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FDA formalizes proposal to regulate herbs, vitamin


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#31 steelheader

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Posted 23 April 2007 - 04:04 PM

The treatment of disease is a multi-billion dollar industry. Ineffective and/or dangerous supplements pose no threat to that industry. But effective low cost supplement alternatives (resveratrol?) to FDA approved and big pharma manufactured drugs are a threat.

In light of the politicalization of federal agencies which has happened during the Bush administration, it is only realistic to expect that the FDA will act to lessen the threat supplements pose to big pharma.

#32

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Posted 23 April 2007 - 07:16 PM

Sure the FDA will regulate supplements and we the consumer will probably see prices go up as a result.

Tobacco is a drug and that is only regulated in terms of how it is not sold to minors.

So the FDA thinks supplements are so much more dangerous than tobacco products. And even chewing tobacco is not regulated other than it is not to be sold to minors. Tobacco is a known cause of about 30% of all cancers. But supplements are to be regulated now. Sure that makes a lot of sense to me. Regulate the vitamins but let the tobacco companies sell their cancer sticks all they want to adults.

If it were about safety than other things would be regulated better including alcohol and the way that is advertised to young people.

Tobacco and pharma companies have powerful lobby groups in Washington. That is what this is about. Big business gets what it wants and consumers get screwed having to pay more.

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#33 Anthony_Loera

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Posted 23 April 2007 - 07:26 PM

Wayside,

I agree with your thinking on your last post, where the FDA seems to say something is a drug based on the claim made of say... 'vegetable soup, juice, etc'...

The FDA needs to rethink this, because if this is the way it will be... and a pharma company's ad says something like...

"We Sell Popular SuperDuperPharma Resveratrol, it is used to treat and prevent alzheimers, cancer, etc"...

Then I am tempted to have our ads read something like...

"RevGenetics Resveratrol, same ingredients as SuperDuperPharma Resveratrol. Simply made for your overall health and well being..."

I can work with it I suppose, but really if we are going to be playing games with words instead of looking at the overall health of the US population, then I think we need to replace the FDA with a group of lawyers and save the USA taxpayers some cash.

The FDA really needs to rethink how they are approaching this for the common good of people and small business.

Anthony Loera

#34 Mind

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Posted 23 April 2007 - 09:12 PM

I don't like the idea of the FDA regulating herbs, vitamins, and concentrated food products. Sounds like a big waste of time and money for the FDA. They will have to hire a lot more people to handle all the new regulated products (which would be about everything). Maybe there could be some small changes or oversight, but they just can't treat everything as a "drug". That's just dumb.

#35 wayside

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Posted 24 April 2007 - 03:09 AM

"RevGenetics Resveratrol, same ingredients as SuperDuperPharma Resveratrol. Simply made for your overall health and well being..."

I can work with it I suppose...


What worries me more is the FDA saying "SuperDuperPharma got resveratrol classified as a drug, therefore *all* resveratrol is now considered a drug, regardless of what claims you make or not, and you can't sell it unless your formulation also passes as a drug, and even then you can only sell it to people licensed to dispense drugs."

That would put a nice damper on the supplements industry...

#36 maxwatt

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Posted 24 April 2007 - 03:49 AM

I don't like the idea of the FDA regulating herbs, vitamins, and concentrated food products. Sounds like a big waste of time and money for the FDA. They will have to hire a lot more people to handle all the new regulated products (which would be about everything). Maybe there could be some small changes or oversight, but they just can't treat everything as a "drug". That's just dumb.


They are so overwhelmed and understaffed, they cannot take on more. If someone died, or was seriously injured from a resveratrol (or other herb) overdose, they'd step in, but only in such a case. What I've heard from a Washington lawyer, is they will ignore resveratrol -- and most herbs -- unless they are shown to be dangerous. They are scheduled to re-evaluate resveratrol in June; that's where one would expect to find "big pharma" pressure brought to bear. I don't expect it to happen in the case of resveratrol. Sirtris and Biomol are developing patentable analogues and betting on those. The "lipitor" people don't see it as a threat; doctors will still prescribe lipitor over unproven resveratrol. And like what was done with St. John's Wort, they can always fund studies showing resveratrol doesn't work.

#37 Anthony_Loera

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Posted 24 April 2007 - 10:50 PM

"RevGenetics Resveratrol, same ingredients as SuperDuperPharma Resveratrol. Simply made for your overall health and well being..."

I can work with it I suppose...


What worries me more is the FDA saying "SuperDuperPharma got resveratrol classified as a drug, therefore *all* resveratrol is now considered a drug, regardless of what claims you make or not, and you can't sell it unless your formulation also passes as a drug, and even then you can only sell it to people licensed to dispense drugs."

That would put a nice damper on the supplements industry...



With the current 'proposal' they will not be able to do that... but I agree with you. If things start getting classified left and right as 'drugs' and on top of that the FDA decides that everything that is a drug can't be sold unless it is tested as done by current "big pharma" testing procedures that will probably be written in by lobbyists ...

yikes!

I am leaning more to Maxwatt's short term expectations of the future rather than thinking the FDA will just run crazy with changes and cause chaos...

I think we will be fine, but I just don't like the baby steps the are taking in this new direction.

Anthony

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Posted 26 April 2007 - 12:52 PM

When it comes to health freedom, this is the FDA's end game. A new FDA "guidance" document, published on the FDA's website, reveals plans to reclassify virtually all vitamins, supplements, herbs and even vegetable juices as FDA-regulated drugs. Massage oils and massage rocks will be classified as "medical devices" and require FDA approval. The document is called Docket No. 2006D-0480. Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration.

The FDA is accepting public comments on the docket until April 30th. They tried to sneak this under the radar, but word got out and now the natural health community is up in arms over this rule. If you wish to protect your access to nutritional supplements, herbs, essential oils, homeopathic medicine or any other "complementary" or "alternative" modality, it is crucial that you take action to post your comments with the FDA right now and write your representatives in Washington to put a stop to this outrageous effort to destroy natural medicine. (And be sure to really write them. Just sending an email has virtually no impact compared to writing a physical letter in your own words.)

Click here for the direct link to the FDA's comment posting page for this docket.

This move by the FDA is designed to once and for all destroy the 1994 DSHEA law that has made supplements "legal" while eliminating nutritional supplements and natural medicine from the United States, ensuring monopoly profits and control by drug companies and the FDA. It is the latest action item by the FDA / Big Pharma conspiracy that will not stop until health freedom has been abolished, drug companies rule the nation, and every citizen is diagnosied with a fictitious disease and drugged up on monopoly-priced pharmaceuticals.

FDA "experts" will decide what's a drug or medical device
Under these proposed guidelines, FDA "experts" (the same corrupt officials who reapproved Vioxx after it killed over 50,000 Americans) will decide whether herbs, supplements, vitamins or simple devices like massage stones are to be regulated as drugs and medical devices. If the FDA experts, in their infinite wisdom, decide that these things are to be reclassified, they will essentially be outlawed, stripped from the shelves, and regulated out of existence. Anyone who dares to manufacture, promote or sell such products may be branded a criminal and rounded up by armed FDA agents who have a well established history of suppressing natural medicine.

I've documented much of the criminal history of the FDA in my recent book, Natural Health Solutions and the Conspiracy to Keep You From Knowing About Them, which suddenly seems even more relevant today than when I wrote it. In that book, I documented the FDA ordered book burnings, the raids on vitamin shops, the kidnapping of natural health practitioners, the threats, intimidation and oppression tactics that have been used to suppress natural medicine for nearly a hundred years now. And now, with this CAM Products Regulation effort, the FDA is about to deal a final, fatal blow to the alternative medicine industry, outlawing nutritional supplements, functional foods, homeopathy and natural therapies all at once.

This is not a drill. It really is time to be alarmed. Nothing else I've written about this year is as important as this sinister plot to destroy natural medicine and force the American population to resort to dangerous prescription medications sold at monopoly prices under a system of medical tyranny.

Your access to vitamins, supplements, herbs, and even energy medicine modalities is now directly threatened, and you have until April 30 to make your voice heard.

Action items
First, read the document yourself. Click here for the PDF version.

Take special care to notice the following text, taken directly from the FDA's own document: (italicized text is from the FDA, with my own translation following)

"...a product used in a CAM therapy or practice may be subject to regulation as a biological product, cosmetic, drug, device, or food (including food additives and dietary supplements) under the act or the PHS Act. Second, neither the act nor the PHS Act exempts CAM products from regulation."

Translation: Anything used in any system of medicine may now be regulated as a drug or medical device by the FDA. This includes a biofeedback machine, acupuncture needles, a cup of herbal tea, massage oil, a glass of vegetable juice or even a bottle of water.

"...if a person decides to produce and sell raw vegetable juice for use in juice therapy to promote optimal health... [and] if the juice therapy is intended for use as part of a disease treatment regimen instead of for the general wellness, the vegetable juice would also be subject to regulation as a drug under the Act."

Translation: Raw vegetable juice will be regulated as a drug and must be FDA approved as a drug if it has any health effect whatsoever. Handing a cup of raw vegetable juice to someone and telling them it's good for the detoxification of their liver will get you arrested for practicing medicine without a license and promoting an "unapproved drug."

..."biologically based practices" includes, but is not limited to, botanicals, animal-derived extracts, vitamins, minerals, fatty acids, amino acids, proteins, prebiotics and probiotics: whole diets, and "functional foods". ...a botanical product intended for use in treating a disease would generally be regulated as a drug." ..."functional foods" may be subject to FDA regulation as foods, dietary supplements, or drugs under the Act.

Translation: All foods, supplements, superfoods and functional foods may be reclassified as drugs by the FDA, then regulated off the market.

If... the manipulative and body-based practices involve the use of equipment (such as massage devices) or the application of a product (such as a lotion, cream, or oil) to the skin or other parts of the body, those products may be subject to regulation under the Act."

Translation: Massage oils and creams will be regulated as "drugs" and acupuncture needles as "medical devices." Taking this absurdity one step further, massage therapists who use their fingers to touch patients may have their fingers regulated as "medical devices" and be accused of practicing medicine for merely touching patients.

Things that will be regulated out of existence
It is very clear that the FDA is intending to regulate and ultimately destroy the entire CAM industry (Complementary and Alternative Medicine). Based on the explanations in the FDA's own document, the following things are likely to occur:

All vitamins, nutritional supplements and functional foods will be stripped of their structure & function claims, reducing them to empty labels where virtually nothing at all is allowed to be stated.

Vegetable juice will be regulated as a drug. Raw juice retreats will be raided or shut down.

Growing and selling common garden herbs will get you arrested as a drug dealer.

Massage oils and handheld massagers will be regulated as "medical devices."
Yoga props, pilates machines and weight machines will be regulated as "medical devices" and require FDA approval before being sold or used.

Raw sprouts and other anti-cancer foods will be regulated as drugs.

Bottled water that "treats" dehydration will be regulated as a drug.

Massage therapists who use hot rocks as part of their therapy will have the ROCKS regulated as medical devices! (It's true. The FDA will actually look at a pile of rocks and declare, "Those are medical devices!")

Functional foods, supplements, vitamins and homeopathic remedies will disappear from store shelves, pending FDA "review." (The only things remaining will be processed junk foods and pharmaceuticals, which is exactly what Big Business wants.)

Therapeutic tea products, such as green tea, will be outlawed and confiscated.

Vitamin store owners will be arrested and prosecuted for "practicing medicine without a license."

Citizens owning personal inventories of "unapproved drugs" (vitamins and herbs) may have their homes raided at gunpoint and their inventories confiscated by armed law enforcement agents.

The importation of herbs and functional foods from all countries may be banned.


Keep in mind that the FDA is the same agency that:

Wants to label irradiated foods as "pasteurized."

Voted to put the deadly drug Vioxx back on the market after tens of thousands of deaths, even after its own manufacurer pulled it from pharmacies.

Raided a church at gunpoint, confiscating biofeedback machines and charging that they were "practicing medicine" by counseling church members on issues like depression.

Openly allows corrupt, "on the take" experts to vote on new drug approvals, even when those experts are taking money from the same companies impacted by their votes.

Refuses to legalize stevia, the safe, natural herbal sweetener that's used virtually everywhere else in the world. The agenda? Protect the profits of aspartame and other chemical sweeteners.

Openly allows the mass poisoning of the public with cancer-causing food additives such as sodium nitrite.

Refuses to enforce its own laws regarding unsafe chemical toxins in personal care products, allowing perfume and lotion companies to continue poisoning the public with cancer-causing chemicals that don't even have to be listed on the label, nor proven safe.

Ordered the destruction of recipe books that mentioned stevia. (A campaign to keep the public ignorant of the herb.)

Does everything in its power to protect drug company profits, including discrediting herbs, supplements and alternative medicine.


Does anyone honestly believe that this criminal organization has any capacity whatsoever to act in the public interest? Even many Senators are fed up with the FDA's unprecedented level of corruption and criminal behavior.

Action items, continued...
Read Jon Barron's comments on this rule at the JonBarron.org website

Next, lodge your complaint against the FDA by commenting on this docket through the FDA's docket comment form.

And finally, write your Senator or Congressperson about this issue and let them know, in blatant language, that you will not stand by and allow the criminals running medicine today to take away your access to vitamins, supplements, herbs and homeopathic medicine. Write the letter in your own words, even if it's just two sentences. Individual letters have a hundred times the impact of form letters.

Medical wasteland USA
Everything is at stake here. If the FDA gets its way, the United States will become a medical wasteland, dominated by corporate drug company interests, where the naturopaths are imprisoned and their products destroyed. Supplements and herbs will become contraband, and gardeners who grow their own medicinal herbs may be raided and arrested by DEA agents wielding assault rifles. Simply selling dried broccoli sprouts as being "good anti-cancer foods" may land you in prison, and running a vitamin shop could result in you being arrested for "practicing medicine."

Imagine a nation where Whole Foods stores are stripped of all herbs and supplements, where vitamin shops are emptied and abandoned, where books that promote herbs are bulldozed into large piles and burned, where natural healers are rounded up and "disappeared" into incarceration centers. This is the future that will become reality if the FDA has its way. The plan has been explained to us in plain language. Any agency that openly states "vegetable juice will be regulated as a drug" has quite simply lost its marbles. We're are now clearly being regulated by clinically insane bureaucrats.

With this desperate proposal by the FDA -- clearly designed as a last-ditch effort to save the failing conventional medical industry from a massive public shift towards natural medicine -- the war against health freedom has reached our shores, and the FDA is plotting a 9/11-style attack to bring down the towers of health freedom in one swift motion.

This is the same agency that currently represents the greatest threat to the health and safety of the American people, far outweighing the threat of real terrorism. This agency, we have seen, will do ANYTHING to protect the profits and power of drug companies. It will lie, steal, accept bribes, hide scientific evidence, distort statistics, commit scientific fraud, break federal laws, threaten its own drug safety scientists, conspire with drug company executives, intimidate American citizens and use terror-style tactics to achieve its goals of complete domination over foods, drugs and health.

Why do Americans tolerate terrorism in their own government?

It is time we put a stop to this home-grown tyranny. We have fought too hard for freedom in the United States to allow us all to be steamrolled by a criminal front group covertly working for Big Pharma. The FDA has declared war on natural medicine and the American people, and we will lose our family members, children, brothers and sisters as casualties of this war if we don't stand up now and demand radical changes. It's time to stop this terrorist organization from destroying the lives of yet more U.S. citizens.

Make your voice heard now, or forever surrender your access to supplements, herbs, superfoods and functional foods. By the time the FDA is done with this country, we'll all be eating medication for breakfast, lunch and dinner.

Action reminders:
1. Lodge a complaint with the FDA by clicking here. MAKE SURE you include the docket number 2006D-0480. But don't trust this to be enough. The FDA will probably simply delete half the complaints it receives, so don't trust your complaint to actually count. It's important to continue...

2. Send a strongly-worded letter to your representatives in Washington. Be sure to cite Docket No. 2006D-0480. Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration. Tell them you support open access to vitamins, herbs, and supplements, and you do not want CAM to be regulated by the FDA.

3. Send this story to everyone you know. Spread the word. Raise the alarm. With enough public support, the FDA will be forced to back off this insane proposal.

And stay tuned to NewsTarget for more news, analysis and action alerts on health freedom. Even though we're under constant attack by criminal organizations trying to disrupt our servers and take us off line, we're still here, beating the drum for health freedom, and hoping that we have enough sane-minded Americans remaining to save this country from its government.

Actual FDA quote is gobbledygook
Here's an actual FDA statement from the CAM Guidance report:

For example, naturopathic cranberry tablets might be labeled for use to maintain the health of the urinary tract. In this example, the cranberry tablets generally would be regulated as "dietary supplements" ...if they were labeled for use to "maintain the health of the urinary tract" rather than "prevent urinary tract infections." The cranberry tablets would be regulated as "drugs" ...if they were labeled for use to "treat urinary tract infections" even if they were labeled as dietary supplements.

Additional phone numbers as listed in the FDA document
Sheryl Lard-Whiteford at 301-827-0379
Daniel Nguyen at 301-827-8971
Ted Stevens at 301-594-1184
Wayne Amchin at 301-827-6739

About the author: Mike Adams is a consumer health advocate with a passion for sharing empowering information to help improve personal and planetary health He is a prolific writer and has published thousands of articles, interviews, reports and consumer guides, reaching millions of readers with information that is saving lives and improving personal health around the world. Adams is a trusted, independent journalist who receives no money or promotional fees whatsoever to write about other companies' products. He's also a noted technology pioneer and founded a software company in 1993 that developed the HTML email newsletter software currently powering the NewsTarget subscriptions. Adams volunteers his time to serve as the executive director of the Consumer Wellness Center, a 501©3 non-profit organization, and practices nature photography, Capoeira, Pilates and organic gardening. He's also author of numerous health books published by Truth Publishing and is the creator of several consumer-oriented grassroots campaigns, including the Spam. Don't Buy It! campaign, and the free downloadable Honest Food Guide. He also created the free reference sites HerbReference.com and HealingFoodReference.com. Adams believes in free speech, free access to nutritional supplements and the ending of corporate control over medicines, genes and seeds. Known on the 'net as 'the Health Ranger,' Adams shares his ethics, mission statements and personal health statistics at www.HealthRanger.org

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#39 Anthony_Loera

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Posted 08 May 2007 - 09:33 PM

An Update from the NPA RevGenetics is associated with, in regards to the FDA Guidance Draft:

=======================================================

Natural Products Association Files Comments on the CAM Guidance Draft…The Natural Products Association contacted members concerning a draft “guidance” document from the Food and Drug Administration (FDA) on complementary and alternative medicine (CAM) that some sources claimed will, among other things, classify all dietary supplements as drugs and restrict the practice of CAM therapies.

This was not an accurate representation of the facts, and the association assured members of the truth in the April 16 and April 30 issues of The Supplement. While the association recognizes that the guidance document itself does not affect the practices or products used in CAM, it does represent the FDA’s current viewpoint about CAM, and in that regard, could be clearer.

The association filed formal comments(Comment Document).. with the FDA. You can also read ..answers to some of the more common questions the association received, and view a copy of the guidance, posted on the FDA’s site: www.fda.gov/OHRMS/DOCKETS/98fr/06d-0480-gld0001.pdf.

Based on an updated submission date of May 29, 2007, which had been posted on the FDA Web site, the Natural Products Association had previously reported that the deadline for submission of comments had been extended. However, the FDA later removed the listing of May 29 as the submission deadline from its Web site and is now confirming that April 30, 2007 was the actual deadline for comments.

=======================================================

Great stuff... Seems like the FDA is changing deadline for submission of public comments regarding CAM to dissalow dissent on the Draft?

how completely interesting...

Anthony Loera




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