Why FDA Proposes an ‘Action Level’ for Arsenic in Apple Juice

By: Michael R. Taylor, J.D. 

FDA has always been—and will always be—committed to making sure that the food you eat is safe for you and your family. It’s a challenging job in today’s complex, global marketplace. 

One of those challenges can be summed up in one word: arsenic. This chemical element is found in the Earth’s crust. It’s everywhere in the environment and can be found in water, air and soil, in both organic and inorganic forms. Human activities also can introduce arsenic into the environment. That means that it can also be found in some foods and beverages. 

Today, FDA is acting to help ensure that consumers do not come in contact with apple juice that has levels of inorganic arsenic that exceed 10 parts per billion. That’s the same level that the Environmental Protection Agency (EPA) has set for drinking water, which is consumed in much greater quantities. 

FDA tests hundreds of foods and beverages for all kinds of potentially harmful substances, and we have been monitoring the levels of arsenic in foods for decades. Of the two forms of arsenic, we worry about the inorganic kind because long-term exposure can be harmful. 

The agency has always found that the amount of arsenic in apple juice is generally low—much lower, in fact, than the levels allowed in drinking water. Consumer Reports did an important story highlighting its own testing. And in 2011, we substantially increased testing and analysis of apple juice to continue and enhance our monitoring efforts. 

We found that our original belief was correct, that the levels of inorganic arsenic in apple juice are too low to cause immediate or short-term health damage. Working with colleagues in EPA, the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC), we then looked at potential risk from long-term exposure. 

That risk assessment helped lead us to the “action level” of 10 parts per billion. We believe that this action level will keep any apple juice that may have more inorganic arsenic than that out of the marketplace.  

We will continue to remain vigilant, work with the food industry, and take regulatory action when appropriate to minimize as much as we can the presence of arsenic and other unwanted contaminants in our food supply. 

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

Setting the Bar High for FDA

By: Margaret A. Hamburg, M.D.

Rick Pazdur receiving ASCO Public Service Award

Rick Pazdur, accompanied by Margaret Hamburg, receiving ASCO Public Service Award

To say that Rick Pazdur faces enormous challenges in his job is an understatement. To say that he faces each day with energy, insight and resolve still falls short of the mark.

It’s my privilege to tell you that the American Society of Clinical Oncology (ASCO) has awarded Dr. Pazdur with its prestigious Public Service Award for his dedication to improving the lives of people living with cancer.

As director of the Office of Hematology and Oncology Products (OHOP) at FDA, Dr. Pazdur leads a staff of more than 130 oncologists, toxicologists and other specialists.

Their mission is making safe and effective drugs for cancer and hematologic (blood-related) conditions available to the patients who need them. The office is committed to facilitating rapid development, review and action on promising new treatments for these diseases.

Dr. Pazdur sets the bar high. His demand for excellence in his staff as well as in the treatments they review is unparalleled. Ultimately, Dr .Pazdur and his staff must decide whether or not an investigational drug can be tested in a clinical trial and, after testing, be approved for more widespread use. Sometimes, after careful investigation, they conclude that a drug has not been proven effective enough to outweigh the potential risks. These are the types of challenges and the tough decisions that Dr. Pazdur faces on a daily basis. A man of personal integrity with great compassion for those who are ill, he nonetheless is  often the recipient of criticism from patients, advocacy groups, drug companies and others. I have heard him say ruefully, but with characteristic humor, that you can’t win in this job—that if he approves a drug, he’s accused of lowering standards.  And if he doesn’t, he is insensitive to the plight of patients with cancer. Nothing could be farther from the truth.

Since his arrival at FDA in 1999, Dr. Pazdur has worked tirelessly to speed the development and availability of drugs that treat serious diseases, especially when the drugs are the first available treatment or have advantages over existing therapies. He has made a special effort to reach out to patient and advocacy groups, professional associations and foreign regulatory agencies. In 2012, nearly 40 percent of the new molecular entities approved in the Center for Drug Evaluation and Research were to treat cancer, often when few therapeutic options previously existed.

Members of Dr. Pazdur’s staff speak with warmth and enthusiasm of his dedication to cancer patients and his unflagging efforts to streamline the drug approval process. They call him not just a manager, but “a visionary,” and “one of the most unique people I know.” I quite agree.

To one of the most dedicated and accomplished people I know: It’s a pleasure to work at your side, Dr. Pazdur. Congratulations for this well-deserved honor.

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

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

What Happens Behind the Scenes before You Receive Your Flu Vaccine

By: Maureen Hess, MPH, RD

You probably think about influenza once a year — during the winter months when flu season rolls in as it does every year. But, for FDA, it’s a year-round initiative; we are on the front lines of making sure there is an adequate supply of safe and effective vaccine every year. And even though the current flu season is just getting started, we are already making preparations for next year.

Woman getting flu shotVaccination is the single best way to prevent influenza. Influenza is a contagious respiratory disease caused by a number of different influenza viruses, infecting the nose, throat and lungs. Even if you are healthy, you can pass the influenza virus to someone else one day before symptoms begin, and, you can continue to infect others up to five days after getting sick. Therefore, it’s possible for a healthy person to unknowingly spread the virus.

Preparing for influenza season each year is a time-critical, highly orchestrated, collaborative effort by FDA, the Centers for Disease Control and Prevention (CDC), the World Health Organization (WHO), vaccine manufacturers, and the public health community.

FDA is at the center of the process. Working with the WHO and CDC to review disease surveillance and laboratory data, and with the input of our advisory committee, we select the three influenza strains for the vaccine that will be made available in the United States. Once the strains have been selected, work continues to get vaccine manufactured and distributed well before influenza season starts. We inspect the manufacturing facilities and we prepare and provide the reagents used by vaccine manufacturers to verify the vaccine’s identity and strength.

FDA also evaluates each manufacturer’s vaccine each year for approval and conducts lot release, that is, we perform certain tests and review the results of the manufacturers’ tests on the vaccines prior to vaccine distribution. And, we continue to monitor the safety of the vaccines once they are distributed and used to vaccinate the public. The manufacturing demands are tremendous, especially since a new vaccine must be  manufactured each year. And, this new vaccine contains not just one but three new vaccine components each year, specifically, the three strains of influenza virus within the seasonal vaccine: one influenza A (H3N2) virus, one influenza A (H1N1) virus, and one influenza B virus.

Why is FDA focused on influenza? Influenza seasons are unpredictable and present a serious public health issue. Vaccination is one of the most important ways to prevent influenza. Influenza can cause various symptoms, which may include fever, cough, sore throat, headache, body aches and chills and tiredness. And the disease can range from mild to serious: over a 30 year period between 1976 and 2006, estimates of seasonal influenza-associated deaths range from a low of about 3,000 to a high of about 49,000 people.

Vaccines to prevent seasonal influenza have a long and successful track record of safety and effectiveness in the United States. The vaccine won’t give you the flu, and not only should it protect you from getting sick, it can also make your illness milder if you are exposed to a different influenza virus strain that’s not included in the vaccine.

Have you gotten your flu vaccine? It’s not too late!

Maureen Hess, MPH, RD, is Health Science Advisor, Office of Vaccines Research and Review, in FDA’s Center for Biologics Evaluation and & Research