FDA Attacks Natural Thyroid Millions Depend On

http://www.healthfreedom.net/index.php?option=com_content&task=view&id=878

We have learned that Time-Cap Labs, producer of a generic version of the brand name drug Armour, a natural and bioidentical thyroid replacement, has been ordered by the FDA to stop production. The FDA has decided to classify the company’s product, available for over a century, as an unapproved new drug. Since the new drug approval process is prohibitively expensive for a non-patentable substance, the FDA is in effect banning the natural product. The purpose? Presumably to protect the profits of other, inferior drugs that have been FDA approved.

According to statistics by the American Association of Clinical Endocrinologists and other medical organizations, approximately twenty-seven million Americans have a thyroid disorder. Thyroid consumer advocate Mary Shomon projects that 2 million of these patients take either Armour Thyroid or a generic equivalent.

Armour and other “whole” natural thyroid preparations (including Westhroid and Nathroid as well as Time-Cap Lab’s Thyroid) are bio-identical, complete hormone preparations, containing “T4” “T3” “T2” and “T1” in the same proportions made by the human thyroid.

The FDA approved preparations Synthroid (T4), Cytomel (T3), and Levethyroxine (T4) include bio-identical molecules, but are not complete or totally bio-identical as they do not contain “T2” or “T1”. It’s no wonder so many people feel much better with the balanced natural products that have been available for generations.

As famed physician Dr. Jonathan Wright observes: “Natural thyroid has never killed or severely harmed anyone since its first use in the 1890s, prior to the FDA itself. It is a mainstay not only in the treatment of hypothyroidism but also in ‘healthy aging’ therapy. That the FDA should even be thinking of requiring a new drug approval for a safe, 100 plus year old natural treatment is outrageous.”

We will report further as soon as we confirm more of the facts, and as always, we’ll let you know how you can get involved.

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7 Comments

Filed under Abbott, Armour, Autoimmune, Back-order, Bio-identical, Depression, Desiccated thyroid, FDA, Government, Hormone, Hypothyroidism, Naturethroid, Obama, SSRI, Synthroid, T3, T4, Thryoid, Uncategorized

7 responses to “FDA Attacks Natural Thyroid Millions Depend On

  1. jeaton79

    Be very afraid. People this is getting scary. Why couldn’t the FDA tell everyone what was happening straight up. Instead they kind of back doored it. Medco let the cat of the bag by telling doctors the natural thyroid drugs were off the market. People please contact the FDA. This is not right. Millions of people will be effected.

    • pat steph

      i have been taking thryoid since i was 8 years old and the only drug that gave me reflief was the armour thyroid which I can’t find at the moment .

      It is a shame that the government tells me what is good for me in the way of medicine – they are not in my body …..

      this is an outrage

  2. Chris Moore

    I agree, this is totally unacceptable. My solution so far is to have as many people who use Armour contact their local paper (mine is the Chicago Tribune) to try to get this some press. Then I suggested that everyone contact their local congressman/senator to put pressure on the FDA if possible. The FDA feels no pressure from the common man but might from other government groups(?). Just an idea

  3. Leslie

    The FDA denies stopping Time-Cap and states they do not discuss actions… Nevermind once the action is taken it is public record. Here is a qoute from the FDA. I asked them about it….

    Thank you for writing to the Division of Drug Information in the Center for Drug Evaluation and Research (CDER).

    Please note that these products are on the market and available to consumers, even though they are not FDA-approved. In addition, FDA has NOT ordered any of the unapproved thyroid products off the market. Rather, FDA has urged all companies who market unapproved drug products, including thyroid products, to submit applications for approval. FDA is concerned that drugs marketed without required FDA approval have never been submitted to rigorous scientific evaluation, and therefore may not meet required standards for safety, effectiveness, quality, and labeling. Marketers of drug products in the U.S. have an obligation to the public to ensure through the FDA approval process that their products meet modern standards for safety, efficacy, quality, and labeling. If you would like more information on the drug review process, please refer to the article at http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143455.htm.

    We have received inquiries citing reports of shortages of unapproved thyroid products. RLC (also known as Western Research, manufacturer of West-Throid and Nature-Throid) reports that they are currently in backorder for all Westhroid and Nature-Throid products. Major and Forest report they have some of their strengths available. The reason provided by the companies for the current unavailability of some presentations has been manufacturing delays.

    Lastly, regarding possible future action against unapproved thyroid products, as a policy matter we do not discuss potential, pending, or ongoing actions except with the firms and individuals who are the subject of those actions. Class actions against unapproved drugs are made in accordance with the priorities discussed in FDA’s Compliance Policy Guide on Marketed Unapproved Drugs, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070290.pdf. Information about enforcement actions against classes of unapproved drugs is posted on the FDA website. For additional information regarding unapproved drugs, please access our unapproved drugs website at the following link:

    http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/default.htm

    Thank you for making us aware of your situation. We appreciate you expressing your concerns on this matter.

    Sincerely,

    Division of Drug Information LL
    Center for Drug Evaluation and Research
    Food and Drug Administration

  4. Sibyl Berg

    I do not approve of the FDA taking the thyroid med
    Armour and Westhroid off the market. It is a natural thyroid medication in which I have had no side effects as I did with the FDA approved synthetic thyroid. I think this is just a FDA money making scam. I think they had better stay out of indiviual’s business concerning the medication they take as long as it is not harmful and is beneficial to them. They need to investigate the synthetic thyroids. I know of a lot of people who cannot take them because of poor results. I for one will not take your synthetic drug.

  5. Seriously, is this still off the market? I am at my wit’s end with Synthroid and was looking forward to trying a more natural alternative.

  6. Judy Richardson

    I, as well as thousands of people who had to take synthroid and suffered the side affects and still did not get relief, would truly appreciate an educated person to write a letter indicating our need for natural thyroid treatment. It would be good to indicate the despiration that it woud cause people such as myself. Many people are already purchasing desicated thyroid online due to desperation.

    If a letter was written and put online for all of us to sign and send to our government officials. I am sure we would have an overwhelming response from others in our posistion. Please please would someone who has the knowledge to create such a letter please do so and help us little people who just want to be able to get up and go to work to survive. I know without this medication I am pretty much bed bound and cannot function. I will sign and I know many many others that will too. Please help us.
    Lets send our Governours, Senators even the President.

    Please – looking for help
    Judy Richardson

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