Congress wants more power to ban our Supplements!!

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Don't Give the FDA More Power to Ban Our Supplements!

This bill is called The Dietary Supplement Safety Act (DSSA), which is a misleading title because it purports that there are lethal problems associated with dietary supplements. The reality is the FDA has all the power it needs now to protect the public against supplements that are spiked with prescription drugs, or otherwise adulterated.

The Dietary Supplement Safety Act will give the FDA discretionary authority to ban any supplement it chooses. What some have yet to comprehend is the horrific way the FDA has historically abused powers Congress bestows them.

By way of example, we at Life Extension were subjected to a rigorous inspection by the FDA in year 2003. The FDA investigator spent an inordinate amount of time reviewing our eye drop products. When we asked why out of all our products the eye drops were being so heavily scrutinized, the response was "because I can."

What this FDA agent was telling us was that since the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA), the FDA's power to regulate dietary supplements was limited. This act did not apply to eye drops. The result was that our statements about eye drop products could be censored, and since the FDA had the power to do it, they used it.

Until you've been on the front line, it is difficult to imagine the egregious ways that government agencies abuse their powers.

I was in a Walgreens last week picking up some pictures, when a recorded voice came on to the store's speaker system announcing the heart healthy benefits of fish oil and CoQ10.

This brought a flashback to the year 1987 when FDA agents stormed Life Extension's premises and seized these supplements, along with a brochure that described how they could help protect against heart attack.

Accompanied by armed US marshals, I vividly recall FDA agents ridiculing me about the concept that fish oil had any relationship to cardiac disorders. The sad fact in this story is the millions of heart attacks suffered by Americans because the FDA had the power for so long to censor the truth about omega-3 supplements.

Before DSHEA was passed in 1994, the FDA routinely seized dietary supplements when a health claim was made. Some individuals have apparently forgotten the past and are determined to relive it by not understanding the unintended consequences of the Dietary Supplement Safety Act of 2010.

I have brought out these real-world examples to better enable everyone to understand the dangers of giving an agency like the FDA discretionary authority, defined in this new bill as "reasonable probability," to remove dietary supplements from the marketplace. As I stated last week:

"The FDA already has broad powers to remove dangerous products. This legislation would enable the FDA to ban anything if they have only ‘reasonable probability' that there is a serious problem with a product. This kind of discretionary authority gives the FDA tyrannical power to ban supplements, a power they have not hesitated to use when they've had it."

I ask that all members take action now to protest this bill, or read more about why the Dietary Supplement Safety Act should not be enacted into law.

*These statements have not been evaluated by the Food and Drug Administration.
This product is not intended to diagnose, treat, cure, or prevent any disease.

Comments

  • Nan56143
    Nan56143 Member Posts: 349
    edited February 2010

    Here is the link you can use to take action. I had intended to post this on Monday and forgot. Thanks Carol!!

    http://www.capwiz.com/lef/issues/alert/?alertid=14665781&type=CO

    Here is the link for the article

    http://www.lef.org/featured-articles/Dietary-Supplement-Safety-Act-of-2010.htm

  • Anonymous
    Anonymous Member Posts: 1,376
    edited February 2010

    Carol. thank you for starting this thread. We need to be proactive before the right to choose our individual  treatment plans are stripped away. 

    FDA Running Extortion Racket: Natural Supplement Companies Threatened with Arrest if They Don't Pay Up
    by Mike Adams, the Health Ranger, NaturalNews Editor

    Drug Administration is running a criminal extortion racket designed to drain cash from health supplement companies and shift it into the pockets of top FDA contractors. This organized crime operation has been running for years, and it has operated with impunity because each company targeted by the scam feels isolated and alone, unable to face the astronomical legal bills of going to court and battling the FDA. So one by one, they agree to "settle" with the FDA for crimes they never committed. Part of the settlement, of course, involves the payment of FDA employees or contractors who pocket the money extorted from health companies.

    (NaturalNews) NaturalNews has learned the U.S. Food and NaturalNews has interviewed executives from three different companies who have been targeted for extortion by U.S. Food and Drug Administration employees. At their request, the names of those companies are being kept confidential until legal action being taken against them is resolved. Interviews have been recorded, with permission, with two of those companies and will be released to the public at a later date. Documents proving this FDA extortion racket are included here.


    How the FDA extorts money from nutritional supplement companies.
    The FDA extortion racket works like this: FDA employees use keyword-scanning software to scan the web pages of natural health product and supplement companies, searching for terms like cancer, cures, treatment, remedies and other "forbidden" words. FDA employees then review the discovered pages to determine if they contain any words that might inform consumers of the health benefits of the nutritional products. FDA employees also look for links that might point web users to scientific articles from peer-reviewed medical journals that further explain the health benefits of specific foods, supplements or nutrients.

    When offending words or links are found by the FDA, their extortion team goes into full swing. First, they contact the company and warn them to remove all information and links from their websites. This is the most important step from the FDA's standpoint, because by doing this, they can keep the health-conscious public in a state of nutritional ignorance about the scientifically-supported healing properties of natural supplements. Cherry products, for example, cannot link to scientific articles explaining the simple biological fact that cherries ease inflammation in human beings. Such links are considered "drug claims" by the FDA.

    Continue reading at: http://www.naturalnews.com/024567_health_the_FDA_websites.html

    Carole "And when I am ill, it is He who cures me" Ash-Shu'arâ' 26:80
  • Anonymous
    Anonymous Member Posts: 1,376
    edited February 2010

    www.rmhiherbal.org

    Stop FDA attempts to restrict availability of herbs and natural products

    American herbalists' realpolitik, essay #6. The Food and Drug Administration (FDA) persists in attempting to restrict the availability of herbal products by regulations, in spite of public outrage. Suggestions for political strategy in defeating these trends are outlined. Note: this article is of an educational nature and should not be construed as providing legal advice.

    By Roger Wicke, Ph.D.

    Page contents.....
    •Introduction
    •A brief compendium of recent FDA raids
    •Some concerns about herbal quality
    •Principles of law, limitations of FDA authority
    •Strategies for countering increased FDA restrictions of herbal products
    Copyright ©1997 by RMH-Publications Trust. Permission is given to reproduce and distribute this document without modification for non-commercial, not-for-profit purposes only; all other rights are reserved by RMH-Publications Trust.

    Note: All footnotes and references within the body of text are denoted by a three or four-character alphanumeric code enclosed within brackets, i.e., [exa1]. This document has been designed for ease of use in either online or printed version.


    --------------------------------------------------------------------------------

    Introduction
    In spite of recent passage of the Dietary Supplement and Health Education Act (DSHEA) by Congress, which was intended to protect the access of consumers to nutritional supplements and herbal products, the FDA is currently proposing GMP ("Good Manufacturing Practice") regulations that could potentially jeopardize the viability of small herbal product manufacturers. If proposed regulations requiring expensive lab testing are adopted, small herbal businesses may be forced to close due to the burdensome expenses these regulations may impose. Similar legislation is being promoted worldwide by the pharmaceutical cartels, both on an individual national level and through an international treaty proposal referred to as Codex. (See "Other resources" section, below, for information on the Codex and FDA proposals.) The FDA has claimed that it wants input from the community of professional herbalists and manufacturers before drafting final versions of its proposals.

    Go to site for complete article.........

  • carol1949
    carol1949 Member Posts: 562
    edited February 2010

    Thanks Nan! and Carole!

  • Jaybird627
    Jaybird627 Member Posts: 2,144
    edited February 2010

    Thanks for the link, I registered my protest via e-mail.

  • Yazmin
    Yazmin Member Posts: 840
    edited February 2010

    Carol, Efflorescing, and Nan: Thanks for the information. It is important that we all register our disagreement.

  • Anonymous
    Anonymous Member Posts: 1,376
    edited February 2010

    FDA One Step Away From Declaring Dietary Supplements Drugs

    by Bill Sardi

    President Barack Obama has appointed two experts, one in food the other in drugs, to head up the soon to be reorganized Food & Drug Administration in preparation for an agency split that would separate the FDA into two --- one agency to oversee foods and the other to regulate drugs. But just exactly where does that leave dietary supplements?

    Read the rest of the story here: http://www.lewrockwell.com/sardi/sardi108.html

  • ICanDoThis
    ICanDoThis Member Posts: 1,473
    edited February 2010

    Hate to sound negative, but you all do know that about half of all supplements sold in this country do not contain what is on the label, according to Consumer Reports?

    And that the FDA can't do anything about it, because the Supplements industry has its own congresscritter - Orin Hatch from Utah the Senator from the Supplements Industry.

    These people have managed to remove all consumer protections from their industry - there is no protection against fatal substances - like Ephedra. I'm an asthmatic, and that stuff is vicious, but the supplements industry sells it as a weight loss product. Congress finally managed to ban it, but not before many young women had died.

    Natural doesn't mean safe - unless you like the side effects of natural substances like foxglove and botulism

  • makingway
    makingway Member Posts: 799
    edited February 2010

    Thank you for posting that info. I registered my disapproval by signing the petition.

  • carol1949
    carol1949 Member Posts: 562
    edited February 2010

    I can do this. 

     Thank you for your input as well.  It is  very important to do our own research and use quality products in anything.  Certainly there are people who are not as well informed as others.  
    I trust the holistic physicians and advisers that I use and I do a lot of my own research.  I trust that the right information will come to me and I also know how my body feels!   

    Unfortunately, there are good and bad  products in everything.  I have a niece who works for the CDC in Atlanta.  You would be amazed at the information she shares with me.  She is in research and holds 2 masters degrees.  Quite frankly, I have forgotten exactly what they are, but she is in childhood diseases.  I will tell you, that she and her family eat almost totally organically, and they do take supplements. 

    Many medicines are also plant based as well. Taxol and Taxotere are examples.  They just poison us !

     Consumer Reports has it's own issues as well!  They now charge for their information!

  • Anonymous
    Anonymous Member Posts: 1,376
    edited February 2010

    DSHEA Ten Years Later: Now What?

    Source: Nutrition Business Journal, excerpted with permission.
    30 June 2004
    by Loren Israelsen and Thomas D. Aarts

    Editor's Note by Wyn Snow:

    Ten Years of DSHEA: Law At Risk In Today's Political Climate

    Ten years ago, the Dietary Supplement Health and Education Act (DSHEA) established new guidelines for the dietary supplement industry. The new law nurtured a brief golden age where it was easier for consumers to purchase supplements and easier for manufacturers to bring new products to market. Sales rose dramatically.

    Over the past decade, the press increasingly described supplements as "unregulated" -- which is untrue; unscrupulous manufacturers used the new law as an opportunity to market dubious products and make exaggerated and false advertising claims; manufacturers have struggled with issues of quality; reports appeared in the media that bottle contents didn't always match the label; FDA did not establish new GMP regulations required by DSHEA, and was woefully slow to enforce existing law.

    After initial strong growth at the beginning of the decade, consumer confidence has now waned and sales have slumped.

    The controversy over ephedra tarred the herbal products industry with widespread public perception that herbs are dangerous, despite extensive evidence that most herbs are quite safe. Calls for increased regulation abound-and the FDA's new proposed final rule for GMP regulations are far more stringent than the industry's original proposals of 1995.

    A year ago, Israelsen and Aarts called for supplement executives to take a hard look in the mirror and fix the problems plaguing the industry. They now call for executives to take a three-pronged approach:

    • resolve four key issues in the debate about DSHEA
    • protect the most vital provisions of DSHEA
    • restore consumer confidence

    The following is excerpted from "DSHEA Ten Years Later: Now What?" by Loren Israelsen and Thomas D. Aarts. We have paraphrased some of their industry-specific language, while doing our best to preserve the arguments and intent of the original, which appeared in the Nutrition Business Journal in January 2004.

    Read the complete article at: http://www.supplementquality.com/editorials/DSHEA_anniversary.html

  • Anonymous
    Anonymous Member Posts: 1,376
    edited February 2010

    John McCain Files New Bill Attacking Your Access to Supplements

    http://www.resistnet.com/forum/topics/john-mccain-files-new-bill

    The Dietary Supplement Health and Education Act of 1994 (DSHEA) defines dietary supplements as food and not drugs. This is critical to maintaining access to high quality, natural food-supplements. A natural product, by definition, may not be patent-protected. if supplements were categorized as drugs and required to go through the new-drug approval process, we would see most of our supplements disappear.

    The Dietary Supplement Health and Education Act of 1994, which spells out regulations regarding the manufacture and sale of dietary supplements, defines a dietary supplement as "a product (other than tobacco) intended to supplement the diet that bears or contains one of more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any ingredient noted in clause (A), (B), (C), (D), or (E)." The act defines permissible labeling claims and places the burden of proof on the Food and Drug Administration to show that a product is unsafe. It also outlines safety requirements for new dietary ingredients.

    But Dietary Supplements are regulated...you will hear the media, big pharma and politicians claim they are unsafe and unregulated and for OUR SAFETY they need new regulations and laws.
    DSHEA grants the FDA the authority to regulate dietary supplements in two important respects. First, the FDA regulates product labeling. Whenever a marketer wants to make a claim about a supplement, it must submit the proposed claim to the FDA within 30 days after its first use. Claims are limited to "general structure function" and as a rule may not assert that a product prevents or treats disease. The FDA may stop the manufacturer from advertising the claim if it is deemed impermissible. Second, DSHEA holds supplement manufacturers to what are known as "good manufacturing practices." In addition, the Federal Trade Commission maintains authority over supplement advertising:

    Manufacturers must report truthfully what their products contain and must have proof backing up any claims they make. Finally, the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006 requires what's known as "adverse event reporting."

    This new bill (The Dietary Supplement Safety Act (DSSA)) is being introduced by Senator McCain that will grant the FDA even greater power over supplements and alternative health treatments. It would repeal key sections of the Dietary Supplement Health and Education Act (DSHEA). It would give the FDA full discretion and power to compile a discreet list of supplements allowed to remain on the market while banning all others. Under this bill, this same Agency could quite arbitrarily ban any supplement it wished or turn it over to drug companies to be developed as a drug and sold for multiples of its price as a supplement.

    Here is something to be concerned about...McCains Dietary Supplement Safety Act (DSSA) appears to be supported by the US Anti-Doping Agency (USADA) which is funded by major league sports teams including baseball, football and others. The recent suspensions of NFL and other professional sports figures is much in the news, and the goal of the sports industry appears to be to shift the spotlight from their players to the supplements industry. In his comments, Senator McCain cited six NFL players recently suspended for testing positive for banned substances and purportedly exposed to these substances through dietary supplements.

    The problem here of course is one of illegal sale and use of steroids.
    They are going to try and include the supplements you and I buy at our health food store with the banned substances misused by athletes and will dismantle the supplement industry in order to control already illegal substances. The FDA currently has complete and total authority to stop illegal steroids and to regulate dietary supplements. If the agency were doing its job, it could and would have prevented the sale of illegal steroids. The answer to this problem is not to give the FDA more power. The Agency simply needs to do its job!!

    We really need to stop this before it gets anywhere and with this kind of money behind it we need to work fast!

  • Anonymous
    Anonymous Member Posts: 1,376
    edited February 2010

    Government Accountability Office: FDA fails to follow up on unproven drugs
    By MATTHEW PERRONE (AP)

    WASHINGTON - The Food and Drug Administration has allowed drugs for cancer and other diseases to stay on the market even when follow-up studies showed they didn't extend patients' lives, say congressional investigators.

    A report due out Monday from the Government Accountability Office also shows that the FDA has never pulled a drug off the market due to a lack of required follow-up about its actual benefits - even when such information is more than a decade overdue.

    When pressed about that policy, agency officials said they have no plans to get more aggressive.

    The GAO says the FDA should do more to track whether drugs approved based on preliminary results actually have lived up to their promise.

    The FDA responded that the report paints an overly negative picture of its so-called "accelerated approval" program, which is only used to approve drugs for the most serious diseases.

    "Millions of patients with serious or life-threatening illnesses have had earlier access to new safe and effective treatments," thanks to the program, the FDA said in its response to the report.

    In 1992, the FDA began speeding up the approval of novel drugs based on so-called surrogate endpoints, or laboratory measures that suggest the drug will make real improvements in patient health. HIV drugs, for example, are cleared based on their virus-lowering power, a predictor of increased survival.

    Drugmakers favor the program because it helps them get products to market sooner, without conducting long-term patient studies that can take years and cost hundreds of millions of dollars. A condition of quicker approvals is that drugmakers conduct follow-up studies to show the drug's benefits actually panned out.

    But the GAO report, a copy of which was obtained by The Associated Press, identified several drugs still on the market that never lived up to their initial promise. And in the 16 years that the FDA has used accelerated approval, it has never once pulled a drug off the market due to missing or unimpressive follow-up data.

    "FDA has fallen far short of where it should be for patient safety," said Sen. Charles Grassley, R-Iowa, who requested the investigation.

    Of the 144 studies the FDA has required under the program since 1992, 64 percent have been completed and more than one-third are still pending, according to the GAO. Investigators said the FDA does not rigorously track whether companies are making progress on their required studies, although the agency is improving.

    Continue reading at:

    http://informedcitizens.wordpress.com/2009/10/26/government-accountability-office-fda-fails-to-follow-up-on-unproven-drugs/

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