Tragic Deaths Highlight the Dangers of Powdered Pure Caffeine

By Michael M. Landa

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

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

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

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

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

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

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

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

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

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

Regulators Caught in the Act of Protecting Public Health

By: Melinda K. Plaisier and Michael M. Landa

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

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

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

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

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

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

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

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

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

Michael M. Landa

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

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

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

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

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

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

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

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

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

Progress on FSMA: Getting Down to Implementation

By: Michael R. Taylor

This is the second of two FDA Voice blogs about state listening sessions on updates to four of the rules proposed to implement the FDA Food Safety Modernization Act (FSMA).

It appears to me that people all over the country are rolling up their sleeves and preparing to make FSMA a reality.

Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine.My team and I have just returned from visits to Georgia, North Carolina and Florida, states that are top producers of the fruits and vegetables that the world enjoys. We were there for listening sessions on the updates, or supplements, that FDA published in September to four proposed FSMA rules overseeing human and animal foods, both domestic and imported. Earlier in the month we visited California and Vermont for similar meetings.

When we visited states last year to discuss the FSMA rules that FDA originally proposed, beginning in January 2013, there were strong feelings that some aspects of our original proposals, such as the water quality standard, would be overly costly and not adequately adaptable to the range of production practices and conditions across the country. Farmers, manufacturers and importers want their foods to be safe, but they want rules that are as targeted as possible to risk and are practical to implement. We listened to their concerns, and we reviewed a wide range of written comments. They all formed the basis for the supplemental proposals that we issued in September, which have been well received.

During these most recent state visits, all of which were hosted by the heads of state agriculture departments, we heard continued support for FSMA and the need to implement it well, with mostly clarifying questions about the content of the rules. In fact, most of the discussion revolved around what has to be done once the rules take effect. We’re getting down to the nitty gritty of implementation.

Our day in Georgia began with breakfast with Commissioner of Agriculture Gary Black and Natalie Adan, director of the agriculture department’s Food Safety Division. The conversation centered on the importance of our partnerships with the states. FDA will be relying heavily on its state counterparts to provide training, technical assistance and compliance oversight.

There was also an appreciation, and a strong sense of priority, expressed by Commissioner Black and all of the state agriculture leaders, that the proposed FSMA rules will hold imported foods to the same standards as those produced in this country. That levels the playing field in the eyes of U.S. food producers, and it is also essential for food safety.

In all three Southern States, as well as in Vermont and California, there was some confusion about some of the specific terms of the proposed rules, especially the water quality and testing requirements. We are committed to providing clear guidance so that expectations are understood, as well as education, technical assistance and practical tools to facilitate compliance.

In North Carolina, we received a warm welcome from Agriculture Commissioner Steve Troxler who, as an elected official, has made food safety a campaign issue and a priority for his leadership and his department. In the listening session, Debbie Hamrick of the North Carolina Farm Bureau was very interested in how we will train our workforce to go out onto the farms, and how farmers will know how to meet the requirements. She offered to rent a bus and fill it with FDA officials and farmers to tour the area. Our reply: You’re on. She wants to work with us and we want to work with her.

We were also asked how we’re going to pay for all this and that brought up the critical issue of funding, which is a concern. It is urgent that FDA receive adequate funding for the training, technical assistance, state partnerships and import oversight that is essential for sound implementation of the FSMA rules beginning in late 2016 and 2017.

Florida was the final leg of this journey, which was fitting given Florida’s history of commitment to agriculture and food. Adam Putnam, the commissioner of agriculture, is a former U.S. congressman who had a leadership role in getting FSMA enacted. And Florida has been a pioneer in food safety, enacting seven years ago mandatory on-farm safety standards for the growing of tomatoes.

The listening session took place at the Gulf Coast Research and Education Center at the University of Florida’s Institute of Food and Agricultural Sciences. Driving there, we left the interstate highway to find ourselves suddenly in the midst of tomato fields, citrus groves and grazing cattle. We may think of Disney and spring training when we think of Florida, but agriculture is woven into the fabric of the state.

It was great to see Martha Rhodes Roberts, a long-time food safety leader in Florida, who moderated our listening session. As in Georgia and North Carolina, the Florida audience was a diverse mix of growers and people involved in various aspects of the food industry. The people we met in all three states appreciated both the changes we proposed in the supplemental rules and the continuing dialogue we are having on their implementation. They are ready now to get the job done.

I’d like to close with a reminder that the deadline for commenting on the four proposed supplemental rules for Produce Safety, Preventive Controls for Human Food, Preventive Controls for Animal Food and Foreign Supplier Verification Programs is Dec. 15. Visit our FSMA page on fda.gov for more information.

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

From Wariness to Welcome: Engaging New England on Food Safety

By: Michael R. Taylor

This is the first of two FDA Voice blogs about state listening sessions on updates to four of the rules proposed to implement the FDA Food Safety Modernization Act (FSMA).

What a difference a year makes.

In August last year, my team and I visited New England to talk about the rules proposed in 2013 to implement FSMA. We were met with skepticism and some genuine fear that our produce safety proposals did not take full account of local growing practices and would both disrupt traditional practices and deter innovation. These weren’t easy conversations, but they proved instrumental in FDA’s decision to propose—on Sept. 29, 2014—updates, or supplements, to four of the proposed FSMA rules overseeing human and animal foods, both domestic and imported. These proposals include significant changes in the produce safety proposal and related elements of the preventive controls rules for food facilities.

Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine.We weren’t quite sure what to expect when we flew to Vermont on Sunday, November 16, for a listening session the next day on the proposed supplemental rules. But the tenor of this visit was dramatically different, and very positive, beginning with the detour we took from our FSMA mission on Sunday to visit leading players in Vermont’s local food movement and artisanal cheese-making community.

Accompanied by Vermont Agriculture Secretary Chuck Ross, we first toured the Vermont Food Venture Center (VFVC) in Hardwick, a regional food hub that leases space to small food businesses, providing kitchen equipment, food storage and business consultations. The goal of this modern, well-equipped facility, as executive director Sarah Waring explained, is to strengthen Vermont’s local food network and agricultural economy.

We then toured Jasper Hill Farm in Greensboro, a renowned maker of artisanal cheeses.  We were welcomed by brothers Mateo and Andy Kehler, who have taken an innovative approach to making cheese, using both traditional methods and the latest technology. Their goal is to establish a network of local farms that supply the milk, with Jasper Hill aging and distributing the cheeses in an effort to support small dairy operations.

Our goal was to continue the dialogue we started this year with the cheese-making community to better understand, as food safety regulators, what goes into making artisanal cheeses. We learned a lot, tasted some great cheese, and left impressed by the community-oriented commitment at both VFVC and Jasper Hill Farm, and by their use of top-tier tools to strengthen Vermont’s local food system.

When we arrived back in Montpelier Sunday night, the setting was like something out of a postcard. This picturesque town, the nation’s smallest state capital, was dusted in the season’s first snow, which only accentuated its natural beauty and charm. We were happy to be there.

Monday morning we drove to the Vermont Law School in South Royalton for the FSMA listening session. This school, set in the rolling landscape of rural Vermont, is renowned for its commitment to sustainable environmental practices.

We saw familiar faces. Some had come to the meeting directly from their farm—through the snow. There were people from all over the Northeast—people who had participated in our series of listening sessions throughout New England in 2013. But this time, the response and dialogue were different. We heard acknowledgement and appreciation that we had addressed many of their concerns in our revised proposals by making the proposed rules more feasible, while still meeting our public health goals.

Much of the discussion focused on implementation of the rules, and, interestingly, some of the concerns echoed those we had heard in a November 6 listening session in Sacramento, CA, a place not only on the opposite side of the country but so different in its production systems. Many are finding the complexity of the proposed rules daunting, such as the technical underpinnings of the E.coli benchmark for water quality and the various boundary lines and exemptions that determine who is covered. We’ve always said that we wouldn’t take a “one size fits all” approach, which has contributed to making the rules more complicated. This only underscores our responsibility to explain the rules clearly and to provide education, technical assistance and guidance.

Secretary Chuck Ross said early and often that we need to educate before and as we regulate. And he’s right. I am struck anew by the importance of our partnerships with state leaders. Vermont’s Ross and California Secretary of Food and Agriculture Karen Ross have been invaluable in helping us develop these rules, as they will continue to be as we move towards implementation.

We were grateful for the participation in the listening session by food safety advocates Lauren Bush and Gabrielle Meunier, who each spoke of the devastating effects of foodborne illnesses. Lauren almost died after eating a salad contaminated by E.coli in 2006 and Gabrielle’s young son fought, and recovered from, a Salmonella infection in 2008 after eating tainted peanut butter crackers. Their stories underscore the underlying reason for the effort that so many are making to implement FSMA—to keep people safe.

Some participants expressed the view that even though we decided to defer, pending further study, our decision on an appropriate interval between the application of raw manure and harvest, some kind of interval is needed to protect crops from pathogens. Some suggested that the 90 to 120-day intervals set forth by the U.S. Department of Agriculture’s National Organic Program be adopted as an interim measure.

Others inquired how the FSMA rules would affect them based on very individual scenarios. We asked them, and we’re asking everyone, to comment on the supplemental rules and include those scenarios for us to consider in drafting the final rules. We don’t want to create unintended harmful consequences.

The deadline for commenting on the four supplemental rules for Produce Safety, Preventive Controls for Human Food, Preventive Controls for Animal Food and Foreign Supplier Verification Programs is Dec. 15. Visit our FSMA page on fda.gov for more information.

Our Vermont trip was followed by state listening sessions in Georgia, North Carolina and Florida. I will be filing another FDA Voice blog on what we learned in those Southern states.

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

Reflecting on our steps to give Americans more informed food choices

By: Michael R. Taylor

Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine.Yesterday we released final rules to make it easier for Americans to make informed choices about the foods they buy at major chain restaurants and similar retail food establishments and from vending machines. Every day, for years to come, millions of consumers will see and benefit from ready access to calorie information they would otherwise lack.

In evaluating public health issues, FDA must often make difficult decisions and strike delicate balances. For an issue like menu labeling that touches so many people and must address the complexities of our modern food system, it is natural that there would be a wide range of views. So we appreciate the very positive reactions to our rules from the restaurant industry, the vending industry, consumer groups and public health experts, including the following:

We also know that, while our FDA team worked long and hard on these final rules, crafting them after carefully reviewing more than 1,000 comments on our original proposals, our work is not done. We will continue to work with all affected industries to answer questions about the rules and facilitate compliance in a practical way that can benefit the health of Americans for many years to come.

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

Providing Consumers More Information with Menu and Vending Labeling

By: Margaret A. Hamburg, M.D.

Increasingly, Americans are paying more attention to the foods we eat – the kinds, the quantities, the sources, and the individual ingredients that go into our meals. We know that when we have more information about the nutritional content of our food, we have the opportunity to make more informed choices.

Margaret Hamburg, M.D.Increased awareness about the choices we make certainly does not mean that we always eat what is healthy. But whether we choose to eat french fries or a tuna sandwich, those selections should reflect informed decision-making. That can only happen if the right information is available to make those choices. That’s why the two new rules FDA issued today on menu and vending machine labeling are so valuable for consumers.

Some states, localities and big restaurant chains are already doing their own forms of menu labeling. The new rules will require calorie information to be listed in a consistent, direct and accessible manner on menus in chain restaurants and similar retail food establishments, and on vending machines. Under the menu labeling rule, certain additional nutrition information will need to be available in writing when customers ask for it.

This is especially important, because about one third of the calories Americans eat and drink come from foods and beverages consumed away from home. In addition, research shows that when we eat out we often consume less nutritious foods and underestimate the number of calories we are taking in.

People can clearly benefit by knowing more, and the new FDA rules will help to do just that. They are not requirements about what people should eat or what restaurants should serve, but rather they will place more information in the customer’s hands so that they can make more informed choices for themselves and their families.

After considering more than 1,100 comments on the proposed versions of these rules, the rules create a consistent approach that will establish a level playing field for larger chain restaurants, while not being overly burdensome on small businesses or individual food establishments. The menu labeling rule applies to restaurants and similar retail food establishments only if they are part of a chain of 20 or more locations and satisfy other criteria.

Few decisions are as critical to our health and our daily lives as those involving the foods we eat. With these new rules on menu and vending machine labeling, Americans can be more certain that those choices are informed ones.

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

China Journal: strengthening relationships to protect public health

By: Margaret A. Hamburg, M.D.

I am just about to wrap up a jam-packed five-day visit to China, a fascinating country with a dramatically growing economy and with an increasingly significant impact on the products that Americans consume. Indeed, a key reason for my trip is the important and growing collaboration between FDA and our counterpart agencies in China to ensure the safety of the large volume of foods and medical products exchanged between our two nations.

Margaret Hamburg, M.D.Of the 200 countries that export their products to the United States, China ranks first in exports (in dollar value) to our nation. It is the sixth largest provider of food and the sixth largest provider of drugs and biologics. Only the United States has more FDA-registered drug establishments than China. And these numbers are growing. Between 2007 and 2013, China’s annual exports of FDA-regulated products to the U.S. nearly quadrupled, reaching 5.2 million “lines” (portions of a shipment) of imported goods in 2013.

Ensuring the safety and quality of these and other U.S.-destined FDA-regulated goods is a major challenge. To meet it, FDA has transformed itself— from a domestic agency that focused primarily on products manufactured in the U.S. to a truly global agency grappling with the many challenges of globalization.

Among the many efforts in this area, an important component is the FDA’s establishment of permanent outposts staffed by FDA experts in all major exporting regions, including in China. We have 13 FDA staff members currently stationed in the country, primarily in Beijing. Their job is to help ensure that the food and medical products being exported from China meet our standards. FDA’s China Office does this by providing significant support for the Agency’s inspections in China, by strengthening our relationships with Chinese regulators, by working with industry and other stakeholders, by providing important information and technical assistance to all interested parties, and by analyzing trends and events that might affect the safety of FDA-regulated products exported from China to the United States.

Given the volume of U.S. trade with China, we are working to more than triple the number of American staff we place in China. Placing more FDA experts in China will allow FDA to increase significantly the number of inspections it performs in this dynamic, strategic country, as well as to be more effective partners with our colleagues here in China. Such dramatic staffing increases will also allow FDA to enhance its training efforts and technical collaboration with Chinese regulators, industry and others.

This week, we took an important step forward in strengthening our relationship with China when we signed an Implementing Arrangement with the China Food and Drug Administration (CFDA). We expect to sign a similar Implementing Arrangement with the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) in the coming weeks. These documents, which build on 2007 agreements with the same two agencies, help to frame the work our inspectors will do in China and create mechanisms for collaboration on inspections.

FDA is also engaging with other stakeholders to create sustainable models for training future champions of regulatory science and quality. Here in China, we helped to create a world-class graduate degree program in international pharmaceutical engineering management (IPEM) at Peking University (PKU), an institution renowned for educating Chinese leaders and thinkers.

This partnership with PKU began in 2005 with just two courses on current good manufacturing practices. These proved hugely successful, and drew attention from Chinese drug companies and regulatory agencies, as well as industry and regulators in neighboring countries. The following year, PKU established a master’s degree program in IPEM, with support from FDA and multinational pharmaceutical companies. The program was formally launched in March 2007, with courses in regulatory science, pharmaceutical science, engineering, and more.

One of the highlights of my trip this week was speaking to more than 200 PKU students, future leaders who will help to accelerate the modernization of this nation’s pharmaceutical industry. I discussed not only FDA’s growing regulatory cooperation with China but the importance of strengthening regulatory science in China to ensure that the highest standards are used to support the development, review, and approval of new medical products, as well as the manufacturing and safety monitoring of medical products. All of this can make an enormous difference in the lives of patients in China, the U.S. and beyond.

Also this week, I met with top Chinese regulatory officials, toured CFDA’s mobile laboratories that test for counterfeit drugs and contaminants in food, and attended the 9th International Summit of Heads of Medicines Regulatory Authorities in Beijing.

Throughout the week, we addressed tough problems that require global solutions. Our discussions ranged from how best to advance biomedical product innovation, expand access to important pharmaceuticals through generic and biosimilar regulatory pathways, and how coordinated action, along with using new, state-of-the art technologies and analytical methods, will more effectively protect the public from substandard or counterfeit products. We are also making tangible progress in strengthening FDA’s partnership with our Chinese counterparts to better oversee the increasingly complex international supply chain and to prevent problems before they occur.

As I prepare for the journey home, I am encouraged by what we accomplished. And all of this bodes well for our ability to promote and protect protect public health in the future.

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

View Photos from China:

Commissioner Margaret A. Hamburg, M.D., tours an FDA China Office mobile lab that tests for counterfeit OTC drugs and contaminants in food

Commissioner Margaret A. Hamburg, M.D., meets with Chinese pharmaceutical executives

Commissioner Margaret A. Hamburg, M.D., with students of Peking University

 

FDA and Asia-Pacific Colleagues Focus on Food Safety

By: Camille Brewer, M.S., R.D., and Christopher Hickey, Ph.D.

In the alphabet soup of international affairs— UN, NATO, WTO— APEC is perhaps one of the lesser-known entities. In FDA’s world, APEC (Asia-Pacific Economic Cooperation), which focuses on facilitating economic growth, cooperation, trade and investment in the Asia-Pacific region, is a significant focus of collaboration in the area of food safety.

Camille Brewer

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

Food safety is one of the priority areas for APEC, as evidenced by the establishment of the Food Safety Cooperation Forum (FSCF), which has been co-chaired by China and Australia since the forum was formally established in April 2007. FSCF was founded to bring together APEC’s 21 member economies to make the region’s food standards consistent with those of the international food standards body (Codex Alimentarius Commission) – all for the ultimate purpose of improving public health while facilitating trade. (The word “economies,” rather than “nations,” is used to describe APEC members because of their focus on trade and economic issues.)

In September, FDA joined colleagues for APEC food safety meetings in Beijing. Because of the importance of building the capacity for food safety protections in China and the region, China hosted a “Special Session” of FSCF to consider progress from technical working groups on export certificates and maximum residue limits of pesticide in food products. There was also a meeting called the “High-Level Regulator Industry Dialogue” to spotlight numerous cooperative ventures between the private and public sectors. This overview of APEC projects gave us a sense of how well the regions’ economies function together.

Christopher Hickey

Christopher Hickey, Ph.D., FDA’s Country Director for the People’s Republic of China.

While FSCF aims to support dialogue among regulators, many of APEC’s food safety initiatives are built on collaboration with government, industry and academia. At the High-Level Regulator-Industry Dialogue session, the group discussed how working with partners is enhancing food safety by leveraging the benefits of our shared work. FDA talked about how the FDA Food Safety Modernization Act (FSMA) creates new tools to prevent food safety problems, and how FDA’s foreign offices are working with fellow regulators to bolster a coordinated approach.  It was especially heartening to see China present its challenges in the area of food safety as an opportunity to lead development of deeper food safety capacity in the APEC region.

The central role of partnerships was a predominant theme throughout, and when Pam Bailey, CEO and president of the Grocery Manufacturers of America (GMA), addressed participants, she implored delegates to “work together to create conduits for the private sector to interface with governments as they develop newfound safety regimes.”  Bailey highlighted the U.S. notice and comment rule-making process, and noted GMA’s proactive engagement in this process. She emphasized the transparency of the U.S. system, and spoke of GMA’s active engagement to provide constructive feedback on the rules that FDA has proposed to implement FSMA. The importance of transparency in regulatory operations was a message repeated by all representatives from private and public sectors.

Camille Brewer

Camille Brewer, M.S., R.D., at the APEC food safety meetings in Beijing.

There is exceptional collaborative work taking place. The value of these partnerships was evident in technical sessions of the meetings, which covered best practices in laboratory proficiency testing, pilot projects on export certificates in the wine industry, and the convergence of approaches to regulate maximum residue limits for pesticides in wine grapes. It was exciting for us to hear constructive proposals from both developing and developed countries, industry and academia, each with a vital role to play in addressing the challenges of a globalized food safety system. The candid exchange of views is a recipe for success.

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

Christopher Hickey, Ph.D., is FDA’s Country Director for the People’s Republic of China.

FDA Invites Students to Sharpen their Research Skills

By: Nysia George, Ph.D., and Tom Powers

NCTR Intern Claire Boyle, a graduate student from Florida State University

NCTR Intern Claire Boyle, is a graduate student from Florida State University. Get this and other NCTR photos on Flickr.

Biology. Chemistry. Bioinformatics. Toxicology.

Practical, hands-on laboratory work is important for all college students who want to become scientists—but, for many of them, such experiences are out of reach.

That’s one of the reasons why every summer, our National Center for Toxicological Research (NCTR)—FDA’s internationally acclaimed toxicological research center in Jefferson, Arkansas—hosts a special internship program for science students interested in toxicology research.

The 2014 program was exceptionally successful for both the students and the Center.

Applications poured in from more than 200 students pursuing a variety of majors in universities from coast-to-coast. The competition was intense, and the 21 selected students came from schools in 13 states. But they were all alike in two fundamental ways: they were top students, and were eager to hone their scientific skills in real FDA laboratories.

NCTR Intern Luis Valencia, a senior from Texas A&M University

NCTR Intern Luis Valencia, is a senior from Texas A&M University. Get this and other NCTR photos on Flickr.

During their 10 weeks at NCTR, the students worked on projects varying from the development of bioinformatics and statistical methods for RNA sequencing data, to evaluating effects of silver nanoparticles in plastic food containers. They conducted in-vitro experiments; examined effects of nicotine treatment; gained lab experience in cell culture; and were trained in computational modeling or statistical programming.

Each student’s experience was unique and addressed the student’s interests.

The interns gave the program top grades. For example Claire Boyle, a graduate student from Florida State University, said about the lab work: “I like it a lot more than classes. There they tell you that you can do research once you get into the real world. I’ve never had an opportunity to do that before coming here [to NCTR], and that’s the aspect of the program I like best. It’s given me insight into what I want to do for the rest of my life!”

Luis Valencia, a senior from Texas A&M University, echoed similar praise. “This isn’t some pointless classroom assignment; this is the FDA. Something you discover [in this lab] could save a life.” He continued, “I’m having a great experience at NCTR. [My NCTR mentor] let me design my own experiment and helps me a lot. I’m already on my second trial and we’re getting good results.”

The internship program, which was partly funded by the FDA’s Office of Minority Health, is one of the many ways NCTR reaches far and wide to strengthen the scientific foundations of our agency. We engage with scientists within FDA and across other government agencies, industry, and academia to develop scientific information that is vital for sound regulatory policy. We cooperate with colleagues abroad to advance international standardization of regulatory science. And we’re mindful that all quest for knowledge starts with education.

If you are a science student interested in toxicology research, or if you know someone who is, it’s not too early to consider the NCTR’s 2015 internship program. To qualify for admission, a candidate must meet the GPA requirements and provide evidence of success in science courses. He or she will also need letters of recommendation and a personal statement describing his or her research interests.

If you believe you have what it takes, you could be among the select few chosen to join us in the summer of 2015. Applications are accepted throughout the month of February. We look forward to your application!

For more information about the program go to: Summer Student Research Program (NCTR)

For more information about the FDA Office of Minority Health go to: Minority Health

Nysia George, Ph.D., is the National Center for Toxicological Research’s Intern Program Coordinator.

Tom Powers is the National Center for Toxicological Research’s Communication Officer.

Regulatory Science Collaborations Support Emergency Preparedness

By: Jean Hu-Primmer, M.S.

Scientists love a challenge. And coordinating government agencies, healthcare providers, and numerous additional partners to protect public health in emergency situations is definitely a challenge.

Jean Hu-Primmer

Jean Hu-Primmer, Director of Regulatory Science Programs in FDA’s Office of Counterterrorism and Emerging Threats.

FDA’s Medical Countermeasures Initiative (MCMi) is working with federal agencies (through the Public Health Emergency Medical Countermeasures Enterprise), product developers, healthcare professionals, and researchers, among other partners, to help translate cutting-edge science and technology into safe, effective medical countermeasures. Through these collaborations, MCMi supports research to help develop solutions to complex regulatory science challenges.

Data are critical to help FDA evaluate the safety and effectiveness of medical countermeasures—products that can save lives—during public health emergencies. But collecting data in the midst of an emergency is exceptionally challenging. Working with the Biomedical Advanced Research and Development Authority (BARDA), FDA is teaming with critical care physicians nationwide to help address these challenges.

Under a contract awarded last month, FDA and BARDA will work with the U.S. Critical Illness and Injury Trials Group (USCIITG) to gather important information about medical countermeasures used during public health emergencies. Physicians will help address challenges with collecting and sharing data rapidly in emergencies, including streamlining electronic case reporting for clinical trials and rapidly disseminating key findings to FDA and other stakeholders to support clinical decision-making.

During this four-year project, USCIITG will also develop and pre-position a simple influenza treatment protocol in 10 hospitals throughout the U.S. during the 2015-2016 influenza season. The project will help doctors more easily use an investigational treatment protocol for patients with severe influenza, and test the data collection and reporting system during peak times. The goal is to help streamline the process during future influenza seasons and emergencies.

When it is not ethical or feasible to test the effectiveness of products in humans—such as countermeasures for potential bioterror agents—products may be approved under the Animal Rule. When products are approved under the Animal Rule, FDA requires additional studies, called phase 4 clinical trials, to confirm safety and effectiveness. In addition to the MCMi work, BARDA is funding USCIITG to investigate conducting phase 4 clinical studies during public health emergencies. USCIITG partners will train on these protocols, have them reviewed through their Institutional Review Boards (a requirement for all human studies), and create plans for enactment. USCIITG will then conduct an annual exercise to test these plans, a unique approach to broader science preparedness.

MCMi has also recently awarded regulatory science contracts to support other aspects of emergency preparedness, including two projects to investigate decontamination and reuse of respirators in public health emergencies (awarded to Battelle and Applied Research Associates, Inc.), and an award to support appropriate public use of medical countermeasures through effective emergency communication.

Our work involves big challenges. Through regulatory science, and through new and expanding collaborations, we continue to address these challenges to better prepare our nation to use medical countermeasures in emergencies.

Want to help? We’re currently accepting submissions for additional research to support medical countermeasure preparedness. If you have an idea for a new medical countermeasure regulatory science collaboration, we’d love to hear from you.

You can also visit BARDA’s MCM Procurements and Grants page for more information.

Jean Hu-Primmer, M.S., is Director of Regulatory Science Programs in FDA’s Office of Counterterrorism and Emerging Threats.