FDA to Limit Access to Natural Health Products (Deadline April 30)

« WellTellMe • Forum • Health Products • The AMA & Drugs • FDA to Limit Access to Natural Health Products (Deadline April 30) »

(Read 5154 times) [1] 2 3

FDA to Limit Access to Natural Health Products (Deadline April 30)
« on: April 13, 2007, 01:14:47 PM » by paprika

I hope this is okay to post but I am going to a natural health school and we just got this post in our boxes this morning. I thought it might be of interests to others interested in alternative health.

Paprika

FDA and CAM Announcement: The FDA has put out a document for comments titled "Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration: DRAFT GUIDANCE"
Here is the link to the pdf of the draft comments:
http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0480-gld0001.pdf

This has caused an alert to be issued by the health freedom organizations, concerned that the wording in the draft is an attempt by the FDA to erode the freedom of access to holistic health products currently governed by the FDA under DSHEA. The draft uses terms such as treat and medicine, which imply the practice of medicine, and as such, may erode the ability of unlicensed complementary and alternative health care providers, such as nutritionists, herbalists, aromatherapists, and holistic health practitioners, to recommend their use.

The draft would not affect the structure function claim allowed for dietary supplements under the current regulations and does not change the current law. Rather it is guidance on the interpretation of the existing law, and that is the concern, as it is being interpreted in a very allopathic way that could pave the way for inroads into holistic health access.

One area that is of particular concern is where the draft leaves essential oils, particularly when used in massage or bath formulas, or otherwise applied to the skin. According to the draft, adding a cosmetic to affect even the structure and function of the body would make it a drug. Under this interpretation, an essential oil blend for massage for relaxation would be considered a drug!

Would this stop the practice of holistic health practitioners in the US? In most cases, no. Most of the concern is how this affects the sale of CAM products and devices. Most of it is already followed by the responsible markers, for instance, not making disease claims for dietary supplements or juices. But it is a slippery slope, and we must all act to avoid any erosion of consumers rights to freedom of access to the health care of their choice.

Please visit the website for the Natural Solutions Foundation http://www.healthfreedomusa.org - click on FDA Trying to Kill Natural Medicine, Supplements Again. Comment Period Ends April 30,
2007

Take Action NOW!

FDA and CAM Announcement (cont): We strongly recommend you send your comments to the FDA URGENTLY before the comment period ends. The health freedom website contains an automated form that you can use, or send your own comments. The comments that are included reiterate the role of CAM as a non allopathic model, focused on wellness, and its importance to consumers.
You may want to forward this information to colleagues, friends, family - Anyone that enjoys being able to access holistic health modalities. A strong response from consumers and industry members of the holistic health community will make a difference - it has stopped prior attempts by the FDA, which many see as an attempt by pharmaceutical industry to capture the income being lost when consumers choose holistic options to get and stay well.

Best wishes
Erika Yigzaw B.Com, LL.B. (Hons)
Senior Vice President

FDA & CAM: Action needed: The FDA has put out a document for comments titled "Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration: DRAFT GUIDANCE" This has caused an alert to be issued by the health freedom organizations, concerned that the wording in the draft is an attempt by the FDA to erode the freedom of access to holistic health products currently governed by the FDA under DSHEA. The draft uses terms such as treat, medicine, which imply the practice of medicine, and as such, may erode the ability of unlicensed complementary and alternative health care providers, such as nutritionists, herbalists, aromatherapists, and holistic health practitioners, to recommend their use. Please visit the website for the Natural Solutions Foundation http://www.healthfreedom.usa.org - click on FDA Trying to Kill Natural Medicine, Supplements Again. Comment Period Ends April 30, 2007 Take Action NOW! We strongly recommend you send your comments to the FDA URGENTLY before the comment period ends. The health freedom website contais an automated form that you can use, or send your own comments. You may want to forward this information to colleagues, friends, family - Anyone that enjoys being able to access holistic health modalities. A strong response from consumers and industry members of the holistic health community will make a difference - it has stopped prior attempts by the FDA, which may see as an attempt by pharmaceutical industry to capture the income being lost when consumers choose holistic options to get and stay well.

Logged

Re: FDA to Limit Access to Natural Health Products (Deadline April 30)
« Reply #1 on: April 13, 2007, 01:27:45 PM » by mexmarr

Here is a copy of the e-mail that my midwife sent me. It is bascially the same info, just a shortened version, and has some different links.

Quote

Once again - our reliable FDA is trying to take away our freedom in order to redirect more $$$$ to the drug companies, Docs, etc.

Subject: Comments on FDA Guidance for CAM Products and Regulation

There is a crisis in health freedom. On April 30, 2007 the FDA will
close the public comment period on a "Guidance" which will classify
every alternative practice as medicine so that only licensed physicians
can carry out the procedure AND vitamins, minerals, herbs, etc., will
suddenly become "untested drugs" which will be forbidden.

Bad? Real Bad! But public outcry can stop this assault on your
health and your freedom.

Spread the word! Tell everyone in your Circle of Influence,
professionals, alternative practitioners, nutrient and herb companies,
everyone! Let them know how important their participation is to make sure the
FDA backs off from this repressive course.

Please share this link with them and urge them to take action:
http://tinyurl.com/2u7ghc

Yours in health and freedom,

Rima E. Laibow, MD
Medical Director
Natural Solutions Foundation
www.HealthFreedomUSA.org

"Thus the sage rules by stilling minds and opening hearts, by filling bellies and strengthening bones..."

Logged

Re: FDA to Limit Access to Natural Health Products (Deadline April 30)
« Reply #2 on: April 13, 2007, 09:05:21 PM » by herbalmom

Bump to get this back on the board.

Logged

Re: FDA to Limit Access to Natural Health Products (Deadline April 30)
« Reply #3 on: April 14, 2007, 07:03:10 PM » by makingchanges

This makes me so mad. We have freedom here in America? Maybe we moved to a Communist country and we just didn't know it. Embarrassed

Logged

Re: FDA to Limit Access to Natural Health Products (Deadline April 30)
« Reply #4 on: April 14, 2007, 07:12:40 PM » by petrimama

Quote

[/quote]

She says to spread the word. Does that mean I can copy her e-mail and send it to a bunch of friends? ~L

Logged

Re: FDA to Limit Access to Natural Health Products (Deadline April 30)
« Reply #5 on: April 14, 2007, 07:16:05 PM » by Julia

If you click on the link you can sign a petition and send to others.

Logged

Re: FDA to Limit Access to Natural Health Products (Deadline April 30)
« Reply #6 on: April 15, 2007, 12:31:14 AM » by herbalmom

Bumping to keep it on the board.

Logged

Re: FDA to Limit Access to Natural Health Products (Deadline April 30)
« Reply #7 on: April 15, 2007, 04:01:47 PM » by Julia

I tried to write a friendly but pointed comment. If you want to use it to make your own comment you may! Feel free to modify.

Quote

Can this be true? I want to have faith in my government but I cannot believe that this regulation is best for the American people. Are Americans doomed to depend on the expensive and often incapable health-care system? Can we not take responsibility for our own bodies, making decisions to consult medical professionals when necessary? Or are our bodies owned by the state? Let me highlight just two situations:

1.   Prenatal vitamins. Right now, if a woman purchases prescription prenatal vitamins, they will cost her around $20/month with a decent insurance policy or up to $120/month with no insurance. Or, a financially savvy pregnant woman will go down to her nearest Sam’s Club and buy a year’s supply of prenatals for under $10. Can forcing these women to use the expensive prescription vitamins when many cannot afford them actually be good for women and their babies? Are we going to end up with a new generation of birth defects and other diseases? And, for those of us who have found herbal-based vitamins to be more effective, will they even be available? Gosh, I hate to be suspicious of the FDA, but everything points toward more money in the coffers of drug companies!
2.   Pandemic. You yourselves have told us it is possible. But we know that in the case of a flu pandemic:
a.   There will not be enough doctors and hospitals available to prescribe “medicines” to all the sick people
b.   Doctors haven’t come up with a drug that is effective and available for treating the flu anyway
c.   Alternative cures are the only way to improve flu symptoms
d.   Alternative cures will not be available except through the unavailable doctors
e.   Doctors don’t like alternative cures
Are we doomed to depend on an understaffed and incapable health-care system in the case of a pandemic?

This act sounds like a violation of American freedom and a recipe for disaster.

Please consider what is best for the men, women, and children of the United States of America and discard this regulation!

Logged

Re: FDA to Limit Access to Natural Health Products (Deadline April 30)
« Reply #8 on: April 15, 2007, 05:17:08 PM » by kaira

Quote from: JuliaofSunnyside on April 15, 2007, 04:01:47 PM

I tried to write a friendly but pointed comment. If you want to use it to make your own comment you may! Feel free to modify.

Quote

I am confused - this only looks like one post - where did the quote come from? And, what is the background of this issue? I saw something yesterday on here about the FDA "passing regulations" but it was a comment without any background as well. More info??? Please.
and thank you.
Kaira

Logged

Re: FDA to Limit Access to Natural Health Products (Deadline April 30)
« Reply #9 on: April 15, 2007, 05:23:37 PM » by kaira

Well, this time the whole thread showed up - now I see the rest of the story. That was strange Huh

Logged

Re: FDA to Limit Access to Natural Health Products (Deadline April 30)
« Reply #10 on: April 16, 2007, 02:35:10 PM » by herbalmom

Bumping again to get it back on the board.

Logged

Re: FDA to Limit Access to Natural Health Products (Deadline April 30)
« Reply #11 on: April 18, 2007, 12:34:22 AM » by miff aka Missi

Quote from: herbfever on April 14, 2007, 05:50:37 PM

Bump

April 30 cut off date to contact FDA!

bumpity bump bump

Logged

My intro

Re: FDA to Limit Access to Natural Health Products (Deadline April 30)
« Reply #12 on: April 19, 2007, 12:37:19 AM » by AgainstTheGrain

I was dumbfounded after reading this info from Learning Herbs.com newsletter last night. Shocked

Seems like we're moving more towards a dictatorship all the time Undecided

Honestly, does our government think we are SO stupid that we can not take responsibility for ourselves? OH! this issue make me so mad Angry

Please, Please let your voice be heard by April 30!
http://www.democracyinaction.org/dia/organizationsORG/healthfreedomusa/campaign.jsp?campaign_KEY=7185

And - if you haven't viewed the video at HealthFreedomUSA.org it is an EYE OPENER about Codex. I thought I'd watch a little of it and watched the entire thing!!

Logged

Vanessa in Iowa
Mom to 5 boys and 1 baby girl ages Newborn to 12

Re: FDA to Limit Access to Natural Health Products (Deadline April 30)
« Reply #13 on: April 19, 2007, 10:31:37 PM » by AllinHisTime

Not sure if any of you have heard but I did receive an email today from a well-known online herbal and alternative medicine store about the FDA and their agenda to gain control and make alternative medicines illegal. I've heard of things like this before and have been keeping an eye on it through various news outlets.

Here is a link to the FDA's page and docket info:

http://www.fda.gov/ohrms/dockets/dockets/06d0480/06d0480.htm

I guess we can leave comments regarding this and the link above should provide you with all you need to do that. The deadline for all commentary is April 30.

I pray that we all keep our government in our prayers and may God's will be done!

Logged

A truth's initial commotion is directly proportional to how deeply the lie was believed...When a well packaged web of lies has been sold gradually to the masses over generations, the truth will seem utterly preposterous and its speaker a raving lunatic.-- Dresden James

Re: FDA to Limit Access to Natural Health Products (Deadline April 30)
« Reply #14 on: April 19, 2007, 10:34:39 PM » by babymakers

I am glad you posted this on here. I added my name and info this morning. Is the FDA good for anything besides trying to take our rights away?!?!?! Angry

Logged

Visit my-

eBay Store, and <a href="http://www.homeschoolblogger.com/babymakers/ ">blog[/url].

Re: FDA to Limit Access to Natural Health Products (Deadline April 30)
« Reply #15 on: April 19, 2007, 10:40:54 PM » by AllinHisTime

they are a tough bunch to deal with that's for sure. It seems that everything good, right and healthy for consumers is labeled "non effective", "unhealthy" or "dangerous". I am just praying that they won't win this one. There are too many educated consumers out here. We can't allow our rights to be taken away if we can help it.

Logged

Re: FDA to Limit Access to Natural Health Products (Deadline April 30)
« Reply #16 on: April 19, 2007, 10:52:42 PM » by herbalmom

Here's a thread on this:

FDA looking to limit access to natural health products

Blessings ~herbalmom

Logged

Re: FDA to Limit Access to Natural Health Products (Deadline April 30)
« Reply #17 on: April 19, 2007, 11:02:35 PM » by AllinHisTime

Thanks!! The thread you linked is more in-depth than what I posted....so everyone...click on thread above!!!

Logged

Re: FDA to Limit Access to Natural Health Products (Deadline April 30)
« Reply #18 on: April 19, 2007, 11:09:43 PM » by miff aka Missi

Quote from: AllinHisTime on April 19, 2007, 11:02:35 PM

Thanks!! The thread you linked is more in-depth than what I posted....so everyone...click on thread above!!!

HB will probably merge the threads.

Logged

My intro

Re: FDA to Limit Access to Natural Health Products (Deadline April 30)
« Reply #19 on: April 19, 2007, 11:33:45 PM » by AllinHisTime

Ya know, I get a little leary about these public record document things....I have to admit, I usually think they want the info so they know who to track first! Undecided

I can't imagine there isn't some sort of "backlash" to signing these deals. I understand their purpose and honestly do try to be optimistic, but have lost trust in the government concerning our rights and healthcare. I only wish I was being paranoid.

Logged

Re: FDA to Limit Access to Natural Health Products (Deadline April 30)
« Reply #20 on: April 20, 2007, 08:23:44 AM » by healthybratt

It took me awhile, but I found the direct electronic submission page on the FDA site.

Docket# 2006D-0480

« Last Edit: April 20, 2007, 08:27:10 AM by healthybratt »
Logged

My favorite herb book!!

Re: FDA to Limit Access to Natural Health Products (Deadline April 30)
« Reply #21 on: April 20, 2007, 08:57:40 AM » by healthybratt

Quote from: herbfever on April 20, 2007, 08:49:29 AM

Quote from: healthybratt on April 20, 2007, 08:23:44 AM

It took me awhile, but I found the direct electronic submission page on the FDA site.

Docket# 2006D-0480

I am so ignored Tongue

see post #7

Nope, not ignored. I was commenting on the other thread. I merged two together. I suppose, I should have looked closer. Thanks. Grin

Logged

My favorite herb book!!

Re: FDA to Limit Access to Natural Health Products (Deadline April 30)
« Reply #22 on: April 20, 2007, 11:17:13 AM » by healthybratt

I put in my comment. It wasn't pretty and thanks to my very astute editor Kati*did, it's grammatically and politically correct as well. Grin

Logged

My favorite herb book!!

Re: FDA to Limit Access to Natural Health Products (Deadline April 30)
« Reply #23 on: April 20, 2007, 11:41:35 AM » by larissakissa

Quote from: makingchanges on April 14, 2007, 07:03:10 PM

This makes me so mad. We have freedom here in America? Maybe we moved to a Communist country and we just didn't know it. Embarrassed

You know, even during communist we had more freedom. Trust me, I use to live there!

Logged

Re: FDA to Limit Access to Natural Health Products (Deadline April 30)
« Reply #24 on: April 20, 2007, 01:29:41 PM » by AllinHisTime

Quote from: larissakissa on April 20, 2007, 11:41:35 AM

Quote from: makingchanges on April 14, 2007, 07:03:10 PM

This makes me so mad. We have freedom here in America? Maybe we moved to a Communist country and we just didn't know it. Embarrassed

You know, even during communist we had more freedom. Trust me, I use to live there!

Ya know, if you read the Communist Manifest by Karl Marx, there are some scary similarities.....

My husband seems to think that it won't matter if we submit our comments because they are going to do what they want to anyway. I think we only have "perceived" rights in this. I would love to be shown otherwise. We all know it's a $$ issue and the FDA and pharmaceutical companies are mad that they can't control this market. Honestly, more people die from their drugs, misdiagnosis and treatment (I think it's up to 250,000 deaths per year see article: http://v.mercola.com/blogs/public_blog/The-Medical-Mistakes-That-Kill-Americans-Every-Day-9346.aspx) than anyone even reporting an ill side effect or symptom from natural, herbal things.

Logged

Re: FDA to Limit Access to Natural Health Products (Deadline April 30)
« Reply #25 on: April 20, 2007, 06:52:15 PM » by herbalmom

Bump

Logged

Re: FDA to Limit Access to Natural Health Products (Deadline April 30)
« Reply #26 on: April 20, 2007, 08:32:53 PM » by Julia

I noticed this on the FDA website if you are making a comment.

Quote

Here are some other suggestions for making sure your comment has the greatest possible impact:

Clearly indicate if you are for or against the proposed rule or some part of it and why. FDA regulatory decisions are based largely on law and science, and agency reviewers look for reasoning, logic, and good science in comments they evaluate.
Refer to the docket number, listed in Federal Register notice.
Include a copy of articles or other references that support your comments. (Electronic attachments will not be forwarded if the "Comment" box is left empty.)
Only relevant material should be submitted. If an article or reference is in a foreign language, it must be accompanied by an English translation verified to be accurate. Translations should be accompanied by a copy of the original publication.
To protect privacy when submitting medical information, delete names or other information that would identify patients.
Comments must be postmarked, e-mailed or delivered in person by the last day of the comment period

Logged

Re: FDA to Limit Access to Natural Health Products (Deadline April 30)
« Reply #27 on: April 21, 2007, 09:16:08 AM » by healthybratt

Quote

FDA regulatory decisions are based largely on law and science, and agency reviewers look for reasoning, logic, and good science in comments they evaluate.

How's It's none of your business for reasoning & logic? Shocked

Logged

My favorite herb book!!

Re: FDA to Limit Access to Natural Health Products (Deadline April 30)
« Reply #28 on: April 21, 2007, 09:24:34 AM » by AllinHisTime

Quote from: healthybratt on April 21, 2007, 09:16:08 AM

Quote

FDA regulatory decisions are based largely on law and science, and agency reviewers look for reasoning, logic, and good science in comments they evaluate.

How's It's none of your business for reasoning & logic? Shocked

Sounds like pretty good reasoning and logic to me, 'cept I don't think they'll think so!! Tongue

Logged

Re: FDA to Limit Access to Natural Health Products (Deadline April 30)
« Reply #29 on: April 21, 2007, 09:39:01 AM » by AllinHisTime

[quote author=JuliaofSunnyside link=topic=6809.msg73330#msg73330
Clearly indicate if you are for or against the proposed rule or some part of it and why. FDA regulatory decisions are based largely on law and science, and agency reviewers look for reasoning, logic, and good science in comments they evaluate.
Only relevant material should be submitted. [/quote]
[/quote]

We've "clearly indicated" for years why FDA's control of pharmeceuticals and healthcare isn't "the answer" as well as proven for hundreds of years that natural, herbal medicinals(that have little to no side effects compared to the drugs) are much safer and more effective than what they recommend. It's interesting to me that herbs still account for approximately 25-40% of all basic compounds for pharmaceuticals!

Notice their wording? ( I've highlighted words or changed for emphasis) It's all relative...what is "good science" to the FDA? (insert comment here________ I have several and I'm sure you do too). Their "good science" has not been proven, IMO, to be "proper and beneficial healthcare." Then they ask for only "relevant" material to be submitted. Again, "relevant" to them is not "relevant" to us. Relevant to us would mean "common sense" or something along those lines.

I don't mean to sound hopeless but I tend to believe that they are going to do what they want to anyway. This battle will be best fought on our knees in prayer.

Ephesians 6:12 " For we wrestle not against flesh and blood, but against principalities, against powers, against the rulers of the darkness of this world, against spiritual wickedness in high places."

Logged

(Read 5154 times) [1] 2 3