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.
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.”
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.
August 30, 2012
Birth control pills that contain drospirenone may be associated with a higher risk of blood clots than other progestin-containing pills. FDA bases this conclusion on its review of recent studies on the risk of blood clots in women taking drospirenone-containing birth control pills.
Drospirenone is a synthetic version of the female hormone progesterone, also referred to as a progestin. FDA is adding information about the studies to the labels of drospirenone-containing birth control pills, which include:
- Drospirenone and ethinyl estradiol
Risk: The revised drug labels will state that some studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins, but other studies found no additional risk of blood clots with drospirenone-containing products.
Recommendation: Women should talk to their health care professional about their risk for blood clots before deciding which birth control method to use.
July 19, 2012
In 1959, a Nobel Prize-winning physicist challenged his colleagues to use submicroscopic particles to manufacture a wide range of products—an idea that captivated the imagination of scientists and inspired the science fiction movies “Fantastic Voyage” and “Innerspace.”
Fifty years later, “nano” (small) technology has moved from the science fiction realm to scientific fact, and federal regulators are laying the groundwork for monitoring a new generation of medical devices, drugs, cosmetics, and other products.
The Food and Drug Administration is continuing a dialogue on nanotechnology begun in 2011 by publishing proposed guidelines on the evaluation and use of nanomaterials in FDA-regulated products.
The first draft guideline, “Draft Guidance for Industry, Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology”, was published in the Federal Register in June, 2011. The FDA is still reviewing and receiving comments on this document from the public.
In April 2012 the FDA is issuing two new draft guidelines for manufacturers of food substances and cosmetics, which are also open for public comment.
FDA Commissioner Margaret A. Hamburg, M.D., says the guidelines provide a starting point for the nanotechnology discussion. “Our goal is to regulate these products using the best possible science,” Hamburg says. “Understanding nanotechnology remains a top priority within the agency’s regulatory science initiative and, in doing so, we will be prepared to usher science, public health, and FDA into a new, more innovative era.”
FDA is working with the White House, the National Nanotechnology Initiative, other U.S. government agencies, and international regulators to focus on generating data and coordinating policy approaches to ensure the safety and effectiveness of products using nanomaterials.
June 26, 2012
FDA has notified health care professionals and warned consumers not to use skin creams, beauty and antiseptic soaps or lotions that might contain the toxic metal mercury. These products, found in at least seven states, claim to be skin lighteners and anti-aging treatments that remove age spots, freckles, blemishes and wrinkles. Adolescents may use them to treat acne. They are manufactured abroad and sold illegally in the United States—often in shops in Latino, Asian, African or Middle Eastern neighborhoods, and online—or brought to the U.S. from other countries. FDA and state health officials have found more than 35 products containing unacceptable levels of mercury.
Risk: Mercury poisoning can cause damage to the kidneys and the nervous system, and interfere with brain development in unborn children and very young children.
- Check the label of any skin lightening, anti-aging, or other skin product. If there is no label or no ingredients listed, do not use the product.
- Do not use—or immediately stop using—products that list these ingredients: mercurous chloride, calomel, mercuric, mercurio or mercury.
- Thoroughly wash hands and any other body parts that have come in contact with the product.
- Contact a health care professional or medical clinic for advice.