American Academy of Environmental Medicine

September 9, 2009

Dear Tipu,

For those of you wondering about the shortage of Armour Thyroid, I am forwarding information on the thyroid medication shortage from the American Association for Health Freedom.

Last week, we told you that the FDA has ordered Time-Cap Labs, producer of a generic version of the brand name drug Armour Thyroid, a complete and bioidentical thyroid replacement, to stop production.  According to the warning letter, the FDA has decided to classify the company's product, a generic version of a drug available for over a century, as an unapproved new drug.

AAHF has subsequently learned that two additional manufacturers of "whole" natural thyroid preparation have discontinued their products for reasons as yet unknown.

In addition to the one banned and two discontinued products, natural thyroid preparations Westhroid and Nature-throid are currently on backorder for 60 to 90 business days. The manufacturer, RLC Labs, says that this is a result of high demand.  RLC denies receiving letters from the FDA regarding their Westhroid and Nature-throid products.

The 3, 1 1/2, 1, 1/2, and 1/4 grain doses of Armour, the brand name thyroid drug  manufactured by Forest Labs, are also currently unavailable. The company is unable to provide a target date for their return to market.  According to Forest Labs representatives, the raw powdered thyroid used to manufacture Armour is on backorder and no Armour orders for the above doses are being filled at the present time.

There are numerous questions that remain to be answered . Keep in mind that the FDA banned the Time Caps Lab thyroid product not for any stated reason related to the drug's manufacture, but as an "unapproved drug". Did the FDA really ban one such product as an "unapproved drug" while leaving other similar products alone?  If so, why?

Some observers are speculating that the FDA is in discussions with the other producers, discussions that are being kept quiet at the request of the FDA. If this were true, the back orders would mean that the companies are buying time while they try to work out a deal with the FDA . This is of course pure speculation.  At the moment, the only thing we can be sure of is that the FDA's move against Time Cap Labs does not appear to make any sense, and there are back orders of other, similar products. We will of course keep investigating and immediately share what we learn.

For further background on why these products are so important for natural medicine and for millions of users, please see last week's Pulse.

September 8, 2009

Thanks to the AAHF for keeping everyone up-to-date and for allowing AAEM to forward the information.

Sincerely,

De Fox
American Academy of Environmental Medicine