Re: so Naturethroid West throid and Armour are all totally unavailable ?

August 22, 2009

synthetic thyroid meds are far more profitable...both for big pharma...and the

docs (so many stay sick).

and no - PETA not involved....

cindi

>

> Why would they do this? Are they trying to push a certain drug? Is Peta

> involved? Seems pretty nasty to try and get the docs to prescribe another

> drug, really underhanded!

August 22, 2009

I was just going to ask the doctor to switch me to Naturethyroid after taking the synthyroid

for two months now I don’t think it’s the best thing for me. I think treating

the free T3 and free T4 might be a better way to go as a lot of my symptons don’t seem to be leaving.

So it’s possible if my pharmacy (Target) doesn’t have it I can get

it online?

Bronwen

From: Thyroiditis

[mailto:Thyroiditis ] On Behalf Of beckyjov

Sent: Saturday, August 22, 2009 4:21 PM

To: Thyroiditis

Subject: Re: so Naturethroid West throid and Armour are

all totally unavailable ?

Hi,

I doubt PETA has

anything at all to do with this. However, it appears that Carol is

justified in her concerns to get natural desiccated thyroid hormone. Here

is the article that, I believe, Cindi was referring to.

http://thyroid.about.com/b/2009/08/19/fda-desiccated-thyroid-armour-nature-throid.htm

Beware it is maddening

-- anyway it was to me.

The pharmacy I go to

would only fill a 30 day supply of NatureThroid although I had a 90 day

script. They did forgo the co-pays for the extra two months. So, I could

be in trouble in less than two weeks when I refill.

Carol, for what its

worth I ordered a hefty 11 month supply of a generic natural desiccated

thyroid. It cost roughly $12.50 per month. I am paying a $3.00

co-pay now a month, but I don't want to cry about not having any later.

This is all so scary and unpredictable! I don't know what I am getting,

but was told by other hypos they didn't notice any difference. In fact, they

all thought it was as good if not better than the old Armour. So, anyway,

I may or may not have spent my money wisely; time will tell. Keeping my

fingers crossed and wishing good thoughts. Nonetheless, I didn't have a

script as mine is at my local pharmacy so I ordered via a online pharmacy that

doesn't demand a script -- risky I know.

Us - ALL OF US -

NATURAL THYROID Users MUST unite together NOW and tell the FDA - OUR

Senators/Reps - I am also in the process of writing a note to TX Rep Ron

who is a trusted natural medicine advocate and a thorn for the FDA. http://www.house.gov/paul/ We

MUST TELL them ALL our stories… That synthetic T4 just doesn't do it for us

etc… What the FDA is doing is totally UNACCEPTABLE,

period! Lawmakers want and need to hear from us -- they are much

more apt to read pleasant informative letters. Here is links to

help find your reps: http://www.house.gov/

and http://www.senate.gov/

Some people think

Forest deliberately caused this mess, but I not convienced and still lean on

the notion that Forest was forced into reformulating Armour. I don't

condone its deceptive practices by any means on the antidepressant studies.

Maybe just wishful thinking on my part.

Carol, do you have a

link to the Thyrolar ban? Is the generic, Liotrix, still available?

I looked but only found that Thyrolar is still on back order. I have a

friend who is struggling to get her Thyrolar -- she was able to get the Liotrix

the generic of Thyrolar though, but doesn't think it's as potent as Thyrolar.

There definitely is a

SHORTAGE... RCL has declared backorder on NatureThroid

http://thyroid.about.com/b/2009/08/17/nature-throid-backorder-thyroid.htm

Some people on the

East Coast of the USA say pharmacies have plenty of Westhroid (which is the

same product as NatureThroid, both made by RCL) but out here in the Pacific NW,

USA we are told that Westhroid has been discontinued and no longer manufactured

since May 2009 and only NatureThroid is available if you can get it. The

supply is VERY limited.

--

As far as I know, compounding pharmacies do not

process raw thyroid. Compounded desiccated thyroid is made with Thyroid USP

powder. All thyroid powder in the USA comes from one company, American

Laboratories in Omaha, NE. And they are in BIG trouble right

now! Making me very nervous! Surely, both Forest and RLC are

working with them to increase their own supplies.

Another contributor to the shortage is due to

fewer pigs being slaughtered for the export market because of swine flu mania.

If all else fails, look into natural thyroid made in

other countries. Canada has its own natural thyroid manufactured by Erfa Sciences Canada

called " Thyroid. " Germany's thyroid is named " Thyreogland. "

Italy's is called " Cinetic. " " Thyreoidum " is made in Denmark. New

Zealand has " Whole Thyroid " , which is compounded desiccated

thyroid. Thailand manufactures " Thyroid-S " and " generic Armour " the

main ingredient is USP. Sriprasit

Dispensary R.O.P (Thyroid-S) and Greater Pharma (generic Armour) are both

located in Bangkok.

--

When the thyroid supply is restored, it will BE

much more costly!

As far as I can tell there is natural `Thyroid'

(Erfa) in Canada and a valid prescription is required to order from any

Canadian pharmacies. Mastermarketing.com in the UK now requires a script

from USA customers and WOW OH WOW has its prices SkyRocketed – I paid

$3.50 four years ago for 30 – 10mg tabs of Hydrocortisone,

now the cost is $76.20. YIKES!

Natural thyroid is no longer sold there.

--

Again -- We all MUST -- EACH and EVERY ONE of US

-- MUST stand firm, speak loud, and stick together flooding policy makers

inboxes and/or mailboxes. Or lose our meds and whine about it later.

Hang in there,

~Bj

> >

> > Carol,

> >

> > Did you see 's web page about this the other day?

> >

> > Medco Thyroid Scandal: Thyroid Patients Demand Answers Regarding

> Misleading Thyroid Drug Shortage Notices

>

> No virus found in this incoming message.

> Checked by AVG - www.avg.com

> Version: 8.5.409 / Virus Database: 270.13.63/2317 - Release Date: 08/21/09

> 06:04:00

>

No virus

found in this incoming message.

Checked by AVG - www.avg.com

Version: 8.5.409 / Virus Database: 270.13.63/2317 - Release Date: 08/21/09

06:04:00

August 23, 2009

Maybe the reformulation is to get rid of the antigens?

I have personal bias against big pharma (ie: will lean to more natural

approaches if they are proven work, and am fully aware that big pharma has too

powerful a grip on our medical industry)

But I also like to look at the facts of our disease without allowing my personal

bias to get in the way.

Autoimmune disease is when the body attacks a NATURAL protein. Anytime a natural

protien we make becomes a target of the immune system (an " antigen " ) we make

anti-bodies to destroy that protein. That's how we develop an 'autoimmune

disease'.

Nobody is sure why natural proteins become antigens. But we do know that our

bodies are missing the regulation of the immmune system --- which is controlled

by an immune system cell called T-Reg.

When my doctor offered me a " natural " approach to treating my hypothyroidism (I

was on block and replace therapy), I began to take Armour thyroid to replace the

Synthroid I had previously been using.

Just a month before this, I had antibodies tested: TSH Receptor antibodies

(which target the TSH receptors found on the thyroid surface and interfere with

thyroid function). These abs had slowly fallen over the course of my therapy

(methimazole + levothyroxine) from 230 down to 108. My TBII antibody test had

fallen very slowly - from 22 to 8% (range <16%). I was so excited that I was so

SUPER close to remission!

But my doctor thought I would feel better if I was on Armour.

Just over one month later, my TSI antibodies were tested. They had surged for

the first time during my therapy --- from 108 to 177! I did not have TPOabs

tested at that time, but am now assuming they probably also rose, since Armour

will contain the antigen that triggers TPOabs (peroxidase).

Very concerned, I began looking at Armour thyroid (natural thyroid) and found

that the entire pig thyroid gland is ground up to make this product - including

these " natural " protiens that my body has mistaken as " enemy " .

Very concerned, I asked my doctor if the Armour might contain TSH receptor

antigens that was igniting such an immune system response? And could that be why

my immune system reacted, erasing my near-remission so suddenly?

He had no idea, but said " Very good question " .

So he switched me back off of Armour and my TSH receptor antibodies began to

decline once again.

I'm not trying to convince anyone that one product is better than another ----

but I do hope that everyone looks at their own personal situations, and analyzes

how their immune system reacts to any " dessicated " thyroid drug.

What I've learned on a personal level, is that you really don't want to be

taking a med that may be aggravating your immune system. There is a synthetic T3

(Cytomel) that you can take that will not carry those natural antigens so you

don't have to live with low T3.

A version of this same question was posed to Dr. Brownstein on Shoman's

site, but misunderstood the question that we were asking. They both assumed

worries were that " pig thyroid " would be mistaken as " foreign " . That's not what

our worries are. In people with autoimmune disease, the opposite is what we

worry about -- the pig thyroid protiens may be mistaken as our own " NATURAL "

antigens --- and the nature of our disease is that those " natural antigens " are

what launches the attack.

Just something to ponder! Take care.

Val

> > >

> > > Carol,

> > >

> > > Did you see 's web page about this the other day?

> > >

> > > Medco Thyroid Scandal: Thyroid Patients Demand Answers Regarding

> > Misleading Thyroid Drug Shortage Notices

> >

> > No virus found in this incoming message.

> > Checked by AVG - www.avg.com

> > Version: 8.5.409 / Virus Database: 270.13.63/2317 - Release Date: 08/21/09

> > 06:04:00

> >

>

> No virus found in this incoming message.

> Checked by AVG - www.avg.com

> Version: 8.5.409 / Virus Database: 270.13.63/2317 - Release Date: 08/21/09

> 06:04:00

>

August 23, 2009

Was this company (Time Cap Labs) manufacturing all the natural thyroid drugs

(Westhroid, Armour et al)? Here's the full warning letter sent to Time Cap, for

those who want to see the entire article:

Time-Cap Labs 4-10-2009

Department of Health and Human Services Public Health Service

Food and Drug Administration

New York District

158-15 Liberty Ave.

Jamaica, NY 11433

April 10, 2009

WARNING LETTER

VIA FED EX

Ref NYK 2009-11

Mr. ph Errigo

Owner/President

Time-Cap Laboratories, Inc.

7 Avenue

Farmingdale, NY 11735-3921

Dear Mr. Errigo:

An inspection of your facility located at 7 Avenue, Farmingdale, New

York, in which you manufacture prescription and over-the-counter (OTC) drug

products for human use as well as a prescription drug for veterinary use, was

conducted on October 28, 2008, through December 5, 2008, by investigators of the

U.S. Food and Drug Administration (FDA). The inspection revealed that your drug

products are adulterated within the meaning of Section 501(a)(2)( [21 U.S.C. §

351 (a)(2)(] of the Federal Food, Drug, and Cosmetic Act (Act) in that the

methods used in, or the facilities or controls used for, their manufacture,

processing, packing or holding do not conform to or are not operated or

administered in conformity with Current Good Manufacturing Practice (CGMP)

regulations for drugs, Title 21, Code of Federal Regulations (CFR), Part 211.

In addition, you manufacture a number of prescription drugs without approved

applications. As described below, these drugs are unapproved new drugs, and by

introducing them into interstate commerce you are in violation of 21 U.S.C. §

355(a) (section 505(a) of the Act). These drugs are also misbranded under 21

U.S.C. § 352(0(1) (section 502(f)(1) of the Act).

CGMP Deviations

We acknowledge receipt of your letter dated December 18, 2008, as well as your

updated responses dated January 7 and 26, 2009 and March 13, 2009. The

violations we observed, along with comments regarding your responses to FDA Form

483 include, but are not limited to, the following:

1. Failure to establish reliable, meaningful and specific test methods as part

of a written testing program designed to assess the stability characteristics of

your firm's drug products to determine appropriate storage conditions and

expiration dates [21 CFR § 211.166(a)(3)]. For example, your firm's analytical

methods have not been validated to demonstrate that they are stability

indicating. Review of validation results for your analytical methods noted that

forced degradation studies had been performed, but at the time the validation

work was conducted, your firm did not have the analytical instrumentation

capable of evaluating the data to determine if co-elution between potential

degradants and analytes was present. Therefore, these methods were not shown to

be stability indicating. Equipment was subsequently purchased and additional

data was generated. However, review of the data generated confirmed that

significant degradation was not present and that the additional work did not

establish the methods as stability indicating.

Your response stated that your firm is reviewing all of your analytical methods

to assess their validation status and suitability for determining the stability

of your drug products. You committed to complete this assessment within thirty

(30) days of the date of your correspondence (February 26, 2009). In addition,

you committed to conduct any validation studies necessary to demonstrate that

your analytical methods are stability indicating. However, the proposed

validation studies do not have specific timeframes for completion. The adequacy

of the implemented corrective actions will be reviewed at the next inspection.

This is a repeat observation from the October 2006 inspection.

2. Failure to establish scientifically sound and appropriate specifications,

standards, sampling plans and test procedures that are designed to assure each

drug product satisfactorily conforms to appropriate standards of identity,

strength, quality, and purity. [21 CFR § 211.160(] For example, your firm

failed to perform residual solvent testing on drug products that were

manufactured using solvents that are required to be limited in drug products. At

the time of inspection, ((4) drug products required residual solvent testing.

Your response stated that your firm intends to complete the residual solvent

testing within the next nine months (or when the product is manufactured for

infrequently manufactured products). However our response does not include any

plans for future periodic residual solvent (RS) testing of these ((4) drug

products to ensure the RS specifications of these drug products remains below

the required levels. Further, your corrective action did not address products

that have been distributed that were not tested for RS. Finally, please note

that any analytical method you select to test for RS must be suitable for its

intended use.

3. Failure to establish time limits for completion of each phase of production

to assure the quality of the drug product. [21 CFR § 211.111] Time limits have

not been established in a written procedure or in master production records for

all drug products. For example, investigators noted that Thyroid Tablets 65mg,

lot GO 15U, was blended on May 13, 2008. However, tablet compression for the

finished product was not started until September 17, 2008.

Regarding this issue, your response states in part that your firm has stability

data extending to 48 months. However, you have not established a correlation

between the extended stability data test results and the extended product hold

times. In addition, regarding testing of this specific lot, your response states

" Our finished product testing of all Thyroid Tablets includes both chemical and

microbiological analysis. The finished product release testing of Thyroid

Tablets, 65 mg (lot D013U/G015U) confirmed the potency, purity and integrity of

the lot of product. " Finished product release testing is not a substitute for

CGMP controls. Further, although not provided, your response indicates that a

procedure establishing time limitations for each phase of the production process

will be created and implemented by February 26, 2009. Please ensure that you

establish hold times for all your firm's drug products. The adequacy of the

implemented corrective actions will be reviewed at the next inspection.

1. Failure to establish test procedures or other laboratory control mechanisms

that are designed to assure that drug products conform to appropriate standards

of identity, strength, quality, and purity and to assure that any deviation from

the written test procedures or laboratory control mechanisms are recorded and

justified. [21 CFR 211.160(a)]. For example:

a) Investigators observed that analysts did not follow your firm's established

method on four dissolution drug release tests for Aspirin Delayed Release

Tablets, lots C116U and RD H017U. There was no documented justification for

these deviations from the established procedures.

Your firm failed to follow your written procedures for qualification of raw

materials as in-house reference standards. Specifically, raw materials (e.g.

Phenylephrine HC1, Chlorpheniramine Maleate) are not always ((4) prior to

determining their potency as required by your procedure. This step is necessary

to correctly determine the standard's potency.

c) Your firm's laboratory assay testing method for preparing Thyroid Tablets USP

does not include instructions to protect standard laboratory solutions from

light exposure, per USP requirement. Your QC laboratory supervisor told our

investigator that any laboratory glassware could be used in preparing standard

solutions for Thyroid Tablets USP without precautions to protect the solution

from light exposure.

Your January 26, 2009 response to these observations [FDA-483 item #

8(subparagraphs 3 & 4) and FDA-483 item #9] included revised procedures,

eliminating inadequate sampling methods and use of glassware by your firm's

analysts. Please provide your rationale for the distribution of products with

standards that were characterized incorrectly. Finally, please include

justification regarding the use of test results obtained using inadequate

glassware for standard solutions sensitive to light.

5. Failure to maintain complete laboratory records with complete data from all

tests necessary to assure compliance with established specifications and

standards, including a complete record of all data secured in the course of each

test. [21 CFR § 211.194(a)]

For example, your firm's system suitability testing under the nine-month time

point for the CRT stability assay and dissolution analysis of Nitroglycerin

Extended Release Capsules Lot M041S is inadequate. Your firm's analyst discarded

data from a total of seven standard injections for system suitability and

standard average calculations. The analyst failed to provide any justification

for discarding the selected data. Further, the analyst and supervisor failed to

review this discarded data, as required by SOP 3.194. Inclusion of this

discarded data would have resulted in the failure to meet both system

suitability and standard average specifications as required by your firm's

method, AP 121(A) and SOP 3.194.

Your response stated in part, " Although it was not documented, the data were

legitimately discarded because they did not meet system suitability

requirements. " Not meeting system suitability requirements alone it is not

adequate justification to discard data. In addition, your response indicates

that you reviewed every case over the prior 12 months where analytical data were

disqualified and no similar cases of not following the procedure were noted.

Please note that SOP 3.194 is inadequate because it only requires the analyst to

explain why an injection was eliminated from a calculation.

A decision to discard data should be based on a detailed assessment of the steps

taken during the test. If laboratory or calculation errors are not identified in

the first test, there is no scientific basis for invalidating initial

out-of-specification (OOS) results in favor of passing test results. All test

results, both passing and suspect, should be reported in accordance with 21 CFR

§ 211.188 and 21 CFR § 211.192 and considered in batch release decisions.

In addition, adequate corrective action should include training for the analysts

and supervisor on the proper handling of OOS results.

6. Failure to conduct calibration of instruments, apparatus, gauges, and

recording devices at suitable intervals in accordance with an established

written program. Instruments, apparatus, gauges, and recording devices not

meeting established specifications shall not be used. [21 CFR § 211.160((4)

For example:

a) The investigators observed the following deficiencies:

• The baskets used for dissolution testing were severely warped, resulting in

significant wobble. The Director of Quality Control (QC) concurred with this

visual observation. In addition, all available baskets used for dissolution

testing were examined by both our investigator and the Director of QC and found

to be in the same warped condition. Wobbling is not checked during apparatus

calibration and set up.

• Our investigator estimated that the distance from the inside bottom of the

dissolution vessel and the bottom of the basket was different than the USP

specification (25mm (± 2mm)) to assure adequate instrument conditions prior and

during testing. This deviation was also confirmed by the Director of QC.

Your response stated: " There were approximately a dozen baskets stored in a

cabinet that were in very good condition and available for use. " However, during

the inspection, the Director of QC identified to our investigator additional

dissolution baskets that were stored in a laboratory drawer, and were in the

same warped condition. We acknowledge your corrective action to replace

unacceptable baskets.

In addition, the revised SOP 3.181(A), ((4) dated January 9, 2009, is

inadequate due to the following reasons: 1) The SOP fails to describe how to use

a wobble meter, 2) The SOP fails to define what is considered unacceptable

wobbling; and, 3) The SOP fails to describe what is considered a physical defect

for baskets and paddles.

You failed to follow SOP 3.159(A), ((4) for annual calibration of your QC

laboratory's ((4) HPLC units. This equipment calibration was performed between

May and July 2008. However, to determine HPLC instrument carryover, the analyst

failed to ((4) per the SOP, but instead re-injected a standard solution and

proceeded to calculate the carryover incorrectly. In addition, three different

analysts, including the Director of QC, reviewed and approved these final

calibration test results.

Your response stated that your firm conducted a training session with the

analyst involved with the Calibration Protocol ((4) for HPLC Unit. However,

review of this training record, dated November 13, 2008, revealed training for

two analysts . You did not include training documentation for the additional

analysts and the Director of QC that reviewed and approved these incorrect test

results.

7. Failure to establish and follow written procedures for cleaning and

maintenance of equipment used in the manufacture of drug products. [21 CFR §

211.67(] Specifically, your firm's Disintegration apparatus was observed in

the following condition:

• Basket-rack assemblies were observed unclean and containing excessive residue

from previous analysis.

• Disks that were available for use did not all have smooth surfaces free from

chips as required by the USP. Further, the disks were discolored.

Your response for the above two examples indicates that your firm revised your

procedure for the Disintegration apparatus. Your response is inadequate in that

your revised SOP 3.205(A) ((4) fails to indicate if these physical defects and

unclean basket-racks or disks are discarded or removed from use when observed.

Further, your response failed to indicate if: a) the unclean basket-racks noted

in the above observation were subsequently cleaned or discarded or the disks

noted in the above observation that did not have smooth surfaces were discarded.

8. Failure to establish written procedures for production and process control

designed to assure that the drug products have the identity, strength, quality,

and purity they purport or are represented to possess. [21 CFR § 211.100 (a)]

For example, your firm failed to complete the process validation study report

for Thyroid Tablets, USP. Data were collected for this product in July 1999 and

July 2004, but the documentation was not evaluated to show that product

performance is consistent and reproducible from batch-to-batch.

Your response stated, in part: " . . .; however, a study report was not written.

Therefore, we will review the process validation study obtained for Thyroid

Tablets, USP in July 1999 and July 2004, and issue a summary report on each of

these validation studies within sixty (60) days of the date of this

correspondence [March 26, 2009]. " The adequacy of the implemented corrective

actions will be reviewed at the next inspection.

In addition, note that assuring that a manufacturing process produces the

outcome that it was designed to produce is considered an ongoing process. It is

necessary to conduct additional periodic process verification.

9. Failure to maintain separate or defined areas necessary to prevent mix-ups

during manufacturing and processing operations. [21 CFR § 211.42©(5)]

Specifically, ((4) adjacent tablet compression areas are separated by

pass-through clear plastic curtains with interleaved strips from the top of the

door to the floor. Different formulated solid oral drug products are tableted in

these various compression areas, separated by the pass-through plastic curtains.

Your Regulatory Affairs Manager stated the plastic curtains were set up to allow

operators to move freely through the curtains that are between the various

compression areas to perform operations on different batches.

Your response for this item stated: " The interleaved six (6) inch strips act as

a solid barrier. As a result, the curtain imparts what is tantamount to a solid

wall between the adjacent compression suites, thus preventing any

cross-contamination. " FDA disagrees with this assessment in that pass-through

plastic curtains are not considered the same as solid walls. Current industry

practice includes a well-defined system of control of separate areas in a drug

manufacturing facility.

Unapproved New Prescription Drugs

In addition to the CGMP violations discussed above, this inspection also

revealed that your firm manufactures and markets unapproved new drugs in

violation of Section 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and

355(a)]. Based on the information your firm submitted to FDA's Drug Registration

and Listing System and information collected during the inspection of your

facility, your firm manufactures the following prescription drugs:

• Thyroid 1/2 gr. (32.5 mg) Tablets

• Thyroid.l gr. (65 mg) Tablet s

• Thyroid 2 gr. (130 mg) Tablets

• Thyroid 3 gr. (195 mg) Tablets

The above products are drugs within the meaning of Section 201(g) of the Act,

[21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure,

mitigation, treatment, or prevention of diseases.

Further, they are " new drugs " within the meaning of Section 201(p) of the Act

[21 U.S.C. § 321(p)] because they are not generally recognized as safe and

effective for their labeled uses. Under Sections 301(d) and 505(a) of the Act

[21 U.S.C. §§§ 331(a), (d) and 355(a)] a new drug may not be introduced into or

delivered for introduction into interstate commerce unless an FDA-approved

application is in effect for the drug. Based on our information, you do not have

any FDA-approved applications on file for these drug products.

Additionally, the above products are misbranded because, as prescription drugs,

adequate directions cannot be written for them so that a layman can use these

products safely for their intended uses. Consequently, their labeling fails to

bear adequate directions for use as required under Section 502(f)(1) of the Act

[21 U.S.C. § 352(f)(1)] and because they lack required approved applications,

they are not exempt from this requirement under 21 CFR § 201.115. The

introduction or delivery for introduction into interstate commerce of these

products without approved new drug applications violates Section 301(a) and (d)

of the Act [21 U.S.C. §§ 331(a) and (d)].

We acknowledge your commitment to discontinue manufacturing the following

unapproved drugs and other unapproved extended release products, in your written

response to the Form FDA 483, dated January 26, 2009:

• Papaverine HCl 150 mg / Chlorpheniramine Maleate 8 mg E.R. capsules

• Chlorpheniramine Maleate 4 mg / Phenylephrine 20 mg capsule

• Chlorpheniramine Maleate 8 mg / Pseudoephedrine HCl 120 mg capsule

• Chlorpheniramine Maleate 12 mg / Pseudoephedrine HCl 100 mg capsule

We also request that you outline the actions you are taking to cease

distribution of these or any other unapproved drug products from your facility.

Please provide the following information in your response: 1) an inventory of

all unapproved drugs at your firm and 2) disposition of these unapproved drugs

by your firm. Also, please note that if you are no longer marketing these

products, you must update the Drug Listing files in accordance with 21 CFR §

207.30 (a)(2).

The violations cited in this letter are not intended to be an all-inclusive

statement of violations that exist at your facility. You are responsible for

investigating and determining the causes of the violations identified above and

for preventing their recurrence or the occurrence of other violations.

It is your responsibility to assure that your firm complies with all

requirements of federal law and FDA regulations.

You should take prompt action to correct the violations cited in this letter.

Failure to promptly correct these violations may result in legal action without

further notice, including, without limitation, seizure and injunction. Other

federal agencies may take this Warning Letter into account when considering the

award of contracts.

Additionally, FDA may withhold approval of requests for export certificates, or

approval of pending new drug applications, listing your facility as a supplier

or manufacturer until the above violations are corrected. A reinspection may be

necessary.

Within fifteen working days of receipt of this letter, please notify this office

in writing of the specific steps that you have taken to correct the violations.

Include an explanation of each step being taken to prevent the recurrence of

violations, as well as copies of related documentation. If you cannot complete

corrective action within fifteen working days, state the reason for the delay

and the time within which you will complete the correction. In addition to the

drugs you committed to cease manufacturing, if you no longer manufacture any

other drugs, your response should so indicate, including the reasons that, and

the date on which, you ceased production.

Your reply should be sent to Compliance Branch, Food and Drug Administration,

158-15 Liberty Avenue, Jamaica, NY 11433 Attention: Lillian C. Aveta, Compliance

Officer.

Sincerely,

/s/

Otto D. Vitillo

District Director

New York District

Enclosure: Form FDA 483 dated December 5, 2008

August 23, 2009

ms_sisyphus_00 wrote:

> any ideas where we can find some more?

>

So far as I can tell, except for a few pharmacies that may still have

some on hand, there isn't any more anywhere. Some are getting Rxs and

trying to get Canadian Thyroid, but I wonder if that won't just exhaust

supplies of that med too? I don't know who makes the Canadian Thyroid,

but one problem stated by the others is lack of supply of the raw

thyroid material. Surely that will impact Canadian Thyroid too at some

point?

> i am read a post today that Foreest's THhyrolar RX (The synethetic t4/t3 rx)

has just been ? banned? by the US Pharamcopia ?

> - for not complying with some requiremnt?

> was it a Potency issue on a curent batch or ?

>

Can you post more info? Where does that claim come from?

> any one heard any info on how long all these supply problems are TRULY going

to take?

>

Well, when Cynomel vanished it took nearly a year before it became

available again, so I personally would not bet on it lasting only 90

days. Besides 90 days without thyroid meds will be very bad for people

who depend on it.

I myself am doing well with an OTC product American Biologics " Thyroid "

(bovine).

There is also HSF (Hypo support Formula), and Nutrimeds also has an OTC

bovine thyroid product.

I have a friend who is using T4 and T3 together, ratio subject to

experimentation. For those who are self-treating or whose doctors refuse

to Rx any T3 even temporarily, both T4 only and T3 only meds are

available online from overseas pharms.

Some people may choose to switch to T3 only for the duration.

This is going to be really tough on the millions of people who depend on

dessicated thyroid meds..............and it may last a very long time. I

hope not, but I'm not optimistic.

sol

>

August 24, 2009

Hi Bronwen,

If your body can tolerate the synthetic T4 like Synthroid, Levoxyl, or Unithroid

etc then by all means stay with it. (I did best on Unithroid) Synthetic T3 is

Cytomel. You could try both synthetic T4 and T3 to see if that helps with

symptoms, especially right now since the natural T3/T4 hormone combo replacement

meds are so hard to find.

T3 is fast acting -- meaning it only stays in the body for a short time, about

eight hours; so it will need to be taken several times a day. There is also

SRT3 -compounded slow-release T3- that can be taken every 12 hours, but when I

tried it I found it didn't work well in my body and it was quite expensive like

most compounded meds.

Yet there are quite a few of us that just don't tolerate the synthetics and need

the natural meds.

I encourage you to give Cytomel a try. If it doesn't work move on and try

something else. Also, check the inactive ingredients before you give up on a

certain kind of med, as that may be the problem.

I have seen Cytomel online; you may or may not need a prescription.

Best,

~Bj

> > >

> > > Carol,

> > >

> > > Did you see 's web page about this the other day?

> > >

> > > Medco Thyroid Scandal: Thyroid Patients Demand Answers Regarding

> > Misleading Thyroid Drug Shortage Notices

> >

> > No virus found in this incoming message.

> > Checked by AVG - www.avg.com

> > Version: 8.5.409 / Virus Database: 270.13.63/2317 - Release Date: 08/21/09

> > 06:04:00

> >

>

> No virus found in this incoming message.

> Checked by AVG - www.avg.com

> Version: 8.5.409 / Virus Database: 270.13.63/2317 - Release Date: 08/21/09

> 06:04:00

>

August 24, 2009

Hi Val,

What an interesting throught. We can speculate, but hopefully someday we'll

know for sure why Forest reformulated Armour.

I agree wholeheartedly that every one of us has to make our own choices in

thyroid treatment. For me (and many others) the bottom line is I got worse on

synthetic replacement hormone and simply do BEST on natural hormone. I NEED the

natural T hormone to survive with any quality of life. Armour or pig thyroid

didn't cause my AI system to flare up but it sure has helped calm it down.

I can't count on my fingers the number of people I've meant here who don't

tolerate natural hormone, but it would take hundreds, maybe even thousands, of

fingers to count all the patients who react badly to synthetic T4. I went to an

ND who has a similar philosophy as you on the natural antigens. She had me on

575 mcg of T4 and 75 mcg of SRT3 plus a bunch of other remedies and I still felt

horrible. My aTPO and aTG antibodies increased significantly. I stuck it out

for about a year and went back to natural T hormone. I do thank her though for

the twice-weekly B-12 shots because they did help considerably.

I believe there is no cut and dried answer to fix AI thyroid disease -- we each

have to find what works for us as individuals.

I have meant people who cleaned up their diets and others who ridded their

bodies of parasites and/or yeast and NO longer have AI Thyroiditis or Graves.

For all I know the unnatural products, GMO etc that we consume are what change

the genetic makeup of our 'natural proteins' and set off the immune system.

In case you are not aware or for anyone else as well, studies in UCLA now show

thyroid disease is a symptom of Gluten Intolerance or Celiac disease.

Previously research thought GI/CD was found in AI thyroid disease --- It's

actually the opposite. So, since there is NO test for gluten intolerance it may

be worth concentrated effort diet, well-being and lifestyle wise.

To brainstorming and health,

~Bj

> > > >

> > > > Carol,

> > > >

> > > > Did you see 's web page about this the other day?

> > > >

> > > > Medco Thyroid Scandal: Thyroid Patients Demand Answers Regarding

> > > Misleading Thyroid Drug Shortage Notices

> > >

> > > No virus found in this incoming message.

> > > Checked by AVG - www.avg.com

> > > Version: 8.5.409 / Virus Database: 270.13.63/2317 - Release Date: 08/21/09

> > > 06:04:00

> > >

> >

> > No virus found in this incoming message.

> > Checked by AVG - www.avg.com

> > Version: 8.5.409 / Virus Database: 270.13.63/2317 - Release Date: 08/21/09

> > 06:04:00

> >

>

August 24, 2009

Val,

Armour is made by Forest Pharm and WestThroid and NatureThroid are made by RC

Labs formerly Western Research Labs.

THYRIOD is/was a " grandfathered " drug that did not require an NDA (new drug

application) to be filed with the FDA by the manufacturer. The FDA is now

eliminating the production of ALL drugs that had been " grandfathered " and now

calling them UNApproved NEW Prescription Drugs. This will eventually affect

all manufacturers of ALL dessicated thyroid tablets. Read Shomon's

articles for more info -- links are in this thread.

~Bj

>

> Was this company (Time Cap Labs) manufacturing all the natural thyroid drugs

(Westhroid, Armour et al)? Here's the full warning letter sent to Time Cap, for

those who want to see the entire article:

>

> Time-Cap Labs 4-10-2009

>

> Department of Health and Human Services Public Health Service

> Food and Drug Administration

> New York District

> 158-15 Liberty Ave.

> Jamaica, NY 11433

>

> April 10, 2009

>

> WARNING LETTER

>

> VIA FED EX

>

> Ref NYK 2009-11

>

> Mr. ph Errigo

> Owner/President

> Time-Cap Laboratories, Inc.

> 7 Avenue

> Farmingdale, NY 11735-3921

>

> Dear Mr. Errigo:

>

> An inspection of your facility located at 7 Avenue, Farmingdale, New