A New Era of “Gluten-free” Labeling

By: Michael R. Taylor

For most of us, choosing a meal is not a make or break decision. Most people prepare a meal without fearing that it will endanger their health. That’s not the case with people who suffer from celiac disease. I’ve learned first-hand from talking with people with the disease how much it means to them to be able to select gluten-free foods with confidence.

Michael Taylor

Michael Taylor

Celiac disease is a serious health issue and there is no cure. The only choice for the more than 3 million Americans living with the disease is adherence to a diet free of gluten — 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 possibly leading to a host of other health problems.

Last year FDA issued a rule on food labeling to improve life for people with celiac disease. The rule ensures that “gluten-free” claims on food packages are reliable and consistent. It provides a clear definition of the term so that all packaged food products bearing the claim “gluten-free” contain less than 20 parts per million of the protein.

And today is the compliance date for this rule. This is important because it means that any packaged food product labeled with the “gluten-free” claim, as of today, must meet the standard set by the FDA.

FDA gave companies a year to make the necessary changes to their products if they used the “gluten-free” claim. This past year, we took steps to educate industry about the rule and what it means to be gluten-free. In June, we issued a guide to help small businesses comply with the rule.

The gluten-free final rule applies to packaged foods, which may be sold in some retail and food-service establishments such as some carry-out restaurants. However, given the public health significance of “gluten-free” labeling, FDA says that restaurants making a gluten-free claim on their menus should be consistent with FDA’s definition. I’m pleased to note that the National Restaurant Association also advised operators offering “gluten-free” items on their menus to make sure their claims are consistent with the definition.

Honest and accurate “gluten-free” labeling will strengthen consumers’ confidence in the products that carry it. One of the rule’s requirements is that it establishes a threshold of 20 parts per million — meaning that to be labeled as free of gluten, each kilogram of the product must contain less than 20 milligrams of the protein. This is consistent with the threshold established by other countries and international bodies that set food safety standards.

I commend companies that have already stepped up to the plate to meet the definition for “gluten-free” labeling. They make it possible for consumers to have labels they can trust as they make well-informed food choices.

Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine

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

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.