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

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

FDA Voice Interviews Jesse Goodman, M.D., M.P.H., on the DARPA and NIH Project Collaboration: Human on a Chip

FDA Voice: FDA has embarked on an exciting collaboration with the Defense Advanced Research Projects Agency (DARPA) and NIH—to develop a groundbreaking tool that could help bring new treatments to patients faster, more cheaply, and more safely. Can you talk about this new technology?

Dr. Goodman:  Yes, it’s what we’re calling Human on a Chip. This is an ambitious project to create a tool that could revolutionize toxicology testing and it’s something I’m really excited to talk about.  Scientists have relied largely on animal studies to determine if a drug is toxic before testing it in humans.  And while animal testing is useful, it’s also expensive, time consuming, and has drawbacks. For example, it doesn’t always detect toxic effects specific to humans and doesn’t usually provide information about the role that genetic differences within human populations play in toxicity. It can also generate false alarms, showing an effect in animals that doesn’t predict an actual effect in people, which leads us to abandon promising new drugs. FDA is collaborating with DARPA, NIH, and the scientific community to spur innovation in this field by exploring how tools like Human on a Chip can be integrated into our development tool box to improve testing for toxicity and potentially reduce the need for animal testing.

FDA Voice:  Can you describe Human on a Chip?

Dr. Goodman: Researchers are developing microsystems using human cells to test the effects of drugs or other substances. For example, scientists have developed a micro machine chip with human lung cells that grow on a surface to form a lung-like tissue that has both air spaces and blood circulation. FDA is supporting the coupling of this chip to a heart-like chip that beats and pumps blood. We can use this type of system to evaluate, with human cells, how specialized organs like the lung and heart react to a specific chemical.

The Human on a Chip builds on this approach. FDA’s collaboration with NIH and DARPA aims to create a 3D representation of 10 different human organ systems that mimic the processes and activities of those systems, potentially linking them to form a system with major features of human biology. For instance, in a living human, the interactions of heart, lung, kidney, and liver are crucial in the functioning of all 4 organs, and all are common targets of toxicity. A tool that creates and links organ-like systems will enable scientists to observe a substance’s effects on several interacting systems simultaneously. This can make it possible to test for beneficial effects as well as for toxicity. 

Once these systems are refined, if successful, they could not only improve testing beyond currently available tools, but could also be engineered to mimic disease states or be implanted with cells with a specific genetic background that is involved in specific diseases or drug interactions.

FDA Voice:  Why transform toxicology testing?

Dr. Goodman: Toxicity has been a major challenge in medical product development and in assessing environmental hazards. Technologies like Human on a Chip could help shrink the time frame it takes for new treatments to move to human testing and approval. These new tools can help identify toxicity earlier in product development, thus protecting patients, lowering development costs, and speeding new treatments to patients in need.

Human on a Chip could also contribute to developing medical countermeasures because the diseases and conditions we might need to treat in a public health emergency—like anthrax, smallpox, pandemic influenza, and radiation and toxin exposure—rarely occur naturally, often making animal models the only available tools for evaluating a new treatment’s effectiveness.

FDA Voice:  What makes FDA essential to this collaboration?

Dr. Goodman:  Our FDA scientists have vast experience using available tools to make tough scientific decisions about the safety and effectiveness of a multitude of products. They’ve seen what works and what doesn’t, and thus can provide insights and help solve challenges in defining how best to develop and evaluate new tools. Before accepting a new tool for use, FDA scientists must have the needed scientific data on how it performs to ensure that it is as safe and effective as possible. Once FDA accepts a scientific tool, industry can use it for its qualified purpose during product development.

FDA Voice:  In what other ways has FDA worked to drive innovation in toxicology testing?

Through the Critical Path and Advancing Regulatory Science initiatives, we are working to harness the use of new science and technology to transform regulatory science and help get needed products to people quickly and safely. FDA identified transforming toxicology as one of the eight priority areas where collaborative regulatory science research is essential and offers huge opportunities. In addition to Human on a Chip, FDA is collaborating with other Federal agencies, academia, and industry to bring new science to toxicology, such as on the cell-based Tox-21 project with EPA and NIH, and on FDA grants to evaluate cell-based approaches to evaluate risks of reproductive and developmental toxicity. 

My office has also formed a new FDA-wide council, together with scientists from across the agency, to explore, promote, and coordinate efforts concerning chemical and toxicology-related issues. FDA’s partnership throughout the development and evaluation cycle is critical to ensuring that exciting new tools and approaches like Human on a chip speed the delivery of safe and effective new treatments to people who need them.

Jesse L. Goodman, M.D., M.P.H., is FDA’s Chief Scientist and Deputy Commissioner for Science and Public Health