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Docket: 2006D-0480 - Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration; Availability

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Feel free to use any or all of my comments to protest this legislation.

 

 

Docket Management Comment Form

Docket: 2006D-0480 - Draft Guidance for Industry on Complementary and

Alternative Medicine Products and Their Regulation by the Food and Drug

Administration; Availability

Temporary Comment Number: 118626

Submitter: Date:

Organization:

Category:

 

 

Issue Areas/Comments

 

 

General

 

I (and many, many, others) are outraged that you are attempting

to steal our right to take vitamins, herbal supplements and natural foods,

label them as " drugs " , and vitually destroy natural medicine. We have had

enough of your attempts to overturn DSHEA and force in a back-door attack to

promote CODEX type legislation in this country. This is a drug company

backed proposal and we know it. This legislation is another assault on the

so called " freedoms " we supposedly are entitled to enjoy in this country.

And another attempt to institute CODEX type laws and put natural products

into the hands of the pharmaceutical industry - where, if you haven't worked

BEFORE you came to the FDA, I'm sure you'll surely wind up working for them

AFTER you leave the FDA. Supplement sales totaled $18.7 billion in 2002.

This is a trivial amount compared to pharmaceutical sales that totaled

$430.3 billion in 2002. Whom do you think has the power and motivation to

bring dietary supplements and vitamins into the realm of prescription drugs?

Statistics regarding the rise in prices of supplements in countries that

have adopted these CODEX guidelines show why the pharmaceutical companies

are in favor of this legislation and why its adoption would detrimentally

impact the health of US citizens. We can clearly see the connection to drug

company interests here as there are many inexpensive natural products that

promote health, which is at odds with the highly profitable pharmaceutical

companies that need diseases to treat with dangerous drugs. Obviously,

with the health supplement and vitamin competition gone, nothing will stop

their drug profits. And how long would it be, after you drive the present

health product companies out of business, before Big Pharma is selling the

same vitamins and natural products as " prescription drugs " , but at

outrageous prices and probably, if my experience with generic drugs is any

indication, at diluted strengths and adulterated with synthetic chemicals.

CODEX now applies to Norway and Germany, among others, where zinc tablets

rose from $4 per bottle to $52. Echinacea (an ancient immune-enhancement

herb) rose from $14 to $153 (both examples are now allowed by prescription

only). They are now " drugs " . Any honest examination of the data gathered by

the National Association of Poison Control Centers will indicate that there

are very serious problems and deaths associated with and caused by

prescription drugs, but there have been very few serious problems and mostly

minor problems caused by natural remedies. You, the FDA have allowed

dangerous drugs such as celebrex and vioxx on the market, knowing that they

have proven deadly side effects for thousands. There are no dangerous

dietary supplements, only dangerous pharmaceutical drugs. These are just two

examples of the witch hunt mentality that is already present in the FDA

who acts more like a trade association for the pharmaceutical corporations

because there is a revolving door between their employees and the drug

companies. Public record will easily reveal that. This legislation is not

designed to protect the health of American citizens, but to jeopardize that

health, and to increase the profits of the pharmaceutical industry Too many

people have been damaged by prescriptions drugs, put on the market with

cherry-picked " trials " . We also realize that you have no interest in finding

cures for anything; selling drugs to treat syptoms and make money is where

your interest lies. Big Pharma and it's revolving-door FDA cronies are in

for a big fight. Believe it.

 

 

Attachments

No Attachments

 

 

 

 

 

 

NewsTarget.com http://www.newstarget.com/021789.html

 

Originally published April 11 2007

Health freedom action alert: FDA attempting to regulate supplements, herbs

and juices as " drugs "

by Mike Adams

 

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:

 

 

 

a.. 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.

 

b.. Vegetable juice will be regulated as a drug. Raw juice retreats will

be raided or shut down.

 

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

drug dealer.

 

d.. Massage oils and handheld massagers will be regulated as " medical

devices. "

 

e.. Yoga props, pilates machines and weight machines will be regulated as

" medical devices " and require FDA approval before being sold or used.

 

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

 

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

 

h.. 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! " )

 

i.. 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.)

 

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

confiscated.

 

k.. Vitamin store owners will be arrested and prosecuted for " practicing

medicine without a license. "

 

l.. 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.

 

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

be banned.

 

 

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

 

 

 

a.. Wants to label irradiated foods as " pasteurized. "

 

b.. 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.

 

c.. Raided a church at gunpoint, confiscating biofeedback machines and

charging that they were " practicing medicine " by counseling church members

on issues like depression.

 

d.. 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.

 

e.. 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.

 

f.. Openly allows the mass poisoning of the public with cancer-causing

food additives such as sodium nitrite.

 

g.. 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.

 

h.. Ordered the destruction of recipe books that mentioned stevia. (A

campaign to keep the public ignorant of the herb.)

 

i.. 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

 

 

 

--

 

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material, visit www.NewsTarget.com/terms.shtml

 

 

 

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