Getting to the CORE of Foodborne Illness

By: Kathleen Gensheimer, M.D., MPH

Peanut butter. Cantaloupe. Dog food. Tuna. Cheese.

Any of these products might show up on your weekly grocery list.

Each was found to be the source of a foodborne illness outbreak over the past two years.

In the first 17 months since it was launched in August 2011, FDA’s Coordinated Outbreak Response and Evaluation Network (CORE) evaluated 211 incidents of illnesses that were possibly related to FDA-regulated products. After careful analysis, 63 of those incidents were determined to indeed be related to FDA-regulated products and an active CORE response began with one goal: Stop the outbreak.

The highlights of CORE’s work are outlined in our new report entitled “FDA’s CORE: A Food Safety Network 2011-2012.”  As CORE’s director, I could say that I’m proud of what my team has accomplished. But that would be an understatement.

Every day, members of the CORE network at FDA, the Centers for Disease Control and Prevention and state and local agencies, are working to identify, stop and prevent outbreaks. Each outbreak is unique, and so are the results of each investigation. In many cases, though, the network is able to identify, trace and stop an outbreak in its tracks. Contaminated products are pulled out of distribution and removed from grocery store shelves—and hundreds of people may have been spared illness.

CORE introduced a whole new concept into FDA’s response to foodborne illness outbreaks. That is, not just to assemble a team of experts when an outbreak strikes, but to have a full-time, ongoing “core” staff of three teams—Signals and Surveillance, Response, and Post-Response—dedicated respectively to finding the outbreak, stopping the outbreak, and preventing the next outbreak.     

There’s a seamless passing of the baton, and it’s exciting, too. CORE is constantly changing and evolving. Every unique outbreak teaches us new lessons we can apply to the next.

In very short order, CORE proved that FDA could work in close and vital partnership with a huge cast of supporting characters across the country, an extended network of experts from regulatory, public health, agricultural agencies and laboratory staff at the federal, state and local levels. CORE also proved that these partnerships would pay off.

We learn lessons about the science of illness and how it spreads, about the role manufacturers or farmers or packagers or a host of others play. We learn new ways to collect and then crunch the data, and new ways to apply it. We build new relationships and extend our network of experts across the country.

Most importantly, we see first-hand the health hazards that could develop and—if we do our jobs right—we learn how to minimize the chance that they will develop.

So we’re not simply responding to the outbreak. In the intricate chain from farm, to manufacturer, to shipper, to grocer, to your kitchen table, we’re finding ways to help prevent foodborne illness from ever harming you and your family.

Kathleen Gensheimer, M.D., MPH, is Chief Medical Officer and FDA’s Director of Outbreak Investigation and Response

FDA’s Rusty Katz Honored for Research on Alzheimer’s

By: Bob Temple, M.D.

Bob Temple, M.D. is Deputy Director for Clinical Science in FDA’s Center for Drug Evaluation and Research

Bob Temple, M.D.

Alzheimer’s disease is one of America’s most pressing and rapidly growing public health problems.

Therefore I announce with great pride and respect that one of FDA’s leaders in the field of Alzheimer’s disease research and drug development has been nationally recognized for his contributions to combating this progressive and debilitating disease. I cannot think of a more deserving individual than Dr. Russell Katz, “Rusty” to us, to be so honored.

At its recent National Alzheimer’s Dinner, the Alzheimer’s Association awarded Rusty the Ronald and Nancy Reagan Research Award, which honors researchers who are leading the way in promising and innovative approaches to Alzheimer’s treatment, prevention and care. He joins a distinguished list of past honorees from the Mayo Clinic, University of Virginia, Johns Hopkins University School of Medicine, Harvard Medical School, and many other outstanding organizations.

Dr. Katz first joined FDA in 1983. Today, he is director of FDA’s Division of Neurology Products, the division that reviews and approves drugs for neurological conditions, including those for patients with Alzheimer’s disease.

One in eight older Americans suffers from Alzheimer’s disease (AD), the sixth-leading cause of death in the United States. As Rusty has noted, “The aging of the baby boomers is fueling what could turn a public health problem into a public health crisis.” If no treatments are developed to prevent, cure or slow the progression of AD, the number of Americans suffering from this pernicious disease will grow from 5.4 million to as many as 16 million by 2050, according to estimates by the Alzheimer’s Association.

Dr. Katz has been a critical figure in the advancement of research and drug development for Alzheimer’s disease, building strong partnerships in the Alzheimer’s community and strengthening the science needed to evaluate the safety and effectiveness of potential new drugs.

He has been particularly instrumental in helping drug developers focus on ways to study drugs in the early stages of AD, and when there is hope that disease progression can be stopped or delayed before too much damage is done. With his colleagues he drafted an FDA “guidance” on conducting studies in early stages of AD. It addresses difficult questions, such as these: how do we select patients for clinical trials for early-stage AD drugs despite the fact that early stages of the disease are hard to diagnose? And how can we determine the effectiveness of a drug for early-onset AD when symptoms are difficult to define?

FDA is devoted to seeing new treatments for AD enter the development pipeline. No one has been more instrumental in helping to implement that vision than Dr. Katz. We thank him for his dedication and hard work, and along with the Alzheimer’s Association, applaud him for all that he does to advance public health.

Bob Temple, M.D., is Deputy Director for Clinical Science in FDA’s Center for Drug Evaluation and Research.

FDA Counterfeit Detector to Aid Battle Against Malaria

By: Deborah M. Autor, Esq. and Melinda K. Plaisier

Deborah M. Autor

Somewhere right now, malaria patients facing a life-threatening illness are being treated with counterfeit or substandard anti-malarial drugs, including falsified products, that threaten their recovery and can contribute to drug resistance. We are proud to announce the Food and Drug Administration’s launch of a partnership that will use a clever, innovative tool invented by FDA scientists to quickly and cheaply test suspect counterfeit or substandard anti-malarial drugs, including falsified products. The partnership will test the effectiveness of this hand-held, battery-operated tool, called Counterfeit Detection Device, Version 3, or, simply, CD-3. It will be deployed first in Ghana and then, after data is collected, in a second testing region.

This effort, which we hope will expand worldwide, is aimed at catching products that both deprive people of critical, life-saving help and add to disease burden because substandard doses can lead to drug resistant strains of the malarial parasite.

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

Melinda K. Plaisier

Malaria kills more than a 660,000 people each year, mostly children. It is most prevalent in Africa and Southeast Asia. In Southeast Asia and sub-Saharan Africa, more than a third of anti-malaria drugs are counterfeit or substandard, and a recent review indicates that number might be as high as two-thirds.

CD-3 is the brainchild of FDA scientists Nicola Ranieri and Mark Witkowski of FDA’s Forensic Chemistry Center (FCC), who recognized that since substances have unique responses to light, they might be able to develop a portable tool that could identify counterfeits on the spot, even in remote locations. As the initial tool has undergone a number of revisions, capabilities have been added, applications have been developed, and CD-3 has become a more powerful tool. From prototypes, scientists at FCC built a number of CD-3s, which are currently being used in the U.S. at ports and international mail centers, and during criminal investigations at the FCC.

To gear up for a global deployment strategy, FDA has separately signed a letter of intent with Corning, Inc., to optimize the tool, using information gathered from the studies in Ghana and the second testing region. FDA is hopeful that the improved tool will eventually be manufactured for use around the world.

The CD-3 tool contains a library of information about authentic drugs and the packaging they come in. It allows the user to compare authentic images of a product with the suspect product, instantaneously showing clear differences between suspect and authentic products that would not have been clear to the naked eye.

The Unites States Pharmacopeia, with funding through the U.S. Agency for International Development and the President’s Malaria Initiative, currently conducts drug surveillance programs at the test sites where CD-3 will be tested. FDA is providing ten CD-3s in the first test, and technical support will be provided by the Centers for Disease Control and Prevention and the National Institutes of Health. The non-profit Skoll Global Threats Fund is providing additional funding for the initial testing in Ghana.

We are thrilled about these developments and proud of this important, multi-sector collaboration and our highly dedicated staff who are making it possible. It is a credit to them, to our partners, and to all of FDA, that they are able to bring this innovative solution to such a significant global public health problem.

To learn more watch the CD-3 video below and read the Consumer Update: FDA Invention Fights Counterfeit Malaria Drugs

Deborah M. Autor, Esq., is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy

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

High-Tech Methods to Monitor High-Tech Devices

By: William Maisel, M.D., M.P.H.

Whether they are inserted into the human body to repair organs and joints or used outside the body to test and treat injuries and disease, medical devices in our high-tech world can seem miraculous.

William Maisel, M.D., M.P.H.But while they can help the lame to walk, make damaged hearts beat and even, in a recent innovation, help the blind with a rare disease to actually perceive some images and movement, they are not always perfect.

Before most medical devices are allowed on the market, the U.S. Food and Drug Administration works intensively with manufacturers to analyze and review their scientific and technical data on the device. But not everything can be known about a device before it is marketed. That’s why it’s important to have a robust post-market system to collect data on how well medical devices work for patients once they have been marketed. While our current monitoring system is working well, we have proposed updates that rely in part on new technologies to collect better quality and more timely data.

These updates will combine new technologies with a reporting system that expands the engagement of both health professionals and patients in identifying problems, and is intended to more quickly and accurately identify problems as devices are used by a larger number of patients. At the same time, information from our updated system can help new devices get to patients who need them as quickly as possible.

These updates include:

  • A Unique Device Identification system: As proposed, a unique device identifier (UDI) is an alphanumeric and automatically identifiable code that would have to be assigned to every device model, unless exempt, and appear on their label and package. Once available, the UDI will allow rapid and precise responses to a reported problem while avoiding unnecessary responses. Data from the UDI might be able to pinpoint the source of a safety problem to a specific model, avoiding broader recalls of similar devices and even preventing unnecessary surgeries to remove a device that although similar, may not be the actual source of the problem.
  • The MedWatcher mobile application (app). This app allows medical device users to easily report suspected or known problems with a device from their smartphone or tablet. Manufacturers and health care facilities will continue to be required to report problems through the Medical Devices Reporting System and the Medical Product Safety Network.
  • A new planning board, which includes stakeholders outside the FDA, to facilitate the creation of a sustainable, integrated medical device post-market surveillance system; and
  • Medical device registries for selected medical devices.

All of these updates are tailored to protect the privacy of patients, and they can be accomplished under existing FDA authorities. They were developed in consultation with patient groups, academic experts, health care professionals and device makers.

Rapid technological advances are creating increasingly complex devices. We are determined to keep up, and believe this enhanced system will help us protect patients while making sure they can take advantage of life-saving and life-enhancing devices.

William H. Maisel, M.D., M.P.H., is Deputy Director for Science and Chief Scientist at FDA’s Center for Devices and Radiological Health

Help FDA Help Patients Have a Bigger Voice

By: Margaret A. Hamburg, M.D.

Get Informed. Get Involved. Help FDA Help Patients Have a Bigger Voice.  That’s the slogan of a new FDA web site that I’m excited to announce today. The FDA Patient Network has been designed from the ground up to focus entirely on patients.

Margaret Hamburg, M.D.FDA has long been developing ways to increase patients’ interest and participation in the agency’s work, and in the policies and decisions that affect them.

Since the early 1990s, FDA has been working directly with patients and patient advocates to help them learn more about how medical products are developed and regulated. Patient representatives participate in FDA advisory meetings, and contribute the important perspective of their patient community. When patients better understand the intricacies of how medical products are studied, reviewed, assessed and brought to market, their input will be that much more focused and valuable. We hope, with the launch of this new web site, to expand the role of patients beyond the select group of patient representatives and to engage a wider audience of patients in new and broader ways.

The FDA Patient Network web site is an interactive tool for educating patients, patient advocates, and consumers on how their medications – both prescription and over-the-counter ­–and medical devices move from the realm of idea to the realm of the marketplace. It brings together, in one place, information that is important to patients, making it easier for them to find what they are looking for and to understand the significance of their findings.

This web site will open new channels of communication with the public, such as live chats with senior agency officials. It will help patients and consumers better understand the process for determining whether medical products are safe and effective and encourage them to contribute their ideas and concerns about the development and regulation of these products.

I am excited because this new Patient Network web site provides a new model for FDA to follow in making its inner workings transparent to the public. It ushers in a new era of access and input for patients and consumers that will evolve with the needs of both communities. I encourage you to explore the new site at PatientNetwork.FDA.gov.

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

Watch this video to learn more about FDA’s Patient Network initiative:

FDA’s Criminal Enforcement Priorities Protecting Public Health

By: John Roth

Although perhaps not widely known, FDA’s Office of Criminal Investigations (OCI) is an integral part of FDA’s mission to protect the public’s health.  FDA’s team of top-flight federal agents – who have the same type of arrest authority as other federal law enforcement agents – gives the FDA unique fact-finding tools and provides for strong, industry-wide deterrence. Their work is different from, but enhances, the regulatory work typically conducted by inspectors and investigators that makes up the bulk of FDA’s field operations.

OCI focuses its efforts on threats to the public health in four areas: we investigate criminals who can’t be reached by the rest of FDA, particularly in the area of counterfeit and unapproved medical products; we move against public health problems when our ordinary regulatory tools aren’t the best option; we seek criminal penalties against conduct in which the harm to the public is so grievous that a criminal response is appropriate; and we investigate lying to the FDA and other behavior that deprives the FDA of its ability to regulate. We have a variety of tools at our disposal to accomplish our mission, including felony charges under the Federal Food, Drug, and Cosmetic Act, misdemeanor prosecutions of responsible corporate officers, and prosecutions for fraud, money laundering and obstruction of justice.

It’s a big job.  FDA regulation affects more than 20 cents of every consumer dollar spent on products in the U.S. And the fact is, some conduct by individuals and entities is beyond the reach of FDA’s typical administrative and civil enforcement tools. This conduct includes rogue internet pharmacies, purveyors in grey and black market unapproved medicines, and counterfeiters, both in the United States and overseas. Individuals intent on defrauding an unsuspecting public are often part of a larger organized criminal enterprise and don’t respond to the normal FDA regulatory process. They are engaged in a crime, and as a result the FDA treats it as a crime, and that’s where OCI steps in. 

The case of Shengyang Zhou is a good example. In January 2010, the FDA became aware of counterfeit versions of the popular weight loss drug Alli being distributed in the United States, and warned consumers about its dangers. The counterfeit product had entered the legitimate supply chain lacking the active ingredient contained in the genuine Alli and, especially alarming, contained undeclared amounts of the drug sibutramine, which is no longer sold in the United States because of concerns over its association with increased heart attacks and strokes. OCI agents had initiated a criminal investigation after intercepting unapproved dietary supplements laced with sibutramine and phenolphthalein that had been shipped from China to an individual in Colorado. This seizure ultimately led to OCI agents developing an undercover operation against a Chinese counterfeiter, Shengyang “Tom” Zhou. Posing as buyers, OCI Special Agents met with Zhou in Bangkok and negotiated a sale of counterfeit drugs to be shipped to the United States. During the undercover operation, Zhou bragged that he had a factory in southwest China that could make thousands of boxes of weight-loss products per day. Zhou was ultimately arrested, pled guilty, and was sentenced to 87 months’ imprisonment.  Evidence presented at Zhou’s sentencing included a physician who had unsuspectingly taken the counterfeit Alli and suffered a stroke.

Admittedly, not all our work is this interesting and dramatic. But this is a good example of the truly remarkable skills – from technological and scientific, to the intangible personal skills of working undercover overseas – that our agents bring to the task. In a future blog, I’ll explain our work when ordinary regulation is insufficient and when we move against people who lie to the FDA, which prevents the Agency from doing its regulatory job. Some may not be as colorful as the example above – but all will show the key role of OCI in furthering the FDA mission in protecting the public health. 

John Roth is the Director of FDA’s Office of Criminal Investigations

 

 

The Science of Abuse-Deterrence – Progress Toward Creating Safer Opioids

By: Douglas C. Throckmorton, M.D.

Since the 1990’s, extended-release and high-potency opioids have been on the U.S. market, providing a new option to help the treatment of pain. Unfortunately, while these pain relievers often have provided tremendous relief for many, their abuse has reached epidemic levels in the U.S., with devastating consequences to families and patients.

Douglas C. Throckmorton, M.D.Over the years, FDA has worked diligently with many partners to address this crisis, while also working to ensure that patients in pain have appropriate access to opioid pain relievers.

One important step towards the goal of creating safer opioids, and one that is a high public health priority for FDA, is to encourage the development of formulations of these drugs that deter their abuse.

Today we’ve announced two actions that signal progress in the battle against the abuse of opioid drugs. First, we approved updated labeling for Purdue Pharma’s reformulated version of OxyContin extended-release (ER) tablets. The new labeling describes the product’s abuse-deterrent properties. These physical and chemical properties make it more difficult to crush, break, or dissolve the tablets. These properties are expected to make abuse by injection difficult and to reduce abuse by snorting. This is the first time we have approved such language in opioid drug labeling, and we made this determination after carefully reviewing the available science.

Our other action today was determining that the original formulation of OxyContin ER, which Purdue Pharma stopped shipping in August 2010, was removed from the market for reasons of safety or effectiveness. This finding is important because it means that FDA will not accept or approve any generic forms of the original OxyContin ER.

In making these decisions, FDA was focused on the relatively-new science of abuse deterrence in which the analytical, clinical, and statistical methods for evaluating these technologies are rapidly evolving. Our decision was grounded in the best available science. To guide drug development in this new field, FDA also issued a draft guidance for industry in January, announcing a flexible, adaptive approach to encourage the development of abuse-deterrent opioids. We believe such products have promise to help reduce prescription drug abuse and improve public health.

In the guidance, we describe four categories of abuse deterrence studies and lay out the kinds of labeling language we would consider approving, depending on the scientific data available. And because the science of abuse deterrence is evolving, we’re encouraging feedback and further development in this area, to help speed progress.

Moving forward, FDA will review every application on its own merits, based on applicable scientific and legal standards, and encourage an ongoing dialogue with manufacturers as they consider developing abuse deterrent opioid analgesic products. In addition to scientific rigor, flexibility is essential to encourage innovation, and, in essence, we’ll let manufacturers know where we want them to go, but not prescribe how exactly to get there. Our general goal, overall, is to encourage development of abuse-deterrent opioid products.

Today’s actions are significant components in a much larger effort to address prescription opioid abuse. We will continue to engage with the many groups active in this area – advocacy organizations, patients and family members, Congress, healthcare providers, and other federal government partners. Reducing the tragic toll of opioid abuse in the U.S. depends on this vital collaboration.

Douglas C. Throckmorton, M.D., is FDA’s Deputy Director for Regulatory Programs in the Center for Drug Evaluation and Research.

Proactive Inspections Further Highlight Need for New Authorities for Pharmacy Compounding

By: Margaret A. Hamburg, M.D.

Ever since the recent fungal meningitis outbreak tragically took so many lives and injured so many others, we have been very clear that we all must act aggressively to help make sure nothing like this ever happens again. Last month I wrote in FDAVoice about the legislation and resources we believe are urgently needed to effectively oversee the evolving compounding pharmacy industry.

Margaret Hamburg, M.D.Above all, patient safety is our greatest priority. In addition to working with Congress and other stakeholders on legislation, we also have been very focused on evaluating our current surveillance and enforcement approach to compounding pharmacies and are using our existing, yet limited, authorities more effectively to protect consumers.

FDA has continued to conduct for-cause inspections upon receiving reports or complaints about serious adverse events related to drugs made by compounding pharmacies, or when states have requested our assistance.

And in coordination with state officials from around the country, we have just recently completed proactive inspections of 31 firms that are known to have produced sterile drugs in the past. We identified these firms using a risk-based model that included factors such as serious adverse event reports, historical inspection data, and reports of product quality problems. The inspections specifically focused on each firm’s processing of sterile drugs to identify firms that may pose a higher risk of producing contaminated sterile products. A summary of these inspections can be found on our website.

During the course of both our proactive and reactive inspections over the past few months, we observed concerning sterility practices, inappropriate conditions for sterile processing and other practices that create risk of contamination. As of this week, we have issued to all but one pharmacy that we inspected an inspection observation report (called an FDA Form 483, or just a “483”) that lists objectionable conditions observed at the facilities. The one firm not receiving a FDA Form 483 was not producing sterile drugs.  

As noted on some of these 483s, select FDA observations during the inspections include:  unidentified black particles floating in vials of supposedly sterile medicine; rust and mold in “clean rooms” where sterile injectable medications were produced; technicians handling supposedly sterile products with bare hands; and employees wearing non-sterile lab coats.

In part, due to FDA’s inspectional observations noted during the inspections, several firms have voluntarily recalled their products, and others temporarily suspended production of their products intended to be sterile while they correct deficiencies found by the investigators.

It may surprise some people to know that, even in light of the recent tragic events, some of the firms we inspect still challenge our authority to conduct full inspections of their facilities. Our inspections have been delayed or the inspectors were denied full access to records at some of these facilities. At least four of our recent inspections were delayed by such resistance; and in two other instances, we had to get administrative warrants from the courts, resulting in U.S. marshals accompanying FDA inspectors back to the firms so FDA could complete the inspection. These challenges and others highlight the need for clearer authorities for FDA to efficiently protect public health.

Additionally, these inspectional observations reveal that there continues to be reason for concern about sterility deficiencies and other problems in some compounding pharmacies across the country – problems that could potentially affect the health of patients. To carry out this proactive inspection effort, FDA had to shift resources from other areas, and this is not a sustainable approach for the longer term. 

We are committed to working with the states, industry and Congress to put the necessary protections in place, but we need to act quickly. And we will continue to work tirelessly on this issue. Patients deserve nothing less.

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

FDA Collaborates with Mexico to Improve Food-Safety Testing

By: Carl Sciacchitano

En Español

FDA and public health officials in Mexico are working together to increase the capacity and capabilities of laboratories used to test the safety of foods.

In January, 2012, FDA scientists met with Mexico’s National Service of Health, Food Safety and Agro-Alimentary Quality (SENASICA) officials to better understand laboratory operations, practices, methods and quality assurance. Our scientists were also able to visit the SENASICA laboratories and discuss opportunities that would enhance laboratory collaboration and capacity building efforts. 

FDA’s 2011 special report, “Pathway to Global Product Safety and Quality,” states that the agency will partner with nations around the world to enhance global product safety and quality. Additionally, FDA recently released its International Food Safety Capacity-Building Plan that addresses both the acceptance of laboratory methods across the international community and the exchange of information on current and new laboratory methods.

In Mexico, the key objectives of this FDA/SENASICA collaboration include improving communications and laboratory capacity, consulting with SENASICA on the development, validation and implementation of testing methods, and participation in proficiency programs.

To reach our joint goals, the FDA/SENASICA Laboratory Capacity Collaboration Program (LCCP) has been established to enhance our collective ability to strengthen laboratory capacity and capabilities in effective and sustainable ways. 

LCCP participation includes our experts from FDA’s Office of International Programs in Mexico City, Office of Regulatory Affairs (ORA), and Center for Food Safety and Applied Nutrition (CFSAN). Working with representatives from the SENASICA National Laboratories, these experts formed a cohesive unit and prioritized key leveraging opportunities to enhance public health through the LCCP. Highlights of LCCP’s work include:

  • In March 2012, FDA’s Northeast Regional Laboratory (NRL) hosted a Mexican delegation of laboratory experts representing SENASICA’s three main laboratories. NRL provided an overview of FDA’s food testing laboratory, highlighting microbiological and chemical (food and drug) disciplines. NRL scientists shared methods currently used by FDA for the analysis of microbiological and chemical contaminants in foods under FDA’s jurisdiction. A portion of the visit was devoted to discussion and observation of the equipment, laboratory environment and methods used to perform these analyses. Communication channels were created to enhance collaboration.   
  • This effort between FDA and SENASICA scientists was very timely as SENASICA is pursuing efforts to strengthen its laboratory infrastructure for microbiological testing.  The information shared by our FDA scientists directly impacted SENASICA’s early thinking and understanding, resulting in the development of a state-of-the art microbiological testing laboratory. This laboratory will monitor the safety conditions of food during production, processing and packaging through the microbiological analysis of water, fresh produce (fruits and vegetables) and environmental samples of risk areas. In December 2012, we participated in the laboratory opening ceremony in Mexico City. The opening of this laboratory highlights the success of the LCCP efforts.  
  • Mexico’s Sinaloa state lab and FDA provided a training course for SENASICA microbiologists in December 2012 on Pulse-Field-Gel-Electrophoresis (PFGE) and serological techniques. Both techniques are staple methods utilized for the identification and traceback of bacterial strains – critical information that often augments foodborne outbreak investigations. The course was held in SENASICA’s new pathogen detection laboratory.

In 2013, our governments’ goal is to build on the progress from 2012 to enhance public health protection. Sharing information on best laboratory practices and collaborative efforts in method development and validation studies headline some of our key objectives for 2013.

Carl Sciacchitano is a Senior Advisor for Scientific International Affairs in FDA’s Office of International Programs

Leave the Chocolate Out of Rover’s Celebrations

By: Bernadette Dunham, DVM, PhD, and Carmen Stamper, DVM

Holidays and chocolate seem to go together. For birthdays, anniversaries, Mother’s Day and many other holidays — chocolate is everywhere. But, there is someplace chocolate should never be, and that’s in your dog. Chocolate is toxic to dogs and can kill them. And since a lot of the chocolate treats might be the kids’, make sure to pass along the message to them to never give chocolate to Rover.

Here’s why chocolate is so dangerous for dogs:

Bernadette Dunham, DVM, PhD

Chocolate contains theobromine, a compound in the same family as caffeine.  In certain quantities, theobromine is toxic to dogs.  In general, the minimum toxic theobromine dose in dogs ranges from 46 to 68 milligrams/pound (mg/lb).  Half the dogs that consume 114 to 228 mg/lb or greater of theobromine will die. Lots of things can play a role in whether your dog will have a toxic reaction including the amount of chocolate your dog ate, your dog’s size, and whether your dog happens to be extra-sensitive to theobromine. One of the most important things in chocolate toxicity is the kind of chocolate your dog ate.  For instance:

  • Milk chocolate contains 44 mg of theobromine per oz.  (704 mg theobromine/lb milk chocolate)
  • Semisweet chocolate chips contain 150mg/oz. (2400 mg theobromine/lb semisweet chocolate)
  • Baking chocolate contains 390mg/oz. (6240 mg theobromine/lb baking chocolate)

Carmen Stamper, DVM

So, if we do the math, Rover is eyeing the ears and tail from a leftover chocolate bunny.  How much would he have to eat to get a 46 mg/lb dose of theobromine?  Depending on the type of chocolate, he’d have to eat:

  • 1 ounce per 1 pound of his body weight of milk chocolate bunny
  • 1 ounce per 3 pounds of his body weight of semisweet chocolate bunny, or
  • 1 ounce per 9 pounds of his body weight of baking chocolate bunny.

And, if Rover eats enough chocolate, he might show signs of chocolate toxicity:

Theobromine toxicity can cause a variety of signs ranging from mild to severe.  These signs can include vomiting, diarrhea, rapid heart rate, restlessness, hyperactivity, urinating more, muscle spasms and seizures.

If you think your dog has eaten chocolate call your veterinarian immediately! Only your veterinarian can determine the proper treatment for your pet.

Bernadette Dunham, DVM, PhD, is Director of FDA’s Center for Veterinary Medicine

Carmen Stamper, DVM, is on the Communication Staff of FDA’s Center for Veterinary Medicine