Posts Tagged ‘ FDA ’

FDA Makes Move to Ban Trans Fats

Thursday, November 7th, 2013

The Food and Drug Administration of the federal government has announced a that partially hydrogenated oils, which are a major source of “trans fats” in processed foods, are no longer “generally recognized as safe” in the U.S. food supply.  The move is considered a first step toward a ban of the artificial fats in most foods, as CNN.com reports:

If the preliminary determination is finalized, according to the FDA, then partially hydrogenated oils will become food additives that could not be used in food without approval. Foods with unapproved additives cannot legally be sold.

Trans fat can be found in processed foods including desserts, microwave popcorn products, frozen pizza, margarine and coffee creamer, and has been linked to an increased risk of heart disease.

Partially hydrogenated oil is formed when hydrogen is added to liquid oils to make solid fats, like shortening and margarine. It increases the shelf life and the flavor of foods. Partially hydrogenated vegetable oil, or shortening, was used in American kitchens as early as 1911.

However, in recent years many food manufacturers have taken steps to limit or eliminate trans fat from their products.

McDonald’s, for instance, stopped cooking its french fries in trans fat more than a decade ago. The company’s website says all its fried menu items are free of trans fat.

New York City in 2007 adopted a regulation banning partially hydrogenated vegetable oils and spreads in restaurants.

Trans fat intake among American consumers decreased from 4.6 grams per day in 2003 to about a gram a day in 2012, according to the FDA.

However, “current intake remains a significant public health concern,” FDA Commissioner Margaret Hamburg said in a written statement.

There is no safe level of consumption of trans fat, Hamburg said. It has been shown to raise the “bad,” or LDL, cholesterol.

Image: Margarine on bread, via Shutterstock

Add a Comment

FDA to Regulate Gluten Free Labeling

Tuesday, August 6th, 2013

For the first time, and after six years of debate, the US Food and Drug Administration has agreed to regulate what a label of “gluten free” means on foods. Before the new guidelines, food manufacturers could include traces of gluten at their discretion. The news will come as a relief to parents whose children are diagnosed with celiac disease, or who have other gluten intolerances.  More from The Associated Press:

Under an FDA rule announced Friday, products labeled “gluten free” still won’t have to be technically free of wheat, rye and barley and their derivatives. But they almost will: “Gluten-free” products will have to contain less than 20 parts per million of gluten.

That amount is generally recognized by the medical community to be low enough that most people who have celiac disease won’t get sick if they eat it.

People who suffer from celiac disease don’t absorb nutrients well and can get sick from the gluten found in wheat and other cereal grains. Other countries already have similar standards.

Celiac disease affects up to 3 million Americans. It causes abdominal pain, bloating and diarrhea, and people who have it can suffer weight loss, fatigue, rashes and other long-term medical problems. Celiac is a diagnosed illness that is more severe than gluten sensitivity, which some people self-diagnose.

Only a very small number of people wouldn’t be able to ingest the amount of gluten that will be allowed under the new rule, FDA officials said.

“Adherence to a gluten-free diet is the key to treating celiac disease, which can be very disruptive to everyday life,” FDA Commissioner Margaret A. Hamburg said. “The FDA’s new ‘gluten-free’ definition will help people with this condition make food choices with confidence and allow them to better manage their health.”

The rule would also ensure that foods with the labels “no gluten,” “free of gluten,” and “without gluten” meet the definition. Manufacturers will have a year to comply, but the FDA urged companies to meet the definition sooner.

Image: Gluten free sign, via Shutterstock

Add a Comment

Spray Sunscreens Could Be Flammable, FDA Warns

Thursday, July 25th, 2013

Families are getting more serious about using sunscreen consistently, which is an important practice for skin health.  But the US Food and Drug Administration is warning that spray sunscreens, if applied near very hot surfaces like grills or campfires, could become flammable and cause serious injury.  No children have reported injuries from spray sunscreen, but the FDA urged parents to read labels carefully and avoid any products that are flammable.

The FDA issued a statement, which reads, in part:

The Food and Drug Administration (FDA) has become aware of five separate incidents in which people wearing sunscreen spray near sources of flame suffered significant burns that required medical treatment. The specific products reported to have been used in these cases were voluntarily recalled from the market, so should no longer be on store shelves.

However, many other sunscreen spray products contain flammable ingredients, commonly alcohol. The same is true for certain other spray products, such as hairspray and insect repellants, and even some non-spray sunscreens may contain flammable ingredients. Many flammable products have a label warning against their use near an open flame.

You should never apply a product labeled as flammable while you are near a source of flame. In the five incidents reported to FDA, however, the burns occurred after the sunscreen spray had been applied. The ignition sources were varied and involved lighting a cigarette, standing too close to a lit citronella candle, approaching a grill, and in one case, doing some welding. These incidents suggest that there is a possibility of catching fire if you are near an open flame or a spark after spraying on a flammable sunscreen—even if you believe you have waited a sufficient time for the sunscreen to dry and your skin feels dry.

“Based on this information, we recommend that after you have applied a sunscreen spray labeled as flammable, you consider avoiding being near an open flame, sparks or an ignition source,” says Narayan Nair, M.D., a lead medical officer at FDA.

Image: Spray sunscreen, via Shutterstock

Add a Comment

FDA Approves ADHD Diagnostic Device

Thursday, July 18th, 2013

A brainwave-measuring device that could help diagnose kids with ADHD has been approved by the US Food and Drug Administration.  The device’s creators earned the approval after conducting research showing that a 20-minute test on the device, when combined with standard ADHD diagnostic measures, increased the accuracy of doctors’ diagnoses.  More on how the device works from the website PopSci.com:

The device detects two different types of brainwaves, theta and beta, and how frequently they occur. Kids with attention-deficit/hyperactivity disorder have more theta than beta brainwaves, compared to kids without ADHD.

The FDA approved the device, called the Neuropsychiatric Electroencephalogram-Based Assessment Aid or NEBA, for use with a full medical exam. In a statement, the director of the agency’s Office of Device Evaluation, Christy Foreman, emphasized that the device has to work with other clinical measures.

To get their FDA approval, NEBA’s creators performed a study with 275 kids with attention problems. The study, which the FDA didn’t make public, found that adding a 20-minute NEBA test to standard diagnostic procedures helped doctors diagnose ADHD more accurately.

Add a Comment

Tags: , , | Categories: Child Health, New Research

FDA Proposes New Arsenic Limit for Apple Juice

Monday, July 15th, 2013

The US Food & Drug Administration has announced it will limit the amount of inorganic arsenic allowed in apple juice drinks, proposing a limit that would be the same as is allowed in drinking water. The news comes after decades of debate, which flared in 2011 when Dr. Mehmet Oz released a widely publicized study finding higher-than-allowed amounts of total arsenic in popular brands of apple juice, including Gerber.

Oz’s research did not distinguish between “organic” and “inorganic” arsenic, which scientists liken to cholesterol, which has “good” and “bad” types that should be measured separately.  At the time, Oz argued for the inorganic arsenic level to be lowered to the allowable drinking water level, which the new FDA announcement appears to do.

More on the new ruling from Reuters:

“This action level will keep any apple juice that may have more inorganic arsenic than that out of the marketplace,” Michael Taylor, the FDA’s deputy commissioner for foods and veterinary medicine, said in a blog post.

Last year the agency tested 94 samples of arsenic in apple juice and found that all were below the 10 ppb threshold for inorganic arsenic. The FDA is now setting that limit as the allowable future benchmark. It will accept public comments on its recommendations for 60 days.

Inorganic arsenic may be found in foods because it is present in the environment, both as a naturally occurring mineral and due to the use of arsenic-containing pesticides.

Inorganic arsenic has been associated with skin lesions, developmental effects, cardiovascular disease, neurotoxicity and diabetes. Organic forms of arsenic, also found in soil and ground water, are considered essentially harmless.

Some consumer groups said the limit on arsenic is a good first step, but the carcinogen needs to be limited further.

“The standard they’ve chosen may not be adequate to fully protect the public,” said Caroline Smith DeWaal, director of food safety at the Center for Science in the Public Interest.

Image: Apple juice, via Shutterstock

Add a Comment