Arsenic in Rice

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.”

Why Rice?

“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.

The Story So Far

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.

What is Gluten-Free?

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.

What Is Gluten?

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.

How Does FDA Define ‘Gluten-Free’?

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:

  1. an ingredient that is any type of wheat, rye, barley, or crossbreeds of these grains
  2. an ingredient derived from these grains and that has not been processed to remove gluten
  3. 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.”

Imported Foods

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.

Food Labels

June 9, 2013

As someone who cares about what your family eats, you make it a practice when shopping to read the labels on food packages.  And you have the right to expect that the information on the label, including the ingredient list, is accurate.

The good news is that the Food and Drug Administration (FDA) has your back.

The Federal Food, Drug and Cosmetic Act—which provides authority for FDA’s consumer-protection work—requires that labels on packaged food products in interstate commerce not be false or misleading in any way.

To that end, as resources permit, FDA monitors food products to ensure that the labels are truthful and not misleading, explains Michael W. Roosevelt, acting director of compliance at FDA’s Center for Food Safety and Applied Nutrition (CFSAN). If a product is not labeled as required by law, the agency takes appropriate action.

For example, when FDA received complaints from U.S. firms and attorneys alleging that imports of pomegranate juice concentrates were not, as labeled, 100% pomegranate, the agency took a closer look.

After conducting its own analyses, FDA found that some of the samples contained undeclared ingredients, including artificial colors, sweeteners and less expensive fruit juices, such as black currant, apple, pear or cherry juices, in place of pomegranate juice.

FDA issued an import alert for pomegranate juice exported by certain companies in Iran and Turkey, based on findings that the samples FDA analyzed were “not as they were represented to be on the labels and therefore adulterated and misbranded.” An import alert allows FDA to detain, without physical examination,   imported products that appear to violate the Federal Food, Drug, and Cosmetic Act. When a shipment is detained, the importer has a window of opportunity to introduce evidence to overcome the appearance of a violation, during which time the product cannot be distributed.

In other circumstances, when the agency identifies a food product with labeling that is false or misleading (misbranded), it may inform the manufacturer, often in the form of a warning letter, of the violation of law and ask the firm to correct the problem. Most firms contacted by FDA about a labeling violation voluntarily comply, Roosevelt says.

Those that do not can be subject to additional legal action to remove the misbranded products from commerce. Under such circumstances, these products cannot return to the market until the manufacturers take action to correct the violations.

“In the case of the pomegranate juice,” Roosevelt says, “the burden is on the importer to show that the product labeling is accurate.” “Otherwise, the juice is not going to make it into the U.S.”

Nutrition Facts Labels

May 16, 2013

When you’re walking down the aisles of a supermarket, it’s not unusual to see fellow shoppers reading the information on the back of a food package, box or can.  They might want to know how many calories are in the food, or they might be watching their sodium intake.

They could be trying to limit sugars and eat more dietary fiber. Or they could be parents trying to make the most nutritious choices for their children.

All this information is available thanks to an important addition to food packaging that was introduced to the American public 20 years ago: the Nutrition Facts label. This familiar rectangular box provides, in a standard format, important information about the nutritional content for most packaged foods, including breads, cereals, canned and frozen foods, snacks, desserts and drinks.

“It was revolutionary,” says Jessica Leighton, Ph.D., senior nutrition science and policy advisor in FDA’s Office of Foods and Veterinary Medicine. “For the first time, people had consistent information they need right at the point of purchase for the majority of packaged food products.”

In the years since FDA issued the final rule for this labeling on Jan. 6, 1993, the Nutrition Facts label has influenced many companies to make their foods more healthful. Additionally, notes Claudine Kavanaugh, Ph.D.,M.P.H.,R.D., a scientist at the agency, “FDA was really a trailblazer in nutrition labeling. The Nutrition Facts label has been adapted by countries around the world that have chosen to mandate food.

Label Use Increasing

The Nutrition Facts label was mandated after passage of the Nutrition Labeling and Education Act of 1990. Before it became standard practice, manufacturers provided nutritional information on a voluntary basis that wasn’t consistent from product to product, explains Felicia Billingslea, M.S., director of FDA’s food labeling and standards staff.

“The label is all about the attributes of the food,” says Billingslea. “It’s not to say that this is a good food or a bad food. It provides information that consumers can use and rely upon in developing healthful diets for themselves.”

FDA survey data shows that use of the Nutrition Facts label has been increasing. In comparing the Health and Diet Survey conducted in 2002 with the most recent one conducted in 2008, the percentage of consumers reporting that they often use the label rose from 44 to 54 percent.

This usage has influenced many companies to change their ingredients to make the foods more healthful and thus more appealing to many consumers.

FDA cites as an example the decrease in consumption of trans fat, which has been linked to heart disease, primarily because of a decrease in manufacturers’ use of partially hydrogenated oils. From the late 1990s to 2010, trans fat intake in adults decreased from 4.6 grams to 1.3 grams per day, with most of the reduction occurring after trans fat was added to the food label in 2003.

FDA has oversight of more than 166,000 registered domestic food facilities, including manufacturers, processors, warehouses, storage tanks and grain elevators. Under the new preventive control rules, most human food facilities would be required to have a written plan that

  • evaluates hazards that are reasonably likely to occur in food, such as pathogens (disease-causing organisms) and allergens.
  • specifies the steps that will be put in place to minimize or prevent those hazards.
  • specifies how these controls will be monitored.
  • maintains routine records of the monitoring.
  • specifies what actions will be taken to correct problems that arise.

The plan would specify the steps that will be put in place to minimize or prevent those hazards, and the actions that will be taken when problems arise.

Food facilities “must think up front about what they have to do to keep the food safe,” says Michael Taylor, FDA deputy commissioner for foods.

“While the plan will come from the food companies, the planning and execution are done under the watchful eye of FDA,” notes Donald Kraemer, senior advisor at FDA’s Center for Food Safety and Applied Nutrition. “The agency will evaluate the plans and will continue to inspect the facilities,” he says.

Produce Safety

These standards include requirements addressing major areas specific to agriculture that can be the conduit for contaminants:

  • Irrigation and other agricultural water
  • Farm worker hygiene
  • Manure and other additions to the soil
  • Intrusion of animals in the growing fields.
  • Sanitation conditions affecting buildings, equipment and tools

The proposed rule also includes additional provisions applicable to the growing, harvesting and packing of sprouts, which are more vulnerable in their growing environment to harmful bacteria.

FDA staff traveled to 13 states and numerous farms to get a first-hand understanding of the diversity of farms and farming practices. “We met with Amish growers in the Ohio valley, organic and sustainable farmers throughout the nation’s heartland, small farmer cooperative members who supply major metropolitan areas, and large commercial growers and shippers,” says Kraemer.

Kraemer explains that there are many variables to consider. With water, for example, the actions farmers would be required to take depend in part on the kind of irrigation system used and whether the water comes in direct contact with the fruit or vegetable. The bottom line, though, would be that “you can’t use water that would cause food to be contaminated,” he says.

Food Safety Foundation

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.