FDA 2015: A Look Back (and Ahead) – Part 3: Food, Tobacco, and Antimicrobial Resistance

By: Stephen M. Ostroff, M.D.

In my third and final post reflecting on FDA’s work to protect and promote public health in 2015, we’ll take a look at our achievements in food, antimicrobial resistance, and tobacco product regulation.

Acting FDA Commissioner, Stephen Ostroff, M.D.Modernizing Food Safety

In a groundbreaking development, in 2015 FDA took several major steps to prevent foodborne illness by finalizing five rules that will implement the landmark FDA Food Safety Modernization Act (FSMA).

In September, we issued the first two final FSMA rules mandating modern, preventive practices in both human and animal food facilities. They will help establish a food safety system in which industry systematically implements measures we know are effective in preventing contamination.

In November, we took another step toward modernizing our food-safety system by issuing the final produce safety rule and two import safety rules. For the first time, these new rules establish enforceable science-based safety standards for the growing and harvesting of produce and make importers accountable for conducting risk-based verification to determine that imported food meets U.S. safety standards. In addition, through this rulemaking we established a program for the accreditation of third-party certification bodies to conduct food safety audits of foreign food facilities.

Together, these rules are designed to reduce the burden of foodborne illness in the United States. They support the broad goal of the law to proactively prevent problems across the entire food system, and to strengthen food safety coordination with other nations that produce the foods that Americans consume.

Strengthening Nutrition, Protecting Health

2015 also saw important progress in the area of nutrition. We finalized our determination that partially hydrogenated oils, the primary dietary source of artificial trans fat in processed foods, are not generally recognized as safe (GRAS) for use in human food, a decision that will make an enormously positive difference in the health of Americans. We also are continuing to work to develop sodium reduction targets, which have the potential for major public health gains and cost savings to the health care system.

And late in 2014, we finalized two new rules requiring caloric information on restaurant menus and menu boards and on vending machines. These rules are designed to provide consumers with more information so they can make informed choices for themselves and their families, without placing an undue burden on small businesses or individual food establishments. We are working with industry to support implementation.

We also proposed additional changes to the familiar “Nutrition Facts” label on packaged foods which, when finalized, will give Americans updated nutrition information, reflecting the most current nutrition science, to help them make healthy choices when purchasing packaged foods. This includes a revision that would establish a Daily Reference Value for added sugars and require the percent Daily Value on the label. There is strong evidence healthy dietary patterns of intake associated with a decreased risk of cardiovascular disease are characterized, in part, by lower intakes of sugar-sweetened foods and beverages.

Combating Antibiotic Resistance

Another area in which we saw great progress in 2015, thanks to collaborative efforts across our government and with our international partners, was in combating antibiotic resistance. If left unchecked, this growing problem threatens to turn back the clock on decades of progress in infectious disease control and medical discoveries, drive health care costs higher, and increase human disease and death.

Early in 2015, the White House released the National Action Plan for Combating Antibiotic-resistant Bacteria, a plan that that recognizes that humans and animals share the same environment – and the same microbes – and so we must address the use of antibiotics in both.

One of the central principles for slowing the development of resistance – in both humans and animals – is the judicious use of antibiotics. For decades medically-important antibiotics have been used not only to treat sick animals, but to promote growth in healthy ones. The FDA has already made significant progress developing policies to promote appropriate use of antibiotics in animal health. For instance, we issued the Veterinary Feed Directive (VFD) final rule, an important part of our overall strategy because it promotes judicious use of medically important antimicrobials in feed for food-producing animals by bringing the use of these drugs under veterinary supervision.

But a critical part of combating resistance is to know the changing patterns and use of antibiotics in farming and how these changes impact resistance patterns among foodborne pathogens associated with farm animals. We are strengthening our data collection under the National Antimicrobial Resistance Monitoring Program in several ways, and in September we held a Public Meeting with several other federal agencies on data collection on farms. This and other work will help us to develop a more comprehensive and science-based understanding of antimicrobial drug use and resistance in animal agriculture and help us to measure the impact of our regulatory actions.

While the problem of antimicrobial resistance is finally getting the attention it warrants, it will require an ongoing and sustained effort to overcome the decades of neglect that led to the current situation.

Regulating Tobacco Products

Our newest area of regulatory oversight is one of our busiest. It’s hard to believe it was more than 50 years ago that the Surgeon General issued the first Report on Smoking and Health. But it’s been just six years since Congress passed the Tobacco Control Act, which gave FDA the authority to oversee the manufacture, marketing, distribution, and sale of regulated tobacco products and protect the public from their dangers.

We’ve already built a great deal on that foundation, creating our Center for Tobacco Products and establishing a framework for industry registration, product listing and submission of information on ingredients in tobacco products; implementing and enforcing a statutory ban on cigarettes with certain characterizing flavors; and restricting access and marketing of cigarettes and smokeless tobacco products to youth. We’ve also already begun to build a robust regulatory science program to conduct and fund science and research programs designed to help us better understand the risks associated with tobacco use.

After an extraordinary amount of study and research, and review of tens of thousands of public comments, FDA is preparing to publish the final rule to extend the agency’s authority over additional, unregulated tobacco products, such as e-cigarettes, cigars, hookah tobacco, and pipe tobacco. Like everything we do at FDA, this policy will be based on a thorough scientific evaluation of how individual products in each category may affect public health.

And in 2015, we unveiled a dynamic public education campaign designed to prevent and reduce tobacco use among at-risk African Americans, Hispanics, and Asian American/Pacific Islander youth age 12 to 17. This promising effort flows from our “Real Cost” campaign launched in 2014, which I’m pleased to note, won a gold “Effie Award” for effectiveness in advertising in the Disease Awareness and Education category.

It’s been a fruitful and productive year at the FDA. I am proud of all we have accomplished in 2015 and look forward to our continued progress.

Stephen M. Ostroff, M.D., is Acting Commissioner of Food and Drugs

FDA Enforcement: Protecting Consumers and Enhancing Public Confidence

By: Howard Sklamberg, J.D. and Michael R. Taylor, J.D.

Under the Federal Food, Drug, and Cosmetic Act, companies producing food, including dietary supplement products, for American consumers have a legal responsibility to make them safe. Most companies take this responsibility seriously. FDA will work collaboratively with companies that are making a good faith effort to produce safe products and meet regulatory requirements.

Howard Sklamberg

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

But when companies fail to meet their responsibility and violate the law in a way that jeopardizes public health, FDA can—and will—move decisively. This fall, for example, a federal court case in New Jersey illustrates the careful field work, close teamwork, and skillful investigation that are hallmarks of FDA criminal enforcement, which plays a vital role in food and dietary supplement safety.

The case involves Raw Deal, Inc., a manufacturer of dietary supplements based in Flanders, N.J. On September 9, Raw Deal’s owner and president, Barry Steinlight, pled guilty to one count of conspiracy to commit wire fraud involving a scheme to introduce adulterated and misbranded products into interstate commerce. Steinlight was sentenced to 40 months in prison and ordered to forfeit $1 million in profits from the fraudulent scheme.

Then, today the company’s former executive vice president, Catherine Palmer, was sentenced to a year’s probation and a criminal forfeiture of $100,000, after she pled guilty to obstructing an FDA investigation.

Last year, we wrote about federal-court convictions in the Peanut Corporation of America (PCA) case involving Salmonella-tainted peanuts and peanut products. In that case, two former officials of, and one broker for, PCA were prosecuted for practices that led to a deadly 46-state outbreak of Salmonella poisoning in 2009.

Michael R. Taylor

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

Today, we are highlighting the Raw Deal prosecution, which demonstrates our enforcement work in the dietary supplement field. The convictions arose from illegal practices by the firm, which included manufacturing adulterated and misbranded products by using fillers to cut costs, reusing returned and contaminated products, and falsifying batch records and certificates of analysis.

This story begins more than four years ago. Over the course of those years, FDA undertook a number of enforcement activities before criminal charges were filed by the U.S. Department of Justice:

  • In August 2011, FDA’s Office of Criminal Investigations (OCI), now headed by Director George Karavetsos, received an anonymous complaint that Raw Deal was manufacturing dietary supplements with fillers such as wheat-based products and the food additive Maltodextrin. The complainant also informed OCI that the manufacturer resold returned products that contained such contaminants as E. coli bacteria, lead and mold.
  • During the OCI investigation, FDA’s Office of Regulatory Affairs’ New Jersey District Office received four anonymous letters that described Raw Deal’s adulteration scheme, including the creation of false certificates of analysis.
  • The District Office conducted a compliance inspection and found that the manufacturer substituted ingredients without informing customers of the presence of fillers. As a result, the District Office issued Raw Deal a Warning Letter citing misbranding and adulteration violations.
  • OCI later determined that Raw Deal did not heed this warning and instead continued misbranding and adulterating its products. OCI then obtained and executed a search warrant at the manufacturing facility, with some of the samples collected subsequently revealing the presence of Salmonella, a bacterium frequently associated with foodborne illnesses.
  • This resulted in a Class I recall of certain Raw Deal products in March 2014. This recall classification means the products could cause serious health problems or death.

This case is just one example of FDA enforcement in action. Companies are given the opportunity to correct violations but if they don’t, there are serious consequences. Indeed, during the past two years, FDA criminal enforcement has resulted in 407 cases opened, 348 arrests, 305 convictions, and $694,131,579 in fines and restitutions.

Of note in this case is an excerpt from U.S District Court Judge Esther Salas’ remarks at Steinlight’s sentencing hearing:

“There is nothing more sacred than consumers having some peace of mind that people who are selling these supplements are doing it the right way, and are abiding by the laws and regulations that are put forth to protect the consumer…and my sentence has to be one that promotes respect for the law. Because what the FDA does is so critical…they are making sure that the products that we consume and the products that we use are safe for consumption, are safe for usage. And I am going to sentence you to a sentence, sir, that continues to give them the teeth they need, the power they need, to send a message to our society.”

Criminal enforcement actions protect consumers by punishing violators and deterring bad behavior by others. Strong enforcement helps industry too – by maintaining a level playing field for the production of safe foods and products.

FDA is strongly committed to working with companies that take their safety responsibilities seriously – and equally committed to dealing strongly with those that don’t.

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

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

Lessons Learned in Mexico about Food Safety – And Tomatoes

By: Stephen M. Ostroff, M.D.

En Español

As my colleagues at FDA can attest, I like to grow tomatoes in the summer. I often bring portions of the harvest to the office each week of the growing season. Though the total volume is modest, I still like to think of myself as an environmentally conscious and responsible “farmer.”

Group photo of FDA and Mexico Officials and Tomato Growers

From left to right:
Rafael Ávila Julio Mexico-SENASICA-Branch Chief)
Joaquín Rivera Quiroz (Mexico-SENASICA-International Affairs)
SENASICA staff member
Edmundo Garcia (FDA-Regional Director for Latin America)
Mary Lou Valdez (FDA-Associate Commissioner for International Programs)
Stephen Ostroff (FDA- Acting Commissioner)
Sandra Cruz (FDA- Assistant Regional Director for Latin America)
Silvia Rojas Villegas ( Mexico- SENASICA- Director for Food Safety, Aquaculture, and Fisheries)
Jorge Martínez Lambarry (Mexico- General Director Binatur Invernaderos)
Angel Covarrubias Domínguez (Mexico – SENASICA’s staff)
Selma Koekoek (Food Safety Manager – Binatur Invernaderos).

So I was glad to spend some time on food safety issues last month while in Mexico attending the 10th International Summit of Heads of Medicines Regulatory Agencies. In addition to summit activities, I spent time with FDA staff in our Latin America Office and with our regulatory counterparts in Mexico charged with keeping foods safe. In the process, I gained a new appreciation for the partnership we have with Mexico to enhance food safety and to minimize the potential for contamination of fresh produce.

Which brings me back to tomatoes.

Representatives of the Mexican National Service for Agro-Alimentary Public Health, Safety and Quality (SENASICA) accompanied me and other FDA staff on a tour of Bionatur Invernaderos de Mexico, a state-of-the-art tomato-growing operation located in Jocotitlan Estado de Mexico, about 75 miles outside of Mexico City.

While most people think of growing tomatoes as an activity that requires soil, tomatoes can also grow using an alternative substrate and the addition of water, sunshine, and nutrient solutions. Bionatur Inveraderos is among the largest users of this technology, known as hydroponics, in the world. It’s an enormous, state-of-the-art operation, with eight 25-acre greenhouses on the 200-acre farm. And the results are very impressive, with row after row of enormous plants that dwarf my back-deck efforts.

Hydroponic tomatoes

Rows of tomatoes at Bionatur Invernaderos de Mexico, a state-of-the-art tomato-growing operation located in Jocotitlan Estado de Mexico, about 75 miles outside of Mexico City.

For me, there’s a real value to FDA visiting farms of all kinds to see first-hand the importance growers place on producing safe fruits and vegetables and the pride they have in their work, no matter what the size of the operation. Just as in the United States, produce is grown on all different kinds of farms in Mexico, from those using the latest technology to traditional operations that have been in hard-working families for generations. What the U.S. and Mexico also have in common is our mutual commitment to the safety of produce grown on our nations’ farms, which is especially important as the food supply continues to become more global.

For example, while the United States is a leading producer of tomatoes, Mexico is currently the 10th largest in the world. And in the last decade, tomato trade between the U.S. and Mexico has grown considerably — and is likely to continue to expand as global supply chains further diversify.

In light of these trends, assuring the safety of these imports is paramount. That’s why we work closely with our Mexican food safety counterparts: SENASICA and the Federal Commission for the Protection of Sanitary Risk (also known as COFEPRIS). Last year, our three agencies signed The Produce Safety Partnership, which specifically aims to promote the safety of fresh and minimally processed agricultural products in both countries.

SENASICA has a voluntary Risk Reduction System for Contamination (SRRC) program to ensure that fruits and vegetables grown in Mexico are produced in optimal sanitary conditions to reduce the risk of contamination.

Food safety requires everyone’s participation — including farms, facilities, regulatory agencies, and consumers. As we implement the FDA Food Safety Modernization Act (FSMA), we are working closely with our Mexican regulatory counterparts, as well as other nations and international stakeholders, to make sure that they have the understanding, information, and training necessary to meet these important new food safety standards.

FDA’s Latin America Office, with staff located in San Jose, Costa Rica; Santiago, Chile; and Mexico City, will be instrumental in this FSMA outreach as we rely heavily on the Latin American region to ensure the availability of fresh produce year round.

Two FSMA rules that became final this month are particularly important to Mexican farmers growing produce destined for American consumers. The Produce Safety rule establishes science-based safety standards for both domestic produce farms and those in other countries that export to the U.S. And the Foreign Supplier Verification Programs (FSVP) rule requires importers to ensure that their foreign suppliers meet U. S. safety standards.

It is clear to me that Mexico also shares another quality with the U.S. and other nations: It has the academic capital and capacity to engage in both high tech and traditional farming, and to successfully meet these new safety standards designed to prevent foodborne illness.

While there are differences in our systems, technologies, and environments, the U.S. and Mexico both want consumers to be confident in the safety of their food. By working together, we can achieve that goal.

Stephen M. Ostroff, M.D., is Acting Commissioner of Food and Drugs

A Mother’s Loss, an Advocate’s Example, Fuel Our Mission to Keep Foods Safe

By: Michael R. Taylor

For the many people in government, and elsewhere, who have been working on implementation of the FDA Food Safety Modernization Act (FSMA), this has been a week for reflection, celebration, and anticipation. I got to experience all three in the 24 hours I spent this week at the 2015 Food Safety Consortium in Schaumberg, Illinois.

Michael R. TaylorTuesday night I joined the many friends and supporters of the public health organization STOP Foodborne Illness in honoring Nancy Donley for her 22 years of ‎relentless advocacy for improving food safety. She is driven by the memory of her 6-year-old son Alex, who suffered greatly before he died in 1993 after eating a hamburger contaminated with E. coli O157:H7.

This was a time for reflection. Nancy and the many others in the STOP network who have shared their excruciating stories of pain and loss have made it simply unacceptable for those producing food to do anything less than their best to prevent these tragedies from happening.

Nancy, as much as any single person, has catalyzed fundamental change in our food safety culture toward making food safety a central business value for food companies and shifting government oversight toward a model that ensures accountability for minimizing contamination by pathogens.

Nancy has inspired me and many others to see food safety as the deeply personal, primary value it is, and to act accordingly.‎

STOP also honored Walmart’s Frank Yiannas as a STOP Food Safety Hero for his pioneering work to define and instill food safety culture as a primary value in the food industry.

Reflections on Nancy’s and Frank’s contributions are the backdrop for a bit of celebration. Not because the culture change Nancy inspires and the food safety success we seek are complete — far from it. But we are on our way.

The three FSMA rules FDA issued last week to improve produce safety and strengthen oversight of imports, coupled with the preventive controls rules we finalized in September, create a powerful and comprehensive new framework for the prevention of foodborne illness. This framework will be completed next year with final rules on food transport and intentional adulteration. The rules are the product of enormous effort by teams of FDA experts and by the many government, industry and consumer partners whose input has been so important in shaping the rules.

At the conference Wednesday morning, I shared some of these reflections and the sense of celebration and gratitude we are experiencing at FDA. I got some positive nods and no push back, but it was clear that the food safety professionals at this gathering are focused on the future, anticipating the challenges and changes FSMA will bring.

So are we at FDA. We see challenges galore, but also a huge opportunity to fulfill a vision that Nancy and STOP rightfully insist be the guide for our food safety work and our food safety culture.

Food safety is a primary value for many in the food system. It must be so for all.

Science-based prevention is the organizing principle for many food production systems. It must be for all. 

And a spirit of common cause and collaboration on food safety, which has begun to take root in so many positive ways, must be the foundation for all the work ahead to successfully implement FSMA.

So, this week, let’s celebrate where we are as we anticipate and build the future.

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

Forging the Path Forward toward Global Food Safety

By: Camille Brewer, M.S., R.D., Donald Prater, D.V.M., and Leigh Verbois, Ph.D.

Camille Brewer

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

These are exciting times for global food safety. In the last few years, China, Europe and the United States – three countries and regions of the world with complex food systems – have begun adopting sweeping modernization of their food safety laws and regulations. This is significant given these three countries together provide nearly half of the world’s foods!

China, Europe and the United States have a long history of partnering to help make sure that the food traded between us meets the robust food safety standards our consumers expect.

For many years, we’ve held regular meetings under our agreements with one another to talk through important issues affecting the safe production of both domestically consumed and internationally traded food.

Donald Prater

Donald Prater, D.V.M., Director of the Europe Office in the FDA’s Office of International Programs.

We’ve also worked together for decades in venues like the Codex Alimentarius Commission to set global standards for food safety. Up until now, discussions between us have largely happened with only two of our three governments in the room.

On November 2, our three countries and regions met in Beijing to take this cooperation to the next level within our more globalized food safety system. We discussed ways the three of us will work together as a group to improve the safety of the food products our countries manufacture and trade.

Leigh Verbois

Leigh Verbois, Ph.D., Director of the China Office in FDA’s Office of International Programs.

Our countries recognize that by gaining deeper knowledge about each other’s food safety systems and sharing timely information for better regulatory decisions and actions, we can move closer to the reality of global regulatory cooperation and alignment. We can also increase our confidence in the food we feed our families, whether it is produced in the United States, the European Union or China.

In the United States, the FDA recently rolled out the first two final rules to implement the landmark FDA Food Safety Modernization Act (FSMA) of 2011, and will release additional final rules this month.

In 2015, China updated its China Food Safety Law of 2009 to better clarify regulatory responsibility, increase penalties for the adulteration of food making it unsafe to eat, emphasize industry accountability, and improve traceability of food supply chains. In 2014, the European Union rolled out Smarter Rules for Safer Food, regulations that streamline the legal framework for food safety.

Trilateral Meeting

Participants representing the U.S., China, and Europe meet to discuss how the three countries and regions will collaborate and cooperate to improve food safety.

With China, the EU and the United States in agreement on our food safety collaboration, we will begin taking action! A first step is setting a meaningful agenda for a meeting before the summer of 2016.

We will be engaging food safety experts and focusing on closer cooperation through technical and scientific exchanges or workshops. These workshops will bring together experts to discuss food safety challenges.

Trilateral handshake photo

From L-R: Mr. Michael Scannell, Director of Food & Veterinary Office, Directorate-General Health and Food Safety-European Commission; Dr. Leigh Verbois, Director of the China Office, United States Food and Drug Administration; and Mr. BI Kexin, Deputy Director-General for Import and Export Food Safety Bureau (AQSIQ) – People’s Republic of China, shake hands at the conclusion of the meeting.

Among the many topics to consider are our respective new food safety laws and regulations, approaches to preventing food safety hazards during manufacturing, and the importance of recordkeeping.

Through collaboration with our Chinese and European colleagues, the FDA will develop a better understanding of our various approaches to keeping food safe.

This type of common understanding is essential in our increasingly globalized world since food safety knows no borders.

 

 

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

Donald Prater, D.V.M., is Director of the Europe Office in the FDA’s Office of International Programs

Leigh Verbois, Ph.D., is the Director of the China Office in FDA’s Office of International Programs

Traveling to the Heartland to Discuss Antimicrobial Resistance

By: Michael R. Taylor

One of the great privileges and pleasures of my job is getting to see the food system at work. Whether it’s a big cereal manufacturer in Minnesota, a small New England produce operator, or, most recently, a Midwest cattle feeding operation, I always learn something new, and I get to meet people who are working hard to put food on our tables.

Michael R. TaylorLast month, I traveled with some FDA colleagues to Kansas at the invitation of U.S. Sen. Jerry Moran to learn about the practicalities of beef production, including how animal drugs are being used and managed. Senator Moran, who goes by “Jerry” back home and clearly enjoys being there, graciously accompanied us the whole day. We had a great experience.

For starters, to paraphrase Dorothy, when you spend a day in Kansas, you know you’re not in Washington any more. It’s partly the famous Midwestern friendliness, which we encountered at every turn as we walked the Kansas State campus, toured the K-State College of Veterinary Medicine, and visited Great Bend Feeding, Inc.

But it’s also the tangible presence of the land itself and people who for generations have built small communities on the foundation of agriculture and food production. These are folks who live and work far from Washington, and who often view Washington skeptically, but with whom we have a common cause in providing Americans the safest possible food supply.

FDA’s Center for Veterinary Medicine (CVM) regulates the safety and effectiveness of drugs for both food animals and our pets. When it comes to food animals, this includes ensuring that the meat, milk or eggs do not contain any unsafe drug residues. But it also includes minimizing the risk of antimicrobial resistance, which is a natural biological response to the use of antibiotics, whether in human medicine or in animal production. The public health problem occurs when drugs we rely on to treat human infections are rendered ineffective.

FDA is addressing this problem through an initiative that, by December 2016, will make illegal the use of medically important antibiotics for animal production purposes – such as growth promotion – and bring remaining uses for legitimate animal health purposes under veterinary supervision. CVM’s Dr. Bill Flynn, who is leading this initiative, was my partner on our trip to Kansas.

Kansas Cattle

Cattle on the Great Bend Feeding land in Kansas.

Kansas is a leading beef producer and our trip gave us an opportunity for us to see first-hand the work being done to manage antibiotic use and the real challenges that exist so that together we can find the most practical and effective ways to ensure that these drugs are used judiciously to protect both animal and human health.

Our first stop was Kansas State University’s prestigious College of Veterinary Medicine in Manhattan. Dean Tammy Beckham joined us at the college, which prides itself on teaching, research and service to the community. We met with about 25 students involved in the care of all kinds of animals, from those found on farms, including horses and cows, to companion animals like dogs and cats. We saw a horse and cow being cared for and watched students examine, with great kindness, a tiny dog in a radiology laboratory using computer imaging technology.

We also visited the Veterinary Diagnostic Laboratory, which supports the college’s public role in animal agriculture by examining samples taken from ailing farm animals and helping determine the right treatment. We were joined for the day by Dr. Michael Apley, a professor in the college’s clinical sciences department and a newly appointed member of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria. As a researcher and educator who reaches out to the animal production industry, Dr. Apley is at the forefront of efforts to properly manage the use of antimicrobials in food animals.

With Dr. Apley, we drove for more than two hours through the scenic Kansas prairie to reach Great Bend Feeding, a mid-size feed yard with about 30,000 head of cattle. Manager Paul Woydziak is a native of the area and the facility is staffed by local people. This is their life and their livelihood, and they take the issues of food safety and animal health very seriously.

Their job is to optimize the growth of cattle with a custom feeding program, keeping them from 120 to 280 days before they are harvested to enter the food supply. The animals are fed three times a day with feed that is produced in a mill on the property and highly controlled in terms of quality and quantity. Modern day cowboys on horseback constantly patrol the dozens of large pens looking for signs of illness, with potentially sick animals immediately evaluated by a veterinarian.

There are lessons to be learned at farms and feed yards like Great Bend. It is critical that we identify and implement the best “stewardship” practices to ensure that medically important antimicrobials are used judiciously, including for preventing disease in the animals.

And we need solid data to ensure that our strategy to promote judicious use of antimicrobials is working. We were encouraged by the detailed system that was in place at the Great Bend operation for tracking animal health and drug use. Understanding how such information is monitored in actual animal production settings is important to our ongoing discussions about practical strategies for collecting data on antimicrobial use.

So it was a great trip, and we are grateful to Sen. Moran and all of the Kansans who were so generous with their time. Keeping food safe will always involve collaboration between the public and private sectors, and to build that collaboration there is no substitute for being there in person, seeing how our food is produced, and learning from the people who dedicate their lives to that work.

The food safety problem posed by antimicrobial resistance is one that we can solve, working together.

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

FDA Invests in Innovative Ways to Communicate to Hispanics

By: Gloria Sánchez-Contreras, M.A.

En Español

National Hispanic Heritage Month–celebrated annually from September 15 to October 15—gives Americans a great opportunity to celebrate the histories, cultures, and contributions of Hispanic Americans whose roots are in Spain, Mexico, the Caribbean, and Central and South America.

Gloria Sanchez-ContrerasAt FDA, we join in this celebration as we continue to use innovative ways to reach Hispanics as part of our mission to protect the public health. To achieve this goal, FDA uses media strategies that are culturally and linguistically tailored to Hispanics, who, according to research, are avid users of online and social media.

There are 54 million people of Hispanic origin in the United States, making them the nation’s largest ethnic or racial minority group, with 17 percent of the nation’s total population, according to the U.S. Census Bureau. The United States has the second-largest population of Spanish-speaking residents in the world, ahead of Colombia and Spain, and second to Mexico, a recent study by the Instituto Cervantes shows.

These statistics cannot go unnoticed. FDA recognizes the importance of connecting with this growing and diverse segment of our population. Consequently, we have increased our online consumer information in Spanish and developed a variety of bilingual communications strategies to reach and engage all Hispanics.

One of the most important strategies we use is to make sure that messages created for Hispanics speak to them effectively. We consider Hispanics’ informational needs, lifestyles, and cultural health beliefs both when creating new messaging and when translating messaging from English to Spanish.

For example, we know Hispanics respond better when communications are in their primary language – which can be English or Spanish – and when communications use images that relate to them. We do this by employing a bilingual and bicultural team that reviews messaging for cultural competence and adapts translations to ensure they are culturally sensitive and in plain language.

In addition to our English-language communications, we have developed strategies to reach out to Spanish-speaking Hispanics online. Our Consumer Updates and drug safety communications are regularly translated into Spanish. We share Spanish-language information through our social media channels, including Twitter, Facebook, Pinterest, and YouTube.

In addition, we also have a complete Web section in Spanish for consumers (www.FDA.gov/ArticulosConsumidor), a press room (“Comunicados de Prensa”), and a central page (www.FDA.gov/Espanol) that links to a variety of Spanish-language content developed across the Agency’s product centers and offices.

These are exciting times, and it is a privilege to lead some of these efforts for our agency. The Office of External Affairs works diligently across FDA to share important and timely public health news with Latino consumers, stakeholders, media, and community organizations. And during Hispanic Heritage Month—and all the months of the year–we want Hispanics to know that FDA is a trusted source of consumer information.

Gloria Sanchez-Contreras, M.A., is a Bilingual Public Affairs Specialist and the Spanish-Language Communications Lead in FDA’s Office of Media Affairs.

A Quarter Century of Groundbreaking Science: The Forensic Chemistry Center

By: Stephen M. Ostroff, M.D.

This month marks the 25th anniversary of our Forensic Chemistry Center (FCC) in Cincinnati, Ohio. I recently joined former and current administrators and staff of this lab—one of FDA’s many incredible field laboratories—at an event celebrating this milestone.

Acting FDA Commissioner, Stephen Ostroff, M.D.One thing is clear: The last quarter-century has been a period of tremendous success at the FCC. FCC scientists use their scientific analysis and original research to investigate the physical and chemical characteristics and effects of adulterants on products regulated by the Agency, including chemical fingerprinting of poisons, glass, pharmaceuticals, food products and product packaging materials. By analyzing physical samples they can identify counterfeits, trace the origin of a pathogen or solve a crime.

In short, they are the CSI of FDA.

The commitment, expertise, and curiosity of FCC scientists have helped FDA overcome many scientific challenges, and made an extraordinary difference in the lives and safety of millions of Americans. Time and again the sophisticated analyses of puzzling substances by our scientists—often using innovative, esoteric methods, and groundbreaking research, along with the development of new processes and procedures—have made a critical difference in FDA’s ability to investigate and enforce–and protect the American public.

FCC Anniversary group photo

Former and current administrators and staff of the Forensic Chemistry Center (FCC) in Cincinnati, Ohio, at an event celebrating the 25th Anniversary. From left to right: Paul Norris, Director, Office of Regulatory Science; Steve Solomon, Deputy Associate Commissioner for Regulatory Affairs; Dr. Ostroff, Acting Commissioner of Food and Drugs; Phil Walsky, Deputy Director, Office of Criminal Investigations; Fred Fricke, former Director of FCC; and, Duane Satzger, Director of FCC.

FCC’s work has paved the way for passage of important laws, legal prosecutions, and consumer protection activities like recalls. And it has helped strengthen international relationships and advance international cooperation to ensure product quality and consumer safety.

Just a few highlights of FCC’s important efforts include:

  • In the 1990s, the lab supported some of FDA’s early work evaluating nicotine, which was recently cited in the proposed rule to deem additional tobacco products subject to the agency’s tobacco product authorities;
  • In 2001, after 22 people died in the Croatian Republic after receiving dialysis using certain devices, FCC’s analysis identified the presence of a toxic performance fluid in those devices that resulted in their recall by the manufacturers;
  • FCC investigated numerous illnesses and deaths of cats and dogs during 2007-8, which led to the determination that the pet food was adulterated with melamine and related compounds;
  • FCC’s investigation and analysis following the death of cattle in Washington State helped the FBI rule out the possibility that it was caused by terrorism;
  • Following the deaths of a number of infants in India who had been given the measles vaccine, FCC investigated the vaccine’s manufacturing process and discovered that the cause was not, as initially feared, a vaccine of poor quality. Instead the children had received pancuronium bromide, a muscle relaxant, which had been packaged in vials with similar size and shape to the vaccine, rather than the vaccine itself. This discovery was communicated to the Indian government, leading to a critical change in their immunization practices; and,
  • FCC developed a method for examining the sea animals impacted by the Deepwater Horizon oil spill, which helped determine when the seafood would be safe to consume.

It is an extraordinary record. And it’s meant so much to FDA—and the nation—over the past 25 years. But the anniversary and success of this one lab also underscores the remarkable work done by all of FDA’s laboratories across the country. These labs and the districts in which they are located are the critical front line eyes and ears of FDA. And they are the springboard for excellent science.

Good science is fundamental to the mission of FDA. We need it to make good regulatory decisions. It’s what the public expects and deserves. By being able to handle and apply the science of today and anticipate the science of tomorrow we can be more flexible and adaptive, and support innovation.

Having seen the impressive and important work our labs are doing, I’m more committed than ever of the need to invest in better facilities and the best support. We must maintain state-of-the-art laboratories and research facilities, and attract, hire, and retain the best scientists to work in them. First-rate regulatory science requires first-rate scientists working in first-rate facilities.

It’s why I’ve made this a priority for FDA. And why we will put it high on our list of subjects for discussion with Congress as they shape future budgets for the Agency.

The scientists in FDA’s field laboratories are among the unsung heroes of FDA’s work to protect the public health. So let me congratulate and thank those at the FCC and across FDA on the milestone occasion of the 25th anniversary of the Forensic Chemistry Center.

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

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