FDA Advisory Committee Members and ‘Appearance Issues’

By: Michael Ortwerth, Ph.D.

FDA relies on its advisory committees as a source of independent scientific and technical expertise and advice on challenging public health issues. Most advisory committee members are appointed as “special government employees” (SGEs). Like regular government employees, these committee members are subject to Federal conflict of interest laws and regulations.

Michael OrtwerthA lack of understanding about our selection and evaluation process has, at times, resulted in confusion and misunderstandings by the public.  We’ve been working to bring greater transparency to how the financial interests of committee members are evaluated.

In 2008, we published “Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees.” That guidance describes how we apply financial conflict of interest requirements.

What has not been previously addressed in guidance is something called “appearance issues.” Sometimes FDA advisory committee members who do not have interests and relationships that are financial conflicts of interest nevertheless have interests and relationships that may create the appearance that they lack impartiality. Appearance issues are addressed in a government-wide regulation regarding standards of ethical conduct for government employees at 5 CFR 2635.502 (informally known as “Section 502”).

Some examples include:

  • When a member of the household works or is seeking to work for the sponsor with a product before the committee;
  • When a member has had past financial interests with the sponsor with a product before the committee; and,
  • When a member has a current consulting contract with a sponsor but the contract is not related to the product or issue before the committee.

We have recently published new draft guidance describing FDA’s procedures for evaluating appearance issues and how we determine whether to grant an authorization for a member with an appearance issue to participate in an FDA advisory committee.

Section 502 implements the ethical principle that a government employee should be impartial in performing their official duties, meaning that they must not give preferential treatment to any private organization or individual or use public office for private gain. To the extent that an advisory committee member’s performance of official duties might appear to benefit themselves or certain other individuals who are close to them, they must take appropriate steps to avoid an appearance of violating these ethical principles.

We also explain in the draft guidance the circumstances that FDA considers when determining whether an appearance issue may exist. We evaluate the circumstances and assess whether the interests, relationships, or circumstances would cause a reasonable person with knowledge of the relevant facts to question the advisory committee member’s impartiality in the matter before the committee. For example, if an advisory committee member serves on the board of directors of a nonprofit organization and that organization receives donations from the sponsor that is presenting before the committee, we review the details of the donation to determine whether the member should be cleared for service on the advisory committee.

FDA has flexibility and discretion in deciding whether an advisory committee member with an appearance issue should be authorized to participate in the advisory committee meeting. We evaluate whether the government’s interest in the advisory committee member’s participation outweighs the concern that a reasonable person may question the integrity of the agency’s programs and operations. If so, FDA may authorize the member to participate in the meeting.

Although FDA advisory committees provide advice and input to the Agency, FDA makes the final decisions.

The draft guidance is being issued for public comment before we issue a final guidance. Under Federal law, FDA is not permitted to disclose confidential information provided by advisory committee members related to appearance issues. But we are specifically requesting comments on whether the agency should request that advisory committee members voluntarily disclose if they have been granted an appearance authorization.

FDA is committed to ensuring that appropriate expertise and experience is brought to bear on the critical public health issues facing the agency. Often, we convene advisory committee meetings to obtain independent expert advice and perspective. At the same time, it is important that the process we use to screen advisory committee members for participation in meetings be as transparent as possible, and that we protect the credibility and integrity of advisory committee advice. We welcome your comments on how the agency can continue to meet these important goals.

Michael Ortwerth, Ph.D,. is FDA’s Director of the Advisory Committee Oversight and Management Staff

Sleuthing, and a Little Help from Consumers, Helps FDA Track Down Bacteria in Flour

By: Stephen Ostroff, M.D., and Kathleen Gensheimer, M.D., M.P.H.

When many people buy flour, they empty it into a canister and throw out the bag. But three people at the center of a recent outbreak of foodborne illness didn’t do that. They kept their flour in the original packaging, and in so doing enabled the FDA to track down what was making people sick.

Stephen Ostroff, M.D.

Stephen Ostroff, M.D., FDA’s Deputy Commissioner for Foods and Veterinary Medicine

The story of the recent recall of 10 million pounds of baking and cooking flour is one in which federal agencies, consumers and the food company – in this case, General Mills – all had a role in doggedly tracking down the source of an outbreak that has made dozens of people across the country sick and getting the suspect product off the market.

It all began with a signal, or more accurately, with multiple signals that were monitored by FDA’s Coordinated Outbreak Response and Evaluation (CORE) network. This team looks for “signals” that may point to a pending outbreak, including reports of human illness from the Centers for Disease Control and Prevention (CDC), FDA-collected data on food samples and inspections, and related information on illnesses and inspections from state and local public health and regulatory agencies.

The signals this time came from CDC, which in February identified a string of illnesses that began in December as an outbreak of infections caused by Shiga toxin-producing E. coli O121. This pathogen is a much less common cause of foodborne illness than its better-known cousin E. coli O157. Investigators began to interview patients about the foods they had eaten in the week before they became ill. But identifying flour as the source of the outbreak was not easy. Initially, it seemed that produce or other foods might be the culprit.

Kathleen Gensheimer

Kathleen Gensheimer, M.D., M.P.H., director of FDA’s Coordinated Outbreak Response and Evaluation (CORE) network

Then there was a break. By April, investigators had found that all of the people interviewed in depth had been baking at home, and many of them said they used Gold Medal flour. Multiple interviewees also mentioned eating raw cookie dough that had been made at home with the flour.

CORE was now faced with the daunting task of proving that specific batches of flour caused the majority of the illnesses. The reports from some patients could not initially be confirmed because key information about the brand and lot numbers was not available – it had gone out in the garbage with the flour bags.

But in the weeks that followed, investigators made two important discoveries:

Three people who had become ill still had the original flour package. Two of the labels showed that the Gold Medal Brand flour had been packaged at a General Mills facility in Kansas City, Missouri, and that they were packaged on consecutive days. The third was made at that plant within a week of the other two.

And the FDA team became aware of illnesses linked to restaurants that would supply balls of raw dough for children to play with. These illnesses were among children who had eaten different meals at restaurants in separate states. The CORE team learned that the flour used by the restaurants during the estimated time of the children’s exposure was supplied by the same General Mills production facility.

The FDA decided not to wait for laboratory confirmation that there was E. coli in the flour before contacting the company. On May 27, FDA and CDC investigators briefed General Mills leadership about the information they had received from patients and on May 31 the firm voluntarily recalled a massive amount of flour — 10 million pounds produced in the Kansas City plant over a three-week period in November and December of 2015.

The FDA continued its analysis of a sample of flour collected from the home of a patient who had provided one of the labels. Laboratory microbiologists at the agency confirmed the presence of E. coli O121 in that flour sample. On June 10, FDA’s whole genome sequencing analysis of that sample also confirmed that the E. coli O121 was closely related genetically to bacteria found in people who had become ill. The final piece of the puzzle was put into place, although the investigation continues to ensure that all contaminated product is off the market.

This was just one of the hundreds of voluntary recalls that the FDA facilitates every year. Going forward, the agency’s compliance and enforcement strategies, including recalls, will get even stronger with the recent establishment of a decision-making body of key senior leaders to identify timely and efficient measures to mitigate public health risks.

Laying the groundwork for a recall can be a complex and lengthy process, with only bits and pieces of information coming in at any one time. But tenacity, collaboration and a willingness to be proactive in protecting consumers, enabled the FDA, its federal, state, and local partners, and General Mills to quickly and efficiently work to recall a potentially dangerous product and keep even more people from becoming ill.

Stephen Ostroff, M.D., is FDA’s Deputy Commissioner for Foods and Veterinary Medicine

Kathleen Gensheimer, M.D., M.P.H., is the director of FDA’s Coordinated Outbreak Response and Evaluation (CORE) network

FDA: A Great Place for Science…and for Scientists on the New Frontier of Regulatory Science

By: Robert M. Califf, M.D.

Robert CaliffAs FDA Commissioner, I’m proud of our agency’s extraordinary commitment to using the best available science to support our mission to protect and promote the health of the American public. This is especially critical today, as rapid scientific and technological advances are helping to expand our understanding of human biology and underlying disease mechanisms and to identify the molecular profile of a food contaminant.

These breakthroughs offer unprecedented opportunities for us to develop new treatments and cures and to protect our food supply with a robust system that meets the challenges of globalization.

But there’s another benefit that derives from our application of cutting-edge science to the challenges we face, which has become increasingly evident to me through my conversations with some of FDA’s more than 10,000 scientists. And that’s the deep personal and professional satisfaction gained from working in FDA’s state-of-the-art laboratories on front-line issues that make a real difference in the lives of all Americans. As one FDA scientist commented, “At FDA, your work is really at the crossroads of cutting-edge technology, patient care, tough scientific questions, and regulatory science.”

Being Part of a Vibrant Collaborative Scientific Environment

Whether you’re a biologist, chemist, epidemiologist, pharmacist, statistician, veterinarian, nurse, physician, or an engineer and whether you’re a recent graduate or a seasoned scientist, FDA offers an unmatched opportunity to be a part of a vibrant, collaborative culture of regulatory science.

FDA scientists gain a bird’s eye view of the pharmaceutical and food industries, and develop a thorough familiarity and understanding of the regulatory structure that guides these industries. As one young FDA scientist recently commented, “We see a tremendous breadth of different products here, which helps us learn quickly and makes our jobs interesting and challenging.” Another newly trained FDA scientist shared, “We have the chance to work with highly trained colleagues, within and across disciplines, to build and keep our scientific training cutting-edge.”

While the work of FDA scientists helps to advance scientific understanding, it goes much further than that. That’s because our work is directly tied to regulatory decisions. As such it has a powerful and immediate effect on the health of millions of Americans. As another FDA scientist explained, “We get to see how these basic science and clinical advances get applied to producing medical treatments and devices and how these can make differences in people’s lives.”

FDA offers a number of fellowship, internship, graduate, and faculty programs through which newly-minted scientists can join FDA and continue to apply and develop their skills. Many of these individuals remain on as full-time FDA scientists. One former FDA Fellow said they appreciate how “FDA makes room for and respects voices of young, qualified scientists.”

Tackling the Most Challenging Scientific Issues

So, although I may frequently boast about FDA’s responsibility and ability to do rigorous scientific research and its importance for the American public, I’m speaking as much about our scientists as our science. And I hope that when other young talented scientists consider these testimonies from our multifaceted scientific workforce they will be encouraged to join us.

I want to see more professionals take advantage of the opportunities FDA offers to collaborate on some of the most transformative scientific issues of our times – both for their benefit and for the nation’s. We need the best scientific minds to tackle the challenges of food safety, medical product development, and to evaluate how emerging technologies are affecting FDA-regulated products so that our reviewers can make science-based decisions about a product’s benefits and risks.

That’s why we’ve successfully added thousands of qualified new employees over the last several years and worked hard to fill mission-critical positions. It’s also why we continue to seek more hiring flexibilities and other ways that enable us to be more competitive with private-sector salaries for these positions.

The career opportunities at FDA are enormous, and I look forward to welcoming the next generation of scientists of every stripe to help us fulfill our mission. It’s not only good for science and essential to FDA’s ability to protect and promote public health; it’s a unique opportunity for these talented scientists and their careers.

FDA Scientists Discuss Their Cutting-Edge Research in FDA Grand Rounds Webcasts

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

A Tale of 3 Countries: Applying FSMA Standards Globally

By: Stephen Ostroff, M.D., and Camille Brewer, M.S., R.D.

Over the past two months, we have been part of FDA delegations visiting three very diverse countries—Canada, China and Mexico—to discuss food safety. As we are doing in the United States with the FDA Food Safety Modernization Act (FSMA), each country we visited is addressing their national food safety objectives in unique and creative ways.  And each has committed to taking a strong role in supporting compliance with the new food safety regulations mandated by FSMA.

Stephen Ostroff, M.D.

Stephen Ostroff, M.D., is FDA’s Deputy Commissioner for Foods and Veterinary Medicine

Looking at how these nations are different – and how they are the same – opens a window on the challenges and opportunities presented by FSMA implementation on a global scale. The seven foundational FSMA rules are now final and they will have a profound effect on foreign food producers that want to export their products to the United States.

We visited Canada on May 10 and 11 for public meetings on FSMA in Toronto and Ottawa. Canada is modernizing its own food safety system under the Safe Foods for Canadians Act, which, like FSMA, places a strong emphasis on preventive controls. Our nations have a strong interest in achieving as much convergence as possible on food safety standards.

We had the opportunity to explain that the recently signed systems recognition arrangement with Canada does not create a “green lane” for foods shipped to the United States. Instead, it is a reciprocal regulatory cooperation tool that will foster greater risk-based targeting of resources and will foster cooperation in many areas, such as risk assessment and research. The systems recognition arrangement with Canada, signed on May 4, affirms that while our countries’ domestic food safety systems are not identical in all aspects, they currently do achieve a comparable degree of food safety protection.

In addition, considerable interest was expressed in the Voluntary Qualified Importer Program (VQIP), which does provide facilitated entry for food shipments to the United States.

Camille Brewer

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

In late April, our public and private meetings in Mexico strengthened what has become a true partnership between our two countries. In 2014, we started the Produce Safety Partnership with the National Service for Agro Alimentary Health, Safety and Quality (SENASICA), and the Federal Commission for the Protection from Sanitary Risks (COFEPRIS)—our regulatory partners in Mexico—to help prepare growers and packers there to comply with the FSMA requirements. This flagship program forms the basis for extensive collaboration on produce issues.

Mexico continues to modernize and strengthen its own regulatory regime for food safety. Our strong and growing relationship with the Mexican government is a model for partnerships we’d like to forge with other nations. One of our central FSMA themes is working closely with foreign governments that share our food safety goals, and whose own food safety efforts can contribute to the safety of imported food. Our FDA office in Mexico helps to build and sustain our mutual food safety goals.

This is a priority for both Mexico and the United States because of the large volume of produce we trade and the importance of produce safety from a public health and confidence standpoint. Much of the produce we eat in the U.S. is grown in Mexico, including produce that would otherwise be hard to find in the winter months. A lot is at stake for both sides, and our meetings in Mexico reinforced our shared commitment to food safety.

A week before the Mexico trip, we traveled to Beijing for a FSMA public meeting and meetings with our regulatory counterparts in China—the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ), the China Food and Drug Administration (CFDA), and the China National Center for Food Safety Risk Assessment (CFSA). China also has new food safety laws. The interest in meeting FSMA requirements is so intense that the public meeting was shared across China by webinar, with more than 5,200 participants in government agencies, academic institutions, and industry.

There were meetings with Chinese officials about issues of mutual interest and strategic importance, in addition to subjects unique to China, such as the regulation of ceramic tableware and traditional Chinese medicine.

Like FDA, government regulators in China have been working to refine the food-safety infrastructure based on new laws. The sheer vastness of the country and the rapid pace of economic development and change  are key factors that government officials are taking into account as they refine their laws to control and monitor food production.

Progress is being steadily made and the FDA Office in China continues to work effectively with Chinese authorities to identify points of synergy. The visit culminated in a meeting of representatives of China, the European Union and FDA to discuss core food safety principles and other subjects.

So you can see our partnerships take on different forms. What we learned in our travels to Mexico, China and Canada is that each nation has a strong resolve to make their food supply safer for their own citizens and for export to other nations.

We will continue traveling to countries willing to partner with us in this mission. No matter where you live, no matter where you govern, everyone wants safe food.

Stephen Ostroff, M.D., is FDA’s Deputy Commissioner for Foods and Veterinary Medicine

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

Our Goal in Enforcing Food Safety: A Rapid, Science-Based Response

By: Stephen Ostroff and Howard Sklamberg

Recalls of potentially unsafe foods are an important food safety tool. The FDA most often works with companies to bring about voluntary recalls, with the goal of getting the product out of the marketplace as quickly and efficiently as possible.

Stephen Ostroff, M.D.

Stephen Ostroff, M.D., FDA’s Deputy Commissioner for Foods and Veterinary Medicine

The FDA Food Safety Modernization Act (FSMA) empowers the FDA to act when a company does not voluntarily cease distribution and recall a potentially dangerous food product. The enforcement tools provided by FSMA include mandatory recall.

Because the vast majority of companies choose a voluntary recall when presented with science-based evidence that their products are unsafe, or reasonably likely to be unsafe, the FDA has only rarely needed to use its mandatory recall authority. In most instances, companies choose to initiate a recall when faced with the prospect of an enforcement action.

The HHS Office of the Inspector General (OIG) has raised concerns about the sufficiency of processes and procedures the FDA has in place to ensure that firms take prompt and effective action in initiating voluntary recalls. To consumers hearing about the OIG alert, we want to be clear that the FDA is totally committed to its public health mission of ensuring the safety of the food supply. The United States has one of the world’s safest food supplies. The work we do—performing facility and site inspections, conducting surveillance sampling both domestically and at the border, and using laboratory and other analyses to help determine prevalence of food-borne risks—contributes to its safety each and every day.

Howard Sklamberg

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

As a public health agency, the FDA continually works to improve its processes and appreciates the input from the OIG. In fact, the agency is now expediting changes already underway to strengthen its compliance and enforcement strategies, including voluntary and mandatory recalls. This includes, in individual situations, specifying timeframes for voluntary action by the firm and, if necessary, enforcement action by the agency.

But before we get into those changes, it’s helpful to consider what generally occurs before a voluntary recall takes place. The FDA’s actions have to be based in science and we go where the evidence leads us. The scope of a contamination must be ascertained to determine how much of a product must be recalled. The time needed to collect evidence can vary, but to request a recall without evidence risks recalling the wrong product and leaving consumers vulnerable to contaminated food that is still on the market.

Because the FDA acts on science-based evidence, it has credibility with food producers (and their internal and external legal teams) and consumers. Companies know that when they are approached by the agency, the danger is real and must be acted upon promptly. So the FDA, time and again, is able to protect consumers by engineering timely voluntary recalls.

The OIG’s concerns about the FDA’s food recall process are based on their selection of a “judgmental sample” of 30 voluntary recalls between October 1, 2012 and May 4, 2015 chosen based on their risk factor. The alert focuses in particular on two recalls in which the companies did not initiate recalls of all affected products for months despite the fact that FDA notified them as soon as the agency had evidence of a contamination. This finding is unacceptable–no question about that. It bears noting, however, that in those three years, the FDA worked with companies to successfully bring about thousands of recalls to keep unsafe food out of the market and homes of consumers with an average recall initiation time of less than a week.

We fully agree with the OIG that we must move as expeditiously as possible. We also agree that timeframes should be set, but they must be done on an individual basis rather than by setting arbitrary deadlines. The complexities surrounding recall events make it difficult for the FDA to establish a single timeline applicable to all situations.

To speed the FDA’s response when regulated foods are tied to real and potential public health risks, including outbreaks of human illness, the agency has recently established a new process to help streamline and strengthen decisions about compliance and enforcement actions.

We have established the Strategic Coordinated Outbreak Response and Evaluation (SCORE) team, a decision-making body of key senior leaders that will be co-chaired by those responsible for directing compliance and enforcement activities in the foods program and field operations. Team members are from FDA’s Foods and Veterinary Medicine program, the Office of Regulatory Affairs, and the Office of the Chief Counsel. They are advised by senior scientific, medical, communications, and policy experts. This builds on FDA’s establishment of the Coordinated Outbreak Response and Evaluation (CORE) network in 2011 to coordinate and streamline outbreak response, working with state and local authorities and other federal agencies.

What this team brings to the table is an integrated approach to identifying timely and efficient measures to help mitigate public health risks, goals shared by the OIG. It will review investigations that have, or may have, a link to specific foods or a food facility when there is a serious human health risk. It will also be involved when the case involves complex policy questions, when additional expert support is needed, or when response timelines have not been met. The SCORE team’s involvement will speed the FDA’s response by evaluating the whole range of options for use of compliance and enforcement authorities as quickly as possible.

The SCORE team has only recently been established, and we will be reviewing how it works, refining its functions and performance as needed.

There are other ways in which our enforcement strategy is already being strengthened. Since 2014, we have been using whole genome sequencing in the laboratory as a regulatory tool to more rapidly identify foodborne contaminants and trace them to their source with unprecedented speed and precision. This technique has already proven to be a game-changer in outbreak response, and will be increasingly valuable in the future.

Looking ahead, protections will be further strengthened by the FSMA-mandated preventive controls rules for human and animal food, which require covered food facilities to identify potential hazards and take steps to minimize or eliminate risks. They are also required to have a recall plan. Compliance dates begin for certain firms in September 2016.

Our stated mission to protect public health is more than just words on paper. We are always working to be better at our job and will use the OIG’s input as it was intended–to further strengthen our protection of the food supply.

Stephen Ostroff, M.D., is the FDA’s Deputy Commissioner for Foods and Veterinary Medicine; Howard Sklamberg, J.D., is the FDA’s Deputy Commissioner for Global Regulatory Operations and Policy.

Globalization and FDA’s New Partnerships to Ensure Product Safety

By: Howard Sklamberg

Globalization is posing challenges for public health. For FDA, part of that challenge is the ever-increasing volume and complexity of FDA-regulated products coming to America’s shores.

Howard SklambergIn fiscal year 2015, there were more than 34 million shipments of FDA-regulated products into the United States, up from just 15 million shipments a decade ago. These products are handled by 130,000 importers, and are manufactured, processed, or packaged at more than 300,000 foreign facilities.

We know this global trade expansion has ramifications for our nation’s public health. We also know we cannot be the inspectors for the world. Hence, we need to effectively direct our resources in a risk-based manner as we grapple with this tremendous volume of imported goods.

How? One way is to identify foreign regulators whom we can rely upon to partner with in verifying that safety standards are being met and then construct an approach that will meet the requirements of multiple regulatory jurisdictions. We are currently engaged in three innovative programs that meet this challenge.

The Medical Device Single Audit Program

The Medical Device Single Audit Program, or MDSAP, is an international approach to the auditing and monitoring of the manufacture of medical devices to ensure their safety and efficacy. This audit program will allow a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions.

Currently, five nations – Australia, Brazil, Canada, Japan, and the U. S. – are participating in the MDSAP Pilot. It began 18 months ago and will run through the end of 2016. The program’s goals include:

  • Enabling regulatory oversight of medical device manufacturers’ quality management systems;  and,
  •  Promoting more efficient use of regulatory resources through work-sharing and mutual acceptance among regulators.

Mutual Recognition Agreements

In 2014, FDA launched the Mutual Reliance Initiative (MRI), a strategic collaboration between the FDA and the EU Member States. The goal of the program is to determine if the FDA and EU can agree to recognize each other’s drug Good Manufacturing Practice (GMP) inspections, a potentially time-saving approach.

If successful, we could rely upon EU experts to inspect facilities within their own borders, a more practical way of overseeing the large number of drug manufacturing sites outside of the United States. And it would be similarly more practical if the EU relied on FDA experts to inspect facilities within the United States.

Both the EU and the FDA are in the process of evaluating each other’s processes. The EU has visited several of FDA’s district offices in the United States and one drug laboratory and evaluated the work they do. The FDA has a different challenge since each country in the EU has at least one inspectorate, and in Germany, each state has their own inspectorate. To date, FDA has observed eight audits – in Sweden, Greece, Croatia, Germany, Hungary, Italy, the Czech Republic, and the United Kingdom – and will continue to observe audits of other Member States this year and in 2017.

Food Safety Systems Recognition

Preventing problems at relevant points along the global food supply chain can be a daunting job. FDA is soliciting help by leveraging foreign food safety systems that are similar to our own.

The agency’s Systems Recognition program determines whether another country has comparable regulatory programs and public health outcomes to what we have in place in the U.S.

A major advantage of Systems Recognition is that it allows FDA to be more risk-based in its oversight of imported food and we can more wisely plan our overall inspection activities, including foreign facility inspections, import field exams, and import sampling.

Thus far, we’ve completed: New Zealand and the U.S. signed a Systems Recognition Agreement (in 2012) and recently another agreement was signed with the Canadian Food Inspection Agency.

What’s Next? 

The three initiatives I’ve briefly outlined represent the best of FDA innovation and expertise in grappling with the increasing amount of imported FDA-regulated products. Our work will focus on a continued careful reliance on trusted foreign partners; a move away from duplicative work; more risk-based inspections; better data; and the minimization of public health risks globally.

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

Marking the Beginning of a New Era in Food Safety

By: Stephen Ostroff, M.D.

The promises embodied in the FDA Food Safety Modernization Act (FSMA) add up to this: The foods that we eat and serve our families must be as safe as we can make them.

Stephen Ostroff, M.D.These promises mandate that food be produced, packed and transported with an awareness of potential hazards and a commitment to taking whatever systematic steps are necessary to eliminate or greatly reduce any risks. They envision a world in which families can share foods produced halfway around the world, knowing that they are held to the same rigorous safety standards as those produced in the United States.

The past nine months have seen the finalization of the seven rules that make FSMA’s promises a reality – for both domestic and imported foods. The last of those rules, one that adds protections against intentional adulteration, became final on May 27. Together, and individually, these rules represent a paradigm shift from simply responding to outbreaks of foodborne illness to preventing them from happening in the first place.

There’s a lot of work to be done in the implementation phase. But even as we look forward, it’s important to recognize that getting to this point with rules that are final is a spectacular achievement, and that many deserve the credit.

Members of Congress joined together to pass FSMA in 2010 because of widespread concern over multistate outbreaks, and lawmakers like Sen. Jerry Moran of Kansas and Rep. Rosa DeLauro of Connecticut have been unwavering in their support since then. Consumers, such as activists in STOP Foodborne Illness, who became sick themselves or who lost loved ones to contaminated food, put their sorrow aside and became champions for the greater good. Public policy organizations like the Pew Charitable Trusts have been steadfast partners throughout the rulemaking and budget processes.

The food industry mobilized to help FDA find the most effective, practical ways to implement these regulations. We worked with national associations that include the Grocery Manufacturers Association and groups with a more regional focus, such as the New England Farmers Union. Farmers, manufacturers, distributors, retailers and many others whose livelihood is directly affected by these rules brought their concerns to the table and worked with us to make the rules as feasible as possible.

We found dedicated partners in other government agencies at the federal, state and international levels. Leanne Skelton of the U.S. Department of Agriculture has been part of the FDA team. The National Association of State Departments of Agriculture is playing an important role in helping FDA meet the challenges of implementing the produce safety rule. State agriculture leaders like Chuck Ross in Vermont, Katy Coba in Oregon and Steve Troxler in North Carolina became a bridge between FDA and the food producers in their states. Our regulatory counterparts in other nations, such as SENASICA and COFEPRIS in Mexico, have joined the fight to increase food protections worldwide.

The people of FDA, under the leadership of Michael R. Taylor, worked tirelessly to find the right intersection between science and policy; to develop innovative and practical solutions to complex challenges; and, to engage in open and meaningful discussions with the many communities within the diverse food supply system. I recently succeeded Mike as deputy commissioner, and I want to acknowledge the importance of his dedication to public health and food safety.

The FDA teams who drafted and revised the rules worked in tandem with teams laying the groundwork for eventual implementation. They have traveled the nation, and the world, to meet with food producers and government officials. They have worked 24/7 on these rules since FSMA became law.

The road ahead towards full implementation of FSMA is a long one. There are miles to go, but thanks to the commitment and hard work of all those who are making this journey, we will keep the promises of FSMA.

Stephen Ostroff, M.D., is FDA’s Deputy Commissioner for Foods and Veterinary Medicine

A New Partnership with Canada on Food Safety

By: Caroline Smith DeWaal

With a shared border that is more than 5,500 miles long, Canada and the United States have a lot in common — including a shared food supply. So it is no surprise that Canadian food safety agencies and the U.S. Food and Drug Administration (FDA) have signed a “systems recognition arrangement” to mark an important new food safety partnership.  Notably, this is only the second arrangement of this type. The first was signed in December 2012 between FDA and New Zealand’s food safety authority.

Caroline DeWaalSystems recognition not only allows FDA to better plan its oversight of high risk foods, it also increases our reliance on regulators in other parts of the world that have demonstrated they provide a similar system of food safety protection. This is one tool that we use to help ensure that consumers have confidence that their food is safe, whether produced in the U.S. or elsewhere.

Under this arrangement between FDA and Canadian food safety authorities signed on May 4, 2016, FDA recognizes that Canada operates a national food safety control system with regulatory programs comparable to ours. A major advantage of this arrangement is that it allows FDA to be more risk-based in its oversight of imported food.

With systems recognition in place with Canada and New Zealand, FDA can plan more wisely its overall inspection activities, including foreign facility inspections, import field exams, and import sampling. In this reciprocal arrangement, both countries benefit.  Systems recognition advances cooperation and confidence building between our two regulatory systems and it paves the way for sharing information related to food safety.

Systems recognition is a very high bar to reach. Why? For one, the strength of food safety regulatory systems varies widely around the globe. At FDA, systems recognition is an option for countries with domestic food safety systems that have preventive, risk-based programs in place. We understand that any country can have a food safety incident.

For systems recognition to work well, we want to know that the country’s regulatory authorities have the ability to swiftly track down the source of a foodborne illness and take action to stop contaminated food in its tracks –and to follow up to prevent such events from happening again. While systems recognition arrangements are entirely voluntary for the two countries that enter into them, they mark a high degree of trust in participating countries’ abilities to both prevent and respond to food-related outbreaks and contamination events. Following a rigorous review, we are confident that Canada has systems in place to accomplish this.

Before entering into a systems recognition arrangement with Canada, FDA undertook an evidence-based assessment of Canada’s domestic food safety system. We used the International Comparability Assessment Tool (ICAT) to evaluate all aspects of the system, from the regulatory foundation, to the training, inspection, and compliance programs, to the investigation of outbreaks and trackbacks to find contaminated food sources. Onsite reviews were an important part of the assessment process; those reviews allowed FDA to see first-hand how Canada implements the programs they’ve described in the ICAT and Canada conducted a similar review of the way FDA operates its food safety programs.

Systems recognition is intended to facilitate discussions that lead to a continuous improvement process for regulators on both sides of the border. For example, in recent years, new legislation was adopted in each country that emphasizes preventive control systems and import safety: The FDA Food Safety Modernization Act became law in 2011 and the Safe Food for Canadians Act was passed in 2012. As our respective food safety systems, regulatory frameworks, programs and oversight continue to improve, we are committed to this partnership with Canada for the benefit of consumers on both sides of the border.

Caroline Smith DeWaal is the International Food Safety Policy Manager on the International Affairs Staff at FDA’s Center for Food Safety and Applied Nutrition

Reducing Sodium in the Food Supply

By: Susan Mayne, Ph.D.

As the former Chair of the Department of Chronic Disease Epidemiology at the Yale School of Public Health, I have looked critically at the totality of evidence on the link between sodium and chronic disease. The data are clear: Americans are getting too much sodium in their diets. As a scientist, a former academician, and now as a policy maker, I am confident that FDA is on the right path in announcing today draft, voluntary guidance for the industry on meeting short-term and longer-term sodium targets for a wide variety of foods. This guidance is meant to build on existing efforts already underway by many manufacturers to reduce sodium.

Susan MayneBecause we recognize the essential role played by food companies and restaurants on this issue, we are committed to working with the food industry on a gradual approach to sodium reduction.

What the Science Tells Us

The link between sodium consumption and blood pressure is strong and well documented. High blood pressure is a key risk factor for heart disease and stroke. There is strong agreement among expert bodies such as the Institute of Medicine (IOM) on the need to reduce consumption to less than 2,300 milligrams per day (mg/day). And this level of consumption for most people is further supported by the recently issued 2015-2020 Dietary Guidelines for Americans, which involved expert review of the current body of research by the Dietary Guidelines Advisory Committee and federal experts who reviewed the Committee’s recommendations. The totality of scientific evidence, as reviewed by many well-respected scientific organizations, continues to support lowering sodium consumption from current levels.

In fact, it’s very difficult in the current marketplace NOT to consume too much sodium. The average intake today is over 3,400 milligrams—significantly more than the 2,300 milligram limit recommended by federal guidelines. And it’s not just adults who are eating too much sodium: Children and teens consume more than is recommended.

Our Approach

The FDA’s approach takes into account the technological challenges involved in solving this problem. To that end, the FDA assessed the sodium content of thousands of products in the marketplace and engaged with experts in industry, academia, and government to get the best available scientific and technical input. We know that sodium has important functions in many foods, such as taste, texture, and microbial safety, and it simply can’t be removed without careful consideration of those factors.

Our approach encourages gradually reducing sodium in the majority of foods that contain it. Sodium comes from a lot of different types of foods—not just the ones we think of as high in sodium. So we have divided the foods containing sodium into about 150 categories ranging from cereals to combination foods like pizzas and sandwiches, and draft sodium targets for each category. Not only is this approach more precise than a “one size fits all” strategy, but it also recognizes that different foods have different potential for sodium reduction.

Moreover, our draft targets apply to processed and prepared foods that are eaten both at home and outside the home. The fact that about one-half of each food dollar is spent on foods prepared outside the home* makes this a common-sense strategy and helps to create a level playing field for industry.

Why the 2-year and 10-year targets? The answer is simple. We recognize that some reductions can be made in the short term, but that further reductions may require strategies that take time to develop.  We are confident that the two-year targets are readily achievable and that it makes sense to act on them first. That’s in part because many companies have already taken steps on their own initiative to reduce sodium in certain foods, and we applaud these efforts.

The facts speak for themselves. Our food supply is still too high in sodium, and there is important work yet to be done. With today’s announcement we commit to working closely with industry on the best path forward to reduce sodium in our food supply and improve the public’s health.

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

(*One-half of each food dollar spent on foods prepared outside the home- Citation: ERS/USDA)

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