We Moved Forward on Many Fronts This Year

By: Margaret A. Hamburg, M.D.

At the FDA, the agency that I’ve had the privilege to lead for the past five years, I am gratified to report that we have a lot to be proud of this year. In fact, this past year’s accomplishments on behalf of public health have been as substantial as any in FDA’s recent history.

Margaret Hamburg, M.D.We moved significantly forward, for example, in creating a system that will reduce foodborne illness, approving novel medical products in cutting-edge areas of science, and continuing to develop our new tobacco control program. We worked successfully with Congress and with regulated industry to reach agreement on a number of difficult issues, while continuing to use the law to the full extent possible to protect consumers and advance public health.

While there were many significant actions and events to recognize, below are some of the highlights of 2013.

In the foods area, there were many new actions this year that will have a long-standing impact on improving our food supply for consumers. Throughout the year we have been proposing new rules to reach the goals set forth by the FDA Food Safety Modernization Act (FSMA). These science-based standards will help ensure the safety of all foods produced for our market, whether they come from the U.S. or from other countries.

We also took important steps towards reducing artery-clogging trans fat in processed foods, and understanding the health impact of arsenic in rice. With a final rule that defines when baked goods, pastas and other foods can be considered free of gluten, people with celiac disease can have confidence in foods labeled “gluten free.” And we are studying whether adding caffeine to foods may have an effect on the health of young people and others.

There have likewise been many accomplishments in advancing the safety and effectiveness of medical products. We worked closely with Congress on the recently enacted Drug Quality and Security Act, which contains important provisions relating to the oversight of human drug compounding. The law also has provisions to help secure the drug supply chain so that we can better help protect consumers from the dangers of counterfeit, stolen, contaminated, or otherwise harmful drugs.

Using tools provided by last year’s landmark Food and Drug Administration Safety and Innovation Act (FDASIA), we are continuing to improve the speed and efficiency of medical product reviews, including those involving low-cost, high quality generic drugs and innovative new medical devices. The average number of days it takes for pre-market review of a new medical device has been reduced by about one-third since 2010. The percentage of pre-market approval applications that we approve has increased since then, after steadily decreasing each year since 2004.

We launched a powerful new tool to accelerate the development and review of “breakthrough therapies,” allowing FDA to expedite development of a drug or biologic (such as a vaccine) if preliminary clinical evidence indicates that it may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases. This offers real opportunities to get promising drugs more quickly to patients who need them. In fact, using this new approach, FDA recently approved two advanced treatments for rare types of cancer and one for hepatitis C. We have also strengthened efforts to ensure product quality, increased protection of the drug supply chain, and reduced drug shortages.

We confronted the growing misuse of powerful opioid pain relievers by advising manufacturers on how to make these drugs harder to abuse with formulations that are more difficult to crush for inhalation or dissolve for injection. And we recommended that hydrocodone combination products be subject to stricter controls to help prevent abuse. 

We took an important step towards fighting the development of antibiotic-resistant bacteria by implementing a voluntary plan to phase out the use of antibiotics to enhance the growth of food-producing animals, and to move any remaining therapeutic uses of these drugs under the oversight of a licensed veterinarian. So-called “production” use is considered a contributing factor in the development of bacteria that are resistant to the antibiotics used in human medical treatment.

In many areas of our work we are supporting the emerging field of personalized medicine. Advances in sequencing the human genome and greater understanding of the underlying mechanisms of disease, combined with increasingly powerful computers and other technologies, are making it possible to tailor medical treatments to the specific characteristics, needs, and preferences of individual patients.

Many cancer drugs today are increasingly used with companion diagnostic tests that can help determine whether a patient will respond to the drug based on the genetic characteristics of the patient’s tumor. In May, FDA approved two drugs and companion diagnostic testing for the treatment of certain melanoma patients with particular genetic mutations.

Advances in science and technology are also seen in the creation of new medical devices. For example, 3-D printing - the making of a three-dimensional solid object from a digital model – was once considered the wave of the future. But in February, FDA cleared for marketing a device created by 3-D printing – a plate used in a surgical repair of the skull that is built specifically for the individual patient.

While we have worked hard to get therapies to patients, we are at the same time using the tools available to us to remove unsafe and dangerous products from the market. In November, we used new enforcement tools provided by the food-safety law to act quickly in the face of a potential danger to public health presented by certain OxyElite Pro products. These supplements had been linked to dozens of cases of acute liver failure and hepatitis. After FDA took action, the manufacturer agreed to recall and destroy the supplements.

Finally, we made significant progress in implementing the letter and spirit of the Family Smoking Prevention and Tobacco Control Act. We have signed contracts with numerous state and local authorities to enforce the ban on the sale of tobacco to children and teens; conducted close to 240,000 inspections; and written more than 12,100 warning letters to retailers. And, in the first quarter of 2014 we will launch a public education campaign aimed at reducing the number of young people who use tobacco products.

All of us take great pride in the skill and vigor with which we overcame the year’s challenges and new demands. And so, as the year draws to a close, I extend my gratitude to the employees at the FDA who work tirelessly on behalf of the American public year in and year out. To all of our stakeholders, my heartfelt wishes for a joyous holiday season and a safe and healthy 2014.

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

A ‘Vision’ Worth Honoring

By: Heidi Marchand, PharmD

My office serves as a bridge between FDA and a wide range of health professional, patient, consumer, tribal and industry audiences. Among our top priorities is collaborating with public-health minded groups and individuals to help us better understand and respond to the needs of stakeholders.

Dr. Helene Clayton-Jeter accepts award

Dr. Helene Clayton-Jeter, front center, accepts the 2013 AOA Leadership in Public Health Award alongside her colleagues, Beth Fritsch - OHCA Deputy Director, at front left, Heidi Marchand - OHCA Assistant Commissioner, at front right, Dr. Michael Duenas - AOA Chief Public Health Officer, at back left, Matt Willette - AOA Assistant Director, Federal Government Relations, at back center, and Jon Hymes, AOA Director, at back right.

One such example is the work we’re doing with the American Optometric Association (AOA) and the Entertainment Industry Council (EIC) on the Decorative Contact Lens Campaign Project. The goal of this important work is to inform young people about the potential risks of using decorative contact lenses improperly.

These lenses change the appearance of the eyes to give them a “cool” look – like making them look like vampire or cat eyes. They could change the eye color. But they can cause serious eye damage if they’re not fitted by an optometrist or ophthalmologist. Failure to properly clean and care for the lenses could cause vision-threatening infections.

Recently, Helene Clayton-Jeter, O.D., Health Programs Coordinator, who leads the project for my office, was honored by AOA for her superlative work on this project. Dr. Clayton-Jeter, who for years was a practicing optometrist, was instrumental in providing valuable insights that helped shape this public health message.

Dr. Clayton-Jeter is the first recipient of the Leadership in Public Health Award, which AOA plans to give annually hereafter to a member optometrist who has provided innovative and far-reaching solutions to public health challenges, augmented the optometrist’s role in public health, and advanced the provision of health care services by optometrists to Americans.

The project is set to be launched next spring, just in time for spring breaks and end-of-school-year celebrations. This is a time when students are more likely to purchase and use decorative contact lenses. By reinforcing the importance of using these lenses only under the supervision of a health care professional, we hope the project will protect the health and preserve the vision of the many young people who are otherwise apt to use decorative lenses unsafely. Working closely with Dr. Clayton-Jeter on this project were the FDA’s Office of Communications and Center for Devices and Radiological Health, which regulates contact lenses.

While making the formal presentation, Michael Dueñas, O.D., AOA’s Chief Public Health Officer, said this award is a testimony to Dr. Clayton-Jeter’s personal commitment and dedicated work toward the advancement of innovative and effective solutions in safeguarding the health of the American people.

I am very proud of Dr. Clayton-Jeter’s achievements and the integrity that she brings to her work every day at FDA.

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

FDA Takes a Responsive Approach to Mobile Web

By: Chris Mulieri

Since January 1, over 30 million visitors have come to FDA’s website. We know that they come to FDA.gov to get reliable and up-to-date information on everything from food and drug recalls to medical product alerts to regulations and guidance for industry…and the list goes on.

We also know that an increasing number of our visitors use mobile devices to get this information. In the last year alone, the number of mobile visits to FDA.gov has nearly doubled, and now 25 percent of our visitors use a tablet or smartphone to access the site.

Our Visitors Come First

As director of web and digital media for the FDA, I lead a team that is committed to providing a positive experience for visitors to FDA.gov, including our mobile visitors. We are also responsible for supporting the Digital Government Strategy, issued by the White House, which calls for federal agencies to provide government information on demand and on any device.

In plain English, that means that we need to provide a single FDA.gov site that’s available anytime, anywhere, on any device.

To meet the needs of our mobile visitors without creating a separate mobile website, we turned to a proven web development approach called responsive design. This approach uses special code to ensure that web content is easy to read and scroll across a wide range of devices, from desktop computers to mobile phones. Since the first of the year, mobile-friendly responsive designs have been implemented successfully on a number of large non-government websites, such as NYTimes.com and NPR.org. And now, on FDA.gov as well.

Check Out FDA.gov on Mobile

We are excited to announce that our first responsive pages on FDA.gov launched on November 15. If you are using a smartphone or tablet, go to FDA.gov and check it out. You’ll see our most popular content, such as recalls, news, and safety alerts, is now formatted to fit your screen. We’ve also made it easier for mobile visitors to tell us about a problem with the products that FDA regulates, such as food, drugs, medical devices, and animal food and drugs.

This is just the beginning. In keeping with best practices in web design, we are taking an iterative approach to mobile on FDA.gov. In other words, we will apply the lessons learned from our visitors’ experiences to share more mobile friendly content as it becomes available.

Our ultimate goal is to create one website that will provide a quality experience for all visitors who seek information that will benefit their health and safety.

Chris Mulieri is the director of web and digital media for the Food and Drug Administration

On Farms and in Labs, FDA and Partners Are Working to Get Answers on Arsenic in Rice

By: Margaret A. Hamburg, M.D.

This week, my colleagues and I traveled to California to learn more, first-hand, about the presence of arsenic in rice.

FDA Commissioner Margaret Hamburg and Deputy FDA Commissioner for Foods and Veterinary Medicine Michael Taylor, center, don hip waders to go out into the rice fields at Lundberg Family Farms in Richvale, Calif. At left is Bryce Lundberg, the farms' vice president of agriculture, and at right is Mike Denny, vice president of farming operations.

This grain, like other foods, contains traces of arsenic, a chemical element found in water, air and soil. However, rice plants absorb more arsenic than most other crop plants. FDA has been monitoring arsenic levels in foods, including rice, for decades.

On Wednesday, Sept. 4, we toured a research facility in which scientists are working to find ways to improve the quality and safety of rice. And we visited the historic farming community of Richvale — a short drive north of Sacramento — known as the birthplace of California rice.

In each of these places I saw a true commitment to public health and a shared goal of ensuring that any risk is minimized so that people around the world can continue to eat rice and rice products as part of a varied diet.

Today, FDA released the results of tests performed on a total of more than 1,300 samples of rice and rice products. What we found was that the levels of inorganic arsenic are well below the levels that would result in any immediate or short-term health risks. This information will now be considered by FDA in looking at the potential long-term health effects associated with the consumption of arsenic in rice and rice products.

Our visit to California, at the invitation of the rice industry – including the USA Rice Federation – was FDA’s third fact-finding visit to rice-producing states, the earlier trips being to Arkansas and Missouri. My traveling companions included Michael Taylor, FDA’s Deputy Commissioner for Foods and Veterinary Medicine, and Andy Hammond, regional director of the U.S. Department of Agriculture’s Agricultural Research Service (ARS).

Our first stop on Wednesday was at the Rice Experiment Station in Biggs operated by the California Cooperative Rice Research Foundation. Research at the station is funded in large part by assessments on rice growers and involves close collaboration with experts at the University of California/Davis and ARS.

Touring the station’s research fields gave us a sense of the determination by all involved in this work, including industry, to better understand how arsenic gets into rice and what growing and processing strategies might be employed to reduce arsenic levels.

That afternoon we visited two multi-generation family farms in Richvale. Lyle Job and his family have been farming their land for more than 30 years. At the Lundberg Family Farms, in business since 1937, we learned about the different approaches of organic rice farmers.

These farmers take enormous pride in their work. They told us about the soil and climate conditions that make their land ideal to grow rice. At the Job farm, we climbed up into a huge harvester to see how it operates. At the Lundberg farm, we put on hip boots and waded out into flooded fields.

Standing beside these farmers, I was struck by their commitment to making the best product possible and the intensity of their desire to help us understand the challenges they face. Rice is not just a commodity to them; it’s their way of life.

Our last stop, on Thursday, Sept. 5, was to FDA’s laboratory in Alameda, where hundreds of rice samples were tested using a process called “speciation.” FDA scientists developed the speciation method used to measuring total arsenic levels, but most importantly to measure both the organic and the more toxic inorganic forms of arsenic.

So what does this all mean right now? As a mother I can imagine that many of you are asking yourself, “Should I be feeding it to my children?” Our best advice – consistent with that given by the American Academy of Pediatrics – is to eat a well-balanced diet that includes a variety of grains.

We don’t have all the answers yet, but we’re working on it. In collaboration with farmers, industry, academia and other public health agencies, we are doing everything possible to determine if the levels of arsenic in rice pose a long-term health risk and, if so, what can be done to reduce that risk.

The presence of arsenic in rice is a global health issue. The answers we seek will ultimately help protect consumers all over the world.

For more photos of our tour, visit Flickr.

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

The path toward a risk-based regulatory framework for health IT

By: Jodi Daniel, Bakul Patel and Matthew Quinn 

Yesterday, the Health IT Policy Committee (HITPC) accepted and approved recommendations from the Food and Drug Administration Safety and Innovation Act (FDASIA) working group for a risk-based regulatory framework for health information technology. The working group’s recommendations suggest a scope for an IT framework, risk and innovation criteria, and approaches for avoiding regulatory duplication. 

Only six short months ago, the Food and Drug Administration (FDA), the Office of the National Coordinator for Health IT (ONC), and Federal Communications Commission (FCC) kicked off the FDASIA workgroup of the HITPC to provide stakeholder input into a report on a risk-based regulatory framework that promotes safety and innovation and reduces regulatory duplication, consistent with section 618 of FDASIA. This provision permitted the Secretary of Health and Human Services (HHS) to form a workgroup in order to obtain broad stakeholder input from across the health care, IT, patients and innovation spectrum. The FDA, ONC, and FCC actively participated in these discussions with stakeholders from across the health care, IT, patients and innovation spectrum. The working group met more than 28 times, and yesterday FDASIA workgroup chair, David Bates, presented the final recommendations to the HITPC. 

In recognition of this important milestone, and on behalf of the three agencies, we want to express our deep appreciation to the members of the workgroup (and a special thanks to David Bates) for committing themselves to this aggressive timeline and delivering a suite of thoughtful recommendations.

Next Steps

As the FDASIA workgroup’s efforts conclude, the agencies’ efforts now intensify. Over the next few months the FDA, ONC, and FCC will review the HIT Policy Committee’s recommendations and the public comments submitted through the docket we opened on regulations.gov. Using these thoughtful inputs, ONC, FDA, and FCC will work closely together to develop a report (by the January 2014 statutory deadline) that proposes an overarching health IT regulatory strategy and provides recommendations on ways to appropriately promote innovation, protect patient safety, and avoid regulatory duplication. 

We recognize the complex nature of health IT and its importance to our nation’s health.  Therefore, we intend to provide an opportunity for public comment and additional stakeholder input on the draft report following its publication in January 2014. We look forward to continued collaboration with all stakeholders as we advance our thinking on this important topic. 

Jodi Daniel is Director, Office of Policy and Planning, Office of the National Coordinator for Health IT

Bakul Patel is Senior Policy Advisor, FDA’s Center for Devices and Radiological Health

Matthew Quinn is Director of Healthcare Initiatives, Federal Communications Commission (FCC)

Considering Women’s Needs in Developing Medical Devices: Here’s ‘HoW’

By: Michelle McMurry-Heath, MD, Ph.D. 

Women differ from men in anatomy, physiology, risk factors and disease symptoms. They are also likely to use more medical devices over the course of their lives than men do.

That is why FDA is actively trying to learn more about how medical devices uniquely affect women, and how women can be better served by them.

This month we published a snapshot of how FDA is doing with such efforts. A congressionally-required report (Section 907 of the Food and Drug Administration Safety and Innovation Act) looked at the inclusion and analysis of women and other demographic subgroups in clinical studies supporting the approval of medical devices and other FDA-regulated medical products. After reviewing 2011 product applications, including 37 premarket approval applications, or PMAs, for devices, we found that in the majority of cases, sponsors provide information about women, conduct subset analyses and share information with the public in a variety of ways.

One specific activity highlighted in the report was a workshop sponsored earlier this summer by the Center for Devices and Radiological Health (CDRH) to formally launch a new program designed to more closely look at medical device use and the health of women (HoW). The three main goals of HoW are to:

  • Improve the availability, consistency and communication of information to patients and providers that is specific to women’s needs for the safe and effective use of medical devices.
  • Address identified gaps and unmet needs through targeted resources.
  • Foster the development of innovative strategies, technology and clinical study models.

Nearly 200 representatives from industry, academia, health care, federal agencies, patient and advocacy groups, gathered to discuss the issues related to medical devices and health in women and to brainstorm about effective strategies to address clinical research needs in this population.

This work builds on a December 2011 draft guidance, also highlighted in this month’s 907 report. That guidance outlined CDRH’s proposed expectations regarding sex-specific enrollment in clinical studies, data analysis, and reporting of study information. Ideally, the final guidance will provide a clear decision-making framework for when and how to analyze and communicate data involving women in device clinical studies.

The CDRH HoW program also plans to complement this by developing, in partnership with other stakeholders, strategies for communicating information about differences to the people who most need to know: health care professionals, clinical investigators, the medical device industry, and most importantly, patients.

With these activities, we are laying the groundwork for making sure the unique health needs of women are considered in research agendas and device innovation. The goal is to strengthen the focus of FDA, industry and the clinical community in developing medical devices designed to meet the unique clinical needs of women, and to communicate new information as we learn more about how differences affect treatment options and outcomes.

Now, with the issuance of the 907 report, and an accompanying docket to receive comments from the public, we hope to gain an even more in-depth understanding about demographic subgroups. The input we receive will become the starting point for developing an Action Plan, to be released next year.

These are all important steps towards ensuring that medical devices developed will take into account the unique needs of women.

Michelle McMurry-Heath, M.D., Ph.D., is the Associate Director for Science at the FDA’s Center for Devices and Radiological Health

Cutting the Wires: FDA Provides Industry Guidance

By: Bakul Patel

The medical device industry has gone wireless. 

Many medical devices today perform at least one function by using wireless technology to support health care delivery. In telemedicine, for example, a wireless device can enable real-time monitoring of patients from a distance – data from a patient-worn or implanted medical device goes directly to the health care professional. The transfer of data is immediate, accelerating communication, decision time and when necessary, intervention. 

However, the stakes can get high. 

What if a diabetic’s blood glucose monitor malfunctions and sends a wrong glucose reading to a doctor because another wireless device in the clinic interfered with its signal? What if a signal is completely interrupted from a monitor that the patient depends on to transmit time-sensitive health care data?  In such cases, the proper functioning of wireless medical devices can mean the difference – literally – between life and death. 

It is FDA’s role to assure that before such wireless medical devices are introduced into the marketplace, that they have been properly tested. It is essential that manufacturers first consider and test potential limitations of the wireless connectivity associated with their devices to prevent malfunctions that could harm patients. 

There are many factors to consider. For example, is there enough bandwidth (the range of available frequencies) available? In an environment crowded with different kinds of wireless devices, is there a possibility that interference could critically affect the device’s function? 

Today, FDA published the final guidance entitled, “Guidance for Industry and Food and Drug Administration Staff; Radio Frequency Wireless Technology in Medical Devices,” to help industry navigate such challenges. Our recommendations cover devices that are implanted or worn on the body, and others intended for use in locations such as hospitals, homes, clinics, and clinical laboratories. They cover such considerations that relate to the design, testing, deployment  and maintenance of safe, reliable, and secure wireless medical devices and systems. 

For example, designers and manufacturers of wireless medical devices should consider whether these devices can function properly in the environments where they are intended to be used. Another consideration is wireless coexistence. Given the limited availability of the radio frequency spectrum, wireless technologies may compete for access to the same spectrum. As a result, coexistence issues may pose risks that could result in medical device signal loss or delay that can be life-threatening. 

This guidance reflects FDA’s ongoing commitment to the practice of regulatory science; that is, the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products. In this instance, FDA worked closely with the Federal Communications Commission (FCC), which in 2009 was charged by Congress to develop a National Broadband Plan to ensure every American has access to wireless technology and to delineate the respective areas of expertise and jurisdiction between the agencies. 

In a prior meeting with FCC, FDA Commissioner Margaret A. Hamburg, M.D., said that while the benefits of RF wireless technology are clear, “to harness the full power of these benefits, we must navigate a delicate balance between innovation and safety and effectiveness.” 

We hope this guidance accomplishes just that. Our goal is to help industry develop a range of innovative, safe, and effective medical devices that incorporate wireless technology, which can, in turn, help reduce health care costs, enhance quality, and benefit patients and providers alike.

Bakul Patel is senior policy advisor in FDA’s Center for Devices and Radiological Health.

Improving Patient Care by Making Sure Devices Work Well Together

By: Bakul Patel 

Interoperability refers to the ability of medical devices to interact and for electronic health record systems to talk to each other using a common vocabulary. It is similar to the concept of “plug and play” computer attachments like a web cam or mouse, which are made so that products can operate with different brands and models of computers.

While it may seem abstract, successful interoperability among medical devices can improve patient care, reduce errors, and lower costs.

As medical devices become increasingly connected to other medical devices, hospital information systems and electronic health records, there is a growing expectation that they will be interoperable – and that the data they transmit will be secure.

A few examples illustrate the need: 

  • An infusion pump that administers medication to a patient also connects to the hospital’s electronic health record system where the physician inputs orders for specific amounts of medication to be delivered at specific times. If the infusion pump and the electronic health record are not interoperable, with clocks that are synchronized, medication errors could occur. 
  • A patient in surgery is connected to a ventilator and a central monitoring station. If the two devices are not interoperable, the monitor may send a false alarm, or fail to send a needed alarm. Either error could increase the risk to the patient. 
  • Two patients with different medical conditions both have electrocardiogram (EKG) monitors attached to check their hearts’ electrical activity. Both monitors are connected to the same computer system that records the data for later review by a physician. It’s critical that the computer system and the EKG monitors are interoperable so transmission errors do not confuse one patient’s data with the other patient’s data.

Making sure devices are interoperable requires the creation, validation, and recognition of standards that help manufacturers develop products that are harmonious and can “plug and play.”  

We at the FDA have been hard at work on this issue with hospitals, health care providers, manufacturers, standards development organizations, and other interested parties. A 2012 summit organized by FDA and the Association for the Advancement of Medical Instrumentation (AAMI), for example, brought together 266 experts from many disciplines to further the goal of improving patient care and cybersecurity — while at the same time fostering innovation — through interoperability.

As a first step, FDA has recognized a set of voluntary standards that will help manufacturers create devices that work well together and are secure.

We hope this first set of voluntary standards will encourage further efforts to identify standards and create new ones for our review, because improving the care of patients through medical devices increasingly depends on those devices and information systems being “interoperable.”

Bakul Patel is senior policy advisor in FDA’s Center for Devices and Radiological Health.

Gluten-Free Labeling Consumers Can Count On

By: Virginia A. Cox 

Celiac disease is a serious health issue that can lead to critical complications if not treated. 

While there is no cure for celiac disease (CD), there is one way to manage it – following a gluten-free diet. The only choice for the up to three million Americans living with CD is to adhere strictly to a gluten-free diet, avoiding proteins that occur naturally in wheat, rye, barley and cross-bred hybrids of these grains. To do otherwise is to risk gradually damaging the intestines, preventing the absorption of vitamins and minerals and leading to a host of other health problems, including nutritional deficiencies, osteoporosis, miscarriages, and cancer. 

Without a standard definition of “gluten-free,” people with gluten-related health problems can never be certain if a food is likely to be tolerated by them. So as a person living with CD for over a decade, I’m delighted to say that today, FDA is mandating a new rule on food labeling that will help people with CD – people just like me –be able to trust what the words “gluten-free” mean on their food purchases. Not only will this help those with CD manage their disease more carefully, but it will also improve life for many others who are gluten intolerant or gluten sensitive. 

Food manufacturers have come a long way in providing terrific options for those who need to eat a gluten-free diet. And by providing a clear definition of the term “gluten free” for all manufacturers to follow, this rule will help ensure that all of the “gluten-free” claims on food products are reliable, consistent, and truthful. 

This is a very big deal. A celiac patient without access to proper treatment – a strict, gluten-free diet – could suffer severe health problems. I suffered from stomach issues my whole life and was constantly misdiagnosed with ulcers even as a young child. Since my correct diagnosis, I have worked hard to avoid gluten, but it is challenging. This new rule will help all of us with CD better manage our diets and our health. 

According to the National Foundation for Celiac Awareness, one of every 133 Americans has CD, and 83 percent are undiagnosed or misdiagnosed with other conditions. But as consumers and health care professionals become more aware of the disease and how to cope with it, and more confident that they can trust that those products labeled gluten-free meet a standard definition, the better off we’ll all be. 

CD can affect anyone; it doesn’t discriminate against race, age or gender. It can make eating, which I consider one of life’s great pleasures, a minefield, a thrice-daily event that is fraught with anxiety and peril. 

It’s not the FDA’s job to tell people what they should and shouldn’t eat, but it is our responsibility to make sure that people can trust what the labels say on the foods they do choose to eat. I am proud to say that today we have taken a huge step towards helping all of us with CD or any kind of gluten-sensitivity confidently manage our health. And that is good for everyone. 

Virginia A. Cox, J.D., is Associate Commissioner of FDA’s Office of External Affairs.

 

Dietary Supplements Containing Unsafe Food Additive Destroyed

By: Daniel Fabricant, Ph.D. 

In a victory for consumers, a Texas-based distributor of dietary supplements has destroyed its stock of two dietary supplements containing the stimulant dimethylamylamine (DMAA). 

In addition, a major distributor of the products – GNC Inc. - agreed to destroy the supplements in its possession after the Food and Drug Administration (FDA) obtained seizure orders for GNC facilities in three states. GNC has already destroyed its DMAA products in two of the three states, and we expect the products in the third state to be destroyed this week. 

The products – OxyElite Pro and Jack3D, distributed by USPlabs – had an estimated retail value of more than $8.5 million. Dietary supplements containing DMAA – an amphetamine derivative – are advertised as useful for losing weight, enhancing athletic performance and building muscle. Reports implicate DMAA in the narrowing of blood vessels and arteries, which can elevate blood pressure and lead to serious medical conditions, including heart attack, seizures, psychiatric disorders and even death. FDA has received reports of more than 100 illnesses associated with products containing DMAA, including six deaths. 

A noteworthy aspect of this case is that FDA invoked its administrative detention authority to protect consumers. This authority was recently amended so that it can be used more easily. 

Here’s the backstory: 

The quickest method for getting risky products off the market remains voluntary compliance. USPlabs was one of 11 companies to receive warning letters from FDA in 2012 telling them that DMAA is illegal and should not be sold. Ten of the companies quickly agreed to stop using the stimulant as an ingredient in their dietary supplements, but USPlabs challenged the legal theories we had advanced. 

Unlike drugs, dietary supplements do not need to be approved by FDA for safety and effectiveness before they are sold. In order for FDA to ban a compound in a dietary supplement, FDA is required to undertake a series of lengthy scientific and legal steps.  When FDA opts to proceed through enforcement action rather than by issuing a regulation, the process of taking a product off the market typically begins with warning letters and can proceed to a seizure action or an injunction. 

Our scientists investigated USPlabs’ contentions only to conclude that DMAA was an unsafe food additive that couldn’t be used in supplements. In April 2013, FDA sent a response letter to the company giving it 15 days to take corrective action. 

When the company said it would continue to sell the remaining stock of supplements containing DMAA, the state of Texas temporarily embargoed both products and FDA in turn invoked its administrative detention authority. Before Congress passed the FDA Food Safety Modernization Act of 2011 (FSMA), FDA could detain food only if an authorized agency representative had credible evidence or information that the article of food presented a “threat of serious adverse health consequences or death to humans or animals.”  But under FSMA, FDA can now detain food if an authorized agency representative has reason to believe that the product is adulterated or misbranded. If this standard is met, FDA can detain foods for up to 30 days, halting any shipments of suspect products while the agency considers other legal steps such as seizure or injunction. 

In this case, before the 30 days were up, USPlabs agreed to destroy its remaining stock. It had already committed in April 2013 to stop putting DMAA in the products. 

At GNC facilities in Pennsylvania and Arizona, FDA oversaw the destruction of GNC’s stores of OxyElite Pro and Jack3D, and the company has agreed to destroy its remaining supply in South Carolina. 

However, some products with DMAA may remain available on the Internet or store shelves while we continue working on this problem. 

Consumers are advised to read the label of any dietary supplement in their possession and discard the product if the label states it contains DMAA. Also, make sure to check FDA’s DMAA web page. DMAA may still be present in your supplement but under a different name. The website contains the full list of names that are commonly used for DMAA. So be sure to read your labels carefully. 

Finally, FDA asks health care professionals and consumers to report any adverse reactions to products containing DMAA to FDA’s MedWatch program either by:

•             completing and submitting an adverse event report online at www.fda.gov/medwatch/report.htm; or 

•             downloading and completing the adverse event reporting form, then submitting it via fax at 1-800-FDA-0178. 

Daniel Fabricant, Ph.D., is Director of FDA’s Division of Dietary Supplement Programs