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

Why FDA Should Oversee Laboratory Developed Tests

By: Peter Lurie, M.D., M.P.H.

Today FDA is issuing a report that illustrates the real and potential harms to patients and to public health from certain laboratory developed tests (LDTs) – tests that are designed, manufactured and used in a single laboratory.

Dr. Peter LurieWhen FDA first began regulating medical devices under the Medical Device Amendments in the 1970s, we chose not to enforce applicable regulatory requirements for LDTs because they were relatively simple tests generally confined to local labs, and often used for rare conditions.

But times have changed. LDTs have increased in complexity and availability and are now frequently used to diagnose common, serious medical conditions, including cancer and heart disease, with potentially greater impact on patients. And yet, LDTs are still under a general policy of enforcement discretion. That means they have rarely undergone FDA review to determine whether they are accurate, reliable, and provide clinically meaningful results. It also means that FDA’s own adverse event reporting databases rarely capture problems associated with a faulty LDT. Nevertheless, the Agency was able to pull together 20 case studies based on information available in the public domain that show how lack of LDT oversight may be causing or is causing significant harm to patients.

Some LDTs provide positive results even though the patient doesn’t have the disease. For example, a patient can receive a false positive result from a test that is supposed to determine whether someone has been infected with the bacteria that cause Lyme Disease. Patients may then undergo unnecessary treatments and potentially delay diagnosis of their true condition. Such false positives can be even more detrimental when the test is for ovarian cancer, which could prompt women to remove their ovaries.

The report cites other tests that may produce the opposite problem: false negatives. These tests may suggest that a patient doesn’t have a disease or condition, when in fact they do. That’s the case for a test for the gene mutation that makes an excess of human epidermal growth factor receptor 2 (HER2), which promotes the growth of breast cancer cells. Patients who express HER2 typically take drugs that target HER2, in addition to standard chemotherapy. The majority of tests used to detect HER2 protein or gene amplification are LDTs, but, at least in the past, approximately 20 percent of tests may have been inaccurate. That means that some breast cancer patients may not receive the best treatment when the test fails to detect high HER2 levels.

Noninvasive Prenatal Testing to detect a range of fetal chromosomal abnormalities is an example of testing that may result in either false negatives or false positives. Women with false-positive results may abort a normal pregnancy; women with false-negative results may deliver a child with an unanticipated genetic syndrome. The report also lists tests that have no clear relevance to the disease being tested and others that are based on disproven scientific concepts.

And the costs of this lack of oversight are staggering. We were able to derive an estimate of the public health cost for five of the 20 cited tests. For the CARE Clinical Autism Biomarkers Test alone (one of those cited in the report), FDA economists estimated a total public health cost of $66.1 million.

FDA has proposed to step up our oversight of LDTs. We issued a draft guidance last year which we’re currently working to finalize, that proposes to phase in enforcement of premarket review requirements for LDTs. FDA oversight would help ensure that tests are supported by rigorous evidence, that patients and health care providers can have confidence in the test results, and that LDTs have more scientifically accurate product labeling.

As this report demonstrates, strengthening FDA’s oversight over LDTs is critical to protect both patients and the public health.

Peter Lurie, M.D., M.P.H., is FDA’s Associate Commissioner for Public Health Strategy and Analysis

The Case for Quality: Working with Stakeholders to Improve the Safety of Medical Devices for Patients

By: Howard Sklamberg, J.D., Jeffrey Shuren, M.D., J.D., and Melinda K. Plaisier, M.S.W.

Howard Sklamberg

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

Across FDA, we are devoting tremendous effort, in collaboration with a variety of stakeholders, toward activities that drive–and increase–product and manufacturing quality. We believe quality can be quantified through close attention to data and consistent review and analysis of that data, which in turn can promote the practice and culture of quality within firms.

The metrics and assessment tools being developed are key parts of the Case for Quality (CfQ). We are working with a wide variety of stakeholders–including the medical device industry, patients, other governmental and academic colleagues, and payer/provider counterparts–to identify and promote practices that will result in higher quality devices.

The CfQ was launched in October 2011 following an in-depth review of device quality data and feedback from both FDA and industry stakeholders. FDA’s analysis flagged manufacturing quality risks and showed tremendous benefits for firms that drive quality organization-wide. They receive fewer complaints and internal investigations per batch of devices manufactured, often house smaller quality staffs, and have lower quality-related costs, compared with competitors.

Jeffrey Shuren

Jeffrey Shuren, M.D., J.D., Director of FDA’s Center for Devices and Radiological Health

In the four years since the conclusion of the analysis, FDA has continued to observe that the percentage of inspections calling for official action by FDA has remained static, with the same issues recurring frequently year after year. Given this observation, in addition to FDA inspecting device firms on a regular basis, we are thinking about other ways to support quality beyond inspections and traditional regulatory approaches.

FDA introduced the CfQ in an effort to help device manufacturers elevate their focus from the baseline requirements of compliance with regulations alone, and instead focus on predictive and proactive measures they can take independently to improve quality. CfQ also provides FDA the opportunity to change our approach to focus more on what matters most in assuring product and manufacturing quality and safety for patients.

The CfQ has three priorities for addressing the barriers that were identified:

  1. Focus on Quality. FDA and CfQ stakeholders consider compliance to be a baseline, and have shifted our focus increasingly to characteristics and practices that, when present in day-to-day device design and production, correlate to higher-quality outcomes. Through the CfQ, we are collaborating with internal and external customers to identify characteristics that are critical to the quality of a particular device. This will result in a shared understanding of product features and manufacturing processes most important to patient safety.
  2. Stakeholder engagement. FDA works closely with the device industry and a broad group of customers to collaborate on CfQ and solicit feedback. This effort recognizes the extraordinary impact that engagement and agreement among regulators, industry, patients, providers, and payers can have on device quality.
  3. Data transparency. FDA receives a broad array of quality-related data, including information from recalls and adverse event reports. To support device quality, FDA has made device data (except certain information that we are prevented by federal law and regulations from disclosing) available on open.fda.gov.
Melinda Plaisier

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

The outcomes of the CfQ will allow stakeholders to focus resources on activities with the greatest impact on assuring that patients and users receive high-quality devices. This effort brings together metrics, successful quality practices, and our partnerships with stakeholders to promote quality and excellence in the medical device industry. It reflects our commitment to ensuring that devices perform as intended, meeting FDA’s mission of protecting and promoting public health.

For more on the Case for Quality initiative, visit http://www.fda.gov/medicaldevices/deviceregulationandguidance/medicaldevicequalityandcompliance/ucm378185.htm.


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

Jeffrey Shuren, M.D., J.D., is Director of FDA’s Center for Devices and Radiological Health.

Melinda K. Plaisier, M.S.W., is FDA’s Associate Commissioner for Regulatory Affairs.

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

Want to Help the FDA? Become a Consumer Representative on an FDA Advisory Committee

By: CAPT Dornette Spell-LeSane, M.S.N., M.H.A., A.N.P.-B.C.

Have you ever wanted to be part of the food and drug regulatory process? Do you have a history of public interest or a passion for consumer advocacy? Do you have experience analyzing scientific data?

Dornette Spell-LeSaneIf you answered “Yes,” here’s your opportunity to become an advocate for consumers! The Food and Drug Administration continually seeks input from consumers on scientific and medical issues by including Consumer Representatives on Agency advisory committees.

Participation as a Consumer Representative requires a modest time commitment. Travel expenses are paid and representatives receive reasonable compensation.

Consumer Representatives serve as Special Government Employees on a committee for up to a four-year term. Committees meet 1-3 times annually for 1-2 days. All meetings are held in the Washington, D.C. area. Members receive per-diem and travel expenses and are paid at a GS-15/10 hourly rate for the days attending a meeting.

Consumer Representatives provide the perspective of consumers to advisory committees and do not represent their own personal expertise. Their role is to:

  • Represent the consumer perspective on issues and actions before the advisory committee;
  • Serve as a liaison between the committee and interested consumers, associations, coalitions, and consumer organizations; and,
  • Facilitate dialogue with the advisory committees on scientific issues that affect consumers.

To apply you must:

(1) Be an active participant in independent consumer- or community-based organizations or have a history of advocating for the public’s interest; and

(2) Demonstrate an ability to analyze scientific data and critique research design.

FDA’s Consumer Representatives are grass-roots advocates, organizers, policy makers, or leaders of organizations with an interest in a specific subject matter. We encourage all meeting the criteria to apply.

Individuals applying to be a Consumer Representative may nominate themselves or be nominated by an organization. Applications for membership are reviewed and individuals are selected for final nomination by their peers. The Consumer Nominating Organizations, called CNOs, whose objectives are to promote, encourage, and contribute to the advancement of consumer education and to the resolution of consumer problems, receive ballots and rank the nominated candidates. The individual with the highest number of votes is forwarded for final nomination and generally will be the consumer representative for the committee.

FDA utilizes a total of 50 advisory committees and panels to provide independent advice to the agency on a range of complex scientific and policy issues, and they are an important part of the agency’s decision-making processes.

Here is a list of our current and upcoming vacancies on FDA advisory committees:

Medical Device Panels:

Anesthesiology and Respiratory Therapy

Circulatory System

Molecular and Clinical Genetics

Dental Products

Hematology & Pathology

General and Plastic Surgery


General Hospital and Personal Use


Drugs Products Advisory Committees:

Dermatologic and Ophthalmic

Pharmaceutical Science & Clinical Pharmacology

Biological Products Advisory Committees:

Vaccines & Related Biological Products


Science Advisory Board to the Food and Drug Administration

Science Advisory Board to National Center for Toxicological Research (NCTR)

CAPT Dornette Spell-LeSane, M.S.N., M.H.A., A.N.P.-B.C., is Deputy Director of FDA’s Advisory Committee Oversight and Management Staff

The Merging of Medical Products: Enhancing review of therapeutic and diagnostic combination products

By: Robert M. Califf, M.D. and Jill Hartzler Warner, J.D.

Combination products – medical products that do not fit into the traditional categories of drugs, devices, or biological products – are a growing and important category of therapeutic and diagnostic products under FDA’s regulatory authority.

Robert Califf

Robert M. Califf, M.D., FDA’s Deputy Commissioner for Medical Products and Tobacco.

These products, that combine drugs, devices, and/or biological product (“constituent parts”) with one another, come in three configurations. The constituent parts may be physically or chemically combined, co-packaged, or separately distributed with specific labeling for their combined use.

Products in this category range from familiar products such as prefilled syringes and surgical kits to novel and innovative products, which target and enhance therapies. Examples of groundbreaking combination products include antibodies combined with drugs for targeted cancer therapy and products that mimic or replace organs, such as an artificial pancreas.

Combination products pose unique challenges – both because they may involve new, complex technologies – and because their review at FDA often involves the expertise of more than one Center.

While review of such products falls to a cross-center team of experts, it is led by the medical product Center responsible for the constituent part that provides the product’s primary mode of action, which, in the case of a syringe prefilled with a drug, for example, would be FDA’s Center for Drug Evaluation and Research.

Effective coordination among FDA staff, and between FDA and the company, is essential – and depends on identifying the proper experts across Centers, supporting processes for communication, and implementing systems for efficient data access and sharing.

Jill Warner

Jill Hartzler Warner, J.D., FDA’s Associate Commissioner for Special Medical Programs.

FDA’s Office of Combination Products (OCP), within the Office of Special Medical Programs, oversees and coordinates FDA’s regulation of combination products. This includes helping to resolve differences of opinion between Centers or with sponsors, developing guidance and regulations, and working with the medical product Centers to develop processes and policies..

Congress has expressed interest in FDA’s regulation of combination products as part of the 21st Century Cures legislative initiative, with one major theme being the assurance that the premarket review process runs smoothly.

While we already have policies and processes in place to address such issues, we know we can do more. To that end, we’ve recently conducted a focus group study with reviewers from the different Centers based on input from industry to assess how we’re doing. The report confirmed that differences in communication, policies, practices, systems and application types can be challenging when the Centers work together on a review of a combination product. The report also recommended actions to take, confirming the value of efforts already underway. Consistent with these findings, we’re taking a number of steps to clarify regulatory requirements and improve our internal processes and IT systems. It may sound a bit mundane, but doing this work could help us work more efficiently and avoid unnecessary surprises for sponsors. These steps include:

  • Issuing more guidance for review of combination products (e.g., our pending draft guidance document on human factors);
  • Enhancing and simplifying data access and sharing for internal staff;
  • Making it easier for staff to request and monitor inter-center consults;
  • Updating and maintaining our internal contact directory for experts to review a combination product; and
  • Improving our internal standard operating procedures for premarket reviews and compliance activities.

Some improvements are already in place and others will be coming this year and next. We continue to want to hear your ideas for enhancing how we work with you on combination products. We are listening — and excited to do our part by evaluating innovative combination products and helping to improve the well-being of patients by approving new safe and effective therapies.

Robert M. Califf, M.D., is FDA’s Deputy Commissioner for Medical Products and Tobacco.

Jill Hartzler Warner, J.D., is FDA’s Associate Commissioner for Special Medical Programs.

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.

Fresh Empire: FDA launches an Innovative Tobacco Public Education Campaign

By: Dr. Jonca Bull

Tobacco use can damage the body and lead to a range of diseases and conditions, such as cancer, heart disease, and respiratory illness. Unfortunately, the health burdens of tobacco use can disproportionately affect some minority communities.

Jonca BullI’m proud that FDA has recently launched a new tobacco public education campaign, “Fresh Empire.” “Fresh Empire” targets multicultural youth who identify with the hip-hop peer crowd – a hard-to-reach group that historically has been underserved by tobacco prevention campaigns. The aim of the campaign is to associate living tobacco-free with desirable hip-hop lifestyles through a variety of interactive marketing tactics including the use of traditional paid media, engagement through multiple digital platforms, and outreach at the local level.

While multicultural teens identify with multiple peer crowds, FDA is targeting youth who are at risk for tobacco use and who identify with the hip-hop peer crowd because research estimates that these youth are more likely to use tobacco than other youth.

Hip-hop culture encourages positive values, such as working hard to be successful and overcoming personal struggles, but at times it can also portray tobacco use as a desirable behavior. Additionally, by including tobacco use as part of lyrics and modeling the behavior in music videos and magazines, some hip-hop influencers help establish tobacco use as a peer-crowd norm. The “Fresh Empire” campaign seeks to break that norm – we want youth who identify with the hip-hop peer crowd to associate living tobacco-free as compatible with a hip-hop lifestyle.

An important pillar of hip-hop culture is remaining in control. However, because smoking represents a loss of control, tobacco use innately conflicts with the authentic hip-hop lifestyle. With the “Fresh Empire” campaign, we are asking teens to take control of their lives and choose to live tobacco-free. Most of the youth cast in the Fresh Empire ads are real teens and young adults who identify with this peer crowd and who, in many cases, have seen firsthand the damage that tobacco use has done in their communities. Take a look at some of the Fresh Empire ads.

The “Fresh Empire” campaign is another step we are taking towards making tobacco-related disease, disability, and death a part of America’s past, not its future.

Jonca Bull, M.D., is FDA’s Assistant Commissioner for Minority Health

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