Monday, July 15, 2013

FDA Proposes Action Level for Arsenic in Apple Juice

FDA proposed a limit of 10ppb for inorganic arsenic in apple juice.  This is the same level that is in place for drinking water.

This issue garnered attention when that crusader for scaring the heck out of people in the name of public health, Dr. Oz, put a beat down on apple juice claiming that samples had high levels of aresenic.  However, FDA countered with scientific facts -  that they had monitored juice samples for years and had not found such levels AND the methodology used by the Oz quoted study looked at total arsenic and not inorganic aresenic, the harmful form.

If anything, it shows how mass-media-generated misinfomation can be used to force regulation.

 FDA proposes “action level” for arsenic in apple juice

For Immediate Release: July 12, 2013
Media Inquiries: Theresa Eisenman, 301-796-2805,
Consumer Inquiries: 888-INFO-FDA

Agency testing and analysis confirm overall safety of apple juice

The U.S. Food and Drug Administration today proposed an “action level” of 10 parts per billion (ppb) for inorganic arsenic in apple juice. This is the same level set by the U.S. Environmental Protection Agency (EPA) for arsenic in drinking water.

“The FDA is committed to ensuring the safety of the American food supply and to doing what is necessary to protect public health,” said FDA Commissioner Margaret A. Hamburg, M.D. “We have been studying this issue comprehensively, and based on the agency’s data and analytical work, the FDA is confident in the overall safety of apple juice for children and adults.”

“While the levels of arsenic in apple juice are very low, the FDA is proposing an action level to help prevent public exposure to the occasional lots of apple juice with arsenic levels above those permitted in drinking water,” said Michael R. Taylor, the FDA’s deputy commissioner for foods and veterinary medicine.

The FDA is establishing this threshold to provide guidance to industry. The agency takes the action level into account when considering an enforcement action, if it finds a food product exceeds the threshold.

The FDA has been monitoring the presence of arsenic in apple juice for the past 20 years and has consistently found that samples contain levels of arsenic that are low, with few exceptions. New tools, however, have allowed the agency to better understand the breakdown between organic and inorganic arsenic levels. Last year the FDA released findings from its latest data collection and analysis of 94 samples of arsenic in apple juice. The analysis showed that 95 percent of the apple juice samples tested were below 10 ppb total arsenic; 100 percent of the samples were below 10 ppb for inorganic arsenic, the carcinogenic form of arsenic.

The proposed level of 10 ppb takes into account this sampling data plus a recently completed, peer-reviewed risk assessment of inorganic arsenic in apple juice conducted by FDA scientists. The assessment is based on lifetime exposure.

Inorganic arsenic may be found in foods because it is present in the environment, both as a naturally occurring mineral and because of activity such as past use of arsenic-containing pesticides. A known carcinogen, inorganic arsenic also has been associated with skin lesions, developmental effects, cardiovascular disease, neurotoxicity, and diabetes.

In conducting its new assessment on apple juice, the FDA was able to use data from two studies published in 2010, as well as a 2011 evaluation by the Joint Expert Committee on Food Additives and Contaminants of the Food and Agriculture Organization, part of the United Nations and the World Health Organization.

The agency will accept public comments on the proposed action level and the risk assessment for 60 days.

It's Dr. Oz versus the FDA on apple juice and arsenic
September 16, 2011|By Jeannine Stein, Los Angeles Times / For the Booster Shots blog

An apple a day may keep the doctor away, but apple juice? That's asking for trouble.

Witness the white-hot flames of controversy this week over
Dr. Mehmet Oz's claims that apple juice contains unhealthful levels of arsenic. Here's the background in a nutshell: On his syndicated television show, Oz made the claims about apple juice containing arsenic, which prompted the Food and Drug Administration and others to fire back, saying that Oz's claims were unfounded and that the juice was safe to drink.

The Dr. Oz website contains this explainer: "Other countries may use pesticides that contain arsenic, a heavy metal known to cause cancer. After testing dozens of samples from three different cities in America, Dr. Oz discovered that some of the nation's best known brands of apple juice contain arsenic."

No way, says the
FDA, which fired back with not one but two letters to producers of Oz's show. The agency says it has monitored apple and other juices for years for arsenic levels. It disputes the high amounts Dr. Oz says he found -- 36 parts per billion -- and adds that in its own tests, including juice from the same lot Dr. Oz tested, levels were at 2 to 6 ppb.

Oz also tested for total arsenic amount, which the FDA says isn't an accurate reading. Arsenic occurs naturally in foods in organic and inorganic forms, it noted in one of the letters, and only certain levels of inorganic levels are toxic. "We have advised you that the test for total arsenic DOES NOT [all caps is theirs] distinguish inorganic arsenic from organic arsenic."

But Oz will not go gently into that good apple orchard. He continues to defend his position, even appearing on "World News With Diane Sawyer" recently to throw down with Dr. Richard Besser, the network's health and medical editor.

On the show, Oz said he wasn't worried about the short-term effects apple juice may have but was concerned more about what would happen to ensuing generations of apple juice-guzzling kids.

Besser, former acting director of the
Centers for Disease Control and Prevention, was more "meh" about arsenic levels, saying, "When I look at the evidence of what was in those samples of apple and how the study was done, it doesn't raise concerns to me."

Maybe what people should be more worried about is the sugar content in apple juice. A cup has about 27 grams, the equivalent of almost 6.5 teaspoons of sugar.

Better to eat a whole apple, which has about 5 grams of fiber and anywhere from 10 to 18 grams of sugar, depending on the variety. A 2009 study in the journal
Appetite found that whole apples had a greater effect on satiety compared with applesauce and apple juice. For five weeks, 58 men and women ate an apple, applesauce, apple juice or apple juice with added fiber before a meal (a control group ate nothing before the meal). Those who ate an apple before lunch ate 15% less compared with the control group and less than those who ate applesauce or drank the juices. The participants felt fuller after eating the whole apple as well.

Apples may also reduce the risk of stroke. A study released online today in the
Stroke: Journal of the American Heart Assn. looked at fruits and vegetables eaten by 20,069 men and women ages 20 to 65. Researchers divided the produce into colors, such as green, orange/yellow and white. They found that consuming more white fruits and vegetables was linked with a lower incidence of stroke and that apples and pears were most popular in the white fruit and vegetable category.

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