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Title: Has CODEX arrived? Action letter on FDA's proposed regs on vitamins
Source: thepowerherbs.com
URL Source: http://www.thepowerherbs.com/FDALetter.htm
Published: Jul 9, 2007
Author: ???
Post Date: 2007-07-09 01:19:59 by Pinguinite
Ping List: *Big Pharma*     Subscribe to *Big Pharma*
Keywords: None
Views: 91
Comments: 3

Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852.

Re: FDA Dietary Supplements Final Rule

Dear FDA:

I am responding to your June 22, 2007 news release requesting feedback on the
proposed Dietary Supplement Final Rule. The Dietary Supplement Final Rule 
document and link were not available on the www.fda.gov management page for 
consumer feedback and therefore I am writing you.

It is fact that the Dietary Supplement Industry has an established safety 
record, which exceeds any safety record of the pharmaceutical industry. 
Pharmaceutical drugs are regulated and tested and have injured and killed more 
people than any dietary supplement by far.

Therefore, it is evident that the Dietary Supplement Industry, which uses GMP 
(Good Manufacturing Practices) to ensure the quality and safety of their 
product, is sufficient and does not warrant the regulation outlined in the FDA's
Dietary Supplement Final Rule cGMP. The FDA has not revealed what the 
requirements are for the cGMP companion document for exemption of frequent 
product testing.

Furthermore, the regulation outlined in the FDA's Dietary Supplement Final Rule 
seeks to reclassify dietary supplements from a food to a drug category requiring
supplement manufacturers to operate like a pharmaceutical company. Such 
requirements will increase the cost of the dietary supplement to the consumer 
and force small dietary supplement manufacturers, which are without the 
financial means to comply with the new regulations, to close.

Thus forcing the dietary supplement industry to acquire manufacturing and 
testing processes similar to the pharmaceutical industry will not improve 
quality and safety but will remove all but the largest and financially able 
supplement manufacturers from existence. It appears that it is the goal of the 
FDA to transfer the dietary supplement market into the hands of the 
pharmaceutical industry.

Finally, I do not agree with the FDA's proposed Dietary Supplement Final Rule 
and therefore ask that it not be finalized and implemented.

Sincerely,

Signature:

Click for Full Text!


Poster Comment:

A confirmation on the legitimacy of this claim is in order.

The link has this letter attached to a form to print out. Subscribe to *Big Pharma*

Post Comment   Private Reply   Ignore Thread  


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#1. To: Pinguinite (#0)

FDA response to above letter:

Screw you. We don't give a damn what you think. We're the government and you're not. So bend over!

Law Enforcement Against Prohibition

IndieTX  posted on  2007-07-09   1:22:32 ET  Reply   Trace   Private Reply  


#2. To: Pinguinite, *LEAP* (#0)

leap ping

Law Enforcement Against Prohibition

IndieTX  posted on  2007-07-09   1:23:00 ET  Reply   Trace   Private Reply  


#3. To: Pinguinite (#0)

Done - thanks.

Join the Ron Paul Revolution

Lod  posted on  2007-07-09   9:30:49 ET  Reply   Trace   Private Reply  


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