Homing in Faster on Potentially Deadly Bacteria in Food

By: Nilda E. Villegas

Whether an outbreak of foodborne illnesses is caused by Listeria in cantaloupe, E.coli in salad or Salmonella in peanut butter, the faster the disease-causing bacteria are identified, the more illnesses can be averted.

Nilda VillegasLast year scientists based in FDA’s San Juan Laboratory were endowed with seed funding through a Health and Human Services HHSignite award to adapt traditional chemistry methods for the detection of foodborne pathogens. HHSignite (beta) is an internal competitive seed-funding opportunity to test new and unconventional ideas within HHS.

The team is being led by LCDR José Moreno of the U.S. Public Health Service, a microbiologist in FDA’s San Juan Laboratory. Working with Moreno on this project are Joseph Bloom, Ph.D., San Juan Laboratory science advisor, supervisory chemists Adalberto Cajigas and Héctor Espinet, science advisor Osvaldo Rosario, Ph.D., chemist Miguel A. Martínez, and staff fellow Fernando González, Ph.D.  FDA’s San Juan scientists were among 13 teams within HHS to receive such funding when Secretary Sebelius announced the finalists in June 2013.

San Juan Laboratory Team: Left to right in the back: Dr. Joseph Bloom, Dr. Osvaldo Rosario and Dr. Fernando González; standing in front Miguel A. Martínez and LCDR José Moreno.

San Juan Laboratory Team: Left to right in the back: Dr. Joseph Bloom, Dr. Osvaldo Rosario and Dr. Fernando González; standing in front Miguel A. Martínez and LCDR José Moreno.

Their proposal is to assess the utility and practicality of coupling CE-MS, which stands for Capillary Electrophoresis coupled with a Mass Spectrometer, that promises to be the workhorse of many analytical chemistry laboratories for use in identifying pathogenic microorganisms through the identification of specific proteins associated with pathogenicity by their fragmentation patterns. This essentially identifies specific “fingerprints” for disease-causing bacteria, such as E. coli, Salmonella, Listeria and Staphylococcus, in foods.

The research undertaken by Moreno and his team could result in faster screening methods for a wide array of pathogens as part of FDA’s food safety and food defense programs.

What’s next?

The San Juan team is continuing their research on this innovative screening tool to reduce testing times even more, and coordinating their efforts with their scientific colleagues in our Office of Regulatory Affairs and in our Center for Food Safety and Applied Nutrition on the mainland to protect the safety of the U.S. food supply.

Nilda E. Villegas is a Public Affairs Specialist in the San Juan District Office, part of FDA’s Office of Regulatory Affairs

Mexico and the U.S.: Progress on Food Safety Partnerships

By: Michael R. Taylor

En Español

Spring may be on the way, but it’s still winter weather in most areas of the country. If you are enjoying fresh avocados, berries or grapes, there is a good chance they came from Mexico. In fact, about two-thirds of the fresh produce imported into the United States comes from our neighbor to the south.

Food safety meeting attendees, Tubac, Arizona

Food Safety Meeting attendees, from left to right:
Samir Assar, Director, Produce Safety Staff
Bonnie Fernandez-Fenaroli, Executive Director, Center for Produce Safety – UC Davis
Lance Jungmeyer, President, Fresh Produce Association of the Americas
Hugo Fragoso Sanchez, General Director of Food Safety for Food, Agriculture and Fisheries, SENASICA
Walter Ram, Vice President of Food Safety, The Giumarra Companies
Mike Taylor, Deputy Commissioner for Foods and Veterinary Medicine

Ensuring the safety of imported produce is a major focus of FDA’s food safety strategy. That is why I am in Tubac, Arizona to meet with Mexican government officials and producers of fresh fruits and vegetables from both sides of the border. The meeting is sponsored by the Fresh Produce Association of the Americas and the Center for Produce Safety in Davis, California – two organizations that take food safety very seriously.

There’s no substitute for face-to-face meetings like this to move the needle forward on food safety. Under the Food Safety Modernization Act (FSMA), FDA is developing standards for produce safety that, when implemented, will raise the food safety bar for produce sold in the U.S., whether grown here or in other countries. However, we also have to focus on how the new standards can be effectively and efficiently implemented. How will government and industry – both in the U.S. and abroad – operate under the new requirements? How can we take best advantage of our collective efforts to understand and prevent foodborne hazards and verify that applicable standards have been met? That, after all, is where the rubber meets the road.

We don’t have all the answers yet, but we do know we can’t do it alone. I’m joined in Tubac by Samir Assar, who heads FDA’s Produce Safety Team, Dominic Veneziano, who directs our import operations; and Bruce Ross, deputy director of FDA’s Latin America office. And we are sharing the podium with Hugo Fragoso Sanchez from SENASICA and Mario Alanis Garza from COFEPRIS – the two Mexican agencies with which we have long worked closely on food safety.

Historically, our government-to-government collaboration has come mostly in response to outbreaks, import alerts and other incidents. Now, we are focused on work we can do together to better understand potential foodborne hazards and take risk-based steps to prevent or minimize them. This means building partnerships to implement FSMA in the United States and at our common border, as well as collaborating with Mexico to support its food safety modernization initiatives.

Food safety partnerships – at the U.S.-Mexico border and across the food system – must, of course, extend well beyond government. The food safety practices of growers and processors, coupled with private sector supply-chain management, are what make food safe. Government establishes the common base of standards and provides a measure of public accountability for food safety, but verification that standards are being met is a joint public-private effort.

So, we are taking advantage of the Tubac meeting to talk to members of the produce industry about how public and private verification efforts can mesh. Our goal is simple: We want to provide the high levels of assurance about the safety of produce and other food that FSMA calls for and consumers expect. And, in a world of finite resources, we can do that only by relying, where possible, on others to complement our own efforts, and by avoiding duplication.

The next step in building our partnership with Mexico is a three-day meeting in late March with our SENASICA and COFEPRIS colleagues that we will be hosting at our Silver Spring, MD, headquarters. That discussion will build on past collaborative efforts on training, laboratory coordination, risk assessment and outbreak response, but it will be looking ahead to how we can build partnerships for the prevention of food safety problems. After the meeting, we will also be engaging our private stakeholders – industry, consumers, and academia – in this dialogue.

“Partnership” is an easy word to say, but making it real is hard work. We have to learn, continuously, about and from each other; and we have to deal with hard issues in order to expand and align our capacities, share data and information across both public and public-private lines, and build the trust that is the basis for mutual reliance. Some of this will be hard, but we wouldn’t be in Tubac if we didn’t think it were possible – and if we didn’t know active partnership is essential to achieving the food safety goals we all share.

We’ll keep you posted on our progress.

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

Planning Healthy Changes to the Nutrition Facts Label

By: Margaret A. Hamburg, M.D.

When the Nutrition Facts Label was created in 1993, it was revolutionary. For the first time, consumers could read the nutrition information on a food package to know what was in it and that the information was held to government standards for consistency and accuracy. This rectangular box has since become one of the world’s most recognized graphics, with countries around the world adopting their own version.

Margaret Hamburg, M.D.To continue the spirit and purpose of the Nutrition Facts Label, we are proposing important changes to bring it fully into the 21st century. A lot has changed in the past 20 years. Much more is known about food consumption and nutrition, the health of our population and the dietary choices that can help keep us healthy or make us vulnerable to an array of chronic diseases.

The changes that we’re proposing reflect that knowledge, based on an extensive examination of the latest public health trends and research on nutrition and disease, including obesity. There is a lot of information on FDA.gov about our plans, but I’d like to hit the highlights:

  • “Added sugars” would be listed on the label along with the current “Sugars” declaration (which includes both naturally occurring and added sugar). This alone is huge: The average American takes in many calories every day in sugars added during food production. Experts call these “empty calories” that often take the place of foods rich in nutrients.
  • Speaking of nutrients, listing the amount of Vitamin D and potassium – which many of us don’t get enough of – would be required. They would join calcium and iron as nutrients important to public health.
  • People generally eat differently today than they did 20 years ago. The serving size requirements would be updated to more accurately reflect what we’re actually eating. By law, serving sizes must be based on what people actually eat, not on what people “should” be eating.
  • Certain packages that are typically eaten in one sitting would be required to be labeled as a single serving, which would mean you would know how many calories and nutrients you are consuming for the whole package. For example, a 20-ounce soft drink would be one serving under the proposal, not more. Certain larger packages that could be consumed in one sitting or in multiple sittings would be required to be labeled per serving and per package.
  • While continuing to require “Total Fat,” “Saturated Fat,” and “Trans Fat” on the label, “Calories from Fat” would be removed because research shows the type of fat is more important than the amount.
  • The format would be modernized. Calories and serving sizes would be displayed more prominently in larger, bold type. The %DV (daily value) would be moved to the left, so that you can immediately put a nutrient in the context of your daily dietary needs.

I’ve been asked if we’re proposing these changes because an increasing number of people in this country, including children, are obese and at risk of serious diseases tied to food consumption.

The answer is both no – and yes.

No, because the Nutrition Facts Label is for everyone. FDA does not regulate diets, but we can make sure that you know exactly what you’re eating. Having more information can enable you to make an educated decision about the foods you eat and serve your family.

Yes, because we know that too many people’s health is being compromised by the food they eat. This includes those at risk for serious disease like cardiovascular disease, hypertension, strokes, diabetes, and obesity and all of us to wanting to have healthy diets can tell at a glance what is in a particular food.

As a consumer myself, I would find a Nutrition Facts Label that reflects the current science very helpful when making food choices for myself and my family. These changes should make it easier than ever to judge a food by its label.

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

Keeping Foods Safe During Transport

By: Michael R. Taylor

We made great strides in 2013 toward fulfilling the mission set forth by the FDA Food Safety Modernization Act, often known simply by the acronym FSMA. This law is making it possible for us to reinvent ourselves, becoming a force for the prevention of foodborne diseases rather than being mainly first-responders to food safety problems in progress.

Michael TaylorToday we are proposing a new food safety rule that would help prevent the contamination of food during transportation by establishing requirements for sanitary transportation practices.  Certain shippers, carriers, and receivers engaged in transporting food by motor or rail vehicles would be required to follow common sense sanitary practices, such as properly refrigerating food, adequately cleaning vehicles between loads, and properly protecting food during transportation.

This is an important part of the food handling process, one that can introduce contamination even after proper safeguards have been taken by the food producers and processors. Truthfully, it’s uncommon for a foodborne illness to be caused by contamination during transportation. But we have received reports of unsanitary practices, and we want to minimize this potential source of illness.

This proposed Sanitary Transportation of Human and Animal Food Rule is the seventh and final major proposed rule in FSMA’s central framework aimed at systematically building preventive measures across the food system. It builds on the six rules proposed in 2013 to keep produce safe, enact preventive controls in human and animal food-producing facilities, modernize oversight of imported foods, and guard against intentional contamination.

As this next-generation safety network takes shape, the food safety law gave us new authorities that empower us to take immediate action in the meantime to protect public health. Administrative detention enables us to keep a suspect food product out of circulation. Mandatory recall enables us to pull products off store shelves if we have reason to believe they may be unsafe to eat.  We can suspend the registration of a facility if the food it produces, packs or stores presents a serious health hazard.  By using these tools now, we’re practicing what we preach as we plan for the future.

As we’ve traveled the world to explain these new food-safety standards, I’ve developed a mantra of sorts: We’re all in this together. I mean that as much for this transportation proposed rule as I have for each of the ones we proposed last year. When these rules become final, they will be the product of an unprecedented collaboration between food regulators, the food industry, scientists, advocates and consumers.

So let’s start talking about what we need to do to transport foods safely.  As with the other proposed rules, we will work with all stakeholders – including consumers, industry and researchers – to ensure that what we’re proposing is practical and feasible while meeting our food-safety standards.  We look forward to your comments.

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

We Moved Forward on Many Fronts This Year

By: Margaret A. Hamburg, M.D.

At the FDA, the agency that I’ve had the privilege to lead for the past five years, I am gratified to report that we have a lot to be proud of this year. In fact, this past year’s accomplishments on behalf of public health have been as substantial as any in FDA’s recent history.

Margaret Hamburg, M.D.We moved significantly forward, for example, in creating a system that will reduce foodborne illness, approving novel medical products in cutting-edge areas of science, and continuing to develop our new tobacco control program. We worked successfully with Congress and with regulated industry to reach agreement on a number of difficult issues, while continuing to use the law to the full extent possible to protect consumers and advance public health.

While there were many significant actions and events to recognize, below are some of the highlights of 2013.

In the foods area, there were many new actions this year that will have a long-standing impact on improving our food supply for consumers. Throughout the year we have been proposing new rules to reach the goals set forth by the FDA Food Safety Modernization Act (FSMA). These science-based standards will help ensure the safety of all foods produced for our market, whether they come from the U.S. or from other countries.

We also took important steps towards reducing artery-clogging trans fat in processed foods, and understanding the health impact of arsenic in rice. With a final rule that defines when baked goods, pastas and other foods can be considered free of gluten, people with celiac disease can have confidence in foods labeled “gluten free.” And we are studying whether adding caffeine to foods may have an effect on the health of young people and others.

There have likewise been many accomplishments in advancing the safety and effectiveness of medical products. We worked closely with Congress on the recently enacted Drug Quality and Security Act, which contains important provisions relating to the oversight of human drug compounding. The law also has provisions to help secure the drug supply chain so that we can better help protect consumers from the dangers of counterfeit, stolen, contaminated, or otherwise harmful drugs.

Using tools provided by last year’s landmark Food and Drug Administration Safety and Innovation Act (FDASIA), we are continuing to improve the speed and efficiency of medical product reviews, including those involving low-cost, high quality generic drugs and innovative new medical devices. The average number of days it takes for pre-market review of a new medical device has been reduced by about one-third since 2010. The percentage of pre-market approval applications that we approve has increased since then, after steadily decreasing each year since 2004.

We launched a powerful new tool to accelerate the development and review of “breakthrough therapies,” allowing FDA to expedite development of a drug or biologic (such as a vaccine) if preliminary clinical evidence indicates that it may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases. This offers real opportunities to get promising drugs more quickly to patients who need them. In fact, using this new approach, FDA recently approved two advanced treatments for rare types of cancer and one for hepatitis C. We have also strengthened efforts to ensure product quality, increased protection of the drug supply chain, and reduced drug shortages.

We confronted the growing misuse of powerful opioid pain relievers by advising manufacturers on how to make these drugs harder to abuse with formulations that are more difficult to crush for inhalation or dissolve for injection. And we recommended that hydrocodone combination products be subject to stricter controls to help prevent abuse. 

We took an important step towards fighting the development of antibiotic-resistant bacteria by implementing a voluntary plan to phase out the use of antibiotics to enhance the growth of food-producing animals, and to move any remaining therapeutic uses of these drugs under the oversight of a licensed veterinarian. So-called “production” use is considered a contributing factor in the development of bacteria that are resistant to the antibiotics used in human medical treatment.

In many areas of our work we are supporting the emerging field of personalized medicine. Advances in sequencing the human genome and greater understanding of the underlying mechanisms of disease, combined with increasingly powerful computers and other technologies, are making it possible to tailor medical treatments to the specific characteristics, needs, and preferences of individual patients.

Many cancer drugs today are increasingly used with companion diagnostic tests that can help determine whether a patient will respond to the drug based on the genetic characteristics of the patient’s tumor. In May, FDA approved two drugs and companion diagnostic testing for the treatment of certain melanoma patients with particular genetic mutations.

Advances in science and technology are also seen in the creation of new medical devices. For example, 3-D printing - the making of a three-dimensional solid object from a digital model – was once considered the wave of the future. But in February, FDA cleared for marketing a device created by 3-D printing – a plate used in a surgical repair of the skull that is built specifically for the individual patient.

While we have worked hard to get therapies to patients, we are at the same time using the tools available to us to remove unsafe and dangerous products from the market. In November, we used new enforcement tools provided by the food-safety law to act quickly in the face of a potential danger to public health presented by certain OxyElite Pro products. These supplements had been linked to dozens of cases of acute liver failure and hepatitis. After FDA took action, the manufacturer agreed to recall and destroy the supplements.

Finally, we made significant progress in implementing the letter and spirit of the Family Smoking Prevention and Tobacco Control Act. We have signed contracts with numerous state and local authorities to enforce the ban on the sale of tobacco to children and teens; conducted close to 240,000 inspections; and written more than 12,100 warning letters to retailers. And, in the first quarter of 2014 we will launch a public education campaign aimed at reducing the number of young people who use tobacco products.

All of us take great pride in the skill and vigor with which we overcame the year’s challenges and new demands. And so, as the year draws to a close, I extend my gratitude to the employees at the FDA who work tirelessly on behalf of the American public year in and year out. To all of our stakeholders, my heartfelt wishes for a joyous holiday season and a safe and healthy 2014.

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

Your Input is Bringing Change to Food Safety Rules

By: Michael R. Taylor

Michael R. TaylorYou spoke. We heard you.

We began 2013 with the proposal in January of two rules required by the FDA Food Safety Modernization Act: the Produce Safety Rule and Preventive Controls for Human Food. The former would set science-based standards for the produce industry while the latter would set safety requirements for food facilities.

We were determined from the beginning to be transparent in our processes and to engage all stakeholders in the work of crafting final regulations that would work across the broad spectrum of food-producing operations. An unparalleled outreach effort followed the proposal of these rules. My team and I traveled across the country and around the world to discuss these food-safety requirements with the people who would be most affected, including farms of varying types and sizes.

In our travels, we saw first-hand how everyone is committed to food safety.  We especially spent a lot of time talking to farmers, both those who are smaller and work the land their family has owned for generations, and those who oversee large, diverse operations. We have heard concerns that certain provisions, as proposed, would not fully achieve our goal of implementing the law in a way that improves public health protections while minimizing undue burden on farmers and other food producers.

And because of the input we received from farmers and the concerns they expressed about the impact of these rules on their lives and livelihood, we realized that significant changes must be made, while ensuring that the proposed rules remain consistent with our food safety goals.

For that reason, we are planning to revise language in the proposed rules affecting farmers and plan to publish it in the Federal Register for public comment by early summer. These include changes to sections covering water quality standards and testing, standards for using raw manure and compost, certain provisions affecting mixed-use facilities (such as a farm that has a food-processing operation), and procedures used to withdraw the qualified exemption to these requirements for certain farms. As we consider the comments we’ve received, we may decide to include other changes for public comment. We recognize that completing these rules is essential to protecting the public health and are committed to completing them as quickly as possible.

We always knew that the rules governing farmers would be complex, in part because of the incredible diversity in the size and nature of farming operations. The standards we set must accommodate that diversity and be feasible to implement.

In our efforts to get first-hand information about how these rules would work in the real world, we visited nearly 20 states, Europe and Mexico; toured small and large farms and met with farmers across the country; met with the Amish, organic producers and other groups deeply involved in farming; collaborated with officials from other federal and state public health agencies; and held many public meetings. We also met with coalitions of consumer groups and other stakeholders. Our outreach work has been focused on ensuring that we never took our eyes off the ultimate goal: Keeping the food that you and your family eat safe.

We believe that this decision to change  these proposed rules—in response to the careful consideration of many people involved in supplying our food—is critical to fulfilling our commitment to getting them right. I urge you to review these changes when they are ready and let us know what you think.

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

Produce Safety Rule: The Partnership Continues

By: Michael R. Taylor

The comment period for the proposed produce safety rule closed on Friday, Nov. 22, but this is far from the end of FDA’s collaboration on produce safety with growers, the food industry, and consumers. FDA will continue to engage stakeholders, and we are committed to engagement through a final rule’s ultimate implementation.

Michael R. TaylorThe proposed produce safety rule is an important part of the Food Safety Modernization Act (FSMA), along with new measures to prevent problems in food processing facilities and strengthen our assurances that imported foods meet U.S. safety standards. When finalized, the produce rule will set science-based standards for the safe production and harvesting of fruits and vegetables, whether grown here or in another country. It’s crucial for all concerned that the final rule be both right for food safety and as practical and feasible as possible for the many produce operations involved in supplying fresh fruits and vegetables to America’s consumers.

To help get the rules right, my team and I have traveled our country to get input from the people who will be most affected and have the greatest expertise. Just in recent months, we have traveled to the Pacific Northwest, New England, Michigan, and California. We’ve toured all kinds of farms, from small ones that have been in the family for generations and grow many different crops, to huge farms that grow one crop. We’ve visited food hubs, roadside stores and irrigation districts. We’ve been joined by staffers from the U.S. Department of Agriculture, extension agents, state agriculture commissioners and others. And there have been hundreds of listening sessions in which we’ve heard people speak frankly about their concerns about the proposed new requirements. What I want to say first to all the people we met and all those who have submitted comments is simply this:

Thank you.

The people I’ve met in all parts of the produce supply chain take great pride in the quality of their work and are committed to food safety. But they also feel that some parts of the produce rule as drafted won’t work, and they went to considerable effort – taking time out of their day, traveling to where we were, and waiting to speak to us – to help us understand their concerns. Particular concerns include the requirements that would affect irrigation water and the use of manure to fertilize crops. They also told us about parts of the rule with which they fully agree and want to be sure stay in place.

We now turn to the deliberations needed to craft a final rule, based on the thousands of written comments submitted to FDA and the input we received in our travels. While some concerns may be addressed through more precise language, others may need more changes, and a few may require substantial changes in what we’ve proposed. Rest assured that we will carefully consider these concerns and do whatever is possible to get these rules right. 

FDA will also engage stakeholders in the eventual implementation of the final rules. This includes continuing to work with the Produce Safety Alliance, state agriculture departments, and others in the produce community on education, training and technical assistance to support implementation by growers. They won’t be going it alone.

Keeping our food supply safe is FDA’s ultimate goal – and it’s a goal we know is shared widely by farmers, food distributors, and marketers throughout the food system. In field and factory, at the local food system level and over long supply chains, good people are working hard to keep your food safe. We look forward to an enduring partnership with this community as we work to finalize and implement the produce safety rule and the other important elements of the modern food safety system envisioned by FSMA.

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

FDA Uses New Authorities To Get OxyElite Pro Off the Market

By: Daniel Fabricant, Ph.D. 

As the head of the office that oversees dietary supplements, it is my responsibility to ensure that the dietary supplement products on the market — which are used by more than 180 million Americans daily — do not cause harm.

This is not an easy job because FDA’s authority to regulate dietary supplements is very different from the agency’s authority to regulate drugs and medical devices prior to their marketing. Adding to the challenge is the fact that there are more than 85,000 dietary supplement products and no requirement for product registration.

Just recently we had a case that illustrates both the limits of FDA’s authority to regulate supplements and the promise of new enforcement tools provided by the FDA Food Safety Modernization Act (FSMA). Dozens of people were suffering acute liver failure or non-viral hepatitis so severe that several needed liver transplants, and one died. These people, by and large, had been healthy.

The illnesses were linked to certain OxyElite Pro dietary supplement products made by Texas-based USPLabs. Certain OxyElite Pro products and a second product, VERSA-1, contain a new dietary ingredient that has not been shown to be safe for use by consumers. This ingredient, aegeline, is a synthetic version of an alkaloid that exists, in natural form, in a tree that grows in parts of Asia.

This is the second time in little more than a year that USPLabs has produced supplements containing a new dietary ingredient that lack a history of use or other evidence of safety. In the previous case, the company added a stimulant called DMAA (dimethylamylamine) to OxyElite Pro and to a similar product, Jack3D. We were alerted to the addition of DMAA through more than 100 reports of illness, including six deaths, among people who used the products.

Consumers may look at a capsule or tablet, the forms in which many supplements are sold, and not realize our limitations in regulating dietary supplements. In October 1994, the Dietary Supplement Health and Education Act expressly made supplement manufacturers responsible for ensuring that their products are safe. Under this law, manufacturers do not need FDA approval before selling dietary supplements. The burden is generally on FDA to prove that a supplement is unsafe before any actions can be taken to restrict its use or remove it from the market.

The law made an exception for “new dietary ingredients” (i.e., dietary ingredients not marketed in the United States before Oct. 15, 1994). Before supplements containing these new dietary ingredients – vitamins, minerals, herbs and other substances – can be sold, a manufacturer or distributor must provide FDA with information establishing their safety when used under the conditions recommended or suggested in the product labeling. USPLabs should have informed FDA of its plans to add aegeline to its dietary supplements, and it should have established the safety of aegeline in its products. Neither of those things happened.

We do not have the authority to evaluate and approve dietary supplements before they are sold to consumers. However, in this case we were able to invoke new enforcement authorities provided by FSMA to remove them from the market.

Key provisions under the new food safety law – mandatory recall and administrative detention – now play a critical role in allowing FDA to act quickly and decisively. We can now order a recall when there is a reasonable probability that an article of food is adulterated or misbranded under certain sections of the Federal Food, Drug, and Cosmetic Act and there is also a reasonable probability that the articles of food will cause serious adverse health consequences or death to people or animals. 

We also have the authority to administratively detain a food or dietary supplement to prevent its distribution if the agency has reason to believe the product is adulterated or misbranded.

We invoked our recall authority and warned USPlabs that FDA might order it to stop distributing the involved OxyElite Pro dietary supplements if the company did not stop distribution on its own and conduct a voluntary recall. USPLabs agreed to voluntarily recall the OxyElite Pro products and destroy all lots of the products, including remaining warehouse stock, which had an estimated value of $22 million. We will supervise the destruction of these products.

My colleagues and I will continue to use our new authorities, as appropriate, to make sure that the supplements you take will not put you in the hospital. We are committed to keeping you and your family safe, using every tool at our disposal.

Daniel Fabricant, Ph.D., is Director of FDA’s Division of Dietary Supplement Programs

We’re Partnering with Mexico to Keep Foods Safe

By: Michael R. Taylor 

En Español

Food safety is an issue that crosses borders. The reality of this global marketplace is that consumers, industry and governments worldwide are in this together. 

Deputy Commissioner Michael Taylor (on r) and Dr. Ricardo Cavazos, General Director of Economic and International Affairs at the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)

With that in mind, my team and I traveled to Mexico City on Oct. 29, 30 and 31 to discuss the rules that FDA has proposed this year to help ensure the safety of both domestic and imported foods. 

We said at the beginning of our efforts to implement the 2011 FDA Food Safety Modernization Act (FSMA) that we would send FDA delegations to Canada, Mexico, Europe and China to strengthen partnerships with officials there to help accomplish our safety goals. Working with our government partners in the U.S. and abroad is important in making sure that implementation is successful. This trip was the last of these journeys, and it was a great experience. 

Why is a partnership with Mexico important? Because it is one of the United States’ top trading partners. A lot of the produce we eat in the U.S. is grown there, including fruits and vegetables that would otherwise be hard to find in the winter months. 

What we learned in meetings with SENASICA and COFEPRIS – two key food safety agencies in the Mexican government – is that we’re all on the same page when it comes to food safety. We share with Enrique Sanchez Cruz, director general of SENASICA, Mikel Arriola, federal commissioner of COFEPRIS, and their able staffs a commitment to protect our citizens from the contaminated foods that cause so many preventable illnesses each year. 

And there is much we can do to help each other. For example, our counterparts in Mexico have a great deal of data to share based on microbiological sampling of foods and inspections. And, like us, they base their food-safety priorities on risk: What are the greatest potential hazards? We came away with a much deeper understanding of their work in this area. 

One of the key messages we got from our Mexican colleagues was that they are eager and committed to working with us to implement FSMA, and this motivates us to take our partnership to a new level. The benefits will be mutual, as FSMA and Mexico’s own food safety initiatives promise to elevate standards and improve practices on both sides of the border. 

At a public listening session on our FSMA proposals attended by representatives of major commodity groups, the sentiments were much the same. They want to be engaged with us in this important work. 

We envision partnerships with our foreign counterparts as being multi-faceted, including data sharing, recognition of inspection reports, multilateral sharing and acceptance of laboratory methods, and training of government and industry on U.S. food safety requirements, and where appropriate, cooperating under trade agreements. 

We know food safety is more a journey than a destination, and the road we are on with Mexico will have its bumps and seem long at times. But, thankfully, we are on the road together, and we will get there. 

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

Ensuring Safe Food and Medical Products: A Partnership with the Mekong Region

By: Margaret A. Hamburg, M.D.

Several years ago I had the opportunity to visit the Mekong Region of Southeast Asia, which includes the countries of Cambodia, Laos, Myanmar, Thailand and Vietnam. I was struck not only by its beauty, dynamism, and diversity, but also by the commitment of health officials there to building strong health systems and cooperating across borders in the face of potential health threats. I learned that by working together with each other and the United States they were able to build an effective rapid response to outbreaks of an emerging pathogen such as the H5N1 influenza virus.

Margaret Hamburg, M.D.I was reminded of my visit this week during my participation at a forum hosted by the Center for Strategic and International Studies entitled “U.S. Health Partnerships in the Mekong Region.” The day’s discussions highlighted the growing strategic importance of the region to the United States and the long-standing and ongoing partnerships between U.S. agencies and regional partners in health and development, including the central focus of the FDA, to ensure the safety of food and medical products in the United States.

Though Americans may not often think about it, the U.S. is increasingly and inextricably linked to the Mekong Region through global supply chains. For instance, about 15% of the seafood we consume in the United States comes from Mekong region countries, arriving on our shores and in our stores after a long and circuitous journey. Consider tuna, which may be caught in the South Pacific, transported to New Zealand for pre-canning, and shipped to Southeast Asia for canning before it finally makes its way to the East Coast of the United States for distribution in this country. 

Why does this matter to FDA? There is a greater likelihood that food will be exposed to pathogens, contaminants or chemical hazards during a journey of this complexity. That’s why we work closely with our regional counterparts in these countries through such organizations as the Association of Southeast Asian Nations (ASEAN) and the Asia Pacific Economic Cooperation (APEC), sharing with them our own regulatory requirements, our knowledge of good manufacturing practices and our laboratory and inspection techniques. Through such information sharing we believe we can prevent tainted or otherwise unsafe foods from reaching our borders. 

But the risk of potentially unsafe food from this area is not our only concern. A significant threat to human safety today involves substandard, falsified and counterfeit medical products that are part of the global supply chain. These products may contain toxic ingredients, or too much or too little of a drug’s active ingredient, and as a result patients could be poisoned or unwittingly receive inadequate treatment for their disease or even no treatment at all. In addition, if too many patients receive only partial treatment, it might foster the development of drug-resistant disease strains. And there’s this too: a high prevalence of substandard and falsified medicines ultimately will erode public trust in the health care system.

Unfortunately, statistics suggest that substandard and falsified products is a problem in the Mekong Region. A recent comprehensive review found that in Southeast Asia, 35 percent of anti-malarial drugs were substandard and 36 percent were counterfeit. And many of the countries in this region have porous borders and face challenges with regulatory oversight and enforcement practices that cannot adequately protect the supply chain. 

FDA is working with the World Health Organization to build a global monitoring system to monitor substandard, falsified and counterfeit medicines, and collaborating with countries in the region to develop and test the system. In addition to cooperating with our regulatory counterparts across the globe on issues of detection, investigation and enforcement, FDA scientists have developed the Counterfeit Detection Device, or CD-3, which can quickly screen for counterfeit products – not just drugs – at any location, including remote communities and border sites. With our international partners, we are currently planning to expand the use of this tool in several field settings, including in the Mekong region.

Building cooperation for this kind of enforcement is essential not just to ensuring the safety of our food and medical products, but as a means of advancing our national security objectives. That’s why meetings like the one I attended this week are so important. They support opportunities to work with our colleagues in the Mekong region on ways to share information and promote stronger, innovative regulatory systems that are critical to the long-term success of our global public health efforts.

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