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: Cathy L. Backinger, Ph.D., M.P.H. and Cindy Miner, Ph.D.
How dramatic is the increase in e-cigarette use? Why are flavored little cigars and cigarillos increasingly popular among ethnic minorities? What would happen if we reduced the amount of nicotine in cigarettes so that they were no longer addictive?
These are just some of the questions that FDA-funded scientists are answering. Often research is focused on innovation and discovery to expand the body of scientific knowledge. Regulatory science is different—and exciting in its own way. How often do scientists get to see their research findings used to improve people’s lives? Tobacco regulatory scientists are doing just that.
We Need a Strong Science Base to Address Issues that Matter Now
In 2009 Congress passed the Family Smoking Prevention and Tobacco Control Act, creating the Center for Tobacco Products (CTP) at FDA and giving us the responsibility to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco to protect public health.
Our challenge is to regulate effectively in a changing marketplace. The 2014 National Youth Tobacco Survey found that while cigarette smoking has continued to decline, a new trend emerged—more middle- and high-school students used e-cigarettes than traditional cigarettes and 2.2 million students reported using two or more types of tobacco products. In April 2014, FDA proposed a new rule to extend FDA’s authority to cover additional tobacco products, including e-cigarettes, little cigars, and cigarillos.
Data on these and other key topics—from harmful chemicals in tobacco to the effect of chewing tobacco on oral health to tobacco advertising—will help inform future regulatory actions and monitor the impact of those actions on public health.
Some of the Researchers Who Are Leading the Way
FDA is currently funding a broad range of important research, including the following via a partnership with the National Institutes of Health:
Andrew Hyland (Roswell Park Cancer Institute) is the lead investigator for the landmark Population Assessment of Tobacco and Health (PATH) Study, which will help us learn how and why people start using tobacco, switch from one tobacco product to another, quit using it, and start using it again after they’ve quit. The PATH Study collects information on new tobacco products like e-cigarettes and will give us many insights.
Watch Andrew Hyland’s “Tobacco Regulatory Science in Action” interview on FDA’s website.
Eric Donny (University of Pittsburgh) is studying how reduced levels of nicotine in cigarettes might affect the way people smoke. What are the benefits? Could there be adverse effects, such as people smoking more cigarettes to get the same amount of nicotine? Does it make a difference whether the levels are reduced gradually or at once?
Watch Eric Donny’s “Tobacco Regulatory Science in Action” interview on FDA’s website.
Kymberle Sterling (Georgia State University) is studying what people, especially ethnic minorities, think about little cigars and cigarillos. Little cigars and cigarillos are used by many people who are younger and in ethnic minority groups. Understanding what contributes to this behavior will help the nation begin to address some of the disparities that exist among vulnerable populations.
Watch Kymberle Sterling’s “Tobacco Regulatory Science in Action” interview on FDA’s website.
To learn more about the breadth of research we support, please look at all of our research videos* or look at the abstracts of research we’ve funded in our search tool. These projects are just a part of the work that FDA has undertaken to improve public health and inspire the next generation of researchers interested in tobacco regulatory science.
Cathy L. Backinger, Ph.D., M.P.H, is FDA’s Deputy Director for Research in CTP’s Office of Science
Cindy Miner, Ph.D., is FDA’s Director of the Division of Health, Regulatory and Scientific Communication in CTP’s Office of Health Communication and Education
*The opinions in these videos reflect the views of individual researchers, and not necessarily the official position of the FDA’s Center for Tobacco Products. These videos represent accurate information about the design of these CTP supported studies at the time the interviews were conducted (Spring, 2014).
By: Howard Sklamberg, Richard Moscicki, M.D., and Alonza Cruse
A visit to any one of the cities we visited on this trip – Shanghai, Nanjing and Beijing – would leave anyone marveling at the scale and trajectory of modern China. But it’s not just the sheer size of the population we were struck by. Rather, it was the seemingly tireless dedication to modernity that provided an almost palpable affirmation of what we already knew: that China — its skylines dotted with construction cranes and landscapes crisscrossed by high speed bullet trains — is inextricably connected with our own country’s economy, and increasingly with our agency’s ever-expanding regulatory mission.
We traveled to China for a few reasons. First, we wanted to gain more on-the-ground insight into how its drug industry works. We also wanted to offer some helpful perspective to Chinese regulators and drug companies about the Food and Drug Administration Safety and Innovation Act (FDASIA), which passed three years ago and is in the process of being fully implemented. In part, the law gave the FDA new authorities to ensure the safety of the global drug supply chain, in which China plays an enormous part. How enormous? After the United States, China ranks second for the number of FDA-registered drug establishments that the agency regulates, and is the sixth largest provider of drugs and biologics to the U.S.
Our itinerary also included a meeting with the Chinese Food and Drug Administration (CFDA) and a tour of a Chinese pharmaceutical manufacturing plant. And if you asked us what the most important by-product of our trip has been, it was these face-to-face conversations with our Chinese counterparts.
Specifically, we discussed the responsibilities of firms in the global drug supply chain. These days, the drugs we have in our medicine chests may seemingly come from one company, but the ingredients in them may actually come from numerous companies and countries. China is a major provider of many of the active ingredients in finished drug products Americans rely on every day.
We had productive discussions with the Chinese about how seriously we are committed to making sure that everyone in the drug supply chain – from the companies that make the active ingredients to those that provide the packaging –shares in this collective commitment to quality. As we did when we spoke with our counterparts in India, we stressed that we apply the same quality and data integrity standards to all countries shipping drug ingredients into the United States.
We delivered the same message to a huge crowd of students at an event hosted by China’s Pharmaceutical University in Nanjing. In our remarks, we set forth our expectations for the delivery of drug quality, saying: “…ideally, our approach will complement the baseline, legal requirement of compliance with the higher bar of firms’ self-interest in being recognized for providing quality products and engaging in a different way with FDA.”
While in Nanjing, we had productive discussions with students and stakeholders about FDASIA, quality in contract manufacturing, inspections, regulatory science, and expedited approval pathways that FDA is using to accelerate the process for making novel drugs available to patients.
Additionally, we toured a Chinese pharmaceutical facility and met with CFDA to discuss the revision of China’s Drug Administration Law, our own FDASIA implementation, regulatory science matters, as well as continued collaborative activities. We also had a productive roundtable discussion with leaders from 17 prominent Chinese pharmaceutical companies. We addressed pharmaceutical quality, data integrity, and the approval process for generic and innovator drugs.
As China’s role on the global stage expands, FDA has significantly increased drug and medical device inspections there, but we need to continue to strengthen our efforts. The Office of Regulatory Affairs and our China office have managed a large number of pharmaceutical inspections. The FDA’s office in China has also strengthened relationships with regulators and helped expand the country’s expertise in regulatory operations. And we have worked with industry and academia to explain our regulations and analyze trends and events that might affect the safety of FDA-regulated products exported from China to the U.S.
Given the volume of U.S. trade with China, we are working to expand our presence there to significantly increase the number of inspections we conduct. Staffing increases will allow FDA to enhance its training efforts and technical collaboration with Chinese regulators, industry and others. In fact, in November 2014, we signed a Memorandum of Understanding with the Chinese government that expands our cooperation and will facilitate those staffing increases.
FDA’s priorities in China match its global priorities: we work to ensure the safety and efficacy of FDA-regulated products. China’s size and relentlessly expanding economy have an increasingly significant impact on the products that Americans consume, particularly pharmaceuticals.
We trust our trip to China added to the growing collaboration between FDA and our counterpart agencies there, ensuring the safety of the pharmaceutical products exchanged between our two nations.
Howard Sklamberg is FDA’s Deputy Commissioner, Global Regulatory Operations and Policy
Richard Moscicki, M.D., is FDA’s Deputy Director, Center for Drug Evaluation and Research
Alonza Cruse is FDA’s Acting Director, Pharmaceutical Quality Program, Office of Regulatory Affairs
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: Michael R. Taylor
For the past several years, the FDA has been taking steps to fundamentally change how antimicrobials are legally used in food-producing animals. The agency is moving to eliminate the use of these drugs for production purposes – such as speeding weight gain – and bring their remaining therapeutic uses in feed and water under the supervision of licensed veterinarians. These changes are critical to ensuring these drugs are used judiciously and only when necessary for legitimate animal health purposes.
Today, we added another element to our overall strategy, one that recognizes the important role that veterinarians fulfill as guardians of animal health and preservers of judicious use of medically important antimicrobials. The Veterinary Feed Directive (VFD) final rule lays out what veterinarians must do when they need to authorize the use of these products in feed to protect the animals they serve.
This rule is a key piece of FDA’s initiative to combat the overuse of antimicrobial medications — including antibiotics — in both people and animals, which has created a global health crisis. Disease-causing bacteria commonly develop resistance to the medications created to kill them, but misuse of these important treatments ups the ante. FDA is particularly concerned about the use of “medically important” antibiotics in animal agriculture because they are also used to treat human disease and could become useless if bacteria become resistant to their effects.
Of course, change takes time. Since December 2013, we have been implementing a plan with animal drug companies to phase out the use of medically important antibiotics for enhanced food production. We have been working since then with drug companies, animal producers and veterinarians to change how these antibiotics are used in animals that enter the food supply, such as cattle, hogs and poultry.
Partnership and collaboration is delivering results. All 25 affected animal drug companies agreed to work with FDA to remove production uses for growth promotion and feed efficiency from the approved uses of their drug products, and move the therapeutic uses of these products from over-the-counter availability to a marketing status requiring veterinary oversight. By December 2016, we expect to see significant changes in the way medically important antibiotics are used in animal agriculture as compared to how they have been used for decades.
What will this mean in practice? Once these changes are fully implemented, it will be illegal to use these medically important antibiotics for production purposes, period. Instead of having unrestricted over-the-counter access, animal producers will need to obtain authorization from a licensed veterinarian to use these medications for therapeutic uses — for prevention, control or treatment of a specifically identified disease.
The VFD rule respects the diversity of circumstances that veterinarians encounter on the farm, but also ensures that their oversight is in line with nationally consistent principles. They will be required to have sufficient knowledge of the animals being treated by examining them or visiting the facility at which their care is managed.
Specifically, veterinarians play an important role in animal and human health and their oversight, as an integral part of the VFD process, will help ensure that medically important antimicrobial drugs will be used in feed according to label directions and only when appropriate to meet specific animal health needs. That means using a product for a specifically-identified disease, at the right dose, and for the period of time stipulated on the product label.
We aren’t done yet. The next step is getting the data we need on how medically important antibiotics are now being used on farms, information that will be essential to measuring the impact of our judicious use strategy. Right now we collect antibiotic sales and distribution data but do not have explicit regulatory authority to require data to be submitted on how antibiotics are actually being used in farm animals. We are evaluating how to obtain additional detailed information on such things as the species, indication, dose, and duration of use in order to better understand links between usage patterns and trends in antibiotic resistance. This will help provide a more comprehensive and science-based picture of antibiotic use and resistance in animal agriculture. FDA is actively engaged with the U.S. Department of Agriculture, the Centers for Disease Control and Prevention, and a wide array of stakeholders to fill this need. We plan to hold a public meeting this summer to discuss how to collect and present this data.
Finally, FDA has been actively engaging veterinary organizations, animal producer organizations, and other stakeholders to express concern about some currently-approved preventive, therapeutic uses of medically important antibiotics that have no limit on how long they can be given to the animal. This is not what we consider a judicious use. We believe that veterinarians should work with their clients to explore alternative approaches for managing certain animal health conditions, and we will be working with animal producers and drug companies to make any needed changes in approved conditions of use.
Antimicrobial resistance is everyone’s problem. It requires determination and cooperation to make the changes needed to protect the utility of these life-saving drugs. We are grateful for the way our partners and stakeholders across the food system are responding to this challenge.
Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine
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: Jovonni R. Spinner, M.P.H., C.H.E.S.
Stroke is the leading cause of severe disability, and the fifth leading cause of death for all Americans. The burden is worse in minority communities; minorities have higher stroke risks, strokes at an earlier age, and more severe strokes. For example, African-Americans are twice as likely to die from a stroke compared to Whites.
Often this is because people do not know the warning signs (e.g., sudden numbness, confusion, or loss of balance), or the risk factors that lead to stroke, like high blood pressure, diabetes, and an irregular heart rhythm (atrial fibrillation, or AF). Some minority groups also suffer disproportionately because of cultural and language barriers- which can lead to a delay in treatment or not seeking treatment at all.
Aspirin Therapy: Who should use it?
Although there is broad agreement about the benefits of aspirin in secondary prevention of stroke, (the use of aspirin in people who have already had a stroke) there has been debate in the scientific community about the benefits and risk of using aspirin for primary stroke prevention, i.e., in people without a prior stroke. The Food and Drug Administration has not recommended that use.
To help dispel myths and provide accurate information, we have issued consumer and provider friendly guidance on the appropriate use of aspirin therapy.
Here is the latest evidence on who should and should not use aspirin for stroke prevention.
Primary prevention: In patients who have never had a stroke, aspirin therapy can increase their risk for bleeding in the stomach and brain and a reduction in strokes with aspirin has not been established.
Secondary Prevention: In patients who have already had an ischemic stroke, which happens when a blood vessel that supplies blood to the brain becomes blocked by a blood clot; aspirin therapy has been shown to decrease the risk of having a subsequent event. In general, the benefits may outweigh the risks for these patients.
Aspirin is, of course, readily available in drug stores and grocery stores. Before using it, however, patients should discuss with their healthcare providers whether aspirin therapy is the right course of action for stroke prevention.
Drug Trials Snapshot: Savaysa
On another note, In January 2015, FDA approved Savaysa, a drug used to reduce the risk of stroke in patients with AF, a type of abnormal heart rhythm. This is a blood thinning medication similar to several other recently approved anti-coagulants and an older drug, warfarin. All of these drugs reduce the chance of stroke in patients with this condition by more than 50%. But note, that for patients with kidneys that work really well, Savaysa did not work as well as warfarin.
More than 21,000 people with AF participated in the Savaysa clinical trial. Clinical trial data, which are made available from the “Drug Trials Snapshot”, showed a large stroke reduction and no meaningful differences by sex, race (Whites versus Asians), or age (greater than 75 years) for the drug’s performance or side effects (e.g., major bleeding), a finding that is also true for the other anti-coagulants. Other minority groups were under-represented in this trial, so data are not available for those groups.
The Drug Snapshot is part of FDA’s transparency initiative that displays the clinical trial data analyzed by subgroup (e.g., sex, race, and age). This is an important initiative because it provides information on clinical trial participation among varying groups.
Here at FDA, we strive to make data transparent and easily accessible to our stakeholders. The Office of Minority Health is leading FDA’s efforts to encourage diversity of participants in clinical trials and assess possible differences in effects among varying groups. We know that demographic subgroups (e.g., minorities, women) can respond differently to medications and clinical trial participants should reflect the populations that will most likely use these products.
Visit our website or follow us on Twitter to find out more information about our research programs, outreach, and communications.
Jovonni R. Spinner, M.O.H., C.H.E.S. is a Public Health Advisor in FDA’s Office of Minority Health