September 19, 2014
The Food and Drug Administration (FDA) has taken a major step towards learning whether levels of arsenic in rice and rice products pose a risk to public health.
The agency has collected a total of more than 1,300 samples of rice and rice products and has tested them for both total arsenic and inorganic arsenic, the more toxic form. FDA scientists have determined that the levels of inorganic arsenic found in the samples are too low to cause immediate health damage.
In the rice grains, the average levels of inorganic arsenic ranged from 2.6 to 7.2 micrograms per serving, with instant rice at the low end of the range and brown rice at the high end. In rice products, the average levels of inorganic arsenic ranged from 0.1 to 6.6 micrograms per serving, with infant formula at the low end of the range and rice pasta at the high end. (A microgram is one-millionth of a gram; serving sizes varied with the product types.)
But what about the long-term impact? After all, rice is a food that people eat over the course of a lifetime.
The next step for FDA will be to conduct a comprehensive risk assessment, explains Suzanne C. Fitzpatrick, Ph.D., the senior advisor for toxicology in FDA’s Center for Food Safety and Applied Nutrition (CFSAN). This analysis of the health risk associated with eating rice and rice products will be the foundation of future FDA actions.
“These are the next steps. To look at exposure levels, to analyze the risk, and determine how to minimize that risk for the overall safety of consumers, including vulnerable groups like children and pregnant women,” says Fitzpatrick.
“We must take one step at a time and stay true to our methodological approach,” says Michael R. Taylor, J.D., deputy commissioner for foods and veterinary medicine. “We can’t get ahead of the science.”
“One of the things we need to emphasize is that arsenic is a naturally occurring contaminant, and because it’s in soil and water, it’s going to get into food,” says Fitzpatrick. “It’s not something that we can just pull off the market.”
Arsenic is a chemical element distributed in the Earth’s crust. Human activities such as fuel burning, mining and the use of arsenic compounds in pesticides have also added arsenic to the environment. But Fitzpatrick says that even if you stripped all human contributions, there would still be arsenic in food.
And rice is particularly vulnerable. “Rice is grown in water and takes in arsenic. You’re going to see greater levels in rice than in other foods,” she says.
FDA has been monitoring arsenic levels in foods for more than 20 years, but Fitzpatrick says there have been advances in testing that allow FDA to get much more detailed information.
FDA consumer safety officers collected samples from retail outlets across the country. In addition to rice itself, these samples cover most types of rice-based foods in the American diet, including cereals, cakes, beverages, snack bars and infant and toddler foods.
These samples were then analyzed in FDA labs, in addition to some labs contracted by the agency to do this work. Fitzpatrick says the laboratory workers were required to undergo training in new chemical testing called “speciation.” This testing enables the labs to look beyond just organic vs. inorganic to all the different species of arsenic present in the samples.
“It’s a very complicated process and it involves a lot of people,” Fitzpatrick says. “We’re working very hard to get the best possible scientific answers.”
Meanwhile, FDA was studying arsenic in other ways. Researchers examined studies of populations exposed to high levels of arsenic in such countries as Chile, Taiwan and Bangladesh. They looked at rates of cancer and diseases such as diabetes and cardiovascular illnesses.
The researchers had to consider how the data about these highly exposed cultures would apply to American consumers.
August 25, 2014
People with celiac disease can now have confidence in the meaning of a “gluten-free” label on foods.
The Food and Drug Administration (FDA) has issued a final rule that defines what characteristics a food has to have to bear a label that proclaims it “gluten- free.” The rule also holds foods labeled “without gluten,” “free of gluten,” and “no gluten” to the same standard.
This rule has been eagerly awaited by advocates for people with celiac disease, who face potentially life-threatening illnesses if they eat the gluten found in breads, cakes, cereals, pastas and many other foods.
As one of the criteria for using the claim “gluten-free,” FDA is setting a gluten limit of less than 20 ppm (parts per million) in foods that carry this label. This is the lowest level that can be consistently detected in foods using valid scientific analytical tools. Also, most people with celiac disease can tolerate foods with very small amounts of gluten. This level is consistent with those set by other countries and international bodies that set food safety standards.
“This standard ‘gluten-free’ definition will eliminate uncertainty about how food producers label their products and will assure people with celiac disease that foods labeled ‘gluten-free’ meet a clear standard established and enforced by FDA,” says Michael R. Taylor, J.D., deputy FDA commissioner for foods and veterinary medicine.
Andrea Levario, executive director of the American Celiac Disease Alliance, notes that there is no cure for celiac disease and the only way to manage the disease is dietary—not eating gluten. Without a legal definition of “gluten-free,” these consumers could never really be sure if their body would tolerate a food with that label, she adds.
“This is a tool that has been desperately needed,” Levario says. “It keeps food safe for this population, gives them the tools they need to manage their health, and obviously has long-term benefits for them.”
“Without proper food labeling regulation, celiac patients cannot know what the words ‘gluten free’ mean when they see them on a food label,” says Allessio Fasano, M.D., director of the Center for Celiac Research at MassGeneral Hospital for Children, visiting professor of pediatrics at Harvard Medical School and member of the American Celiac Disease Alliance.
Gluten means the proteins that occur naturally in wheat, rye, barley, and crossbreeds of these grains.
As many as 3 million people in the United States have celiac disease. It 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 (a lower than normal number of red blood cells) and osteoporosis, a disease in which bones become fragile and more likely to break. Other serious health problems may include diabetes, autoimmune thyroid disease and intestinal cancers.
Before the rule there were no federal standards or definitions for the food industry to use in labeling products “gluten-free.” An estimated 5 percent of foods currently labeled “gluten-free” contain 20 ppm or more of gluten.
In addition to limiting the unavoidable presence of gluten to less than 20 ppm, FDA will 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 grains
- an ingredient derived from these grains and that has not been processed to remove gluten
- an 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) gluten
Foods such as bottled spring water, fruits and vegetables, and eggs can also be labeled “gluten-free” if they inherently don’t have any gluten.
The regulation will be published Aug. 5, 2013 in the Federal Register, and manufacturers have one year from the publication date to bring their labels into compliance. Taylor says he believes many foods labeled “gluten free” may be able to meet the new federal definition already. However, he adds, “We encourage the food industry to come into compliance with the rule as soon as possible.”
Under the new rule, a food label that bears the claim “gluten-free,” as well as the claims “free of gluten,” “without gluten,” and “no gluten,” but fails to meet the requirements of the rule would be considered misbranded and subject to regulatory action by FDA.
Those who need to know with certainty that a food is gluten-free are heralding the arrival of this definition. “This is a huge victory for people with celiac disease,” says Levario. “In fact, that’s the understatement of the year.”
Says Taylor, “FDA’s ‘gluten-free’ definition will help people make food choices with confidence.”
June 4, 2014
The Food and Drug Administration (FDA) is proposing two rules that represent a fundamental shift in its oversight of imported foods. The shift is designed to help prevent safety problems before those foods arrive in the United States, rather than having to rely primarily on inspections at U.S. ports of entry.
The proposed Foreign Supplier Verification and Accredited Third Party Certification rules are the next major steps in implementing the FDA Food Safety Modernization Act signed by President Obama in 2011. The law calls for science-based changes to the food safety system to prevent foodborne illnesses.
The new rules would make importers more accountable for food safety, and would establish standards for third-party audits of foreign food producers. These proposals would strengthen FDA’s ability to monitor those facilities and respond if there are unsafe practices. A lot of the food we eat is imported—15 percent of the U.S. food supply, including nearly 50 percent of fresh fruit and 20 percent of fresh vegetables.
“We must work toward global solutions to food safety so that whether you serve your family food grown locally or imported you can be confident that it is safe,” says FDA Commissioner Margaret A. Hamburg, M.D.
The new rules would complement two others proposed in January 2013. The proposed Preventive Controls for Human Food rule would set safety requirements for facilities that process, package or store food for people. And the proposed Produce Safety rule would establish science-based standards for the safe growing, harvesting, packing, and holding of produce on farms.
April 30, 2013
For the Food and Drug Administration, prevention is at the heart of food safety.
“Preventing problems before they cause harm is not only common sense, it is the key to food safety in the 21st century,” says FDA Commissioner Margaret A.
Hamburg, M.D. “We cannot afford to wait until people become ill to realize there is a problem.”
Prevention is the core principle of the FDA Food Safety Modernization Act that President Obama signed into law in 2011, creating a blueprint for the most sweeping changes to the nation’s food protection system since Theodore Roosevelt held office.
In accordance with that law, FDA is promulgating five new rules to support and strengthen the nation’s food safety system for the 21st century. Together, the proposed rules will establish requirements for farmers, food companies and importers to prevent foodborne illness.
The first two have been proposed and published for public comment:
- Preventive Controls for Human Food: This rule sets safety requirements for facilities that process, package or store food for people. (There is a separate, upcoming rule for animal food.) The rule will require that food facilities implement “preventive controls,” a science-based set of measures intended to prevent foodborne illness.
- Produce Safety: The food-safety law requires that science-based standards be set for the production and harvesting of fruits and vegetables, and FDA is proposing such standards for growing, harvesting, packing, and holding produce on farms.
April 9, 2012
If you eat food contaminated with bacteria called Listeria, you could get so sick that you have to be hospitalized. And for certain vulnerable people, the illness could be fatal.
Contaminated food can bring Listeria into the home. Unlike most bacteria, Listeria germs can grow and spread in the refrigerator. So if you unknowingly refrigerate Listeria-contaminated food, the germs could contaminate your refrigerator and spread to other foods there and increase the likelihood that you and your family will become sick.
Those most at risk for listeriosis—the illness caused by Listeria monocytogenes—include pregnant women, older adults and people with compromised immune systems and certain chronic medical conditions (such as HIV/AIDS, cancer, diabetes, kidney disease, and transplant patients). In pregnant women, listeriosis can cause miscarriage, stillbirth, and serious illness or death in newborn babies.
Recently, a multi-state outbreak of listeriosis tied to contaminated cantaloupes has caused illnesses and deaths. Listeria has also been linked to a variety of ready-to-eat foods, including unpasteurized milk and dairy products, Mexican-style or soft cheeses made with unpasteurized milk, processed deli meats, hot dogs, smoked seafood and store-prepared deli-salads.
Donald Zink, Ph.D, senior science advisor at FDA’s Center for Food Safety and Applied Nutrition, says FDA is aware of cases of foodborne illness caused by bacteria that can live in the kitchen and spread to foods.
Consumers are advised to wash all fruits and vegetables under running water just before eating, cutting or cooking, even if you plan to peel the produce first. Scrub firm produce such as melons and cucumbers with a clean produce brush.
September 15, 2011
In the past five years, consumers have faced widespread outbreaks of foodborne illnesses tied to foods—such as spinach, peanut butter and eggs—that are staples of the American diet.
The Food and Drug Administration is taking steps to prevent or shorten these outbreaks by developing the tools needed to rapidly track down foods that may be contaminated.
Two pilot projects—one for processed foods and the other for produce—will be conducted to explore how FDA and the food industry can quickly trace foods back to the common source of contamination that led to an outbreak of foodborne illnesses. These pilots must include at least three different types of foods that were the subject of significant outbreaks in the five years preceding the January 2011 enactment of the Food Safety Modernization Act (FSMA).
The Institute of Food Technologists (IFT) will carry out the pilots, at FDA’s direction, under an existing contract with the agency. IFT is a Chicago-based nonprofit scientific society focused on food science and technology and has previously worked with FDA on product-tracing studies.
These pilots are mandated by the landmark food safety law that requires FDA to implement a system that is based on science and addresses food safety hazards from farm to table.
“We can prevent illnesses and reduce the economic impact to the food industry if we can more quickly discover what food may be causing an outbreak and what foods can be eliminated from consideration,” says Michael R. Taylor, FDA’s deputy commissioner for foods.
March 10, 2011
What’s a building block in the food pyramid that’s important for building and maintaining bone mass? It’s milk. Whether it’s from cows, goats, sheep, or another mammal, milk and milk products are an important source of calcium throughout a person’s life.
Most of the milk sold in the United States is pasteurized, a process during which the milk is heated to 161 degrees and kept there for 15 seconds. Pasteurization kills harmful bacteria—including salmonella, E. coli, and listeria—that can contaminate milk before it gets to your table.
Pasteurization of milk is an effective means of preventing outbreaks of foodborne illness, including tuberculosis, brucellosis, salmonellosis, scarlet fever, and listeriosis. It was first used in the United States more than 100 years ago and has been widely used for more than a half-century, says John Sheehan, an FDA expert on the safety of dairy products. But increasingly, consumers are seeing “raw” milk—and cheeses, yogurts, and other products made from it—in specialty shops, farmers’ markets, and stores.
Although the heating process slightly affects a few of the vitamins—thiamine, vitamin B6 and folic acid within the B-complex, and vitamin C, the changes are not significant. Meanwhile, there is a risk that milk could be contaminated by environmental factors such as soil or animal feces, animal diseases, or bacteria on an animal’s skin.
In countries where pasteurization of milk is less common, outbreaks of foodborne illness attributed to tainted milk or milk products occur more frequently than they do in the United States. In France, for example, the rate of foodborne illness attributed to milk and milk products was reported to be roughly three times what it is in the U.S., citing a 2001 study by researcher Marie-Laure De Buyser and other French scientists.