Welcoming FDA’s New Overseas Leaders: FDA’s Foreign Posts Provide a Vital Resource for Consumer Protection

By: Howard Sklamberg and Mary Lou Valdez

Howard Sklamberg

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

It’s simple but true: relentless global commerce and interaction demand a globalized FDA. That’s why we’ve made determined efforts – sometimes with great difficulty – to place our professionals around the world in the key countries and regions that produce FDA-regulated food and medical products.

The Vital Role of FDA’s Overseas Offices

Our foreign offices add an unsung, yet vital, element to the Agency’s global work. FDA posts in China, Europe, India, and Latin America, in close cooperation with FDA Centers and the Office of Regulatory Affairs, help to strengthen our ability to protect public health. Our foreign posts assist by:

  • Increasing our knowledge and appreciation of the global regulatory landscape;
  • Facilitating collaboration with foreign regulators to strengthen evidenced-based approaches to product safety and quality; and
  • Helping manufacturers in other countries to understand FDA standards and regulations.

Equally important, placing investigators in a top-exporting nation allows us to get to a site more quickly in a public health emergency or investigate indications of violations that could imperil public health.

Recent Accomplishments

The Latin America Office has deepened FDA’s ties with the regulatory partners in the 44 nations and territories comprising that vast region. For example, Mexican regulators have followed up on FDA inspection results and have taken immediate actions against firms and products that violate U.S. and Mexican law. Through a 2014 bilateral Statement of Intent, our Latin America Office is helping to implement a Produce Safety Partnership with Mexico, which is vital inasmuch as nearly one-third of FDA-regulated food products we eat are either grown in or transported through Mexico.

Lou Valdez

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

Thanks to the work of our China Office, FDA signed two Implementing Arrangements in late 2014 with our Chinese food and drug regulatory counterparts: the China Food and Drug Administration and the Administration of Quality Supervision, Inspection and Quarantine. The arrangements expand the number of in-country investigators and significantly increase FDA’s ability to perform inspections of firms that manufacture FDA-regulated products. We also work closely with Chinese officials to help strengthen the Central/Provincial inspectional roles to ensure product quality and safety and better secure supply chains.

The India Office regularly engages with Indian regulators and industry. India is a major source of generic drugs imported to the United Sates and, as such, we work closely with them on pharmaceutical quality. India also is the 7th largest supplier of food to the United States – principally shrimp, spices, and rice. Recently the India Office played a key role in coordinating a Memorandum of Understanding on Food Safety that FDA signed with the Export Inspection Council of India. The India Office also hosts a number of workshops to increase understanding of U.S. requirements such as records management with industries interested in exporting their products to the U.S.

The Europe Office has continued to enhance FDA’s partnership with the European Medicines Agency (EMA), with whom we actively share data, information, and technical expertise. Since 2009, FDA and EMA have strengthened collaboration through the exchange of dedicated liaison officers and by engaging in mutual scientific interests in such areas as advanced medical therapies, biosimilar medicines, blood products, orphan products, and veterinary medicines. In addition, Europe Office professionals have briefed nearly a dozen European Union (EU) nations on the landmark Food Safety Modernization Act, and have also analyzed more than 150 audit reports from the EU’s Food and Veterinary Office to bring FDA expertise to food facility site selection.

The European Office plays a key role in the Mutual Reliance Initiative (MRI), an important FDA-EU endeavor to evaluate our comparable regulatory frameworks for inspections of manufacturers of human pharmaceuticals to determine if we can rely on each other’s inspectional information. The MRI has led to FDA accompanying EU officials on audits of three EU nations. The Europe Office also managed an EU audit of FDA’s oversight of the Active Pharmaceutical Ingredient (API) manufacturers within the U.S. That exchange led to the EU relying on our oversight, and allowing U.S.-made APIs into the European market.

New Leaders at Our Overseas Posts

We can look confidently toward the future and the roles our foreign posts can play in support of the FDA mission globally. It is with an eye on that future that we are marking “a changing of the guard” as we welcome new Office Directors and Deputy Directors to FDA foreign offices.

We extend a warm welcome to:

China Office

Leigh Verbois, Ph.D., Director 

Europe Office

Donald Prater, D.V.M., Director

India Office

Mathew Thomas, M.B., B.S., Director

Latin America Office

Edmundo Garcia, Director, Director

Capt. Philip Budashewitz, Deputy Director

We also share our deepest gratitude as we say good-bye to an outstanding group of foreign post directors who are moving on to new opportunities: Christopher Hickey, Ph.D., (former Director, China Office), Carl Sciacchitano (former Acting Director, India Office), Michael Rogers (former Director, Latin America Office), and Bruce Ross (former Deputy Director, Latin America Office).

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

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

FDA, From a Distance

By: Claudia Heppner, Ph.D.

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

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

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

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

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

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

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

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

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

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

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

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

Find out more about FDA’s Europe Office

Need a Guidance Document? We’ve Got You Covered

By: Chris Mulieri, PMP

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

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

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

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

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

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

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

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

How are we doing?

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

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

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

Talking Across International Borders About FSMA

By: Michael R. Taylor

Michael R. TaylorAll countries face the challenges presented by a food supply that is increasingly global, and consumers rightfully expect that the food they eat is safe no matter where it comes from. We all have the same goals: safe food, consumer confidence, and efficient and effective oversight to reach those goals.

With that in mind, our partnerships with foreign food producers and our regulatory counterparts in other countries are increasingly important. As we get closer to releasing the final rules that will implement the FDA Food Safety Modernization Act (FSMA), we are reaching across borders to ensure that our international stakeholders have the information and training they need to meet these new standards.

The need for this international outreach is a message that came through loud and clear at a public meeting this April on FSMA implementation. The feedback from agricultural attaches, overseas business owners, and representatives from governments worldwide was that they want to hear more about what to expect, and how to prepare for what’s ahead.

To address these concerns, we invited representatives of foreign embassies and other international stakeholders to attend a roundtable discussion on June 23, 2015. In the attached video, you’ll see both the optimism and concerns that surfaced during the meeting at FDA’s Center for Food Safety and Applied Nutrition in College Park, Md.


On June 23, 2015, FDA held a meeting of representatives of foreign embassies and international stakeholders involved in implementation of the FDA Food Safety Modernization Act (FSMA). This is the fifth video blog in which the people who will be helping to make FSMA a reality share their insights on challenges, opportunities and next steps. (The first video is Voices of FSMA: The Road to Implementation; the second: Voices of FSMA: The Opportunities Ahead; the third: Voices of FSMA: The Challenges We Face; the fourth: Voices of FSMA: Moving Forward.)


One sentiment, expressed at the meeting, was: “The United States isn’t the only country concerned about food safety.” From FDA’s perspective, we’re counting on that as we build the partnerships we’ll need to help ensure the safety of foods all over the world. We will join forces with agriculture and public health officials in other countries, international industries and associations, multilateral organizations, and academia to address the unique needs of foreign food producers who must comply with the new FSMA regulations.

We’re operating under the premise that the vast majority of food producers, both foreign and domestic, want to ensure the safety of their foods. We will be relying on our international partners to help us find ways to provide solid verification that the FSMA standards are being met.

The earliest compliance dates will be a year after we publish the first final rules this summer. In the meantime, we are working with our public and private partners to develop training for domestic and international food producers. These partners include the U.S. Department of Agriculture, grower and local food system groups, and the Food Safety Preventive Controls and Produce Safety alliances, whose members include the FDA, local and state regulatory agencies, the food industry, and academia.

We are committed to making FSMA implementation as open and transparent a process as possible. The April public meeting and the June roundtable discussion were just two steps in that process. But they were important steps because both provided open and frank conversations.

We’ve got a long road ahead. We’ve long worked with other countries as trading and regulatory partners. Now, we aspire to be food safety partners, working together and supporting each other when problems arise. These partnerships ultimately will benefit consumers all over the world.

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

Putting Added Sugars Into Context for Consumers

By: Susan Mayne, Ph.D.

For two decades, consumers have been able to check the Nutrition Facts label to understand not only how much saturated fat, dietary fiber and sodium is in any given food, but how that amount fits in the context of their daily diet. Today, FDA proposes a supplemental rule that would provide consumers with access to that same information for added sugars. This would fill a gap by providing the same valuable content already available to consumers for other nutrients.

Susan MayneIn March 2014, FDA proposed to include the amount of added sugars in grams on the Nutrition Facts label but without the percent Daily Value, and we continue to review comments on this proposed rule. Now, in addition, we are proposing to include on the Nutrition Facts label the percent Daily Value (% DV) for added sugars and are accepting comments on this additional provision.

Why propose providing this additional information to consumers? Scientific data shows that it is difficult to meet nutrient needs while staying within calorie requirements if you consume more than 10 percent of your total daily calories from added sugar. The Dietary Guidelines Advisory Committee (DGAC), whose recommendations inform the Dietary Guidelines for Americans, the foundation for national nutrition programs, standards and education, used the same data in the analysis for their recommendations earlier this year.

FDA considered the evidence and determined that it supports setting a Daily Value for added sugars. The Daily Value, which is used to calculate the percent Daily Value that consumers see on the Nutrition Facts label, would be 50 grams of added sugars for adults and children 4 years of age and older and 25 grams for children 1 through 3 years.

FDA’s initial proposal to include the amount of added sugars on the Nutrition Facts label is now further supported by newly reviewed studies suggesting healthy dietary patterns, including lower amounts of sugar-sweetened foods and beverages, are strongly associated with a reduced risk of cardiovascular disease.

Consumers can still choose foods that have added sugars as part of a healthy diet, but the proposed Daily Value would provide a benchmark for intake. Without information like this about a nutrient, it’s hard to know if you’re eating too much or too little in a given day. For example, a consumer who drinks a 20-ounce sugared beverage may be surprised to know it contains about 66 grams of added sugar, which would be listed on the label as 132 percent of the Daily Value.

We know that consumers may need some help getting used to this new information. Coming to FDA from outside of government with a background in public health nutrition, I have a great appreciation for the need to educate people to use the information we provide to them. I look forward to working with the nutrition community in this effort.

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

FDA Science Forum 2015: Views of FDA

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

FDA China Office’s Lixia Wang Wins Award for HHS Locally-Employed Staff

By: Mary Lou Valdez

The FDA’s mission to ensure that food is safe and medical products are effective for use by U.S. consumers and patients is widely recognized.

Lou Valdez

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

A lesser-known fact is that the U.S. Department of Health and Human Services (HHS) employs more than 1,700 locally-employed (LE) staff in 60 countries to uphold its mission across five operating divisions, including FDA. Dr. Lixia Wang, a locally-employed staff member working for FDA in China, exemplifies the contributions of our LE staff and is the recipient of the annual HHS LE Staff of the Year Award.

China is a key supplier of goods imported to the U.S. The FDA has made significant regulatory in-roads since establishing its China post in 2008 and in many ways these are due to the contributions made by Dr. Wang and other LE staff in the world’s most populous country.

For example, Dr. Wang was essential in the negotiations of bilateral agreements for the placement of additional staff in China. With Dr. Wang’s contributions, FDA finalized these important agreements, which pave the way for FDA to more than triple its staff size in China. This move will bolster FDA’s work to protect and promote the health of consumers and patients in the U.S. and around the world.

Dr. Lixia Wang

Dr. Lixia Wang in Beijing

Dr. Wang, who has served as Medical Research Scientist for FDA’s China Office since 2009, was cited for her central role in negotiations concerning the Implementing Arrangements with China’s Food and Drug Administration, and Implementing Arrangement Between the Food and Drug Administration and the General Administration of Quality Supervision, Inspection and Quarantine.

In addition, Dr. Wang has made significant contributions to the HHS mission in China since joining U.S. Embassy Beijing in 2006. From 2006 to 2009, she served as senior local staff in the Office of the HHS Health Attaché, and played a key role in strengthening U.S.-China collaboration on infectious disease.

During that time, she also supported the FDA response to emerging problems associated with melamine in dairy and pet products, and worked to address contaminated blood thinner sourced from China. She played a key role in the 2007 negotiations of binding agreements with the Chinese Government on the safety of FDA-regulated products, and on the opening of FDA’s first-ever overseas office in 2008.

FDA congratulates Dr. Wang, and takes pride in the recognition for excellence and commitment to global public health that she brings to FDA with this award.

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

Looking at the Road Ahead for FSMA

Implementation of the FDA Food Safety Modernization Act (FSMA) involves people at all segments of the food supply chain, from farm to table. On April 23-24, 2015, FDA held a public meeting in Washington D.C. to discuss its plans to implement FSMA rules designed to build a food safety system that focuses on prevention and risk. The meeting drew hundreds of people in person and thousands joined the webcast. They included consumers, growers, manufacturers, importers, advocates, state and federal government officials, and representatives from other nations. And in this last of four video blogs, they share their insights on next steps as FDA moves from rule-making to implementation. (The first video is Voices of FSMA: The Road to Implementation; the second: Voices of FSMA: The Opportunities Ahead; the third: Voices of FSMA: The Challenges We Face.)

Thinking About FSMA Issues

Implementation of the FDA Food Safety Modernization Act (FSMA) involves people at all segments of the food supply chain, from farm to table. On April 23-24, 2015, FDA held a public meeting in Washington D.C. to discuss its plans to implement FSMA rules designed to build a food safety system that focuses on prevention and risk. The meeting drew hundreds of people in person and thousands joined the webcast. They included consumers, growers, manufacturers, importers, advocates, state and federal government officials, and representatives from other nations. And in this third of four video blogs, they share their insights on the challenges ahead as FDA moves from rule-making to implementation. The next blog focuses on next steps. (The first video is Voices of FSMA: The Road to Implementation; the second: Voices of FSMA: The Opportunities Ahead; the fourth: Voices of FSMA: Moving Forward.)

Continuing the Conversation About FSMA

Implementation of the FDA Food Safety Modernization Act (FSMA) involves people at all segments of the food supply chain, from farm to table. On April 23-24, 2015, FDA held a public meeting in Washington D.C. to discuss its plans to implement FSMA rules designed to build a food safety system that focuses on prevention and risk. The meeting drew hundreds of people in person and thousands joined the webcast. They included consumers, growers, manufacturers, importers, advocates, state and federal government officials, and representatives from other nations. And in this second of four video blogs, they share their insights on the opportunities that FSMA makes possible for the global food safety system. The next blogs focus on challenges and momentum. (The first video is Voices of FSMA: The Road to Implementation; the third: Voices of FSMA: The Challenges We Face; the fourth: Voices of FSMA: Moving Forward.)