Do you have questions about medical devices you use at home? There are many such devices, from ventilators to blood pressure monitors.

Learn more during a 30-minute webinar hosted by the Food and Drug Administration’s Center for Devices and Radiological Health. An FDA expert will discuss how FDA plans to address the increased use of medical devices in the home and will talk briefly about the new technology that is focusing on self-care and self-monitoring.

The public will have an opportunity to ask questions following the presentation.

When: Thursday, July 28, 2011, at 2:00 p.m. (ET)

Length: 30 minutes

Where: To join the webinar, see the instructions here

Host: FDA's Center for Devices and Radiological Health

Featured speaker: Mary Brady, senior policy analyst in the Office of the Center Director, Center for Devices and Radiological Health

This webinar is part of a series of online sessions hosted by different FDA centers and offices. The series is part of FDA Basics, a Web-based resource aimed at helping the public better understand what the agency does.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

 

 

Do you know how vaccines are developed and approved? Or how the Food and Drug Administration (FDA) ensures that vaccines are safe and effective in preventing disease?

Learn about the vital role that FDA plays in protecting the health of our nation’s children through regulation of vaccines in this 30-minute webinar. An FDA expert will discuss the importance of vaccines to a child’s health, the development process for vaccines, how FDA makes sure vaccines that are granted licensure (approval) are safe and effective, and how the agency oversees their continued safety and effectiveness.

An opportunity to ask questions will follow the presentation.

When:  Thursday, Aug. 18, 2:00 p.m. ET

Length: 30 minutes

Where:  To join the webinar, see the instructions here. Webinar slides will be posted here also.

Host: Office of Vaccines Research and Review within FDA’s Center for Biologics Evaluation and Research

Featured speaker: Norman Baylor, Ph.D., director of the Office of Vaccines Research and Review within FDA’s Center for Biologics Evaluation and Research

This webinar is part of a series of online sessions hosted by different FDA centers and offices. The series is part of FDA Basics, a Web-based resource aimed at helping the public better understand what the agency does.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

 

Photo courtesy of J. Zirato, University of Arizona BioCommunications

 

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“Once stung, twice shy” are words to live by in the Southwestern United States, where about 11,000 people a year are stung by scorpions in Arizona alone.

Though rarely life threatening, scorpion stings can be extremely painful, causing numbness and burning at the wound site. And there’s been little a victim could do to ease the pain.

Until now.

The Food and Drug Administration has just approved the first treatment specifically for the sting of the Centruroides scorpion, the most common type in the United States.

The new biologic treatment—called Anascorp—was given a priority review because adequate treatment did not exist in the United States, says Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research.

“This product provides a new treatment for children and adults and is designed specifically for scorpion stings,” Midthun says. “Scorpion stings can be life-threatening, especially in infants and children.”

Severe stings can cause loss of muscle control and difficulty breathing, requiring heavy sedation and intensive care in a hospital. Most often, it’s small children who experience severe reactions, but adults can be affected, too, says Keith Boesen, managing director of the Arizona Poison and Drug Information Center (APDIC).

Boesen says Arizona’s two poison centers document about 11,000 scorpion stings each year; 17,000 stings were reported to U.S. poison centers nationwide in 2009.

“We at the APDIC and University of Arizona College of Pharmacy are very excited (about Anascorp’s approval). I am proud of the expertise of the pharmacists and physicians working at the APDIC who helped make this research possible,” he says.

Anascorp was developed in Mexico and has been used there for many years, according to University of Arizona researchers who led the U.S. study of the drug. It’s made from the plasma of horses immunized with scorpion venom and vaccinated against viruses that could infect humans. Researchers began studying the drug in Arizona hospitals in 2004 and found it to be highly effective against the sting of the bark scorpion (also called the Arizona bark scorpion)—the most poisonous scorpion in the U.S.

Without Anascorp, children experiencing the most severe symptoms usually had to stay in intensive care in the hospital for several days; but when Anascorp was administered, researchers found patients’ symptoms disappeared after a few hours in the emergency room—eliminating the need for a hospital stay.

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The bark scorpion is found primarily in Arizona, but it also lives in other areas of the Southwest and northern Mexico, according to the Arizona-Sonora Desert Museum in Tucson, Ariz.

Scorpions are attracted to dark, moist spaces. They like to hide under rocks, wood, loose tree bark or anything else lying on the ground during the day, and they become active at night. Landscapers and others who work outside are at risk of being stung, as are people participating in outdoor activities.

Because they’re small and adept at climbing, scorpions may hitch a ride into homes in a sack of groceries or piece of clothing. Once indoors, they may get trapped in the sink or bathtub, look for a place to hide in an attic or crawl space, or scale the walls or ceiling, according to the desert museum website. Victims often report being stung while sleeping.

In June, a 6-month-old Arizona girl was airlifted from the small town of Oracle, Ariz., to University Medical Center in Tucson after a scorpion stung her as she slept, KSAZ-TV in Phoenix reported. Stephanie Moors, the child’s mother, was attending a yoga retreat and had just put her daughter down for a nap when she saw a scorpion’s tail wriggling under the child’s head. The girl was crying, vomiting, and, eventually, convulsing on the way to the hospital 36 miles away, but she made a full recovery after spending five days in the hospital.

The desert museum says you can check your home for scorpions by illuminating rooms with a black light flashlight or portable unit or a black light bulb in a lamp. Scorpion will glow a light blue-green color under the ultraviolet rays of a black light.

Jude McNally, the medical science liaison at Rare Disease Therapeutics, says the Tennessee company will market the new drug to any health care facility that accepts emergency patients in areas were the bark scorpion is found. That’s Arizona, as well as areas of Clark County, Nev., and parts of New Mexico where the bark scorpion has established colonies, he says.

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The Arizona Poison and Drug Information Center says most stings to healthy, young adults can be managed at home with basic first aid and follow-up. Victims should

clean the site with soap and waterapply a cool compresselevate the affected limb to the same level as your hearttake aspirin or acetaminophen as needed for minor discomfort

If a child is stung or the victim experiences severe symptoms, go to a medical facility immediately. If the child is under 5 years old or if an older patient is experiencing more than minor discomfort, call the poison center at 1-800-222-1222.

Made by Instituto Bioclon in Mexico City, Anascorp may cause early or delayed allergic reactions in people sensitive to horse proteins. The manufacturing process includes steps to decrease the chance of allergic reactions and to reduce the risk of transmission of viruses that may be present in the horse plasma.

FDA determined Anascorp was effective based on the results of an initial placebo-controlled, double-blind study of 15 children with neurological signs of scorpion stings. During placebo-controlled, double-blind studies, some patients get the medicine being tested, and others get a placebo—and even the researcher doesn’t know who gets which treatment. In the Anascorp study, symptoms disappeared within four hours in the eight subjects who received the antidote, but only one of the seven who received a placebo recovered so quickly.

In total, safety and efficacy data were collected from 1,534 patients in the studies led by the University of Arizona. The most common side effects of Anascorp were vomiting, fever, rash, nausea, itchiness, headache, runny nose, and muscle pain.

Experts say desert dwellers should know the symptoms of a scorpion sting and get treatment if severe symptoms develop. Severe symptoms include shortness of breath, fluid in the lungs, breathing problems, excess saliva, blurred vision, slurred speech, trouble swallowing, abnormal eye movements, muscle twitching, thrashing of the arms and legs, trouble walking, and other, uncoordinated muscle movements.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

 

To find out if an over-the-counter medicine contains acetaminophen, look for “acetaminophen” on the Drug Facts label under the section called “Active Ingredient.” Get hi-res version of this photo on Flickr.

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You’re in the drug store, looking for a fever-reducing medicine for your children. They range in age from 6 months to 7 years, and you want to buy one product you can use for all of them. So you buy liquid acetaminophen in concentrated drops for infants, figuring you can use the dropper for the baby and a teaspoon for the oldest.

This could be a dangerous mistake.

This use of concentrated drops in much larger amounts—as would be given with a teaspoon—can cause fatal overdoses, says Sandra Kweder, M.D., deputy director of the Food and Drug Administration’s Office of New Drugs.

You can’t just give an older child more of an infant’s medicine, adds Kweder. “Improper dosing is one of the biggest problems in giving acetaminophen to children.”

Confusion about dosing is partly caused by the availability of different formulas, strengths, and dosage instructions for different ages of children.

Sold as a single active ingredient under such brand names as Tylenol, acetaminophen is commonly used to reduce fever and relieve pain. It is also used in combination with other ingredients in products to relieve multiple symptoms, such as cough and cold medicines. Acetaminophen can be found in more than 600 over-the-counter (OTC, or non-prescription) and prescription medicines.

Improper dosing is one of the biggest problems in giving acetaminophen to children.

Acetaminophen is generally safe and effective if you follow the directions on the package, but if you give a child even a little more than directed or give more than one medicine that contains acetaminophen, it can cause nausea and vomiting, says Kweder.

In some cases—in both adults and children—it can cause liver failure and death. In fact, acetaminophen poisoning is a leading cause of liver failure in the U.S.

An FDA Advisory Panel of outside experts met May 17-18, 2011, to discuss how to minimize medication errors and make children’s OTC medicines that contain acetaminophen safer to use.

The panel recommended:

That liquid, chewable, and tablet forms be made in just one strength. Currently, there are seven strengths available for these forms combined.That dosing instructions to reduce fever be developed for children as young as 6 months. Current instructions apply to children ages 2 to 12 years and for those under 2, only state “consult a doctor.”That dosing instructions be based on weight, not just age.Setting standards for dosing devices, such as spoons and cups, for children’s medicines. Currently, some use milliliters (mL) while others use cubic centimeters (cc) or teaspoons (tsp).

“FDA is considering these recommendations,” says Kweder, and for those that the agency adopts, “we will work with manufacturers to try to get them in place on a voluntary basis.” The process of getting a regulation finalized could take several years, she adds, so having the drug industry act voluntarily would help make acetaminophen safer sooner.

Drug makers have already agreed to phase out the concentrated infant drops to reduce confusion for parents who try to use them for older children. On May 4, 2011, the Consumer Healthcare Products Association, a trade group representing the makers of OTC medicines, announced plans to convert liquid acetaminophen products for children to just one strength (160 mg/5 mL). In addition, the industry is voluntarily standardizing the unit of measurement “mL” on dosing devices for these products.

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Under a 2009 FDA regulation, manufacturers must place the word “acetaminophen” on the front of the package of all OTC products that contain the ingredient and on the “Drug Facts” label on the container and packaging.

However, prescription medicines don’t have Drug Facts labels. Instead, the pharmacy places a computer-printed label based on the doctor’s prescription on the container before giving it to the consumer. Pharmacies often use the acronym “APAP” (N-acetyl-p-aminophenol) or a shortened version of acetaminophen to represent the ingredient. If parents don’t know these abbreviations, they might not recognize that a prescription medicine contains acetaminophen and could accidentally overdose a child by giving a prescription and an OTC acetaminophen medicine at the same time.

FDA’s Safe Use Initiative, which fosters collaborations within the health care community to help prevent harm from medications, has been working to bring about the complete spelling of acetaminophen on prescription containers.

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Never give your child more than one medicine containing acetaminophen at a time. To find out if an OTC medicine contains acetaminophen, look for “acetaminophen” on the Drug Facts label under the section called “Active Ingredient.” For prescription pain relievers, ask the pharmacist if the medicine contains acetaminophen.Choose the right OTC medicine based on your child’s weight and age. The “Directions” section of the Drug Facts label tells you if the medicine is right for your child and how much to give. If a dose for your child’s weight or age is not listed on the label or you can’t tell how much to give, ask your pharmacist or doctor what to do.Never give more of an acetaminophen-containing medicine than directed. If the medicine doesn’t help your child feel better, talk to your doctor, nurse, or pharmacist.If the medicine is a liquid, use the measuring tool that comes with the medicine—not a kitchen spoon.Keep a daily record of the medicines you give to your child. Share this information with anyone who is helping care for your child.If your child swallows too much acetaminophen, get medical help right away, even if your child doesn’t feel sick. For immediate help, call the 24-hour Poison Control Center at 800-222-1222, or call 911.

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The Food and Drug Administration (FDA) has released its “Strategic Plan for Regulatory Science,” a sweeping initiative to modernize the tools and methods that the agency uses to evaluate whether the products it regulates are effective and safe for consumers.

Regulatory science is the foundation of decision-making at FDA. Researchers across FDA gather data, do tests and think of new, better and faster ways to scientifically establish that regulated products enhance—without harming—the lives of the American public.

Products regulated by FDA include biologics (such as blood products and vaccines), human drugs, medical devices, foods, cosmetics, tobacco products, and animal feed and drugs. The broad scope of FDA’s plan covers the personal health of the consumer, the strength of the economy and the security of the nation.

“As new discoveries yield increasingly complex products, FDA’s experts need to be equipped to make science-based decisions resulting in sound regulatory policy,” says Commissioner of Food and Drugs Margaret A. Hamburg, M.D.

“It’s really about using science to protect and promote public health,” says Jan N. Johannessen at FDA’s Center for Drug Evaluation and Research. “Advancements in science create tremendous opportunities to improve how products are developed and evaluated.”

“We want to ensure that these advances benefit patients,” says Johannessen.  “Our research is vital to ensuring the safety and effectiveness of the products we regulate,” adds Carolyn A. Wilson, PhD, at FDA’s Center for Biologics Evaluation and Research.

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The framework of the regulatory science initiative was originally released in October 2010. The new plan fills in the details and focuses on eight key areas:

Modernizing toxicology—the study of chemical, biological or physical agents that can be harmful—and improving the ability of tests, models and measurements to predict product safety issues. This includes, where feasible, the development of new methods that could reduce or replace animal testing.Crafting new tools and approaches for the development of personalized medicine—getting the right medicine to the right person at the right time.Supporting new and improved manufacturing methods by researching how new technologies affect product safety, effectiveness and quality.Ensuring that FDA is ready to evaluate innovative and emerging technologies with the necessary expertise and infrastructure.Expanding and improving FDA’s information technology infrastructure and the application of those resources to support sophisticated analyses of data.Implementing the prevention-focused food-safety system mandated by the Food Safety Modernization Act passed by Congress and signed into law by President Obama in January.Speeding the development of safe and effective medical countermeasures to protect against threats to U.S. health and security, such as chemical, biological, or nuclear threats or naturally occurring infectious disease outbreaks. Such countermeasures include drugs, vaccines, diagnostic tests and personal protective equipment.Developing a communications strategy that will help FDA adapt to rapidly evolving technologies that are changing how people receive and share information.

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“As new discoveries yield increasingly complex products, FDA’s experts need to be equipped to make science-based decisions resulting in sound regulatory policy.”

Why should you care about regulatory science?

What it boils down to, says FDA’s Chief Scientist Jesse Goodman, is that people want new drugs, healthy food and other products that work. They want them to be developed and approved quickly, but they also want these things to be safe.

And that’s where regulatory science comes in. Here are a few examples of how this science has worked so far:

A clinical trial model was developed to help scientists quickly test the most promising drugs in development to treat women with rapidly growing breast cancers. The drugs are targeted to the biology of each woman’s tumor using specific genetic or biological markers.By studying data from hundreds of clinical trials, FDA found that antidepressants can increase the risk of suicide in people under 25. This resulted in FDA placing warnings on the labeling and medication guides for these drugs. After the Deepwater Horizon disaster released in excess of 92 million gallons of oil into the Gulf of Mexico in 2010, FDA developed a more rapid, highly sensitive chemical testing method to ensure that seafood from the Gulf is safe for consumption.

“The headlines are replete with examples of the critically important scientific role the agency plays in addressing crises, such as contaminated heparin, melamine in pet food, outbreaks of foodborne illness, and questions about vaccine safety, seafood safety, or readiness for pandemic influenza,” the strategic plan states.

“A strong FDA science infrastructure provides the essential foundation for ensuring scientific excellence and integrity in all of our regulatory and public health decisions and activities.”

Or, as Goodman says succinctly, “Strong and up-to-date science in these areas will help us do our jobs better—to help people be as healthy, safe and secure as possible.”

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

 

 

This campus in Jefferson, Arkansas, houses all National Center for Toxicological Research operations, as well as the Arkansas Regional Laboratories, another FDA facility. For more photos of NCTR, visit Flickr.

NCTR researchers Dan Buzatu (right) and Jon Wilkes invented the Rapid-B system to detect live pathogens in foods. For more photos of NCTR, visit Flickr.

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A federal research center born in the Cold War era is celebrating its 40th birthday and its reputation as one of the world’s premier science centers.

The National Center for Toxicological Research (NCTR) is marking its anniversary by formalizing a partnership with the state of Arkansas to create a virtual Center for Regulatory Science. The center’s goals will include modernizing this field of research to bring safer products to the market faster, and increasing the understanding of the potential toxicity of nanotechnology-based products.

But all of NCTR’s work, which spans many fields of science and includes a smorgasbord of new technologies, is really about regulatory science, explains Center Director William Slikker, Jr., Ph.D. The center’s focus is on both the development of new approaches to evaluating the safety of products regulated by the Food and Drug Administration (FDA) and the creation of data sets that substantiate and guide regulatory decisions, he says.

NCTR researchers often study a product before it’s even gone through clinical trials. At other times, they study products that have been around a long time but have unforeseen qualities. No matter what the product or health issue, Slikker says, “We develop data to fill the knowledge gap.”

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In 1971, President Richard Nixon announced the establishment of the National Center for Toxicological Research on 500 acres in Jefferson, Arkansas. The site was once part of the U.S. Army’s Pine Bluff Arsenal but when President Nixon ordered the creation of this new center, it got a new home—the FDA.

NCTR’s initial mission was to study the effects of toxic chemicals on people and their environment. In the 40 years that have followed, NCTR has established itself as an internationally renowned research center, one that studies toxicity in chemicals, drugs and food, in addition to identifying the biomarkers for terrorism. The center studies human susceptibility to toxicants and the risk of disease. Toxicants are chemical, biological or physical agents that can be harmful to people, plants and animals.

The multidisciplinary teams of researchers—partnering with colleagues in other government agencies, industry and academia—also tackle a spectrum of personal and public health issues, including those affecting women and minorities in particular, as well as foodborne pathogens, and personalized nutrition and medicine.

The center has more than 500 scientists and other personnel in 30 buildings, in addition to the students, postdoctoral fellows, visiting scientists and FDA staff who come to NCTR to learn new technologies. “We’ve trained hundreds of individuals over the years,” says Slikker.

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“An important part of modernizing the FDA ... to better protect and promote the public health.”

To celebrate its birthday, FDA and NCTR are taking that research another big step further with the signing of an agreement with the State of Arkansas to create the Center of Excellence for Regulatory Science.

Slikker explained that the agreement is, in a sense,  a formalization of NCTR’s long association with researchers at the University of Arkansas for Medical Sciences and other state universities and institutions. There will be a particular focus on the study of the safety and efficacy of nanotechnology, he says.

The center is virtual in the sense that its work will be conducted in both state and federal facilities. There will be an expanded sharing of resources, facilities and education initiatives that target both students and members of the public.

FDA Commissioner Margaret A. Hamburg, M.D.,  calls the agreement with Arkansas “an important part of modernizing the FDA through the leveraging of intellectual, human and financial resources to better protect and promote the public health.”

Beyond this, NCTR has developed technologies that could one day transform healthcare. They include:

RAPID-B, a portable system that can instantly detect live pathogens (infectious agents that can cause disease)—such as E. coli 0157, Salmonella and Listeria. This can be used for on-site surveillance of food-producing facilities and for the detection of potential contamination of biological cells and tissues.Bioinformatics, the use of computers and math to answer questions about biology. In general, an example of this technology would be software tools that search for certain properties within DNA sequences. At  NCTR, teams of scientists from academia, industry and the government have been working together to create the standards, approaches and bioinformatic tools that will enable researchers to mine rich fields of biological data.Improvements in scanning devices—noninvasive magnetic resonance spectroscopy and MicroPET—to provide informative, translatable and much lower-risk diagnostics.Nanotechnology in cancer therapy that could make it possible to target difficult-to-treat or inoperable cancers.

And there’s promising research underway in the area of personalized medicine, says Slikker. “How do you deal with large data sets and try to develop safety information that’s important to the individual—that’s personalized? This is really exciting."

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

 

Click the button below to submit a comment on the proposed guidelines:

Consumers with celiac disease must avoid gluten—proteins found in baked goods made with wheat and some other grains. For people not sensitive to gluten, there is no health benefit to a gluten-free diet.

Some foods are naturally free of gluten. Here are some examples:

milk not flavored with ingredients that contain gluten, such as malt100 percent fruit or vegetable juicesfresh fruits and vegetablesbuttereggslentilspeanutsseeds, such as flaxtree nuts, such as almondsnon-gluten-containing grains, such as cornfresh fish, such as codfresh shellfish, such as clamshoneywater, including bottled, distilled, and spring

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Whether as muffins, rolls, or loaves, wheat bread is found in most households. But few consumers may appreciate the substance that helps the dough rise, keeps the bread from falling apart, makes it chewy, and adds to its flavor.

That substance is gluten. Breads, cakes, cereals, pastas, and many other foods are made with wheat or added wheat gluten to improve their baking quality and texture.

Technically, gluten represents specific proteins that occur naturally in wheat. However, the term “gluten” is commonly used to refer to certain proteins that occur naturally not only in wheat, but also in rye, barley, and crossbreeds of these grains and that can harm people who have celiac disease. The only treatment for this disorder is a life-long gluten-free diet.

Eating gluten doesn’t bother most consumers, but some people with celiac disease have health-threatening reactions, says Stefano Luccioli, M.D., a Food and Drug Administration (FDA) allergist and immunologist. They need to know whether a food contains gluten.

FDA has been working to define “gluten-free” to:

eliminate uncertainty about how food producers may label their products.assure consumers who must avoid gluten that foods labeled “gluten-free” meet a clear standard established and enforced by FDA.

FDA’s actions on Aug. 2 bring the agency one step closer to a standard definition of “gluten-free.” On this date:

FDA reopens the public comment period on its proposed gluten-free labeling rule published on Jan. 23, 2007.FDA makes available, and seeks comments on, a report on the health effects of gluten in people with celiac disease. The report includes a safety assessment on levels of gluten sensitivity in people with the disease.

According to the National Institutes of Health, celiac disease affects as many as 1 percent of the U.S. population.

The disease occurs when the body’s natural defense system reacts to gluten by attacking the lining of the small intestine. Without a healthy intestinal lining, the body cannot absorb the nutrients it needs. Delayed growth and nutrient deficiencies can result and may lead to conditions such as anemia and osteoporosis. Other serious health problems may include diabetes, autoimmune diseases, and intestinal cancers.

“Some people don’t get immediate symptoms, but when they do, they are typically gastrointestinal-related, such as abdominal pain, bloating, and diarrhea,” says Luccioli. “In infants, there may be a lot of vomiting, and they don’t grow and thrive.” And some people do not have any symptoms at all, adds Luccioli, but still may have intestinal damage and risk for long-term complications. It is important for individuals with celiac disease, who may vary in their sensitivity to gluten, to discuss their dietary needs with their health care professional.

Grocery shopping is challenging for people with this disease, says Andrea Levario, J.D., executive director of the American Celiac Disease Alliance. “When they find a product labeled ‘gluten-free,’ they don’t necessarily know what that means because today there is no federal standard for the use of this term.”

Having a federal definition of “gluten-free” is critically important, says Levario. “If we have one national standard, the individual will know that all products labeled ‘gluten-free’ will have no more than a minimal amount of gluten.”

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“Eating gluten-free is not meant to be a diet craze,” says Rhonda Kane, a registered dietitian and consumer safety officer at FDA. “It’s a medical necessity for those who have celiac disease.” 

“There are no nutritional advantages for a person not sensitive to gluten to be on a gluten-free diet,” she adds. “Those who are not sensitive to gluten have more flexibility and can choose from a greater variety of foods to achieve a balanced diet.”

Gluten-free is not synonymous with low fat, low sugar, or low sodium. For people who must be on a gluten-free diet, Kane says it's important to check the ingredients list and Nutrition Facts information on food labels to find the most nutritious options.

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In 2007, FDA proposed to allow manufacturers to label a food “gluten-free” if the food does not contain any of the following:

an ingredient that is any type of wheat, rye, barley, or crossbreeds of these grainsan ingredient derived from these grains and that has not been processed to remove glutenan ingredient derived from these grains and that has been processed to remove gluten, if it results in the food containing 20 or more parts per million (ppm) gluten20 ppm or more gluten

In the notice reopening the comment period, FDA states that it continues to believe the proposed definition of “gluten-free” is the correct one.

FDA’s notice also describes current analytical methods that can reliably and consistently detect gluten at levels of 20 ppm or more in a variety of foods. 

The agency is interested in hearing from the public and industry. The public comment period on the proposed rule will officially open after noon on Aug. 3, 2011, and will remain open for 60 days. To submit comments electronically, go to www.regulations.gov and

choose “Submit a Comment” from the top task barenter the docket number FDA-2005-N-0404 in the “Keyword” spaceselect “Search”

After FDA reviews and considers the comments, the agency will issue a final rule that defines “gluten-free” for labeling food products, including dietary supplements.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Aug. 2, 2011

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