IT'S REALLY IMPORTANT THAT WE ALL STAND UP FOR OUR RIGHT TO CHOOSE FOR
OURSELVES - BEFORE WE LOSE THIS RIGHT ALTOGETHER -
PLEASE READ THIS AND CONTACT YOUR SENATORS AND CONGRESS, IF YOU ARE LEAD -
THANX
L & B
DEE

>Subject: Update on FDA Assault on Health Freedom
>Date: Tue, 24 Apr 2007 18:38:55 -0400 (EDT)
>
>April 25, 2006
>Sometimes Size Really
>DOES Matter
>
>
>
>It is 4:26 AM and I am writing this to you so I can get this email update
>on the FDA anti-CAM Guidance out to you before we leave to attend the
>upcoming Codex Committee on Food Labeling (CCFL). The Natural Solutions
>Foundation has submitted 3 official comments to the FDA on agenda items
>which are on the CCFL docket and will make those available to you in the
>next few days along with on-the-ground updates.
>
>
>
>But right now we have a short window of opportunity during which to make
>our voices heard in the halls of the FDA so we need to focus in on the Cam
>Guidance which the FDA maintains is merely a restatement of the law but
>which distorts and extends the law in ways which Congress never intended or
>authorized.
>
>
>
>The fact that this document comes from very high up in the FDA, from the
>Office of Policy and Planning is quite ominous. But the fact that new
>categories (such as "CAM products" are being created and the concept of
>regulation based on intent (that is, the "off label use" of foods to heal
>or cure, thus turning them into "untested drugs" is much more ominous.
>Labeling all natural practices as medicine and turning therapies (allowed
>by non physicians) into treatments (permitted only by physicians) is even
>more ominous. Think about the harm and mayhem brought about by
>"regulated", supposedly "safe and effective" pharmaceuticals and the real
>safety and effectiveness of natural health procedures and products and you
>see the game very easily: this is a competition squash. Nothing more,
>nothing less. But the 'squashers' have huge resources and the 'squashees'
>have only their voices and their ability to wage this battle creatively.
>
>
>
>I, for one, do not intend to be either squashed or silenced in this battle
>and neither do the 315,257 people who tried to use our site to send their
>comments
>(http://www.democracyinaction.org/dia/organizationsORG/healthfreedomusa/campaign.jsp?campaign_KEY=7185)
>to the FDA on the Guidance so far. Of those, 128,695 succeeded and the
>others have been referred to our back up plan which we are calling "Plan B
>"
>(http://www.democracyinaction.org/dia/organizationsORG/healthfreedomusa/campaign.jsp?campaign_KEY=11143).
>
> Bigger IS Better Here!
>
>
>Before I post a highly significant document on this issue, I want to make a
>comment: Size Matters! In many areas, as we all know, size is immaterial.
>Public comments to government agencies is definitely not one of those
>no-size arenas. The bigger the response, the more people who participate,
>the more collective impact their voices have.
>
>
>One voice is nearly inaudible to unelected bureaucrats. But a huge public
>outcry is easily heard. In preventing the FDA from carrying out what
>appears to be a well crafted sneak attack on our health and health freedom,
>it is imperative that the outcry be deafening. We are on our way there, but
>we are not there yet. If you have submitted your comment, made a promise to
>yourself to help 10 more people submit their comments through the site
>(which we have been told by the FDA has the only reliable link for
>electronic submission). You may also find it interesting that we were told
>by the office to which these documents make their way that written
>documents are not tabulated, but are merely made available to the public
>for reading in the FDA reading room!
>
>
>If you have not done so, please join the 128,695 people who have already
>submitted their comment through the Natural Solutions Foundation website
>(http://www.HealthFreedomUSA.org) by clicking on the link that says "Take
>Action Now!"
>(http://www.democracyinaction.org/dia/organizationsORG/healthfreedomusa/campaign.jsp?campaign_KEY=7185).
>
>
> Who Would Break Our Links?
>
>
>Because this link has been broken and repaired over and over, at least
>187,253 other people have been prevented from submitting their comments,
>too! Hmmmm. Who would do such a thing? Any guesses?
>
>
>More Time for Public Comments
>
>
>The Natural Solutions Foundation submitted a request to the FDA for an
>extension of the comment period on Monday of this week which was denied on
>Tuesday! Do you know of anything else in the FDA that works that fast?
>What does that tell you?
>
>
>
>While in their letter of denial the FDA side stepped the issue of whether
>the real end of the comments period is April 30 (as stated in the CAM
>Guidance) or May 29 (as stated in the Federal Register on February 26) the
>time is short and may be very, very short.
>
>
>
>Therefore it is really imperative that you and everyone you know acts now!
>
>The Department of Policy and Planning has created this distortion of the
>law and can well use it, after the comment period is over, to attack every
>natural health option and product. If that is OK with you, don't do
>anything. If, on the other hand, you value both your freedom to make your
>own choices about health matters and your access to natural modalities and
>products, now would be a really good time to engage in a full court press
>for freedom!
>
>
>
>There has been a lot of cross talk on the internet about what the real
>threat of this Guidance actually is and whether the bland and soothing
>language (and interview by Philip Chao, the FDA employee who is in charge
>of the Guidance) and the fact that Mr. Chao assures us that he is "not
>Darth Vader" is really a meaningful assurance of safety.
>
>
>
>There is a huge difference between the way such documents are written and
>what they actually say and the input of an experienced expert is of great
>help in deciphering it. Here is the latest "threat assessment" prepared by
>Ralph Fucetola, a lawyer who specializes in regulatory matters and who is
>therefore very well acquainted with how the FDA uses seemingly benign
>language to push the limits of enforcement and oppression of pharma-free
>therapies further and further.
>
>
>
>CAM Practices, Products and FDA Regulation: Updated Threat Assessment
>
>
>
>Commentary by Ralph Fucetola JD - www.vitaminlawyer.com
>
>04/24/07 - 1650 words
>
>
>
>The US Food and Drug Administration is a confusing and confused agency,
>charged with administering federal controls over foods, drugs and medical
>devices under a patchwork of laws and regulations that have drastically
>increased costs to American consumers and slowed health care progress,
>without demonstrable safety benefits. It is therefore inevitable that many
>actions taken by the agency are likely to do more harm than good. Such is
>the case with the proposed Complementary and Alternative "Medicine" (CAM)
>guideline that the agency proposed at the end of December, public comment
>period to extend through April 30th. You can go to www.healthfreedomusa.org
>to make your comments. Over 128,695 have done this through April 24th.
>
>
>
>It is true the FDA anti-CAM guidance merely restates the existing law [as
>FDA sees it] -- that, if you intend to "treat disease" with a CAM product,
>that product (for example, says FDA, a "juice") is a "drug." By codifying
>this in a guidance document, FDA is setting the stage for another push to
>control and restrict CAM practices. The FDA uses the term "CAM product" in
>the guidance, although Congress has never defined such a term. The agency
>seeks to create a "status" of being a certain type of product when all
>Congress has authorized is that the FDA can regulate certain products
>"intended" to "treat disease." Of course, the responsible FDA Senior
>Science Advisor did say, in a very recent interview, this is not FDA's
>"intent" and using "CAM Products" is just a matter of convenience. Of
>course, as good Americans, we should all believe exactly what the FDA tells
>us; trust the agency's intent; shut up and take all our prescriptions.
>
>
>
>In addition to telling us that a juice intended to "treat disease" would be
>a drug, a careful reading suggests even items used in religious healing
>ceremonies could now be subject to regulation as drugs or medical devices.
>Holy water, anointing oils, prayer beads, rosaries, sweat lodges and even
>religious paintings or icons could be classified as drugs or medical
>devices and essentially outlawed by the FDA. Does this sound absurd? Well,
>it is absurd!
>
>
>
>Certainly, all this appears a bit less absurd if we are considering using
>an herb or dietary supplement to stay healthy. Says the FDA, if any
>supplement is used to treat a symptom, then it is a drug and will be
>regulated by the FDA, just like any prescription drug.
>
>The FDA does give us a little hope -- the supplement will be exempted if it
>is "generally recognized, among experts qualified by scientific training
>and experience to evaluate the safety and effectiveness of drugs, as safe
>and effective for use under the conditions prescribed, recommended, or
>suggested in the labeling." This is essentially the same standard used for
>substantiating drug claims. In 2004 the FDA gave us the standard for
>making claims about foods and dietary supplements: "FDA intends to apply a
>standard for substantiating claims for dietary supplements that is
>consistent with the Federal Trade Commission's (FTC's) standard for dietary
>supplements and other health related products of 'competent and reliable
>scientific evidence'.'' Quite a difference! This is just one difference
>the anti-CAM guidance will codify. And after codification comes
>enforcement. All alternative practitioners should take note!
>
>
>
>In other words, your freedom to use a dietary ingredient as therapy that
>may benefit a condition will be at the discretion of FDA "experts" who will
>determine whether to regulate it as "medicine." Given the abysmal track
>record of FDA experts, this could be really bad news.
>
>With so much latitude, I cannot predict just how far the FDA might go to
>restrict access to herbs, minerals and supplements, as well as other CAMthe
>two biggest [problems with the guidance] are broadening the definition of
>"health claim" and the desire to pre-empt the states in the regulation of
>some health care issues"
>
>The health freedom movement began to take notice of the pending anti-CAM
>guidance in late March. At the start of April, I assisted one group,
>Natural Solutions Foundation, to write its commentary to submit to the FDA,
>with emphasis on what we see as the important distinction between
>"treatment of disease" and its non-medical alternative, under AMA Ethics
>Code Opinion 3.04, "therapies that may benefit." The comments raised three
>demands: products. Many pro-health freedom groups are offering their
>concerns too. For instance, one commentator, Jenny Thompson of the HSI
>Newsletter suggested, "…[FDA] could take a widely used supplement off the
>market if the label states a benefit; such as using lutein to reduce the
>damage from age-related macular degeneration, or using chondroitin and
>glucosamine to reduce joint pain, or using probiotics to address digestive
>problems - the list goes on and on…" The AAHF (American Association for
>Health Freedom is concerned that "
>
>
>
>1. A public hearing by the FDA before the finalization of the guidance.
>
>2. Changing the title of the guidance to use the phrase "Complementary and
>Alternative Modalities" and not the prejudicial "Complementary and
>Alternative Medicine" as in the draft.
>
>3. FDA recognize that "therapies that may benefit" are not the same as
>"treatment of disease" and do not have to be regulated as "medicine."
>
>
>
>The organization then alerted its elist and asked its supporters to also
>file comments with the FDA, supporting the group's requests. We apparently
>touched a hot button issue; over the following week the buzz spread on the
>Internet
>
>
>
>Propelled by this strong public support, I believe we now have an
>opportunity to turn this FDA "end run" around and use it to protect CAM
>practices. We are now seeking support from members of the US Congress to
>demand that FDA hold public hearings before making the guidance final. If
>FDA fails to hold such hearings, it would be time for Congress to step in,
>hold hearings, and propose legislation to protect CAM practices from FDA
>action that would deny Americans access to alternatives. With John Galt, we
>want to say, "Get out of my way!"
>
>
>
>It has been settled law in this Country for over a century that medical
>regulations exist to protect the public, not to entrench licensed
>allopathic medicine to the detriment of all the evolving healing arts,
>which would refer to as "CAM practices" - though Traditional and Advanced
>Health Care might be a more appropriate term.
>
>
>
>"The state has not restricted the cure of the body to the practice of
>medicine and surgery -- allopathy, as it is termed, -- nor required that,
>before anyone can be treated for any bodily ill, the physician must have
>acquired a competent knowledge of allopathy and be licensed by those
>skilled therein. To do that would be to limit progress by establishing
>allopathy as the state system of healing, and forbidding all others. This
>would be as foreign to ours ystem as a state church for the cure of souls.
>All the state has done has been to enact that, when one wished to practice
>medicine or surgery, he must, as a protection to the public [not to the
>doctor], be examined and licensed by those skilled in surgery and medicine.
>To restrict all healing to that one kind -- to allopathy, excluding
>homeopathy, osteopathy, and all other treatments -- might be a protection
>to doctors in surgery and medicine; but that is not the object of the act,
>and might make it unconstitutional, because creating a monopoly." North
>Carolina's Supreme Court in State v MacKnight, 42 S.E. 580, 1902 at p 582.
>
>
>
>As NSF's medical director, Rima Laibow, MD, has noted,
>
>
>
>"Throughout the world today people are looking to traditional methodologies
>and leading-edge CAM techniques because they offer alternatives to toxic,
>expensive drugs with their dangerous side effects, other invasive
>technologies of modern medicine, and un-manageable and unreasonable costs.
>This search for alternatives is protected by the fundamental right of
>individuals to communicate and learn; to heal and be healed."
>
>
>
>You can read more about this issue and add your comments to the FDA through
>the Natural Solutions Foundation, a non profit NGO at
>http://www.healthfreedomusa.org and submit your comments from the home
>page. Since the FDA Dockets Supervisor tells us her 9 member staff is
>overwhelmed -- apparently the system crashed and only about 128,695 of the
>over 315,000 people who have tried to post comments have succeeded so far -
>we have now made arrangements to email directly to the FDA and expect all
>future comments to get through, so if you did not succeed last week, please
>try again.
>
>
>
>This Monday morning, April 23rd, the Foundation formally filed a written
>request with FDA for an extension of time to file comments. Due (1) to the
>confusion between the April 30th deadline stated in the Federal Register
>and the 90 day comment period, from the date of publication in the
>Register, as stated on the FDA CBER web page,
>http://www.fda.gov/cber/gdlns/altmed.htm (which would put the deadline off
>until May 28th) and (2) the large number of people who want to comment. On
>Tuesday afternoon, we received a letter from FDA denying the extension,
>failing to clarify whether April 30th or May 28th is the deadline, and
>letting us know, per the statute, the guidance, "does not create or confer
>rights for or on any persons…" the FDA representative did not say that it
>would not be used as the basis for actions against persons, or to justify
>the agency's expansive view of its authority.
>
>
>
>The last time Americans got this mad about health freedom, Congress
>unanimously passed the Dietary Supplement Health and Education Act of 1994
>(DSHEA) protecting our access to supplements. This time, we will protect
>our complementary and alternative practices; our vitamins, herbs, minerals
>and healing arts. We are "mad as hell" and "we aren't going to take it any
>more!"
>
>
>
>Ralph Fucetola JD
>
>Trustee - NSF
>www.vitaminlawyer.com
>
>
>
>And Then....
>
>
>
>And here, to keep you will be fully up to date, is the letter we have just
>sent to the FDA seeking clarification and explaining why we are not
>satisfied with the denial of our request:
>
>
>
>Natural Solutions Foundation
>
>c/o Ralph Fucetola JD - ralph.fucetola@usa.net
>
>58 Plotts Road - Newton, New Jersey 07860
>
>973-300-1519 - Fax: 300-5486
>
>
>
>April 24, 2007
>
>
>
>Re: FDA Docket No. 2006D-0480
>
> Request for Clarification of Comment Period Dates
>
>
>
>Via Facsimile to: 301-827-6870 - Att: Ms. Butler
>
>Via Email: fdadockets@oc.fda.gov
>
>
>
>To: Jennifer Butler, Dockets Supervisor
>
>Division of Dockets Management
>
>Food and Drug Administration
>
>5630 Fishers Lane, Room 1061 (HFA-305)
>
>Rockville, MD, 20852
>
>
>
>CC: Philip Chao - Senior Science Advisor
>
>Office of Policy and Planning (HF-23)
>
>Food and Drug Administration
>
>5600 Fishers Lane
>
>Rockville, MD 20857
>
>Via Email: philip.chao@fda.hhs.gov
>
>Via Facsimile: 301-827-4774
>
>
>
>Gentlepeople,
>
>
>
>Reference is made to the Federal Register, February 27, 2007 (Volume 72,
>Number 38, Page 8756-8757),
>http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-3259.htm, entitled: Draft Guidance
>for Industry on Complementary and Alternative Medicine Products and Their
>Regulation by the Food and Drug Administration. This letter is further to
>my letter of April 22, 2007 and acknowledges the letter of April 24, 2007
>over the signature of Jeffrey Shuren, Assistant Commissioner of Policy
>denying the Foundation's request for an extension of time.
>
>
>
>Mr. Shuren's letter did not clarify the evident confusion between the April
>30th deadline stated in the Federal Register and the 90 day comment period,
>from the date of publication in the Register, as stated on the FDA CBER web
>page, http://www.fda.gov/cber/gdlns/altmed.htm , which would put the
>deadline off until May 28th.
>
>
>
>Which date is the correct deadline for comments? The Foundation may want to
>add to its comment or tell its members the correct information. Kindly
>inform me by return email or facsimile of the correct date. The Foundation
>reserves all rights.
>
>
>
>Thank you,
>
>
>
>Ralph Fucetola JD, Trustee
>
>
>
>Cc: Maj. Gen. Albert N. Stubblebine, III (US Army, ret.)
>
>President - National Solutions Foundation
>
>
>
>Facsimile: 1 page.
>
>
>
>Time and Money
>
>
>
>Can you imagine how much time all of this is taking? You know the phrase,
>"Time is Money!" Well, it is. So we urge you to be generous with your
>money while you are giving your time freely (as we are) to make sure that
>health freedom is protected.
>
>
>
>Please remember that this is a long and costly war and we have only each
>other for support! Do you part to help us continue this fight to the
>successful conclusion so we can let health freedom ring! Make your tax
>deductible donation here!
>(http://www.healthfreedomusa.org/index.php?page_id=189) Now would be the
>best time of all!
>
>
>
>Yours in health and freedom,
>
>Rima E. Laibow, MD
>
>Medical Director
>
>Natural Solutions Foundation
>
>www.HealthFreedomUSA.org
>
>
>