Looking at the Road Ahead for FSMA

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.)

Thinking About FSMA Issues

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.)

Continuing the Conversation About FSMA

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.)

Coming Together to Talk About FSMA

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.)

Protecting Consumers from Trans Fat

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.

Susan MaynePHOs 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

FDA Continues its Collaboration with Canada in Phase 2 of the U.S.-Canada Regulatory Cooperation Council

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).

Lou ValdezThe 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.

FDA is committed to continuing our valued partnership with Canada and using the RCC as an important tool upon which to build. Learn more about FDA’s work under the RCC at http://www.trade.gov/rcc/.

Lou Valdez, M.S.M., is FDA’s Associate Commissioner for International Programs

Meeting Face-to-face Makes All the Difference

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.

Heidi MarchandPatient 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

Blue Bell and the Very Real Impact of the Food Safety Modernization Act

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.

Michael TaylorAbove all else, we need to acknowledge the tragic aftermath. Our hearts go out to the friends and family members of the victims – the 10 people who were hospitalized and the three who died.

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

FDA Teams With National Forum to Reduce Deaths from Heart Disease: Program is first of its kind

By: Heidi C. Marchand, Pharm.D.

In the U.S., only about 1 in every 4 prescriptions is taken as directed by a health care provider – a problem that costs our nation more than 125,000 lives a year. Millions of Americans with heart disease – the nation’s No. 1 killer – are especially vulnerable.

Heidi MarchandTo stem that tide, FDA has teamed with the nonprofit National Forum for Heart Disease and Stroke Prevention to advance the cause of a heart-healthy and stroke-free society.

FDA’s Office of Health and Constituent Affairs has signed a Memorandum of Understanding with the National Forum to promote and increase the use of health knowledge, skills and practices by the public in their daily lives. The five-year agreement is a first-of-its-kind cooperative public education program to reduce the burdens of heart disease and stroke.

Heart disease, which kills 1 in 4 Americans, can be managed. To prevent heart attacks, transient ischemic attacks and other cardiac events, doctors prescribe medications and lifestyle therapies (e.g. heart-healthy diets). Because medication is not readily adhered to – and neither are lifestyle treatments – millions of people suffer from preventable cardiac episodes. As a nation, lack of medication adherence (which can be as simple as not getting a prescription filled or refilled) costs more than $100 billion annually in excess hospitalizations.

To confront this problem, FDA is taking the lead in support of Million Hearts®, a national initiative of the Department of Health and Human Services to prevent 1 million heart attacks and strokes by 2017. A key partner in that mission is the National Forum, whose members include more than 80 U.S. and international organizations representing public, private, health care, advocacy, academic, policy and community sectors.

Together we will:

  • Explore, demonstrate and evaluate innovative health promotion concepts.
  • Exchange information on nutrition, heart disease, and ways to increase the number of patients who take their medication and/or therapy.
  • Identify and systematize best practices in behavior modification education.
  • Develop concepts for community-based interventions.

Our goals are clear: create recommendations to improve compliance with prescribed medical therapies and implement the recommendations to improve the lives of patients living with heart disease.

FDA’s Dr. Helene Clayton-Jeter and Dr. Fortunato “Fred” Senatore are leading a diverse team in identifying strategies to help patients take their medicines as directed and follow the advice of their doctors.

Concurrently, the National Forum will recruit a Therapy Adherence Steering Committee, made up of experts and stakeholders from physician and nursing groups, pharmacy (retail/system), behavioral health, consumer/patient groups and others invested in complying with medical therapy.

We’ll then jointly develop action plans for high-probability, high-yield strategies to promote heart health by helping ensure that patients take their medicines and adopt healthier lifestyles. Our plan is to complete all steps in the next several years.

We cannot fix this problem overnight. But by addressing it strategically, we can move forward and improve the odds of preventing and surviving heart disease and stroke among Americans.

Heidi Marchand, PharmD, is Assistant Commissioner in FDA’s Office of Health and Constituent Affairs

The 2014 FDA Food Safety Challenge: And the Finalists Are…

By: Palmer Orlandi, Ph.D.

I am delighted to announce the finalists in FDA’s first Food Safety Challenge, a ground-breaking effort to better protect our food supply by fostering innovation in technologies that will more quickly detect pathogens in produce.

Palmer OrlandiLast September, we invited scientists, academics, entrepreneurs, and innovators from all disciplines to compete by submitting concepts that could improve and accelerate the detection of these disease-causing bacteria in foods. We received 49 submissions.

The five finalists whose proposals will enter the next phase of the Food Safety Challenge are teams of researchers from these companies and universities:

  • Auburn University, Auburn, Ala.
  • Pronucleotein Inc., San Antonio, Texas
  • Purdue University, West Lafayette, Ind.
  • University of California, Davis, Calif.; Dr. Bart Weimer; and Mars, Inc.
  • University of Illinois, Urbana-Champaign, Ill.; and Purdue University

(Purdue is represented twice, teaming with University of Illinois colleagues in one proposal and going solo in another, with different researchers on each team.)

Each team has developed ingenious new technologies for detecting food pathogens that could be real game changers in our ongoing fight against foodborne illness. They will each receive $20,000 and advance to the next stage in the Challenge. The winner or winners (there can be more than one) will share the remainder of the $500,000 total prize.

But before I describe the next step, let me remind you why this Challenge is vital to FDA’s mission to promote and protect the public health.

  • The Centers for Disease Control and Prevention (CDC) estimates that foodborne illness sickens 1 in 6 Americans  annually, resulting in about 3,000 deaths.
  • The overall negative economic impact of foodborne illness in the United States may be as high as $77 billion per year.
  • Salmonella is the leading cause of death and of hospitalization related to foodborne illness.

We believe that by reaching out through this Challenge to entrepreneurs, academia, and the larger scientific, innovation and problems-solving communities, we can view our food safety problems through a different lens. It’s a way to consider approaches, and possible solutions, through the eyes of innovative thinkers, and to use technologies we may not have considered.

What Happens Next?

Now that our panel of expert judges from FDA, CDC, and the U.S. Department of Agriculture has narrowed the competitive field down, we enter the Field Accelerator phase of the Challenge. With the guidance of FDA food safety and pathogen-testing experts, finalists will

  • refine their submissions,
  • clarify their concepts,
  • maximize their impact on food safety,
  • check that they are in line with FDA’s needs and capabilities,
  • and ensure that the proposed ideas can be reasonably executed.

The finalists will participate in a “boot camp” with FDA experts on May 13, 2015 to help strengthen their concepts and applicability to FDA’s testing process. “Demo Day” will be held on July 7, 2015 in College Park, Md. The finalists will present their improved proposals to the judges and a live audience in FDA’s Center for Food Safety and Applied Nutrition headquarters.

I, for one, can’t wait to see the solutions the finalists will come up with. We believe that by thinking outside the box, we can find new ways to help assure the American public that the foods they eat and serve their families are safe.

Palmer Orlandi, Ph.D., is Acting Chief Science Officer and Research Director in the FDA’s Office of Foods and Veterinary Medicine.