it’s why hundreds of my FDA colleagues are working tirelessly with partners across the food system to prepare for FSMA implementation. I’m grateful for the opportunity I’ve had to work with so many people dedicated to food safety.  I think we are all fortunate that Steve Ostroff and other leaders across the food system have their hands on the helm.

And I am confident that we are on the way to success in fulfilling the FSMA vision, from the farms of Vermont and California to that line of trucks at Nogales.

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

A FSMA Update for our Stakeholders in India

By: Howard Sklamberg

Rice at India Spice Market

Deputy Commissioner Howard Sklamberg, Dr. Mathew Thomas, FDA India Office Country Director, and Ritu Nalubola, Ph.D., Senior Policy Advisor, Office of the Commissioner, observing different varieties of rice offered at a whole produce and spice market near Mumbai, India

In an effort to complement our conversations about the FDA Food Safety and Modernization Act (FSMA) in the United States, FDA is reaching out to our international partners and stakeholders to discuss implementation of this historic food safety law.

I recently visited India, accompanied by Andrew Stephens from the Office of Food and Veterinary Medicine, and Ritu Nalubola, Ph.D., with the Commissioner’s Office of Policy. We had extensive discussions with our regulatory counterparts in the Indian government and with key food industry officials.

Spice Market near Mumbai, India

A Mumbai spice wholesaler describing a range of spices available to Deputy Commissioner Howard Sklamberg and Dr. Mathew Thomas, FDA India Office Country Director, at a whole produce and spice market near Mumbai, India

India is the seventh largest supplier of food to the United States. The Indian food products that end up on the dinner tables of Americans every night — including shrimp, spices, and rice — reflect the increasing globalization of our country’s food supply.

Many of these goods come from any of India’s 29 states, produced by thousands of different companies. Such dispersion and volume makes FDA’s close engagement with our Indian counterparts necessary, especially on the export-related parts of FSMA.

Our most recent trip to India follows a similar trip in March 2015 when Mike Taylor, Deputy Commissioner for Foods and Veterinary Medicine, joined me to introduce FSMA to a wide variety of Indian stakeholders.

On that trip, we explained that FSMA mandates a food safety system that is preventive, rather than reactive. FSMA requires that foreign food producers meet U.S. safety standards.

A variety of spices in India

A selection of spice offerings at a whole produce and spice market near Mumbai, India

At that time, we also signed a Memorandum of Understanding (MOU) with the government of India to engage in regulatory, scientific, and public health protection matters related to food products.

Building upon our 2015 trip, and upon the great work of FDA’s India office, our recent meetings focused on three FSMA rules of vital significance to India stakeholders: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Foreign Supplier Verification Programs for Importers of Food for Humans and Animals; and Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications. The overview my FDA team provided was very useful to our Indian counterparts, many of whom have been engaged with FDA’s India Office in learning the details of the new mandates for exporters.

Howard Sklamberg speaking at the World Spice Congress in India

Deputy Commissioner Howard Sklamberg delivering remarks on FDA’s final FSMA rules at the World Spice Congress in Ahmedabad, India

I finished my trip with remarks to the World Spice Congress. As I noted there, the food system grows more global and trade-driven every year, which means we grow more dependent every year on collaboration and real partnership between government and industry across national boundaries.

We all have three goals: We want food to be safe. We want consumers to have confidence. And we want food safety and consumer confidence to enhance trade between nations. FSMA will help us achieve all three.

Howard Sklamberg is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy

A Closer Look at Tea and Rice: FDA Brings FSMA Outreach to Japan

By: Camille Brewer, M.S., R.D., and Sema Hashemi, M.S.

Our delegation of FDA experts traveled to Tokyo and Osaka in the first week of February to hold seminars on our new final rules under the FDA Food Safety Modernization Act (FSMA). These rules will require that foods exported to the United States be produced in a manner that provides the same level of public health protection as that required of U.S. food producers.

FSMA outreach delegation and Ambassador Caroline Kennedy

The FSMA outreach delegation met with Ambassador Caroline Kennedy (center). The delegation members (from left) are: Sema Hashemi, Jess Paulson (from the U.S. Department of Agriculture), Jenny Scott, Samir Assar, Bruce Ross, Camille Brewer, Jeffrey Read, and Brian Pendleton.

We were delighted to see first-hand how receptive the Japanese government and industry have been, both in embracing FSMA’s principles and in bringing a more intense focus on preventive controls and supply chain management. Exports of agricultural, as well as fish and fishery products, to the United States are at a record high. The U.S. is Japan’s second highest export market, and key exports include rice, tea, soy products, confectionary and specialty products. The Japanese food industry is keenly interested in increasing exports to the U.S. and representatives expressed a strong commitment to fostering an understanding of and compliance with our food safety regulations. Throughout our visit, we were reminded of the important link between market growth and maintaining a strong reputation for safe exports.

Interest in FSMA is high. Public seminars in Tokyo and Osaka drew nearly 400 and 200 participants, respectively, our largest FSMA international outreach audiences to date. As a reference document for participants, the Japan External Trade Organization (JETRO) prepared a 315-page manual with translations of key FSMA regulations and FDA presentations for each participant.

JETRO, a government-related organization, has facilitated and delivered numerous informational programs for industry on FSMA since the passage of the law. During our outreach meeting, JETRO also delivered a one-hour FSMA overview, which effectively set the stage for more detailed FDA presentations that followed. These proactive efforts achieved a much greater understanding among participants and more productive interactions during our limited time together.

Our meetings with Japanese government colleagues in the Ministry of Agriculture, Forestry, and Fisheries (MAFF), as well as the Ministry of Health, Labour, and Welfare (MHLW), allowed us to take a step back and discuss ways in which the our governments can work collaboratively to promote food safety. It was clear to us that these ministries are very eager to collaborate closely with FDA to help ensure that Japan’s food exports to the U.S. meet FSMA’s high standards of safety for food production. We are looking forward to further discussions with our Japanese colleagues as FSMA implementation continues.

Our delegation received many thoughtful and detailed questions on how FSMA would apply to Japan’s food exports to the U.S., particularly to green tea and rice — as two foods particularly important to Japanese identity and tradition. Indeed, our delegation learned a great deal about the various steps in the production of both commodities. FDA and the Japanese ministries all committed to exchange more detailed information on traditional production methods for these commodities. They represent valuable case studies on how FSMA operates to ensure prevention-based oversight of the entire food supply chain, including those unique to a culture or community.

U.S. Ambassador to Japan Caroline Kennedy graciously set aside some time to discuss FSMA international outreach activities and food safety issues with our delegation. She was very pleased to hear of Japan’s detailed preparations for these FSMA seminars and the goodwill shown to FDA’s delegation. Ambassador Kennedy stressed the importance of the relationship between the United States and Japan in the area of agricultural trade, agreeing that future dialogue on FSMA would only serve to strengthen these close ties.

We leave Japan with many fond memories of the warmth and hospitality provided by our Japanese hosts. They honored us not only with their kindness but also with the meticulous preparation and education on FSMA that we could see had taken place in advance of our arrival. We move forward more confident than ever in Japan’s strong commitment to food safety and to ensuring that foods exported to the United States will be produced under the effective prevention-based systems that FSMA envisions for food supply chains around the world.

Camille Brewer, M.S., R.D., is Director of International Affairs at FDA’s Office of Foods and Veterinary Medicine

Sema Hashemi, M.S., is Director of the Office of Regional and Country Affairs within FDA’s Office of International Programs

Making Progress in Protecting Consumers from Unsafe Supplements

By: Stephen Ostroff, M.D.

An estimated 200 million Americans take dietary supplements to maintain or improve their health. Protecting consumers from unsafe or contaminated dietary supplements is extremely important to FDA.

Acting FDA Commissioner, Stephen Ostroff, M.D.We’ve recently taken a number of important steps to prevent illnesses and deaths from unsafe supplements, and, while our current authority over supplements is arguably limited, we are doing what we can to strengthen our existing oversight. I’d like to give you a picture of the challenges, achievements and opportunities regarding the regulation of these products, beginning with the challenges.

One challenge is sheer volume. The dietary supplements industry is one of the fastest-growing in the world. When the Dietary Supplement Health and Education Act (DSHEA) was passed by Congress in 1994, annual sales of dietary supplements totaled about $5.8 billion. Since then, sales have risen six-fold to about $35 billion annually. Large volumes of supplements are also now sold on the Internet. The significant growth in the dietary supplements industry, and the various ways supplements reach consumers, outpace FDA’s resources to regulate this industry.

Moreover, tracing these products can be difficult because supply chains are often fragmented, with a single product sometimes passing through numerous suppliers, manufacturers and distributors of all kinds, sizes, and locations (including those overseas). Ultimately, when proper quality control and recordkeeping procedures are not followed across the supply chain, it can be difficult to guarantee what ingredients in what amounts are in the final product, and whether the ingredients are safe or even qualify as dietary supplements.

Under DSHEA, FDA does not have the authority to approve dietary supplements before they are marketed to consumers. However, we do have the authority to take enforcement actions after a product is on the market – only when we can establish that the dietary supplement is adulterated (e.g., unsafe); misbranded (e.g., misrepresentations are made on the product labeling); or cannot be marketed as a dietary supplement (e.g., an unapproved new drug). We monitor the marketplace through market surveys, undercover buys, label reviews, a review of reports of illness or deaths, and product testing. When necessary, we take actions to protect public health, including issuing public warnings, taking legal action, and working with the company to recall the product. But all this must be done based on evidence and within the bounds of our legal authority and limited resources.

Despite these constraints, our actions have produced important results over the past year. Here are just a few key accomplishments:

  • At the request of FDA, this month U.S. Marshals seized almost 90,000 bottles of dietary supplements labeled as containing kratom. Kratom has been indicated to have both narcotic and stimulant-like effects.
  • Use of pure powdered caffeine products has already resulted in the deaths of two teenagers. We took action to help prevent harm, including deaths, from the use of these products, by issuing warning letters to five distributors of these potentially dangerous products.
  • In 2015, FDA identified products containing BMPEA, DMBA and picamilon that are unlawfully marketed and issued a series of warning letters to 24 companies that marketed dietary supplements containing these ingredients. The companies that received the warning letters market products that are either misbranded for falsely declaring the ingredients as dietary ingredients or marketing products containing new dietary ingredients without the required pre-market notification.
  • We worked closely with our government partners, including the Department of Justice, the Federal Trade Commission and the U.S. Postal Inspection Service, on a year-long sweep to identify potentially unsafe products and/or products containing undeclared ingredients. In November 2015, that sweep culminated in civil injunctions and criminal actions against 117 manufacturers and/or distributors of dietary supplements and tainted products.
  • We issued more than 100 consumer alerts warning about products falsely marketed as dietary supplements that were found to contain active pharmaceutical ingredients.
  • We conducted more than 600 inspections of dietary supplement firms in the U.S. and other countries. We also worked with companies on voluntary compliance actions, such as removing illegal claims, destroying inventory and ceasing distribution.

I am excited about the opportunities that await us in this area, and the plans we’re making for the future. For example, within FDA, we have established the new Office of Dietary Supplement Programs and are working on increasing the visibility, capacity and staffing for that new office. This will include hiring permanent leadership to sharpen our focus on potential safety problems and to support regulatory actions.

We want to expand our use of criminal investigation and enforcement tools to address serious safety-related violations and cases of intentional fraud; and further build strategic investigatory and enforcement collaborations with the Federal Trade Commission, Department of Justice, and state governments, including state health departments and attorneys general.

Ultimately our top priority is to protect the consumers who want to improve, not damage, their health and have a right to expect that dietary supplements will be safe for them and their families.

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

FSMA Implementation: The Road Is Challenging, but the Company Is Extraordinary

By: Michael R. Taylor

As we begin 2016, it’s a good time to reflect on the extraordinary engagement we’ve had on food safety with the food-producing community and its continuing impact as we move forward to implement the FDA Food Safety Modernization Act (FSMA).

Michael R. TaylorIn August and September 2013, we took three important trips – to the Pacific Northwest, New England and Europe – to talk about the rules we had proposed earlier that year to implement FSMA.

What we learned on those trips made a huge impression, one that ultimately shaped more than just the rules. It had a profound effect on our understanding of the diverse global community of food producers, and opened our eyes to the food safety imperative that guides them.

More recently, we retraced our steps this November and December, making those journeys again to discuss the five FSMA rules that became final this fall — establishing preventive controls for human and animal food, setting produce safety standards, and strengthening oversight of imported foods.

First, some background. We had been traveling to farms since 2009, well before FSMA was signed into law in 2011, listening to and learning from farmers. The visits in 2013 were particularly important because FSMA had become law by then and we had specific proposals to discuss.

In the Pacific Northwest and New England, we focused on issues as different as the climate and geography of those regions. Growers who created lush farmland in the high desert regions of Idaho, Oregon and Washington using canal-fed irrigation systems were chiefly concerned about the agricultural water standards. In Vermont, Maine and New Hampshire, discussions centered on the impact of FDA’s plans on the local food movement and on farmers’ efforts to innovate and diversify.

There was a common theme, however: Growers have been understandably concerned about where we’re headed with these food safety regulations and how they will affect farms, especially those that have been in families for generations. So in 2013, with specifics on the table, there were some tough conversations about the merits of our proposals – and how they could be improved. In Europe, our discussions were primarily with our foreign regulatory counterparts, but also reflected uneasiness about the FSMA rules, particularly their impact on foreign trade.

The bottom line is that through these trips, our eyes were indeed opened to some realities. It became clear that we’d need to make changes for the regulations to work for the food industry while still protecting public health.

Fast forward to 2015. We saw familiar faces in our return to the Pacific Northwest and New England for public meetings in Portland, Oregon, on December 1, and in Brattleboro, Vermont, on December 14. These are people who were frank about their reservations and then rolled up their sleeves to work with us on finding solutions. And we did find solutions, building flexibility into the rules that give food producers and importers options and alternatives that still meet important safety criteria.

And in Europe, too, the conversation has turned to next steps. In early December we returned to Brussels and again met with our European Union regulatory counterparts. Europe has similar overarching food safety principles as the U.S. and the leaders we met want to leverage their resources and avoid duplication of effort. And we are looking into that now, beginning by comparing the public health protections in the European standards with those built into the FSMA rules.

The reception was enormously positive in all three places. We’re in a good place with the FSMA rules. Five of the seven rules we proposed have now been finalized, and we intend to publish final regulations on sanitary transportation and intentional adulteration in the spring. President Obama’s Fiscal Year 2016 budget request for FSMA implementation was close to fully funded, with FDA set to receive $104.5 million of the $109.5 million requested. This critical funding will enable us to maintain our momentum toward timely, comprehensive implementation.

We at FDA are gratified and grateful for what we’ve seen since we first took to the road in 2009. It’s clear that from the smallest farm to the halls of Congress, from local food centers to operations half-way around the world, there is a deep, shared commitment to produce safe food.

Without any doubt, there’s still a lot of hard work to be done, and we know some food producers are still apprehensive about the impact of our regulations on their livelihood. So, we will hit the road again beginning in January for more state and international meetings. We are committed to continuing the conversation and implementing FSMA in a practical way. Working together, we will create the modern food safety system envisioned by FSMA, one that makes every reasonable effort to prevent food safety problems and protect consumers and their families from foodborne illness.

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