FDA Regulations on Herbal Products
I know it has been quite a while since you heard from me. Long story for another day.
Today I want to pass along some information that is very important.
This past December, the FDA put a document on its web site titled "Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration." This document is open to public comments until April 30, 2007 - just days from now.
After that, FDA officials will evaluate the comments and decide if they will proceed with a regulation that might actually make it a crime to take vitamin C for a cold without a prescription.
The FDA document is 14 pages long, but the bottom line basic is: If you use an herbal or dietary supplement to stay healthy or to help prevent an ailment, that's fine. But if any supplement is used to treat a symptom, then it's a medicine and will be regulated by the FDA, just like any prescription drug.
And there's a qualifying statement to that second part: The supplement will be exempted if it is "generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling."
Excuse me but how many doctors endorse natural herbs? The testing done by the experts hired by the pharmacy companies would hardly prove that natural works. Some of the reports out there in doctor land don't even recognize that Vitamin C is a good thing.
I have a question. Who determines why you are taking a herbal product, cure or prevention? Is this a way for vitamin companies to stay in business? Those certainly are preventative. Do you have to have a note from your doctor indicating that you take flaxseed as a preventative?
Of all the times to raise our voices, none is more important than now.
You can find the full text of the FDA document at this link:
http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0480-gld0001.pdf
And you can use this link to submit your comments:
http://www.accessdata.fda.gov/scripts/oc/dockets/comments/
In addition, we also need to let our representatives in Washington know that we strongly resist this attack on our healthcare freedom. You can find the names and e-mail addresses for your congressmen at this web site: congress.org.
And finally, I hope you'll forward this alert to other people you know who value our right to make our own healthcare choices.
Since my comments are now part of the public record, I thought you might like to read my statement. When you finish putting in your comment there is a warning that your name and comment is part of the public record. Seems almost a veiled threat. I wonder if the pharmacy police will be coming to my door in the middle of the night to take all my herbal products.
I find it sad that our freedom of choice is quietly being taken from us. The insurance companies have done a fine job of regulating which doctor on their payroll we may see. They even dictate which conditions may be treated and for how long. Now you would see fit to take away the alternative medicine solution. Natural herbs have been used since the dawn of man. Yes there is snake oil out there, but is it any worse than the death dealing drugs the big pharmacy companies produce and the FDA endorses. Most people question the cure all statements made about herbs but blindly take the prescription from their doctor on the payroll of some insurance company or pharmacy. Sorry, but I demand my right to choose.
Anyway, if you have ever felt the need to voice your opinion, this would be a very good subject to address. I ask you to also post a comment on this blog with your thoughts on this matter. Contrary to the FDA you may remain nameless here.
until next time smile
Sharon
Today I want to pass along some information that is very important.
This past December, the FDA put a document on its web site titled "Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration." This document is open to public comments until April 30, 2007 - just days from now.
After that, FDA officials will evaluate the comments and decide if they will proceed with a regulation that might actually make it a crime to take vitamin C for a cold without a prescription.
The FDA document is 14 pages long, but the bottom line basic is: If you use an herbal or dietary supplement to stay healthy or to help prevent an ailment, that's fine. But if any supplement is used to treat a symptom, then it's a medicine and will be regulated by the FDA, just like any prescription drug.
And there's a qualifying statement to that second part: The supplement will be exempted if it is "generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling."
Excuse me but how many doctors endorse natural herbs? The testing done by the experts hired by the pharmacy companies would hardly prove that natural works. Some of the reports out there in doctor land don't even recognize that Vitamin C is a good thing.
I have a question. Who determines why you are taking a herbal product, cure or prevention? Is this a way for vitamin companies to stay in business? Those certainly are preventative. Do you have to have a note from your doctor indicating that you take flaxseed as a preventative?
Of all the times to raise our voices, none is more important than now.
You can find the full text of the FDA document at this link:
http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0480-gld0001.pdf
And you can use this link to submit your comments:
http://www.accessdata.fda.gov/scripts/oc/dockets/comments/
In addition, we also need to let our representatives in Washington know that we strongly resist this attack on our healthcare freedom. You can find the names and e-mail addresses for your congressmen at this web site: congress.org.
And finally, I hope you'll forward this alert to other people you know who value our right to make our own healthcare choices.
Since my comments are now part of the public record, I thought you might like to read my statement. When you finish putting in your comment there is a warning that your name and comment is part of the public record. Seems almost a veiled threat. I wonder if the pharmacy police will be coming to my door in the middle of the night to take all my herbal products.
I find it sad that our freedom of choice is quietly being taken from us. The insurance companies have done a fine job of regulating which doctor on their payroll we may see. They even dictate which conditions may be treated and for how long. Now you would see fit to take away the alternative medicine solution. Natural herbs have been used since the dawn of man. Yes there is snake oil out there, but is it any worse than the death dealing drugs the big pharmacy companies produce and the FDA endorses. Most people question the cure all statements made about herbs but blindly take the prescription from their doctor on the payroll of some insurance company or pharmacy. Sorry, but I demand my right to choose.
Anyway, if you have ever felt the need to voice your opinion, this would be a very good subject to address. I ask you to also post a comment on this blog with your thoughts on this matter. Contrary to the FDA you may remain nameless here.
until next time smile
Sharon
posted by sharono at 8:46 AM
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