FDA’s 2015 Science Forum attracted more than 800 people from the scientific community. Here’s what some attendees said about the innovative research going on at the agency and why FDA can be a valuable collaborator in research aimed at transforming food safety and medical product development. If you couldn’t attend the FDA science forum, you can still see all the presentations on our web site.
By: Mary Lou Valdez
The FDA’s mission to ensure that food is safe and medical products are effective for use by U.S. consumers and patients is widely recognized.
A lesser-known fact is that the U.S. Department of Health and Human Services (HHS) employs more than 1,700 locally-employed (LE) staff in 60 countries to uphold its mission across five operating divisions, including FDA. Dr. Lixia Wang, a locally-employed staff member working for FDA in China, exemplifies the contributions of our LE staff and is the recipient of the annual HHS LE Staff of the Year Award.
China is a key supplier of goods imported to the U.S. The FDA has made significant regulatory in-roads since establishing its China post in 2008 and in many ways these are due to the contributions made by Dr. Wang and other LE staff in the world’s most populous country.
For example, Dr. Wang was essential in the negotiations of bilateral agreements for the placement of additional staff in China. With Dr. Wang’s contributions, FDA finalized these important agreements, which pave the way for FDA to more than triple its staff size in China. This move will bolster FDA’s work to protect and promote the health of consumers and patients in the U.S. and around the world.
Dr. Wang, who has served as Medical Research Scientist for FDA’s China Office since 2009, was cited for her central role in negotiations concerning the Implementing Arrangements with China’s Food and Drug Administration, and Implementing Arrangement Between the Food and Drug Administration and the General Administration of Quality Supervision, Inspection and Quarantine.
In addition, Dr. Wang has made significant contributions to the HHS mission in China since joining U.S. Embassy Beijing in 2006. From 2006 to 2009, she served as senior local staff in the Office of the HHS Health Attaché, and played a key role in strengthening U.S.-China collaboration on infectious disease.
During that time, she also supported the FDA response to emerging problems associated with melamine in dairy and pet products, and worked to address contaminated blood thinner sourced from China. She played a key role in the 2007 negotiations of binding agreements with the Chinese Government on the safety of FDA-regulated products, and on the opening of FDA’s first-ever overseas office in 2008.
FDA congratulates Dr. Wang, and takes pride in the recognition for excellence and commitment to global public health that she brings to FDA with this award.
Mary Lou Valdez is FDA’s Associate Commissioner for International Programs
Implementation of the FDA Food Safety Modernization Act (FSMA) involves people at all segments of the food supply chain, from farm to table. On April 23-24, 2015, FDA held a public meeting in Washington D.C. to discuss its plans to implement FSMA rules designed to build a food safety system that focuses on prevention and risk. The meeting drew hundreds of people in person and thousands joined the webcast. They included consumers, growers, manufacturers, importers, advocates, state and federal government officials, and representatives from other nations. And in this last of four video blogs, they share their insights on next steps as FDA moves from rule-making to implementation. (The first video is Voices of FSMA: The Road to Implementation; the second: Voices of FSMA: The Opportunities Ahead; the third: Voices of FSMA: The Challenges We Face.)
Implementation of the FDA Food Safety Modernization Act (FSMA) involves people at all segments of the food supply chain, from farm to table. On April 23-24, 2015, FDA held a public meeting in Washington D.C. to discuss its plans to implement FSMA rules designed to build a food safety system that focuses on prevention and risk. The meeting drew hundreds of people in person and thousands joined the webcast. They included consumers, growers, manufacturers, importers, advocates, state and federal government officials, and representatives from other nations. And in this third of four video blogs, they share their insights on the challenges ahead as FDA moves from rule-making to implementation. The next blog focuses on next steps. (The first video is Voices of FSMA: The Road to Implementation; the second: Voices of FSMA: The Opportunities Ahead; the fourth: Voices of FSMA: Moving Forward.)
Implementation of the FDA Food Safety Modernization Act (FSMA) involves people at all segments of the food supply chain, from farm to table. On April 23-24, 2015, FDA held a public meeting in Washington D.C. to discuss its plans to implement FSMA rules designed to build a food safety system that focuses on prevention and risk. The meeting drew hundreds of people in person and thousands joined the webcast. They included consumers, growers, manufacturers, importers, advocates, state and federal government officials, and representatives from other nations. And in this second of four video blogs, they share their insights on the opportunities that FSMA makes possible for the global food safety system. The next blogs focus on challenges and momentum. (The first video is Voices of FSMA: The Road to Implementation; the third: Voices of FSMA: The Challenges We Face; the fourth: Voices of FSMA: Moving Forward.)
Implementation of the FDA Food Safety Modernization Act (FSMA) involves people at all segments of the food supply chain, from farm to table. On April 23-24, 2015, FDA held a public meeting in Washington D.C. to discuss its plans to implement FSMA rules designed to build a food safety system that focuses on prevention and risk. The meeting drew hundreds of people in person and thousands joined the webcast. They included consumers, growers, manufacturers, importers, advocates, state and federal government officials, and representatives from other nations. This first of four video blogs focuses on the insights of FDA leaders. Over the next few weeks, the blogs will share the insights of FDA experts and other meeting participants, both in the government and the private sector, on the opportunities, challenges and momentum that FSMA presents. (The second video is Voices of FSMA: The Opportunities Ahead; the third: Voices of FSMA: The Challenges We Face; the fourth: Voices of FSMA: Moving Forward.)
By: Susan Mayne
FDA is taking a step today to remove artificial trans fat from the food supply. This action will save many thousands of lives.
PHOs or partially hydrogenated oils have been used as ingredients since the 1950s to improve the shelf-life of processed foods. FDA has issued a final determination that PHOs, the primary source of industrially-produced trans fat in processed foods, are not “Generally Recognized as Safe” or GRAS. This means that PHOs may no longer be added to food after June 18, 2018, unless they are otherwise approved by FDA.
In this case, it has become clear that what’s good for extending shelf-life is not equally good for extending human life. A 2002 report by the National Academy of Sciences’ Institute of Medicine found a direct correlation between intake of trans fat and increased levels of low density lipoprotein (LDL) cholesterol. LDL cholesterol is commonly known as “bad” cholesterol, because it contributes to clogged, damaged arteries.
What this means is that there is an increased risk of heart disease, so much so that this action is expected to reduce coronary heart disease and prevent thousands of fatal heart attacks each year.
In 2006, FDA required that manufacturers declare the amount of trans fat on the Nutrition Facts label because of these public health concerns. Many manufacturers responded by voluntarily changing their product formulations to reduce or eliminate trans fat, and consumers started avoiding foods with trans fat.
Despite the declines in trans fat in foods, PHOs have continued to be found in some brands of popular food products, such as frostings, microwave popcorn, packaged pies, frozen pizzas, stick margarines and coffee creamers. And for consumers who consistently choose products with added PHOs, their daily intake of industrially-produced trans fat is approximately twice as high as the average consumer. Today, FDA has issued its determination that PHOs are not generally recognized as safe.
We are establishing a three year compliance period. This will allow for an orderly process as companies make the transition — to reformulate products and if they choose, to allow companies or other interested parties to use the food additive petition process to present evidence to FDA as to whether any uses of PHOs meet our standard for safety. Thus, industry is responsible for providing evidence to FDA to demonstrate safety, while FDA is responsible for evaluating that evidence to determine whether to approve PHOs for any specific intended use.
We know that many companies have already removed PHOs and we expect that others will accelerate the phasing out of PHOs based on today’s action. FDA encourages consumers seeking to reduce trans fat intake to check the Nutrition Facts label for trans fat. The most effective way to avoid PHOs is to check the ingredient list for partially hydrogenated oils. Even if trans fat is listed as “0”, some PHOs could be in the product.
At the heart of FDA’s mission is a responsibility to ensure that the foods we eat, and share with our family, are as safe as possible. It’s a responsibility to protect health by taking action when needed, based on the best available science. This action will ultimately allow all of us to enjoy safer foods and healthier lives.
Susan Mayne, Ph.D., is the Director of FDA’s Center for Food Safety and Applied Nutrition
By: Lou Valdez, M.S.M.
For more than 30 years, FDA has enjoyed a robust partnership with our Canadian regulatory colleagues. In FDA, we are excited to build upon this relationship in Phase 2 of the U.S.–Canada Regulatory Cooperation Council (RCC).
The RCC was established in 2011 by U.S. President Barack Obama and Canadian Prime Minister Stephen Harper to develop smarter and more efficient and effective approaches to regulatory cooperation between the two countries. The RCC aims to bring the U.S. and Canadian regulators and stakeholders closer in terms of sharing information, combining expertise, eliminating duplicative work and creating an enabling environment to foster and facilitate ideas.
In Phase 1 of the RCC, our governments identified important regulatory issues to work together to improve. For example, as a result of the cooperation between FDA and Health Canada, we reduced the regulatory burden for industry through the development of the Common Electronic Submission Gateway (CESG). Led by our FDA Medical Product Centers, the CESG allows industry to simultaneously submit electronic applications to both FDA and Health Canada for pharmaceutical and biological products.
In Phase 2, over the next three years, FDA has committed to work with the Canadian Food Inspection Agency (CFIA) and Health Canada in the areas of:
- Food Safety
- Medical Devices
- Over-the-Counter Drug Products
- Pharmaceutical and Biological Products, and
- Veterinary Drugs.
Together with CFIA and Health Canada, we developed five individual work plans describing specific activities within the above areas and two Regulatory Partnership Statements outlining the institutional frameworks for this cooperation.
Throughout the implementation of these work plans, American and Canadian stakeholders will have opportunities to engage with the regulatory agencies to provide updates on significant industry and consumer trends and associated implications for regulatory systems.
Lou Valdez, M.S.M., is FDA’s Associate Commissioner for International Programs
By: Heidi C. Marchand, Pharm.D.
While to many, the cherry blossoms in Washington, D.C., signal spring, for my office the season means bountiful opportunities to meet with groups in town for meetings and conventions in our capital city.
Patient and health professional advocacy groups that are some of FDA’s key stakeholders come to FDA Headquarters in nearby Maryland —or we go downtown to their meeting sites—for a mutual exchange of information that often has a profound influence on how we do our jobs protecting and promoting the public health.
So far, we have had informative discussions with groups as varied as the American Association of Nurse Anesthetists, the American Academy of Pediatrics, the American Celiac Disease Alliance, the ALS (Amyotrophic lateral sclerosis) Association, and Parent Project Muscular Dystrophy.
Because we are part of the Office of the Commissioner, we’re familiar with the agency across its various centers and are ideally positioned to connect stakeholders with the experts best suited to answer questions and offer assistance.
We hear from individuals on the front lines—parents of patients with heartbreaking childhood diseases, nurses who witness firsthand the consequences of a medical device that fails to work properly, patients who want to know where and how they can participate in clinical trials.
Many are experts in their area of advocacy—they’ve had to be—and their insights are invaluable.
Putting What We Learn To Good Use
For example, as we developed a rule, mandated by Congress, to define the term “gluten-free” for voluntary use in food labeling, we not only opened the proposed regulation up for public comment on two separate occasions, but we also conducted listening sessions with groups representing people with celiac disease, who must avoid consuming gluten but want a diverse and nutritious diet. They talked about the difficulties they face in trying to identify foods that won’t endanger their health, shared information about their understanding of challenges facing the food industry, and discussed the science that underlies this issue. This information helped us to ensure that the final rule was responsive to their needs. Now people with celiac disease can be assured that if they see “gluten-free” on food labels, that term has a specific, nationally uniform (and federally enforceable) definition.
Of course, our outreach efforts extend beyond these meetings. Our staff keeps in close touch with patient and health professional advocacy groups throughout the year, and through our FDA Patient Network website where we provide information on public meetings, current FDA draft guidances, clinical trials, and drug and device approvals. In addition, our patient newsletter keeps our stakeholders apprised of this and other important work FDA is doing.
But there’s nothing like meeting face-to-face across a table.
We listen to what our constituents have to say, we take it to heart, and we share it with our colleagues. What we learn through these conversations informs our work. It becomes part and parcel of the regulations we put into place to promote and protect the public health.
Heidi C. Marchand, Pharm,D., is Assistant Commissioner in FDA’s Office of Health and Constituent Affairs
By: Michael R. Taylor
Could the deadly outbreak of illnesses tied to contaminated ice cream have been prevented? It’s an important question, one that is on the minds of many in the wake of the multi-state outbreak of Listeria monocytogenes tied to ice cream produced by Blue Bell Creameries.
Our mission in the face of such tragedies is to work to keep them from happening again, first by investigating the cause. If products are found to be contaminated with Listeria monocytogenes or other pathogens, we work with companies to recall anything that has the potential to cause illness. The FDA joins with other federal agencies, states, and industry, while also communicating directly with consumers — all in an effort to ensure that more people don’t get sick or worse.
But more needs to be done, and more is being done. Congress passed the FDA Food Safety Modernization Act (FSMA) in December 2010 because of outbreaks like this, because of a widespread concern among legislators, consumers and industry about foodborne illnesses that kill thousands each year.
Ultimately, the only way we will achieve the goals that we are focused on—the goals that consumers expect us to achieve, and that industry wants us to reach—is if we have a system in which industry is systematically, every day, putting in place the measures that we know are effective in preventing contamination. And it’s not only a domestic issue; it’s an import issue. We’ve got to build prevention into the food safety system globally.
There’s no magic wand here. This is the most sweeping regulatory overhaul in the agency’s history and we’ve got to work systematically to put the right regulations in place. In the four years since FSMA became the law, we have been actively establishing the regulations that we will be issuing in final form beginning later this year.
For example, the preventive controls for human food rule, if finalized as proposed, would require that companies like Blue Bell have a written food safety plan, based on an analysis of likely hazards, and companies would have to show us that plan during inspections. Listeria monocytogenes is a classic example of a hazard that a company should be controlling. Under the proposed standards, companies would be required to have the right controls in place to minimize hazards and would have to verify that their controls are working.
We have in FSMA not only new, enforceable standards, but much stronger inspection and enforcement tools to make sure the standards are being met, such as access to company records and mandatory recalls –authorities we didn’t have before. Most companies want to do the right thing; many are doing it now. Through this law we want to promote strong food safety cultures and create real accountability throughout the industry.
We see broad support for implementing FSMA throughout our stakeholder community and among many people we talk to in Congress. President Obama’s 2016 request for $109.5 million in new budget authority to implement FSMA is crucial. If we receive that funding, we can move forward to implement this new, modern system in an effective and timely way. If we do not get the funding, we will lose momentum, and implementation will be badly disrupted.
No law can guarantee zero risk, from contaminated ice cream or any other food that has come in contact with a dangerous bacteria or other harmful substance. But FSMA is about providing assurances that the food system is doing everything it can to prevent problems and to provide food in grocery stores and restaurants that is as safe as it possibly can be.
Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine