Thursday, April 26, 2007
Thursday, April 19, 2007
Public, professional and industry comments are being accepted on the
FDA proposal to "capture" alternative procedures and products as
"medicine" and then make them illegal. The history of these
repressive attacks by the FDA makes it clear that public outcry,
IN HUGE NUMBERS, is the only effective tool that natural health
supporters have to change this disastrous outcome. Comments will be
accepted until April 30. By contacting everyone you can reach to ask
for their participation in this comment campaign, we can kill this
assault on personal health freedom.
This new proposal is designed to redefine every complementary and
alternative health care modality and product as "medicine." This has
direct implications on the services and products provided by every
alternative health care professional. There is no facet of
complementary and alternative health care that is not affected.
Essential oils, herbs, herbal remedies, homeopathic remedies,
minerals, nutritional supplements, plant enzymes and vitamins are
redefined in this proposal as "medicine." Very simply, medicine is
under the jurisdiction of the FDA and, by law, only licensed medical
doctors may prescribe "medicines." Anybody else who advises,
advocates, counsels, distributes, markets, recommends or suggests
anybody use "medicine" is practicing medicine without a license. This
is a felony in the USA punishable by fines and incarceration.
This subtle change of vocabulary from "alternative health care" to
"alternative medicine" makes all of these industries subject to
control by the FDA as medicine. Only medical doctors would be allowed
to provide, prescribe and supervise the delivery of these services.
Anybody else who provided any of these services would be practicing
medicine without a license and subject to incarceration and fines.
Natural Solutions Foundation has a form letter that you send or edit
Click on Take Action Now on the left of the page
Link to the actual FDA docket - click on htm
Link is also up on HHA Breaking News!
Tuesday, April 17, 2007
Food and Drug Administration
[Docket No. 2006D-0480]
[Federal Register: February 27, 2007 (Volume 72, Number 38)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D-0480]
Draft Guidance for Industry on Complementary and Alternative
Medicine Products and Their Regulation by the Food and Drug
AGENCY: Food and Drug Administration, HHS.
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Complementary
and Alternative Medicine Products and Their Regulation by the Food\\ and
Drug Administration.'' In recent years, the practice of complementary
and alternative medicine (CAM) has increased in the United States, and
we have seen increased confusion as to whether certain products used in
CAM are subject to regulation under the Federal Food, Drug, and
Cosmetic Act (the act) or Public Health Service Act (PHS Act). We have
also seen an increase in the number of CAM products imported into the
United States. Therefore, the draft guidance discusses when a CAM
product is subject to the act or the PHS Act.
DATES: Submit written or electronic comments on the draft guidance by
April 30, 2007. General comments on agency guidance documents are
welcome at any time.
ADDRESSES: Submit written requests for single copies of the draft guidance to the:
Office of Communication, Training, and Manufacturers Assistance (HFM-40),
Center for Biologics Evaluation and Research,
Food and Drug Administration,
1401 Rockville Pike, suite 200N
Rockville, MD 20852-1448.
Send one self-addressed adhesive label to assist that
office in processing your requests. Submit written comments on the
draft guidance to the:
Division of Dockets Management (HFA-305), Food
and Drug Administration,
5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
Submit electronic comments to:
See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Philip L. Chao, Office of Policy and Planning (HF-23),
Food and Drug Administration,
5600 Fishers Lane,
Rockville, MD 20857
FDA is announcing the availability of a draft guidance for industry
entitled ``Complementary and Alternative Medicine Products and Their
Regulation by the Food and Drug Administration.'' The term
``complementary and alternative medicine'' (CAM) encompasses a wide
array of health care practices, products, and therapies that are
distinct from practices, products, and therapies used in
``conventional'' or ``allopathic'' medicine.
In the United States, the practice of CAM has risen dramatically in
recent years. In 1992, Congress established the Office of
Unconventional Therapies, which later became the Office of Alternative
Medicine (OAM), to explore ``unconventional medical practices.'' In
1998, OAM became the National Center for Complementary and Alternative
Medicine (NCCAM). NCCAM is a center within the National Institutes of
Health. The Institute of Medicine, in its book entitled, Complementary
and Alternative Medicine in the United States, stated that more than
one-third of American adults reported using some form of CAM and that
visits to CAM providers each year exceed those to primary care
physicians (see Institute of Medicine, Complementary and Alternative
Medicine in the United States, pages 34 through 35 (2005)).
As the practice of CAM has increased in the United States, we have
seen increased confusion as to whether certain products used in CAM
(which, for convenience, we will refer to as ``CAM products'') are
subject to regulation under the act or the PHS Act. We have also seen
an increase in the number of CAM products imported into the United
States. Therefore, the draft guidance discusses when a CAM product is
subject to the act or the PHS Act. (When the draft guidance mentions a
particular CAM therapy, practice, or product, it does so in order to
provide background information or to serve as an example or
illustration; any mention of a particular CAM therapy, practice, or
product should not be construed as expressing FDA's support for or
endorsement of that particular CAM therapy, practice, or product or,
unless specified otherwise, as an agency determination that a
particular product [[Page 8757]] is safe and effective for its intended
uses or is safe for use.) The draft guidance makes the following two
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.
products from regulation.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on the
regulation of complementary and alternative medicine products by FDA.
It does not create or confer any rights for or on any person and does
not operate to bind FDA or the public. An alternative approach may be
used if such approach satisfies the requirements of the applicable
statutes and regulations.
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4
Source: FDA WEBSITE http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-3259.htm
FDA attempting to regulate supplements,
herbs and juices as "drugs"
NewsTarget.com printable article
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 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.
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
"...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
..."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
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
Massage oils and handheld massagers will be regulated as "medical
Yoga props, pilates machines and weight machines will be regulated
as "medical devices" and require FDA approval before being sold or
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
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
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
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
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
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
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.
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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