Help Us Find Out Why Jerky Treats Are Making Pets Sick

By: Linda Tollefson, D.V.M. 

As a veterinarian and lover of animals, I find that working at FDA is a dream job in many ways. In the Foods and Veterinary Medicine program, there are veterinarians in many different jobs that all have to do with keeping both people and animals safe. 

Within the program, FDA’s Center for Veterinary Medicine (CVM) is a working testimonial to animals and their companion people. Desks and office doors are covered with photos of pets — dogs and cats of course, horses for sure, and even our favorite reptiles, birds, cows, pigs, sheep and a few great goats. Water cooler conversations are full of stories about the antics of our friends and family members (with and without fur, fins or feathers) and the challenges of caring for an aging animal. 

That’s why it means so much to us when we are able to target what is making an animal sick, and why it hurts, both personally and professionally, when the cause of illness eludes us despite global efforts to track it down. 

How to Report a Complaint about Jerky Pet Treats

As of September 24, 2013, over 3,600 dogs and 10 cats have reportedly become ill from eating jerky pet treats, nearly all of which were imported from China. While most pets have fully recovered, approximately 580 of these pets have died. The mystery that CVM is trying to solve is this: What is causing the reported illnesses and deaths in dogs (and some cats) that have eaten jerky pet treats made in China? 

The Center has been investigating these illnesses and deaths since 2007, working with experts in academia, industry, foreign governments and state labs. CVM’s Office of Research has been working with the Veterinary Laboratory Investigation and Response Network (Vet-LIRN), a consortium of animal health labs nationwide, to examine both animal diagnostic and tissue samples from pets that have become ill and the jerky pet treats themselves. 

Researchers in CVM labs, working together with other labs across the country, have tested jerky pet treats for microbiological contaminants, heavy metals and elements, pesticides, rodenticides, molds, antibiotics and other compounds. We’ve also analyzed hundreds of medical records and lab results, including examining and testing fluids and tissues of sickened pets. FDA inspection teams have visited manufacturing plants and suppliers in China and met with representatives from the Administration of Quality Supervision, Inspection and Quarantine (AQSIQ), the Chinese regulatory agency responsible for pet food, to discuss U.S. requirements for pet food safety. Jerky pet treats from pet owner’s homes have been tested and compared with store samples. We’ve even made our own jerky to try to duplicate the commercial process. 

So why don’t we know what exactly is causing these illnesses? We’re not sure, but we know that we need more information about the pets that are getting sick. In order to get that information, we need the help of pet owners and veterinarians. To that end, we have issued a “Dear Veterinarian” letter asking veterinary practitioners who treat animals they suspect may have been sickened by eating jerky treats to report these cases to CVM through the FDA Safety Reporting Portal right away so that we can suggest certain tests (and cover the cost of these tests in many cases) when appropriate. We are working with our partners in Vet-LIRN labs across the country to test urine, blood and tissue samples from ill pets that may have been sickened by jerky treats. This collaboration helps leverage our resources and pool scientific expertise for the greatest effect. 

Despite extensive media coverage of the illnesses associated with these products and our own outreach efforts including through the CVM web site, we know there are still pet owners who are unaware of this issue. In response, FDA has developed a Fact Sheet for pet owners that can be made available at veterinary hospitals, pet supply stores, other stores selling pet food, and anywhere pet owners visit. The Fact Sheet explains what symptoms to look for, how to contact your local FDA office, and the status of our jerky pet treat investigation so far. We hope that these tools will help prevent more pets from becoming sick and will provide us with the clues we need to crack the case. 

What we do know is that our pets bring joy to our lives. It’s our mission, both as public servants and animal lovers, to find – and eliminate – the cause of these illnesses. 

Linda Tollefson is Associate Commissioner for FDA’s Office of Foods and Veterinary Medicine

Salute to Science: FDA’s Student Poster Symposium

By: Margaret A. Hamburg, M.D.

Margaret Hamburg, M.D.For many people, the hot summer months in the nation’s capital mean a time to depart for the beach or other less humid destinations. But one of the events I look forward to each year takes place during the hottest days of summer, right here on FDA’s White Oak Campus just outside of Washington, DC. It’s when I get to participate in the annual Salute to Science Student Poster Symposium.  Each of the posters on display offers a detailed and stimulating summary of the approximately 100 projects undertaken by FDA student interns during their internships.

Now celebrating its 8th year, the internship program provides high school students, college undergraduates and even postgraduates with a great training ground for the next stage of their scientific education. Each intern takes on a hands-on research topic to pursue under the watchful eye of a scientific mentor from either FDA’s Center for Devices and Radiological Health (CDRH), the Center for Veterinary Medicine (CVM) or from the U.S. Air Force Wind Tunnel, which is located next door to our White Oak Campus.

As I looked over the posters and talked to the students about their projects, I was struck by their scientific sophistication as well as the remarkable range of topics addressed, ranging from a “virtual human head simulator,” which provides electrical stimulation that could be used to design novel neuro-prosthetic devices, optimize treatments, and assess the safety of medical devices such as MRIs, to the evaluation of a laser beam profile on optical properties of intraocular lens implants. The array of work demonstrated not only the promise of these students, but the breadth of scientific work undertaken here at FDA.

I was especially pleased to see so many young women participating in our internship program, given that women make up only 24 percent of the nation’s overall science and engineering workforce. The fact is, FDA is a welcoming place for female scientists and engineers; in addition to me, many of our top scientific positions are held by women.

This internship, and the Commissioner’s Fellowship Program for health care professionals, scientists, and engineers who may not have considered FDA in planning their career path, are helping to lay the groundwork for and train the next generation of FDA scientists.

They are part of our efforts to integrate strong science and research training requirements and programs, cultivate the expert institutional knowledge and innovation necessary to address gaps and challenges posed by novel products and areas, and continue to ensure safety and efficacy in the service of medicine and public health.

I am confident that the bright, creative, enthusiastic, and hard-working students who participated in FDA’s intern program will be part of the next generation of scientific leaders and innovators, and seeing their efforts gives me great hope for the future of this agency, and of the nation.

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

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

FDA Commissioner’s Global Health Lectureship: Focusing the Lens on Product Safety

By: Mary Lou Valdez

FDA is responsible for ensuring the safety and quality of tens of millions of foreign shipments of human food, animal feed, medical products and cosmetics that come into the United States every year. Many source countries are part of the developing world that is still forming its economic and industrial base. Thus, we have strong public health interests in making sure that the countries of origin have effective systems of regulatory oversight.

Strengthening the ability of developing countries to regulate their industries could also produce tremendous benefits for the health and quality of life of individuals and communities in those countries. Additionally, the development of stronger regulatory systems in other countries can bolster other U.S. government investments in public health, trade and economic development.  

To enhance FDA’s knowledge of global public health trends, the Office of International Programs launched The Commissioner’s Global Health Lectureship in 2010. The lectureship invites highly respected and recognized leaders in global health to speak to FDA staff, and help the agency explore its role as a public health agency of the 21st century and consider the critical functions of regulatory science and systems that contribute to improved public health. 

Participating thought leaders have included:

  • Julio Frenk, M.D., M.P.H., Ph.D., Dean of the Harvard School of Public Health
  • Margaret Chan, M.D., Director-General of the World Health Organization
  • Sir George Alleyne, M.D., Director Emeritus of the Pan American Health Organization
  • Maria Freire, Ph.D., former President of the Albert and Mary Lasker Foundation and now President of the Foundation for the National Institutes of Health
  • Nils Daulaire, M.D., M.P.H., Director of the Office of Global Affairs, U.S. Department of Health and Human Services
  • Trevor Mundel, M.D., President of the Global Health Program, Bill & Melinda Gates Foundation

These lectures have inspired FDA staff to remain vigilant in protecting U.S. consumers and patients from harmful products, and to take action globally. For example, following Dr. Chan’s lecture, FDA is working with WHO and its member states on a long-term strategy for strengthening the review of applications for new pharmaceutical products and vaccines.  

Similarly, as a result of Dr. Mundel’s lecture, FDA and the Gates Foundation have committed to developing key messages on the strengthening of regulatory systems that the foundation and the agency can consistently and collaboratively deliver to governments and public or private institutions. Here, the Gates Foundation, through its investments in product development partners, supports research and development of medical products to treat diseases affecting poor and vulnerable populations in developing countries. Strong regulatory systems are also essential to ensuring that these products meet science-based quality and safety standards before they are approved for sale, and can be monitored afterwards. The Gates Foundation recognizes the need for regulators to make informed decisions about what products enter their markets. 

Our Global Health Lectureship has provided—and with future speakers will continue to provide—opportunities for FDA staff to engage in issues in new and unique ways, changing the agency’s global lens as we work to expand the product safety net all over the world. To learn more about FDA’s global strategies, read the “Pathway to Global Product Safety and Quality.”     

Mary Lou Valdez is FDA’s Associate Commissioner for International Programs

 

U.S. and Canada Working Together To Provide Access to Needed Veterinary Drugs

en  français

By: Bernadette Dunham, D.V.M, Ph.D. and Murray M. Lumpkin, M.D., M.Sc.

Bernadette Dunham, D.V.M, Ph.D., Director of FDA’s Center for Veterinary Medicine

The first simultaneous review and approval of a veterinary drug by the United States and Canada marks a successful start to a collaboration aimed at providing quicker access to needed veterinary medicines. The collaboration is also intended to remove trade barriers and reduce costs for consumers, regulators and manufacturers.

Here’s the background: Last year, President Obama and Canada’s Prime Minister Stephen Harper announced the creation of the U.S.-Canada Regulatory Cooperation Council (RCC). The council’s goal is to better align several regulatory approaches, to remove duplicative requirements, and to better share regulatory resources.

Eliminating overlapping efforts is expected to result in reduced costs and more timely access to products while encouraging trade and investment.

Murray M. Lumpkin, M.D., M.Sc., FDA Commissioner's Senior Advisor and Representative for Global Issues

 

After the agreement to create the council was signed, one of the first projects was to have drug regulators in both countries simultaneously review the same effectiveness data for approval of Elanco’s new animal drug, Comfortis, used to kill fleas and prevent flea infestation in cats. That effort culminated in this week’s announcement that FDA’s Center for Veterinary Medicine and Health Canada’s Veterinary Drugs Directorate had simultaneously approved the drug.

Regulators in both countries have determined that several other veterinary drugs are also potentially eligible for simultaneous review by both countries under the RCC action plan.

 

Because of this successful initial collaboration, there is much potential opportunity going forward to continue to improve our review efficiency and the use of our review resources to improve access to safe and effective products on both sides of the border.

Bernadette Dunham, D.V.M, Ph.D., is Director of FDA’s Center for Veterinary Medicine.

Murray M. Lumpkin, M.D., M.Sc., is FDA Commissioner’s Senior Advisor and Representative for Global Issues.

 

Is it Something My Pet Ate?

By: Bernadette Dunham, D.V.M., Ph.D.

As a practicing veterinarian I saw first-hand that pets tend to eat odd things, from foreign objects such as stones, fish hooks or sewing needles with thread…to car antifreeze, sometimes with unfortunate outcomes. However, when it comes to the main staple of our pet’s nutritional diet we usually turn to commercially produced pet food that we reach for on the store shelves. 

Millions of pets consume pet food without any problems, but once in a while, as is the Bernadette Dunham, D.V.M., Ph.D.case with human food, bacteria or chemicals may contaminate pet food or pet treats and our pets may get ill. If you think your pet may have become ill from eating pet food or pet treats then I have some important steps for you to follow:

First, call your veterinarian! It is important that your pet receive prompt medical attention. Your veterinarian will most likely ask if your pet vomited, had diarrhea, or was acting lethargic and how soon any of these signs appeared after eating.

Second, while your veterinarian will tend to your pet’s condition, you or your veterinarian can help FDA’s Center for Veterinary Medicine (CVM) investigate your pet’s illness. You or your veterinarian can electronically report cases of animal illness associated with pet foods through the Safety Reporting Portal, or by calling the FDA Consumer Complaint Coordinators in your state.

But before you log-on or pick up the phone, here’s what we need to know:

  • What kind of pet do you have?  Is it a dog, cat, rabbit, fish, bird, or other species?
  • What is the age, weight, and breed of your pet? Is she pregnant or spayed? Is he neutered?
  • How much of the suspected pet food does your pet normally eat at each feeding — and how much has already been eaten from that package?
  • How long has your pet been eating the suspected pet food? Did the signs of illness appear following feeding a new or partially used container of the food?
  • How much of the product do you still have?
  • Also, did any other pets in your household eat the same product? Did they become ill too, or were they unaffected?
  • What other foods or treats does your pet eat?
  • Did your ill pet spend time outside unsupervised (back to they eat odd things) and why do you suspect the pet food caused the illness?
  • Does your pet have any current or previous health problems, and do you give your pet any other food, treats, dietary supplements, or drugs?

The condition of your pet is paramount to determining what happened and why, but also necessary is the information provided on the pet food package. If you transfer dry pet food into other containers for easier handling, please save the original packaging until the pet food has been consumed. FDA will want to know the exact name and the description of the product as it is stated on the label. The type of container such as box, bag, can, or pouch can be useful information as well.

FDA’s investigators will be looking for the lot number, which identifies in which plant your pet’s food was manufactured, and when. Is there a best by, best before, or an expiration date on the package? This, along with the UPC code, or bar code, and the net weight are facts useful to FDA’s investigators. It may also help for you to let us know when and where you purchased the pet food, and how the food was stored, prepared, and handled.

Pet owners should also call the pet food manufacturer to report a suspected pet food illness in their pet. The contact information will be printed on the package.

Like any scientific investigation, there are numerous questions to consider and your ability to provide the information to your veterinarian and to FDA’s CVM is most essential in helping to determine what happened. It is very much like putting on Sherlock Holmes’ thinking cap to solve a mystery.

FDA brings a multitude of resources to pet food investigations. As we evaluate the circumstances that led to your pet’s illness, a variety of FDA experts join forces to solve the puzzle. Investigators with expertise in proper manufacturing practices, plus food and feed safety, examine the manufacturing plants, warehouses and the trucks used for shipping the pet food. They are supported by scientists and other experts at FDA headquarters who can help them determine what might have caused a pet food or pet treat problem.

When a pet food is suspected of causing illness in animals, samples of the food might be sent to FDA laboratories and perhaps FDA’s Forensic Chemistry Center where scientists perform original research to identify any possible contaminants or other hazardous materials in the product.

In addition, CVM has established a veterinary response laboratory network (Vet-LRN), which assists in the investigation by examining samples from pets that have become ill. Vet-LRN works with your veterinarian and the collaborating network laboratories whenever clinical or tissue samples are needed to help diagnose the problem with the pet food.

FDA is committed to the health and well-being of your pet and by working together, you, your veterinarian, and FDA can not only respond to, but more importantly prevent any pet food-borne illness from happening again.  Thank you!

Dr. Bernadette Dunham is the Director of FDA’s Center for Veterinary Medicine

A Strategy to Keep Antimicrobials Effective

By: Michael R. Taylor, J.D.

Over the past century, few innovations have been as important to public health as the development and use of antimicrobial drugs to treat bacterial infections. They have been successfully used for more than 50 years to treat, control, and prevent diseases in both humans and animals. But over the years, while physicians, veterinarians, and the livestock industry have been putting these important medications to their many uses, we’ve also learned a critical lesson:  they have to be used judiciously to ensure they remain effective.

Michael R. Taylor, J.D.There are complex reasons for this development, including the overuse of antimicrobial drugs in human medicine – a problem FDA and the medical community are working to address. But we also know that an additional factor contributing to antimicrobial resistance is the use of medically important drugs for feed efficiency or growth promotion (so-called “production” uses) in food-producing animals. For the FDA, an agency that’s responsible for protecting the health of the public, this fact requires a response to help preserve the continued effectiveness of these drugs for both humans and animals.

So FDA has settled on a strategy to phase out production uses of medically important antimicrobials and provide that they be used only for targeted, FDA-approved animal health purposes under the supervision of a veterinarian. The important sea change that will enable us to implement this strategy efficiently and expeditiously has been the willingness of many drug companies, veterinarians and animal producers to work collaboratively with FDA to ensure that medically important antimicrobial drugs are used in food-producing animals only when necessary to ensure their health. Many animal producers already work in this way, and we look forward to working closely with the animal production community to make judicious use of antimicrobials standard practice throughout the industry.

In developing our strategy, FDA’s Center for Veterinary Medicine has consulted extensively with our colleagues at the U.S. Department of Agriculture, with the agricultural and veterinary communities, with the animal drug and feed industries, and with public health and consumer advocates. And, as a result of that work, we have released three documents that outline a collaborative approach to keeping antimicrobials effective by limiting their food animal use to specific medical needs.

First, we are publishing a final guidance for industry on The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals. This document establishes a framework for phasing out the use of these drugs for feed efficiency or growth promotion and phasing in veterinary consultation or oversight of their medical uses in food-producing animals.

Second, we are asking for public comments on a draft guidance to drug companies on how to revise their FDA-approved product labels for medically important antimicrobial drugs to no longer include use for feed efficiency or growth promotion, and include veterinary oversight or consultation.

And third, we are publishing a draft proposed regulation, also for public comment, to streamline and modernize the current regulation that governs veterinary authorization for the use of certain drugs in animal feed.

I know there will be those who question why we have not taken mandatory action to ban production uses of antimicrobials. The answer is that, with the willingness of drug companies and others in the animal production industry to collaborate in implementing our strategy, we can make changes more quickly than if we had to rely solely on a cumbersome regulatory process that would require us to seek change drug by drug, and labeled use by labeled use. Working together is how we will get good results in a timely manner.

In implementing our strategy, we want to avoid adverse impacts on animal health and disruptions to the agricultural industry. We anticipate that the phase out of production uses of antimicrobials and establishment of veterinary oversight of remaining ones will take three years. For that reason, in the draft guidance to drug companies we are proposing this timeframe for implementation. We intend to monitor progress after the three-year timeframe has elapsed to evaluate the rate of adoption of these changes. If progress is not what we expected, we will consider further action as warranted in accordance with existing provisions of the FD&C for addressing matters related to the safety of approved new animal drugs.

We know, and so do our colleagues at USDA, that change will be more challenging for small-scale and geographically remote animal producers. It will take time to ensure they have the veterinary support these changes will require and other technical assistance to adjust to the phase out. And we won’t forget about these unique needs.

Concerns about the use of antimicrobial drugs in humans and food-producing animals have been on FDA’s agenda for many years. We see the collaborative strategy we are announcing as a major step forward. It is designed to protect and promote the health of the American public while minimizing disruption to animal health and the animal agriculture industry. We look forward to the public’s comments and to the work ahead to achieve these important goals.

Mike Taylor is Deputy Commissioner for Foods at FDA

FDA: Reflection on 2011 and Looking Forward to 2012

By: Margaret A. Hamburg, M.D.

The beginning of a New Year is a wonderful time to reflect on the past year and to think about what lies ahead. While 2011 had its share of challenges for us at FDA, it was also a time of significant accomplishment. We are excited about the many opportunities that 2012 will bring to the Agency.

2011 began with the most sweeping reform of our food laws in more than 70 years. FSMA promises an even safer food supply than we enjoy today and a wonderful opportunity to help promote public health.  We also continued the hard work of implementing the Family Smoking Prevention and Tobacco Control Act.

Margaret Hamburg On the medical product front, there were a multitude of outstanding activities and advances.  Importantly, we renewed our focus on the importance of innovation, in our own work and in the products we are tasked to review.  This was also a remarkable year for innovative drug approvals.  During Fiscal Year 2011, the FDA approved 35 novel drugs, targeting diseases such as late-stage lung cancer, metastatic breast cancer, and hepatitis C.

We also worked to continually strengthen the science that guides our policies, including many important collaborations with key partners and stakeholders.  Even with all of our ongoing work, when crises came in 2011, we acted swiftly to protect the American people.  We also continued to strengthen our capacity to address one of the greatest challenges in this new century – our increasingly globalized world.  “Pathway to Global Product Safety and Quality”

In 2012, FDA will meet new and complex challenges and continue our work in implementing FSMA and the Tobacco Act, promoting advancements and innovation in medical products, and broadening our strategic globalization and regulatory science initiatives. We will be working closely with Congress and stakeholders to support the reauthorization of user fees for pharmaceutical products (PDUFA), and medical devices (MDUFA), as well as to authorize new user fees for generic drugs (GDUFA) and biosimilars.

I am confident, thanks to the dedication of the employees of the FDA, that we will continue to make invaluable contributions to the lives of you, the American people.

I wish you and your family a healthy and happy 2012.

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

FDA Voice

By: Margaret Hamburg, M.D.

I’d like to introduce you to FDA Voice – FDA’s newest communications vehicle designed to give you information from behind the scenes here at FDA, and in our own words.

FDA Voice is a new forum for us.  Although I am writing the first blog post, in the future you will see posts from a wide range of FDA officials and staff, including scientists and public health professionals, employed at headquarters here in the Washington DC area, across the United States, and in posts abroad in countries as far away as China and India.

Margaret HamburgThrough FDA Voice, we hope to give you insights on some of the most pressing public health issues of the day. For example, how does globalization affect the food that we eat? How is the pace of innovation affecting the availability of new medical treatments for you and your family? What does personalized medicine mean for me? And even, what is the latest on food safety for my pet?

I believe that providing a forum like this is especially important for an agency like FDA, where the products that we regulate are directly related to public health and the issues that we work on tend to be complex in nature. FDA Voice will give FDA employees the opportunity to go beneath the surface to tell you about what they are working on and how it impacts your life.

No matter which stakeholder group you consider yourself a member of – consumer, patient, medical professional, scientist, researcher, or industry – it is our hope that you will find this medium an unparalleled opportunity to get more details directly from the source, like details of an official trip, activities in the lab, or more background information about a policy issue or regulation.

You will find FDA Voice on our homepage – and you may notice some additional changes there today as well. We have given the homepage a cleaner look and feel – by updating the design and reducing the number of links on the page. We have been working hard to improve your experience at FDA.gov, and hope that the changes we have made will help you find the information you need as quickly and easily as possible.

As Americans living in the Information Age, we are always looking for new and better ways to communicate. I am glad that you decided to take time out of your day to stop by and read FDA Voice, and I hope you will make it part of your routine in the future.

On behalf of all of the employees at FDA, I wish you and your loved ones a very happy holiday season.

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