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Posts Tagged ‘fda’

FDA Threatens to Seize All Natural Products that Dare to Mention H1N1 Swine Flu

Posted by kandylini on July 13, 2009

I’ve been taking extra vitamin D3 with my daily dose of cod liver oil for almost a year with good results.

Source: Natural News.

In an effort to censor any online text that might inform consumers of the ability of natural products to protect consumers from H1N1 influenza A, the FDA is now sending out a round of warning letters, threatening to “take enforcement action… such as seizure or injunction for violations of the FFDC Act without further notice.”

“Firms that fail to take correction action,” the FDA warns, “may also be referred to the FDA’s Office of Criminal Investigations for possible criminal prosecution for violations of the FFDC Act and other federal laws.”

The message is crystal clear: No product may be described as protecting against or preventing H1N1 infections unless it is approved by the FDA. And which products has the FDA approved? Tamiflu (the anti-viral drug that most people will never have access to), and soon the new H1N1 vaccine that’s being manufactured at a cost of one billion dollars (paid to Big Pharma by the taxpayers). This vaccine, of course, will be utterly useless because H1N1 will undoubtedly mutate between now and the time the vaccine is ready, rendering the vaccine useless.

In other words, according to the tyrants at the FDA, the only products that may be marketed alongside the term “H1N1″ are those products that either don’t work or aren’t available to most people. Anything that really works to prevent influenza infections — such as natural anti-virals, medicinal herbs, etc. — is banned from even mentioning H1N1 without the threat of being criminally prosecuted.

Note: I reveal the five most powerful natural anti-viral remedies in a free report you can read here

Such are the operations of our U.S. Food and Drug Administration — a criminal organization that’s working hard to do what every criminal organization does: Eliminate the competition! As the defender of Big Pharma, the FDA is also the destroyer of knowledge that seeks to remove educational statements from the internet. Truth has nothing to do with it — it is verifiably true that anti-viral herbs, probiotics and other natural products help protect consumers from influenza — but the FDA cannot allow such statements to remain online for the simple fact that people might become informed. And that, it seems, would be a dangerous precedent.

If people were informed about the healing and protective powers of herbs, they would no longer remain enslaved by the medical establishment. Profits would be lost. Power would evaporate. This is why people can never be allowed to attain any real knowledge about herbs, superfoods or nutritional supplements. And the FDA will threaten people with imprisonment just to make sure they don’t dare publish knowledge that the FDA does not want the people to see.

Targeted by the FDA

Who is being attacked and threatened by the FDA? Lots of companies offering highly-effective natural remedies. You can see a list of some of the companies being targeted right here.

Byron Richards’ company Wellness Resources, a favorite target of the FDA (no doubt because Richards wrote a book attacking the FDA), is also targeted in this censorship campaign. You can see the FDA’s ridiculous complaint against his company here.

The FDA sends similar letters to other companies, invoking terrorizing language designed to scare companies into self-censorship. This is the FDA’s key strategy, and it largely works: Most companies are scared to death to take a stand against the FDA because the ones that do end up being shut down, with their owners arrested at gunpoint and thrown in prison.

This is how natural medicine advocates are treated in the United States of America, the “land of the free and the home of the brave.” (It is really the land of the enslaved and the home of the cowards who don’t even have the courage to protest in the streets anymore…)

This is how the FDA secretly intimidates the natural products industry: It sends threatening letters to anyone who dares tell the truth about a natural product they sell. While pharmaceuticals can openly and brazenly lie about their supposed benefits, natural product companies aren’t even allowed to state obvious truths about their products! (Like “Vitamin C helps prevent colds” or “Omega-3 oils improve moods.”)

Note, carefully, that the FDA openly brands the people promoting natural anti-viral products as “criminals.” The language from the FDA’s own website says it is listing “Web sites that are illegally marketing unapproved, uncleared, or unauthorized products in relation to the 2009 H1N1 Flu Virus.”

In reality, this FDA list is a really good list of highly effective natural products that can protect you from Swine Flu. Many of the companies on the list, in fact, offer products that are far more effective than any vaccine or Big Pharma anti-viral drug. And that, by the way, is precisely why the FDA must accuse these companies of being criminals: Products that effectively compete with Big Pharma’s drugs simply cannot be allowed to exist in the marketplace!

This is all about destroying the competition, limiting consumer options and censoring truthful health information on the internet.

And it’s all paid for by your tax dollars, by the way. This is a government operation taking place under the Obama Administration, which apparently continues in the Bush Administration’s footsteps when it comes to destroying the natural products industry and leaving consumers helpless in the next great pandemic.

Learn what the FDA hopes you never find out: Read my free report on the five most powerful anti-viral products for beating swine flu.

Sources:
FDA Fraudulent 2009 H1N1 Influenza Products List

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FDA “Dear Colleague” Letter to the United States Food Manufacturing Industry, Regarding Melamine

Posted by kandylini on October 31, 2008

“Dear Colleague”? Isn’t that a bit of a cozy salutation from an agency that’s supposed to be a watchdog (*snort* yeah right)? According to this letter, other foods with protein may be contaminated, including soy protein. You know, that ubiquitous cheap ingredient that’s in practically every single processed food.

This letter contains polite suggestions and helpful hints, but shouldn’t the FDA be requiring food manufacturers to take these steps? Seeing as how the U.S. imports about 20 million pounds of just milk products from China? Huh?

http://www.cfsan.fda.gov/~dms/melamltr.html

October 10, 2008

This letter is intended to ensure that members of the United States food manufacturing industry are aware of the Food and Drug Administration’s (FDA’s) serious concern about the possibility that foods or food ingredients produced in China and exported to the United States may be contaminated with melamine or its analogues. FDA has information indicating that melamine and its analogues have been added to milk produced in China and that milk contaminated in such a fashion has been used to manufacture infant formulas and other dairy-based products. As of this writing, Chinese authorities are reporting that in China approximately 53,000 infants have suffered illnesses, with 13,000 hospitalizations and four deaths. Approximately 158 of the victims thus far have suffered acute kidney failure. Chinese authorities have disclosed that, in addition to discovering contaminated infant formulas, melamine has been discovered in 24 of 1202 samples of milk and yogurt. There is little information at this stage to determine when the contamination might have begun or how widespread the contamination might be. However, Chinese authorities report that melamine was found in infant formula, milk, yogurt, and ice cream manufactured by 22 companies in China. The Chinese investigation into this matter is ongoing.

There are currently two recalls for products in the United States related to this situation. Tristar Food Wholesale Co., Inc. has issued a recall of Blue Cat Flavor Drink (Lanmao), manufactured in China, due to possible contamination with melamine. Also, seven Mr. Brown brand instant coffee and milk tea products manufactured in China are being recalled by the King Car Food Industrial Co., Ltd. due to possible contamination with melamine. In addition, California and Connecticut report that their testing of White Rabbit Creamy Candies manufactured in China has shown melamine contamination. Further, other countries (South Korea, Singapore, Hong Kong, Japan, Taiwan, Australia, Indonesia, Canada and New Zealand) have all identified products containing melamine including flavored milks, cakes, candies, crackers, rice snacks, coffee creamer, lactoferrin, and cereal.

Milk and milk products that could originate from China include condensed, dried, and non-fat milk, condensed and dried whey, lactose powder, permeate powder, demineralized and partially demineralized whey powders, caseins, yogurt, ice cream, cheese, whey protein concentrate, and milk protein concentrate.

In light of current circumstances, there are several useful steps to help protect the public health available to manufacturers of products containing milk-derived ingredients, including the following:

  • Know the precise origin of each milk-derived ingredient. For example, milk-derived ingredients that are sourced from countries other than China could actually originate from China.
  • Determine that milk-derived ingredients originating from China are free of melamine and its analogues prior to usage.
  • For food manufactured in the last twelve months which might still be on the shelf at retail or in stock elsewhere, determine whether the food might contain any milk-derived ingredients from China. If any such foods exist, verify that they do not contain melamine or its analogues.

In addition, it would be useful for manufacturers to be alert to the possibility that non-milk-derived ingredients from China that are or may be sold on the basis of protein content, such as soy protein, also could be contaminated with melamine.

Should firms decide to recall any of their products because of the presence of melamine, please follow FDA’s guidelines in 21 CFR Part 7 Subpart C. We encourage you to communicate any concerns to your local FDA district office.

A gas chromatography-mass spectrometry (GC-MS) as well as a liquid chromatograph-tandem mass spectrometry (LC-MS/MS) method for determining melamine and its analogues is available at the following link to the FDA website: http://www.fda.gov/oc/opacom/hottopics/melamine.html#testing.

In addition to sending this letter, FDA has taken, and will continue to take, proactive measures to help ensure the safety of the American food supply. In conjunction with state and local officials, FDA will continue to check retail stores for food items imported from China that could contain a significant amount of milk or milk-derived ingredients. At the same time that FDA began working with the States on this matter, it began sampling and testing milk and milk-derived ingredients and finished food products that could contain these milk-derived ingredients from Chinese sources. The sampling is being done either when products are offered for entry into the United States or at the retail level. In addition to working with state and local governments, FDA is working in close cooperation with Customs and Border Protection within the U.S. Department of Homeland Security, the U.S. Department of Agriculture, other federal agencies, and foreign governments.

FDA recognizes and appreciates the extraordinary collaborative efforts to protect consumers by all of the aforementioned government authorities and industry in response to this matter. We are confident that you will continue to work to provide safe food products to the U.S. customer.

If you have any questions regarding this letter, you may contact John F. Sheehan, J.D. at (301)436-2367 or Benson M. Silverman, M.D. (301)436-1459.

Sincerely,

Nega Beru, Ph.D.
Director
Office of Food Safety
Center for Food “Safety” And Applied Nutrition

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Just in time for Halloween: Candy from China may be tainted with toxic Melamine

Posted by kandylini on October 29, 2008

Source: YouTube and BrassCheckTV.

Take this seriously and pass it along

In China, ANYTHING made with Chinese-manufactured milk powder before September 14th was PULLED from their store shelves.

In the US, this garbage is still being sold!

Foods at risk: ANY food manufactured in China and potentially any food containing milk powder. US food manufacturers imported millions of pounds of milk powder from China before September 14th. The FDA continues to allow to be sold.

This includes chocolate, cookies, cakes, and even things like packaged macaroni and cheese.

Background

Mike Mozart is a product designer who also runs a video blog about new developments in the toy industry.

His reviews are normally light, cheerful affairs and completely apolitical.

If he appears distraught, it’s because he is. This is serious.

Mozart has discovered that the US is the ONLY country that still permits potentially melamine-contaminated food on its shelves. Even China has removed these products from its stores.

That’s right. This poison that killed and injured thousands of people, mainly children, may be in US food. We’re the only country that hasn’t pulled it from its shelves.

Here’s what you need to know

1. Melamine was added to food products manufactured in China to simulate protein content. These food products were imported into the US by the ton.

2. Melamine itself is bad, but much worse – and not reported – is that melamine is an industrial product, not a food product and often comes contaminated with a wide range of dangerous industrial toxins.

There is no such thing as food grade melamine. None of it is suitable for food.

3. The widespread practice of adding melamine to powdered milk products has killed and seriously injured thousands of children in China.

Melamine injuries children by damaging their kidneys. There has already been a reported spike in kidney stones in American children.

Last year, when melamine was found in pet food sold in the US and traced to death in animals, it was headline news.

This news, potentially far more serious, is being censored.

4. The Chinese government knew this contaminated food was on the shelves killing children and said nothing so as not to put a damper on the “Olympic spirit.”

5. As much 20 MILLION POUNDS of food manufactured in China that contains milk powder was imported into the US this year. Also, it’s not clear how many US food manufacturers use milk powder manufactured in China in their products.

6. The US Food and Drug Administration (FDA) refuses to test for melamine contamination – or it is has, refuses to make the results of these tests available to the public.

Further, the FDA refuses to force food manufacturers to remove the contaminated food from its shelves, something they are completely capable of doing.

7. Why is this being done?

Mozart theorizes: a) to prevent a scandal before the election and b) to avoid further deterioration of the US stock market.

Are these motivations plausible?

Long-time Brasscheck TV viewers know that the FDA has demonstrated over and over again throughout its history that it is a political agency designed to protect well connected law breakers and has next-to-zero interest in the public welfare.

AVOID all food products manufactured in China and any product that contains milk powder that does not disclose its source. (Egg powder is also being identified as a potential source of this contamination.)

The direct YouTube link for this video is:

Please share this information with friends, family members and colleagues so they can make an informed decision about what they eat.

Knowing the parties involved – China, the FDA, the Bush administration, the US news media, and corporate America – you can be sure that none of them can be trusted to look out for your welfare.

Posted in Food, Health, Politics | Tagged: , , , , , , , , , , , , | Leave a Comment »

The FDA Indicts Itself

Posted by kandylini on July 16, 2008

Source: William Faloon, Life Extension.

Some people enjoy saying “I told you so.” I cannot under these circumstances. What you are going to read is too barbaric for me to brag that we knew it was going on all along.

Back in the early 1980s, Life Extension predicted horrific tragedies if government control over health care was not abolished. The heartbreaking fact is that tens of millions of Americans have needlessly suffered and died because of FDA incompetence… and the FDA now admits its own incompetence!

These tens of millions of lives lost are not statistics of strangers. Virtually everyone reading this column has family or friends who have been victimized by dangerous drugs or denied access to life-saving ones.

Rather than boasting that every flaw we identified about the FDA is now a documented reality, I instead view it as a failure that we could not persuade Congress to abolish the FDA’s totalitarian powers decades ago. We certainly tried.

FDA Uncovers its Own Inadequacies

I have appeared on hundreds of talk shows to expose how the FDA, in collusion with pharmaceutical giants and conventional medical orthodoxy, is the leading cause of suffering and death in the United States.

Back in the early days, the FDA would defend its position by proclaiming that it served to protect the public’s health. An endless number of well-publicized scandals have caused the FDA itself to admit that it is incapable of carrying out its mission.

If all the FDA did was act so cautiously that it almost never approved a dangerous drug, then at least the agency could point to some consumer value it provides. Instead, we are plagued by an antiquated regulatory agency that stifles the development of novel life-saving medications, while allowing a slew of drugs to be sold that have cumulatively cost millions of lives.

Americans thus suffer the “worst of both worlds” as they are poisoned by FDA-sanctioned prescription drugs, but denied the fruits of novel approaches to disease prevention and treatment.

The FDA’s Indictment of Itself

In response to a barrage of criticisms, FDA commissioner Dr. Edward von Eschenbach requested that a special committee assess whether the FDA is capable of doing its job. The premise for the FDA’s massive audit of itself was the fear that “the nation is at risk if FDA science is at risk.”11

Reader’s Digest Asks…

“What’s Ailing the FDA?”

Reader’s Digest is a venerable publication that often publishes pro-government articles. In response to the FDA’s admission of its own incompetence and incapability, Reader’s Digest published a special report titled What’s Ailing the FDA? Here is an excerpt from this Reader’s Digest special report:

“Recent headlines have uncovered one shocking lapse after another at the Food and Drug Administration…Many of the nation’s leading doctors, scientists and lawmakers now agree that the FDA is in crisis…Lurching from one disaster to another, the 102-year-old agency learns of dangers too late and then moves too slow to remedy them…Instead of depending on the FDA, Americans are doubting it—and for good reason.”25

The following are exact quotes from this 60-page report, titled FDA Science and Mission at Risk:11

  1. The FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak.
  2. The FDA cannot fulfill its mission because its scientific workforce does not have sufficient capacity and capability.
  3. The FDA cannot fulfill its mission because its information technology (IT) infrastructure is inadequate.
  4. The FDA does not have the capacity to ensure the safety of food for the nation.
  5. The development of medical products based on “new science” cannot be adequately regulated by the FDA.
  6. There is insufficient capacity in modeling, risk assessment, and analysis.
  7. The FDA science agenda lacks a coherent structure and vision, as well as effective coordination and prioritization.
  8. The FDA has substantial recruitment and retention challenges.
  9. The FDA has an inadequate and ineffective program for scientist performance.
  10. The FDA has not taken sufficient advantage of external and internal collaborations.
  11. The FDA lacks the information science capability and information infrastructure to fulfill its regulatory mandate.
  12. The FDA cannot provide the information infrastructure support to regulate products based on new science.

Most appalling is the FDA’s own finding that it “cannot even keep up with the advances in science.”11 Said differently, this means that the FDA cannot keep up with scientific breakthroughs that could cumulatively save millions of human lives!

Responses to the FDA’s Damning Report of Itself

The Wall Street Journal wrote an editorial titled “The Real FDA Scandal” and quoted the following about the FDA’s admitted statement:

“Particularly in complex and specialized fields like genomics and biotechnology medicine, the FDA lacks the basic competence ‘to understand the impact of product use, to maintain ongoing currency with their evolution or to evaluate the sophisticated products produced’ and ‘to support innovation in the industries and markets that it regulates.’”12

The Wall Street Journal further wrote, “Think about that: We live amid a revolution in biology, but the FDA still thinks like it did when Sputnik launched.”12

Dr. David Kessler was the most publicly recognized FDA commissioner of all time. Dr. Kessler is still sought out by the media as a proponent on FDA issues. In response to this horrific report, however, Dr. Kessler stated, “The problems are way bigger than one commissioner…I’m not sure how anybody could do this job now.”13

FDA commissioner Eschenbach stated, “I think to do what we need to do requires substantially more dollars than what has been invested in the FDA so far…This is a systemic overhaul that must go on for years.”13

Excerpt from 60-page Report

FDA Science and Mission at Risk

The FDA’s indictment of itself should frighten anyone concerned about medical progress being held hostage by an admittedly incompetent government agency.

The report titled FDA Science and Mission at Risk states “the world of drug discovery and development has undergone revolutionary change,” but the FDA’s “evaluation methods have remained largely unchanged over the last half century.”11

Problems are Worse Than FDA Admits

In doing the research to write this editorial, I uncovered many recent reports from outside organizations harshly critical of the FDA. These reports made national news for a day or two and were then quickly forgotten.14-24

We at Life Extension cannot pretend these problems disappear the day after the news reports them. That’s because we are on the front lines every single day battling to keep our aging members alive and in good heath.

Our greatest impediment to saving human lives is an incompetent and corrupt federal bureaucracy that is strangling medical innovation, especially in the areas of genomics and biotechnology where breakthroughs in anti-aging medicine are most expected.

I routinely talk with scientists about methods to significantly extend our life spans, but the problem with “the FDA” inevitably arises. If the FDA’s bureaucratic roadblock is not torn down, we may all succumb to a disease that liberated scientists could readily prevent or cure.

Please know that there is not a magic immortality pill that the FDA is directly suppressing. Instead, the FDA is restraining the ability for medical science to progress. This is no longer just my opinion. The FDA itself admits it cannot keep up with advances in science. So discoveries that could save human lives are not getting approved by the FDA and the cost is thousands of American lives being lost each day.

What Can be Done to Stop This Carnage?

There are a number of proposls to turn around this lethal barrier to medical progress called the Food and Drug Administration (FDA). Some politicians say throw more tax dollars at the problem, while other politicians refuse to reward an agency with so much documented incompetence.

We at Life Extension look at the hard science and the free market as the best solution to quickly end this bureaucratic abomination. Unlike scholars who leisurely debate the best way to reform the FDA, Life Extension is obligated to represent the health interests of our aging members today!

The FDA’s own report makes it clear that scientific innovation is suffocated by bureaucratic red tape and incompetency. Yet a medical renaissance is needed if our generation is to achieve dramatically extended life spans.

The only way to liberate scientific ingenuity is to allow Americans to obtain therapies that are clearly marked Not approved by the FDA. Under this free market scenario, those who want the so-called “protection” the FDA previously pretended it provided could continue receiving it.

Results from Poll of 400,000 Peopleregarding Terminally Ill Cancer Patients

Should have access to any drug that might save their life: 89%

Should only have access to drugs approved by the FDA: 11%

Enlightened individuals and their doctors, on the other hand, would be able to choose novel therapies that are clearly labeled “Not approved by the FDA.”

Since it costs so much for a new drug to be approved, therapies that do not have to go through this arduous (and antiquated) approval process would cost less than outlandishly priced “approved” prescription drugs.

Don’t Let Medical Innovation be Held Hostage to FDA Bureaucracy!

Back in 2003, Life Extension initiated a poll on a website that has about 400,000 new visitors each month.26 The people visiting this site are not part of any anti-FDA group, nor were they exposed to anti-FDA teachings. These people were asked a simple question as to whether terminally ill cancer patients should have the right to any drug that might save their life. The results after 22,506 votes were tabulated are given in the box at the bottom of this page.

We live in a constitutional republic where the people’s wishes are supposed to be adhered to (as long as they don’t infringe on the rights of others). If 89% of the American public thinks terminal cancer patients should have access to any drug that could save their life, then there is no reason for the law not to be changed to allow Americans to access therapies “Not approved by the FDA.”

Companies that engage in fraud could be prosecuted under consumer protection laws that already exist. The FDA could post its opinion about the safety and efficacy of unapproved therapies on its website (www.fda.gov). The civil litigation risks to companies that knowingly sell bogus products would preclude large-scale unsavory activities that some are concerned with. The greater fear Americans face is being diagnosed with a lethal disease only to find out that a cure is nowhere in sight.

Reactions to the FDA’s Confession

The FDA’s admission that it cannot do its job has stirred up a hornet’s nest of outrage from organizations who have long argued that the FDA is the greatest impediment to the advancement of medical science.

A new bill has been drafted that is being presented by health freedom activists to our friends in Congress. Passage of this bill into law will liberate Americans from the FDA’s nearly 50-year tyrannical rule over what therapies an individual is allowed to choose to remain alive.

The name of this proposed bill is the Life Extending Therapies Access Act of 2008. For those who like to read legal verbiage, a copy of this bill can be accessed at www.stopfda.com.

A remarkable number of divergent health organizations are finally recognizing the lethal consequences of ignoring the FDA’s ineptitudes and have committed to backing this legislation.

Email Your Congressional Representative and the Presidential Candidates

American citizens deserve the right to choose what goes into their bodies. Those who prefer therapies that are “Not approved by the FDA” should be allowed to do so, especially now that the FDA has come to the conclusion that it is too incapable and incompetent to keep up with scientific advances.

You can easily email your Congressional Representatives and let them know you want the law changed in order to liberate the fruits of scientific research. To send the special letter we prepared to Congress by email, just log on to www.stopfda.com.

For those without a computer, a form letter that can be mailed to your members of Congress appears on the next page.

The greatest threat to your health is citizen apathy. Please stand up for your fundamental right to access novel medical therapies by informing Congress of

the urgent need to amend the law to enable Americans to access treatments that are clearly labeled “Not Approved by the FDA.”

References

1. Available at: http://www.naturalnews.com/002157.html. Accessed March 19, 2008.

2. Available at: http://www.drugresearcher.com/news/ng.asp?id=58116-fda-in-the. Accessed March 19, 2008.

3. Available at: http://www.drugresearcher.com/news/ng.asp?id=60304-whistleblowers-reveal-fda. Accessed March 19, 2008.

4. Available at: http://www.lawyersandsettlements.com/articles/00680/ketek-scandal.html. Accessed March 19, 2008.

5. Available at: http://www.mises.org/story/1805. Accessed March 19, 2008. Accessed March 19, 2008.

6. Available at: http://www.ghchealth.com/the-aspartame-scandal.html. Accessed March 19, 2008.

7. Available at: http://healthcarescandals.wordpress.com/category/fda/. Accessed March 19, 2008.

8. Available at: http://www.twnside.org.sg/title2/health.info/twninfohealth034.htm. Accessed March 19, 2008.

9. Available at: http://www.naturalnews.com/002439.html. Accessed March 19, 2008.

10. Available at: http://query.nytimes.com/gst/fullpage.html?res=950DE4DD1E38F930A2575BC0A96F948260. Accessed March 19, 2008.

11. Available at: http://www.fda.gov/ohrms/dockets/AC/07/briefing/2007-4329b_02_01_FDA%20Report%20on%20Science%20and%20Technology.pdf. Accessed March 20, 2008.

12. Available at: http://online.wsj.com/article/SB120225742208745785.html?mod=opinion_main_review_and_outlooks. Accessed March 20, 2008.

13. Available at: http://online.wsj.com/article/SB120407552925595245.html?mod=distsmartbrief&apl=y&r=49040. Accessed March 20, 2008.

14. Available at: http://money.cnn.com/2007/08/15/news/companies/fda/index.htm. Accessed March 21, 2008.

15. Available at: http://www.safecosmetics.org/your_health/index.cfm. Accessed March 21, 2008.

16. Available at: http://www.cspinet.org/foodsafety/. Accessed March 21, 2008

17. Available at: http://goliath.ecnext.com/coms2/gi_0199-5599197/GAO-report-criticizes-FDA-drug.html. Accessed March 21, 2008.

18. Available at: http://ahrp.blogspot.com/2008/03/gao-to-investigate-fda-review-process.html. Accessed March 21, 2008

19. Available at: http://www.newsinferno.com/archives/2585. Accessed March 21, 2008.

20. Available at: http://www.ahrp.org/cms/content/view/46/28/. Accessed March 21, 2008.

21. Available at: http://www.uspirg.org/uspirg.asp?id2=24595. Accessed March 21, 2008.

22. Available at: http://www.iom.edu/CMS/3793/26341/37329.aspx. Accessed March 21, 2008.

23. Available at: http://www.lifesitenews.com/ldn/2006/aug/06082405.html. Accessed March 21, 2008.

24. Available at: http://www.psrast.org/bghsalmonella.htm. Accessed March 21, 2008.

25. Available at: http://www.rd.com/national-interest/special-reports-and-surveys/problems-in-the-fda/article55513-1.html. Accessed April 16, 2008.

26. Available at: www.deathclock.com. Accessed March 21, 2008.

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Bad Cow Disease

Posted by kandylini on June 17, 2008

When push comes to shove, it seems, the imperatives of crony capitalism trump professed faith in free markets.” The free market is never truly free from the heavy hand of government, especially if it looks like Big Business will take a Big Hit. But you and me, we’re “free” to fail without any bailouts.

Source: PAUL KRUGMAN, New York Times.

“Mary had a little lamb / And when she saw it sicken / She shipped it off to Packingtown / And now it’s labeled chicken.”

That little ditty famously summarized the message of “The Jungle,” Upton Sinclair’s 1906 exposé of conditions in America’s meat-packing industry. Sinclair’s muckraking helped Theodore Roosevelt pass the Pure Food and Drug Act and the Meat Inspection Act — and for most of the next century, Americans trusted government inspectors to keep their food safe.

Lately, however, there always seems to be at least one food-safety crisis in the headlines — tainted spinach, poisonous peanut butter and, currently, the attack of the killer tomatoes. The declining credibility of U.S. food regulation has even led to a foreign-policy crisis: there have been mass demonstrations in South Korea protesting the pro-American prime minister’s decision to allow imports of U.S. beef, banned after mad cow disease was detected in 2003.

How did America find itself back in The Jungle?

It started with ideology. Hard-core American conservatives have long idealized the Gilded Age, regarding everything that followed — not just the New Deal, but even the Progressive Era — as a great diversion from the true path of capitalism.

Thus, when Grover Norquist, the anti-tax advocate, was asked about his ultimate goal, he replied that he wanted a restoration of the way America was “up until Teddy Roosevelt, when the socialists took over. The income tax, the death tax, regulation, all that.”

The late Milton Friedman agreed, calling for the abolition of the Food and Drug Administration. It was unnecessary, he argued: private companies would avoid taking risks with public health to safeguard their reputations and to avoid damaging class-action lawsuits. (Friedman, unlike almost every other conservative I can think of, viewed lawyers as the guardians of free-market capitalism.)

Such hard-core opponents of regulation were once part of the political fringe, but with the rise of modern movement conservatism they moved into the corridors of power. They never had enough votes to abolish the F.D.A. or eliminate meat inspections, but they could and did set about making the agencies charged with ensuring food safety ineffective.

They did this in part by simply denying these agencies enough resources to do the job. For example, the work of the F.D.A. has become vastly more complex over time thanks to the combination of scientific advances and globalization. Yet the agency has a substantially smaller work force now than it did in 1994, the year Republicans took over Congress.

Perhaps even more important, however, was the systematic appointment of foxes to guard henhouses.

Thus, when mad cow disease was detected in the U.S. in 2003, the Department of Agriculture was headed by Ann M. Veneman, a former food-industry lobbyist. And the department’s response to the crisis — which amounted to consistently downplaying the threat and rejecting calls for more extensive testing — seemed driven by the industry’s agenda.

One amazing decision came in 2004, when a Kansas producer asked for permission to test its own cows, so that it could resume exports to Japan. You might have expected the Bush administration to applaud this example of self-regulation. But permission was denied, because other beef producers feared consumer demands that they follow suit.

When push comes to shove, it seems, the imperatives of crony capitalism trump professed faith in free markets.

Eventually, the department did expand its testing, and at this point most countries that initially banned U.S. beef have allowed it back into their markets. But the South Koreans still don’t trust us. And while some of that distrust may be irrational — the beef issue has become entangled with questions of Korean national pride, which has been insulted by clumsy American diplomacy — it’s hard to blame them.

The ironic thing is that the Agriculture Department’s deference to the beef industry actually ended up backfiring: because potential foreign buyers didn’t trust our safety measures, beef producers spent years excluded from their most important overseas markets.

But then, the same thing can be said of other cases in which the administration stood in the way of effective regulation. Most notably, the administration’s refusal to countenance any restraints on predatory lending helped prepare the ground for the subprime crisis, which has cost the financial industry far more than it ever made on overpriced loans.

The moral of this story is that failure to regulate effectively isn’t just bad for consumers, it’s bad for business.

And in the case of food, what we need to do now — for the sake of both our health and our export markets — is to go back to the way it was after Teddy Roosevelt, when the Socialists took over. It’s time to get back to the business of ensuring that American food is safe.

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Rep. DeLauro Slaps FDA for Bad Tomatoes

Posted by kandylini on June 12, 2008

They’re great at protecting industry, judging from the way they treat raw dairy farmers versus BigAgra growers.

Source: Jesse A. Hamilton, On Background.

People all over the country have been getting some pretty rotten tomatoes contaminated with salmonella (making another wholesome food the object of fear and harkening to bad 1978 cinema.) It’s caused dozens of hospital visits and, in one case, may have contributed to a far more serious result.

Contimated food has been a particular area of work (and frustration) for Rep. Rosa DeLauro, who is chairwoman of the House appropriations subcommittee that controls the budget for the Food and Drug Administration.

Already a congressional bane of the FDA, DeLauro launched a letter today criticizing the vast bureaucracy for failing to keep consumers safe — again. Her letter suggested the FDA has “an emphasis on protecting the industry, and a lesser concern with protecting the consumer who may be at risk.”

Her letter asked a series of questions, including:

“The FDA was able to publish a list of states, territories, and countries where tomatoes are grown and harvested which have NOT been associated with this outbreak. If the agency possesses evidence that would allow it publish such a list, why did the FDA not compel a recall of tomatoes from the other regions that were not listed?”

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Health officials crack down on raw milk

Posted by kandylini on June 11, 2008

When they have a crack down on salmonella tomatoes and mad cow beef, I’ll believe that they care about the nation’s food safety.

By PAUL ELIAS, Associated Press Writer.

SAN FRANCISCO – Dairy owner Mark McAfee started selling raw milk in 2000, marketing it to customers who believe it contains beneficial microbes that treat everything from asthma to autism.

The unpasteurized milk swiftly caught on as part of the growing natural food movement. But the Food and Drug Administration considers McAfee a snake oil salesman and recently launched an investigation into whether his dairy illegally shipped raw milk across state lines. The agency even tried to recruit one of his employees to secretly record conversations with him.

Comment: Snake oil salesman?! That’s professional. Guess they’ve still got their panties in a wringer since the FDA goons couldn’t get McAfee’s employees to wear a wiretap or nark on him!

The case against McAfee is part of a crackdown on raw milk by government health officials who are concerned about the spread of food-borne illnesses. Lawmakers and law enforcement agencies are stepping up efforts to keep unpasteurized milk out of reach, even as demand for the niche product grows.

Comment: Why are they stepping up the efforts just when people want them in larger numbers? At whose behest are they stepping up these efforts, Big Dairy?

McAfee, who was among the first in to sell raw milk on a large scale, brushed off the investigation: “When you’re a pioneer, you have to expect to take a few arrows.”

Twenty-two states prohibit sales of raw milk for human consumption, and the rest allow it within their borders. The FDA bans cross-border sales.

In Pennsylvania, local officials recently busted two dairies unlawfully selling milk straight from the cow.

And in Maryland, health officials issued an emergency ban late last year on “cow-sharing” agreements, claiming they were aimed at skirting a ban on raw milk sales.

“Raw milk should not be consumed by anyone for any reason,” said John Sheehan, head of the FDA’s dairy office. “It is an inherently dangerous product.”

Comment: You keep saying that but no one believes you anymore; in fact every time you spout these dire comments, you just drive more people to the store and/or farm to see what they’re missing. Mark must love you guys!

But shutting down sales is tricky because the federal government has largely let states regulate the raw milk industry. The result is a hodgepodge of laws that confuse consumers, dairy farmers and regulators alike.

McAfee said he expects the FDA’s criminal probe to be dropped without charges in a deal that will require him to guarantee his interstate shipments are for use only as pet food. The FDA declined to comment.

Raw milk proponents insist they are under siege by state and federal regulators intent on snuffing out the industry.

The popularity of raw milk is fueled by consumers’ concerns about the chemicals and hormones used in traditional dairy farming, and a growing interest in unprocessed, organic foods.

Devotees of raw milk ascribe to it almost mythical healing powers. They feed it to babies, believing it strengthens the immune system and staves off digestive troubles. The heat used in pasteurization, they say, kills healthy natural proteins and enzymes.

“It’s a magic food,” said Sally Fallon, president of the Weston A. Price Foundation, a nonprofit that advocates consumption of natural foods.

The FDA insists pasteurization destroys harmful bacteria without significantly changing milk’s nutritional value. The process also extends its shelf life.

Comment: That’s why Big Dairy pasteurizes milk—not because it cares about your health!

Nevertheless, some consumers have formed cooperatives to support dairy farmers who offer raw milk. They also join “cow-sharing” programs in which farmers take care of cows that are “leased” by consumers.

Food safety officials say raw milk has sickened hundreds of people with salmonella, E. coli and other bacteria. According to the Centers for Disease Control and Prevention, 1,000 people fell ill from raw milk between 1998 and 2005. Two died.

Comment: And how does that stack up against other salmonella and E. coli-infected foods? Hundreds of people were sickened and four children died during the Jack in the Box Hamburger Contamination alone. Did the FDA thugs harrass executives and shut down the business? Of course not. This hypocrisy speaks volumes about their objectivity.

The FDA ban on cross-border sales of raw milk led to its criminal investigation of Organic Pastures, a Fresno dairy owned by McAfee that is California’s largest raw milk supplier.

The agency ordered two of McAfee’s employees to testify before a grand jury and offered to pay one of them to surreptitiously record her conversations with McAfee, according to the worker.

“The main issue was selling our products outside the state of California,” said dairy worker Amanda Hall, who refused to wear the wire. The two workers’ grand jury appearances were canceled last month.

Even if McAfee avoids criminal charges, he still faces lawsuits filed by the families of five children who claim his raw milk made them seriously ill.

He denies the allegations and said testing at his dairy did not detect the strain of E. coli that sickened some of the children.

McAfee also is challenging a new California law requiring lower bacteria levels in raw milk. He fears the change will put him out of business. A judge in San Benito County last month ruled for the state, but McAfee appealed the decision on Thursday. Also, a state senator plans to introduce a bill to repeal the law.

Whole Foods Co. lobbied for a law that ensure raw milk dairies can stay in business.

“It is a growing piece of our business,” said Walter Robb, the company’s co-president. “We want to protect consumer choice.”

He and other raw milk proponents argue that the FDA should spend its time working on other agricultural practices that jeopardize food safety, such as the way large farms confine animals.

But parents like Melissa Herzog strongly disagree.

Herzog, whose 10-year-old daughter spent two months in the hospital after her kidneys failed because of E. coli poisoning, is one of the families suing Organic Pastures over the 2006 outbreak that health officials determined was probably caused by raw milk from the dairy.

“I don’t have anything good to say about raw milk,” she said. “It was a horrible experience.”

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Food Dyes Linked to Hyper Kids, Group Asks FDA to Ban

Posted by kandylini on June 11, 2008

I don’t think they should be banned—the best way to get them off the market is to not buy products containing artificial coloring. Vote with your dollars!

There’s plenty of candy and snacks at health food stores that don’t contain food dyes. There’s an M&M knock-off (whose name escapes me right now) made without them.

Be suspicious of foods with dyes added, like butter. It should have a nice yellow color. If it’s dyed, that means it has very little vitamin A (which is standard for butter from factory-farm cows).

Source: Thea Deley, Informity News.

DANGEROUS DYES? A food safety advocacy group claims eight dyes commonly used in food, from Lucky Charms to M&Ms, cause behavioral problems in children. Since the U.S. Food and Drug Administration disputed these claims in the past, it seems unlikely it will ban the artificial colorings.

Monday the Center for Science in the Public Interest formally petitioned the U.S. Food and Drug Administration (FDA) to ban eight food dyes, including the two most common – Red 40 and Yellow 5. The United Kingdom already phased out several of these dyes.

FDA Considers Petition to Ban Artificial Food Colors

The Center for Science in the Public Interest asked the FDA to ban the following dyes:

* Yellow 5
* Red 40
* Blue 1
* Blue 2
* Green 3
* Orange B
* Red 3
* Yellow 6

While the FDA considers the Center’s petition, which could take years, the Center asked the FDA to:

* require products containing the dyes carry a warning about their possible effects
* correct information given to consumers about the dyes’ effect on some children’s behavior
* test neurotoxicity of any new food additives and colors

Red 40 and Yellow 5 are the most common dyes used in foods in the United States.

Kids Fav Foods Colored with Artificial Dyes

Food manufacturers use dyes to simulate fruit or vegetable colors. Here are a few examples:

* Kraft’s Guacamole Dip – green color comes from Yellow 5, Yellow 6 and Blue 1 (not from avocadoes)
* Aunt Jemima Blueberry Waffles – blue color comes from Red 40 and Blue 2 (not blueberries)
* General Mills’ Fruit Roll-Ups – fruity colors come from Yellow 5, Yellow 6, Red 40, and Blue 1 (not from raspberries, strawberries, kiwis, or other real fruits)
* Betty Crocker’s Au Gratin “100% Real” Potatoes – yellow color comes from Yellow 5 and Yellow 6 (not from potatoes)

Food manufacturers often use artificial colors in foods for children, such as cereals and snack foods. Here are a few foods that contain one or more of the disputed dyes:

Cereals:
* Apple Jacks
* Froot Loops
* Fruity Cheerios
* Lucky Charms
* Post’s Fruity Pebbles
* Trix
Candies:
* Starburst Chews
* Skittles
* M&M
* Mars candy bars and other candies

When Great Britain banned artificial dyes, food manufacturers switched to natural colorings. In fact, British versions of the candies listed above all use natural colors.

Here’s another difference: In the United States, McDonalds colors its sundae strawberry sauce with Red 40. In Britain? The sauce’s red color comes from strawberries.

Most artificial dyes come from coal tar and petroleum.

Consumers Drive Food, Say Manufacturers

By petitioning the FDA, the Center for Science in the Public Interest hopes to focus the public on the synthetic food dye issue. Why? Food manufacturers responded to public pressure in the United Kingdom.

When researchers at the U.K.’s Southampton University ran trials with 200 children, they found a link between eating artificially colored foods and acting hyperactive. The U.K.’s Food Standards Agency then recommended that food manufacturers stop using several dyes by the end of 2009.

When Kraft conducted market research in Great Britain, it found Brits worried more about food dyes than Americans. (Americans worry more about calories, fat and salt content.) So, based on its research, Kraft replaced artificial coloring with natural coloring in its food products for Great Britain.

Food Dyes on the Rise

American children eat more artificially dyed foods now than ever before, thanks to the FDA approving increasing amounts of food dyes:

Dye Certified for Food Use
1955 – 12 mgs/person each day
2007 – 59 mgs/person each day

Two psychiatrists, Dr. David Schab of Columbia University and Dr. Nhi-Ha T. Trinh of Harvard University, wanted to find out if artificial food coloring contributes to hyperactivity. They analyzed 15 double-blind placebo-controlled trials evaluating the effects of food dyes on children’s behavior.

“The science shows that kids’ behavior improves when these artificial colorings are removed from their diets and worsens when they’re added to the their diets,” Schab said. “While not all children seem to be sensitive to these chemicals, it’s hard to justify their continued use in foods – especially those foods heavily marketed to young children.” (Center for Science in the Public Interest, 6/2/08)

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Mercury teeth fillings may harm some: U.S. FDA

Posted by kandylini on June 5, 2008

“May harm”? That’s rich. Hopefully in another twenty years they’ll ban it altogether like they’ve done in Europe. But I’m not holding my breath.

Source: Susan Heavey, Yahoo News.

WASHINGTON (Reuters) – Silver-colored metal dental fillings contain mercury that may cause health problems in pregnant women, children and fetuses, the Food and Drug Administration said on Wednesday after settling a related lawsuit.

As part of the settlement with several consumer advocacy groups, the FDA agreed to alert consumers about the potential risks on its website and to issue a more specific rule next year for fillings that contain mercury, FDA spokeswoman Peper Long said.

Millions of Americans have the fillings, or amalgams, to patch cavities in their teeth.

Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses,” the FDA said in a notice on its Web site.

“Pregnant women and persons who may have a health condition that makes them more sensitive to mercury exposure, including individuals with existing high levels of mercury bioburden, should not avoid seeking dental care, but should discuss options with their health practitioner,” the agency said.

The FDA said it did not recommend that people who currently have mercury fillings get them removed.

The FDA must issue the new rules in July 2009, Long said.

Such a rule could impact makers of metal fillings, which include Dentsply International Inc and Danaher Corp unit Kerr.

The new rule will give the agency “special controls (that) can provide reasonable assurance of the safety and effectiveness of the product,” Long said.

The lawsuit settlement was reached on Monday with several advocacy groups, including Moms Against Mercury, which had sought to have mercury fillings removed from the U.S. market.

While the FDA previously said various studies showed no harm from mercury fillings, some consumer groups contend the fillings can trigger a range of health problems such as multiple sclerosis and Alzheimer’s disease. In 2006, an FDA advisory panel of outside experts said most people would not be harmed by them, but said the agency needed more information.

Mercury has been linked to brain and kidney damage at certain levels. Amalgams contain half mercury and half a combination of other metals.

Charles Brown, a lawyer for one of the groups called Consumers for Dental Choice, said the agency’s move represented an about-face. “Gone, gone, gone are all of FDA’s claims that no science exists that amalgam is unsafe,” he said in a statement.

J.P. Morgan Securities Inc. analyst Ipsita Smolinski said the FDA is not likely to outright ban the fillings next year but will probably call for restrictions.

“We do believe that the agency will ask for the label to indicate that mercury is an ingredient in the filling, and that special populations should be exempt from such fillings, such as: nursing women, pregnant women, young children, and immunocompromised individuals,” Smolinski wrote in a research note on Wednesday.

Fewer patients have been opting for mercury fillings in recent years, instead choosing lighter options such as tooth-colored resin composites.

Only 30 percent of fillings given to patients were mercury-filled ones as of 2003, according to the American Dental Association (ADA). Other options include glass cement and porcelain as well as other metals such as gold, but they cost more and are less durable, the group has said.

(Reporting by Susan Heavey; editing by Carol Bishopric)

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Suspicions Deepen on Food Labs

Posted by kandylini on May 28, 2008

I’m sure a lot more than these tests’ results are banned from the public. My reaction to this whole tainted food debacle mess has been to sharply reduce the amount of imported food I buy. Boycotting with dollars will soon get the message across!

By Stephen J. Hedges, Chicago Tribune.

At issue: Were test results of tainted imports withheld?

Testing food

A chemist for a San Francisco laboratory conducts a food test last week. Private labs are not required to inform the FDA when tests of imported food indicate contamination. (Photo for the Tribune by Dino Vournas / May 23, 2008)

WASHINGTON — A congressional committee is investigating whether some private U.S. laboratories were instructed to withhold samples of tainted food so that importers could get their goods into the United States.

In a May 1 letter to 10 labs, the House Committee on Energy and Commerce suggests they may have been encouraged by importing companies to discard test results that had failed Food and Drug Administration standards.

“We’re gathering information from both the FDA and private industry about the labs almost being complicit in helping importers game the system,” said Rep. Bart Stupak (D-Mich.), chairman of the Oversight and Investigations subcommittee that is investigating the labs and food companies. “Someone told us you pay for the result you want to get from the labs.”

The committee’s letter reiterates Stupak’s suspicion that testing on some samples was conducted repeatedly until the food passed.

FDA kept in dark

In other instances, the letter says, importers whose food failed tests at one laboratory would hire a different lab to continue testing until they got a positive result.

“This repeated testing is done without alerting FDA that potentially dangerous food has been imported into this country — a practice which we find deplorable,” the letter states.

The committee asked 50 multinational food companies for a wide range of recall- and food-import records dating to 2000.

A May 8 letter from the committee to the companies asks about instances when food was found to be contaminated with chemicals or bacteria such as E. coli, salmonella or listeria.

“We wish to assess the extent of microbiological and/or chemical contamination occurring during the processing of food and the extent to which controls have failed to prevent or eliminate contamination in food,” the committee wrote.

Three Chicago-area corporations— Kraft Foods Inc., Sara Lee Corp. and the Wm. Wrigley Jr. Co.—are included in the second request.

The committee’s investigation springs from previous hearings on the effectiveness of the FDA and U.S. Department of Agriculture in enforcing food safety through inspections and recalls.

The role of food testing laboratories became an issue in February, when the CEO of one private lab, Anresco Laboratories of San Francisco, said private labs don’t always tell the FDA when tests show that imported food may be contaminated.

That executive, David Eisenberg, told the committee that the FDA “requires that we sign a laboratory director’s statement that we’re submitting all work that we’ve done on a sample.”

In reality, he said, the importers that hire the labs control where the test results go.

“If the importer tells us not to submit the information to the FDA, the FDA never sees it,” Eisenberg testified. “Sometimes they want to keep a clean record on their item with the FDA.”

In an interview, Eisenberg said that a check of his company’s records revealed that it withheld samples from the FDA at a company’s request an average of three times a month. He said the labs break no laws by withholding such information.

“We are employed by the imported-food manufacturer,” Eisenberg said. “We are not employed by the FDA, and the FDA has no authority over private labs that are generating imported-food test results, so we have to follow the advice of our customer.”

Comment: Yes, and it really is a lot for us to expect them to care about people instead of their jobs!

Dr. David Acheson, the FDA’s assistant commissioner for food protection, said the role of private labs is to determine whether importers are complying with requirements outlined in alerts that the FDA issues for certain goods. But those test results, he acknowledged, belong to the companies.

“They’re not required to send us the whole bundle of testing that they have done,” he said. “For the vast majority, these are done by labs that we’re familiar with.”

That familiarity, Acheson said, reduces the possibility that importing companies “lab shop” until they get positive test results. In those instances, he said, “Our guys would probably smell a rat.”

Acheson said he favors congressional proposals that would allow the FDA to accredit private labs, which could give the agency more access to test results and methods.

The potential danger in some imported foods became the subject of scrutiny in March 2007, when pet food ingredients made in China were found to be contaminated with melamine, a compound used to make plastic.

Since then, the FDA has reversed a decision to close 7 of the 13 agency labs it operates and has pledged to expand the inspection of food imports, which have exploded in recent years.

Last autumn the FDA issued an alert on five types of Chinese seafood: eel, shrimp, catfish, basa and dace. The warning was recognition of the fast-growing Asian aquaculture industry and its frequent use of antibiotics banned in the United States.

8 labs not complying

To import those seafoods, companies affected by the alert must prove that their products don’t contain banned substances. Conducting tests to prove it is one of the jobs the private labs perform.

So far, just 2 of the 10 labs targeted by the House committee have complied with the records request, according to committee staffers.

Amir Jalaeikhoo, president of one lab that did comply, Imperial Private Laboratories Inc. of Miami, said that his firm reports negative test results to the FDA. Imperial mostly tests for pesticides in produce imported from Central and South America, Jalaeikhoo said.

“Sometimes we lose clients because our standard operating procedure is that basically if something is … in violation, we submit it,” he said. “Some importers don’t like that policy.”

Officials of the other labs did not comment.

Of the Chicago-area multinationals asked to provide records, Kraft and Sara Lee said they were complying with the House request.

“We take an end-to-end approach to food safety and build it in from start to finish—from product development through production, distribution and product use,” said spokeswoman Susan Davison of Kraft Foods.

Sara Matheu of Sara Lee said her company is cooperating. “We have received the letter and will respond with appropriate information as requested,” she said.

The Wrigley Jr. Co. did not respond to a call.

shedges@tribune.com

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