Scary regulations coming up... at News Forum, topic 855264

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Feds eye control of vitamins, supplements – even water!
FDA looks to regulate natural substances as drugs, with prescriptions from doctors...

"The Food and Drug Administration says vitamins, supplements, herbs and other natural substances, including water when it is used to "treat" dehydration, should be classified as drugs, and opponents have only until April 30 to express their concern about the proposals under Docket No. 2006D-0480."

http://www.worldnetdaily.com/news/article.asp?ARTICLE_ID=55370

Please Note:
I don't normally use world net daily as a news source - I find it cheezy at times - however if this is true, it could become scary quite quickly!

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Re: Scary regulations coming up... #19934 17 y 7,887

#19934

This is a reply to # 855,264

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yes, we all need to comment! here's how:

FDA Regulators Using Legal Trickery to Jeopardize Alternative Procedures and
Products

The FDA has been known to use legal maneuvering to try to end your access to natural health products (like vitamins, minerals and herbs) and natural health therapies of all sorts. We believe they are at it again. This time, their ploy is to issue a "Guidance" that implies these therapies can be "Medicine," which
creates the risk that any non-physician who uses them could be held to be practicing medicine without a license. Since these practices could be considered "Medicine" any products intended for such use could be considered untested drugs and could therefore be forbidden.

Your Comments are Vitally Important

Public, professional and industry comments are being accepted by the FDA on the proposal, that we view as a sly maneuver 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 potentially 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.

While we do not expect our alternatives to be taken away from us immediately, we know it is easier to stop or change a bad guidance before it is finalized, rather than ever getting it repealed afterwards. FDA has given us an opportunity to let them know we want them to respect our right to choose the type of therapies we want for ourselves, including alternatives to pharmaceutical treatments.

Please send the link (http://www.democracyinaction.org/dia/organizationsORG/healthfreedomusa/campai...) to this page to everyone you can reach with a brief explanation of the issues. Urge everyone in your personal and professional circles of influence to protect their health freedom -- their personal right to make their own health choices.

It is important to take a moment to email the manufacturers of the health care products you take an ask them to alert their suppliers and customer base to protect their businesses. Your natural health care providers need to alert their patients and colleagues, too.

Thanks for your activism!

Rima E. Laibow, MD

http://www.democracyinaction.org/dia/organizationsORG/healthfreedomusa/campai...

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Re: Here's the comment form... #19934 17 y 7,951

#19934

This is a reply to # 858,562

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Comments on FDA Guidance for CAM Products and Regulation

FDA Regulators Using Legal Trickery to Jeopardize Alternative Procedures and
Products

Your Comments are Vitally Important

Thanks for your activism!

Rima E. Laibow, MD

Medical Director

Natural Solutions Foundation

www.HealthFreedomUSA.org

>>Learn More

April 29, 2007

Subject:

I assert my fundamental right to control my own health and health care. I want Complementary and Alternative Modalities ("CAM") to be freely available and I endorse the comments of the Natural Solutions Foundation which were submitted on April 6, 2006 and which follow: 04/06/07 Let CAM Continue to Develop Freely To: Food and Drug Administration From: Natural Solutions Foundation Re: FDA Docket No. 2006D-0480 These comments are submitted by Major General Albert N. Stubblebine, Rima Laibow, MD and Ralph Fucetola, JD on behalf of Natural Solutions Foundation with regard to the Food and Drug Administration’s draft “Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration.” They are submitted with reference to the request of FDA for comments on the proposed Guidance stated at: http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-3259.htm. The Natural Solutions Foundation is a tax exempt, recognized nongovernmental organization active in the United States and internationally, communicating Natural Solutions to the many health problems caused by government intervention, with emphasis on FDA and Codex Alimentarius over-regulation of natural foods and supplements. Complementary and Alternative Modalities (CAM), including traditional remedies and nutrition to achieve and maintain a healthy status, are preferred by many Americans to so-called “standard” allopathic medical treatment, primarily due to the well-documented iatrogenic death and disabilities, the dangerous side effects and persistent failures of the so-called “standard” model. The Dietary Supplement and Natural Remedies market has grown to over $28 billion dollars annually as Americans consistently vote with their dollars choosing CAM products out of un-reimbursed funds. The Foundation urges the FDA to take into account an important legal distinction that FDA appears to ignore totally in the draft Guidance. That distinction is between “treatment of disease” and “therapies that may benefit.” In keeping with that distinction, explained below, it is suggested that the Guidance be titled, “Guidance for Industry on Complementary and Alternative Modality Products and Their Regulation by the Food and Drug Administration.” CAM is not “medicine”, does not rest in medical models and allopathic methods and does not seek to be considered “medicine.” In fact, CAM seeks to shed the appearance of “medicine” which is not in keeping with CAM traditions and activities. We request the FDA take the following steps: (1) hold public hearings on the proposed Guidance; (2) formally revise the Guidance title to replace the word “Medicine” with “Modality” and (3) use of the terms “therapy” and “therapeutic” with reference to Complementary and Alternative Modality health practices, instead of the words “treat” and “treatment of disease” which are used exclusively in the draft Guidance. The terms “treat” and “treatment of disease” are, in fact, antithetical to CAM therapies. CAM health practices can be generally defined as traditional or other practices that are used by individuals, often for self-help, to achieve and maintain a healthy status, either on their own or complementary to standard medical care. These practices do not include the potentially dangerous use of invasive techniques and toxic drugs that are the sole province of licensed medicine. They do, however, include developing therapies and nonstandard approaches that are outside the scope of licensed medicine. Such approaches as Nutrition, Homeopathy, Hands-on-Healing, Magnetics, Sound Health, Energy Therapies, Biofeedback, Meditation, Breath Work, Reiki, Chi Gong, Tai Chi and Herbology are examples of complementary and alternative therapeutic practices. Traditional Chinese, Ayurvedic medicine or folk remedies and "Dr. Mom" home remedies are also examples of CAM practices. These practices aim, in the words of the late Philip J. Hodes, PhD., at "more efficient physiological integration and function of the human organism, leading to optimal wellness." This definition is the polar opposite of non CAM practices which seek to suppress or ameliorate symptoms without an approach to optimal wellness. The terms “therapy” and “therapeutic” do not occur, for example, in the context of the Dietary Supplement Health and Education Act of 1994 (DSHEA). Rather, that statute, passed by unanimous Congressional Consent, tells us that Dietary Supplements may not “diagnose, treat, cure or prevent” any disease. It does not specifically forbid the use of the word “therapy” (or “therapeutic”). Under the Supreme Court’s rule in the Thompson v Western Medical case, we should expect that these words would not be forbidden by the Courts and should not therefore be overtaken by the regulators. Further, the Code of Medical Ethics of the American Medical Association also acknowledges an independent use of the term “therapy.” The original Hippocratic Oath, with its injunction to "Do no harm." has been replaced by a complex Code detailing the relationship between physician and patient and alternative practitioner. Changes made during the early 1990's were inspired by anti-trust lawsuits brought (and won) during the 1980's by chiropractors and other non medical practitioners. These changes are just now becoming recognized by regulators and courts. While "treatment which has no scientific basis" remains condemned (Opinion 3.01), under Opinion 3.04, physicians are free to "refer" a patient "for therapeutic or diagnostic services to another physician, limited practitioner or any other provider of health care services permitted by law to furnish such services, whenever he or she believes that this may benefit the patient." Thus, unscientific "treatment" is distinguished from "health care services permitted by law." "Treatment" -- which means the use of standard medicine and surgery to "cure" disease -- is distinguished from other health care services (therapies) which need only meet the lesser "may benefit" standard. While physicians "prescribe" treatments for disease, therapies that may benefit may be subject to "referral" thereby further indicating the distinction. Thus, for example, Dietary Supplements that support normal structure and function to support therapeutic outcomes can be seen to complement licensed medicine, but not to be held to its strictures, nor limited in its practice to licensed physicians. Since such therapies are not prescription services, members of the public may choose such services without the permission of their physician. Purveyors may restrict sale of therapeutic products to physicians, complementary practitioners, exercise and health care professionals, although they should not be required to do so. We have analyzed the word “therapy” and the similar word “therapeutic” because these words are not forbidden by DSHEA and are referenced by the AMA Ethics Code. We recommend “Therapeutic Nutritionals” for alternative practices centered on Nutrition. We recommend the use of the qualifying word, “Nutritional” in this context to make it completely clear that the practitioner is not offering “treatment of disease.” The claims made for Therapeutic Nutritionals must, of course, be allowed Structure and Function Claims. Thus, for example, under current law as interpreted by the FDA, one cannot claim that a nutrient lowers cholesterol levels – since there is now a “disease” of hypercholesterolemia – but can claim that a nutrient maintains normal cholesterol levels for persons with normal cholesterol. A purveyor may say that a certain combination of multivitamins was designed to maintain normal structure and function for a person with diabetes, but not that the combination “treats” diabetes or affects the blood sugar level. Similarly, any Health Claim made for any alternative practice must meet the FTC standard of "truthful and not misleading" and must be based on standard commercial substantiation criteria. CAM products are intended to benefit normal structure and function and are not prescribed as treatment for medical or psychological conditions, nor for diagnosis, care, treatment or rehabilitation of individuals, nor to apply medical, mental health or human development principles.” As the High Court said in Thompson, "We have previously rejected the notion that the Government has an interest in preventing the dissemination of truthful commercial information in order to prevent members of the public from making bad decisions with the information. * * * Even if the Government did argue that it had an interest in preventing misleading advertisements, this interest could be satisfied by the far less restrictive alternative of requiring … a warning..." What is the proper level of substantiation for CAM nutrient or health claims? It is not the "significant scientific agreement" required of drug claims, but rather, the general "competent scientific evidence" standard that applies to all commercial claims. That does not imply that purveyors need to have multiple double-blind experiments (as may be required for drug approval). Substantiation merely needs to be competent and scientific. We urge this to include research studies (which is when scientists review the work of others and apply it to specific questions) and clinical trials (which may be as formal as double-blind, placebo controlled investigations but need not be, since multiple variables, like those involved in CAM practices designed to promote optimal health, are not well studied by double-blind, placebo controlled investigations) as well as traditional knowledge, clinical case studies, observational reports and clinical experience. All of these sources of information and experience have a role to play, but ultimately, such substantiation must rest on the informed professional opinion of some credentialed or appropriately experienced person who can (in the case of Dietary Supplements, for example) sign onto the Structure and Function Claims Notice to the FDA, attesting that "the notifying firm has substantiation that the Statement to which this Notice applies is truthful and not misleading." (Regulations under 21 U.S.C. 403(r) (6)). The Natural Solutions Foundation favors a market approach to these issues and urges the FDA to reduce regulation to those minimum levels that will encourage the continued rapid development of CAM approaches. Especially when dealing with Dietary Supplements and Traditional Remedies, we are dealing with foods which, as foods, are presumed to be safe. There is no need for the high level of regulation that is required for the dangerous and invasive drugs and techniques of so-called “standard” medicine. Even with this stringent level of oversight, drugs are a major cause of death in every developed country while CAM remedies are an insignificant-to-absent cause of death world-wide. Rather, this is a situation where the public is best served by a policy of Laissez-Faire: allow CAM to develop freely in the public interest. 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, un-manageable and unreasonable costs and other invasive technologies of modern medicine. This search for alternatives is protected by the fundamental right of individuals to communicate and learn; to heal and be healed. This has been settled law for over a hundred years. "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 our system 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 MacKinght, 42 S.E. 580, 1902 at p 582. Costs, safety and, most of all, liberty, require that the distinction be made and maintained by the FDA between “treatment” and “therapy” if the US Constitution and public are to be served. Dated: April 6, 2007 Respectfully submitted, Maj. Gen. Albert N. Stubblebine III, (US Army, Ret.) Rima Laibow MD Ralph Fucetola JD For: Natural Solutions Foundation www.HealthFreedomUSA.org Ref: Federal Register: February 27, 2007 (Volume 72, Number 38 [Notices - [Page 8756-8757] [wais.access.gpo.gov - DOCID:fr27fe07-95]

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much ado about nothing: lets get the... chrisb1 17 y 7,935

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General Stubblebine.................Is the General Part of an INSURANCE POLICY to Help Usher In a North American Union & Codex???

Open Letter to Disinformation Specialist General Albert N. Stubblebine III

To: Major General Albert N. Stubblebine III, US Army (Ret) April 27, 2007

The Natural Solutions Foundation
GeneralStubblebine@GlobalHealthFreedom.org

From: John C. Hammell, President: International Advocates for Health Freedom

Sent on Eve of This Urgent Alert Which Must Be Acted on Today and This Weekend:

US HEALTH FREEDOM ON VERGE OF COLLAPSEhttp://www.lef.org/featured-articles/consumer_alert_042707.htm

Dear General Stubblebine:

On the Natural Solutions Foundation website, you announce yourself to be a specialist on the art of disinformation- citing three different types of disinformation being used to confuse vitamin consumers and dietary supplement companies about the Codex vitamin issue regarding which you and your wife Rima Laibow purport to be experts.
http://www.healthfreedomusa.org/index.php?page_id=178

How many people would ever suspect from reading this section of the Natural Solutions Foundation website that the Natural Solutions Foundation THEMSELVES would be disseminating disinformation?

While I have no quarrel with the 3 different types of disinformation that you HAVE discussed on your website, interestingly, you have OMITTED any discussion of the most INSIDIOUS TYPE of disinformation: that which comes from the most TRAITOROUS of groups: the CONTROLLED OPPOSITION GROUP...

THE FDA’S CAM GUIDANCE DOCUMENT: IS THE SKY TRULY FALLING?
OR IS THIS A SLICK ATTEMPT TO DISTRACT & MISLEAD THE PUBLIC?

On April 26th, the Natural Solutions Foundation sent out its most recent in a series of shrill announcements about the FDA Guidance Document that to date “145,541” comments had been sent to the unelected bureaucrats at the FDA. In an ongoing attempt to whip the public into a frenzy NSF claims supposed “denial of service” attacks on its website, and also claims to have “hired data entry people” to “transcribe opposition” to this CAM Guidance document so that the sky will not fall on May 1 or later if the FDA extends the comments period. (Gag me with a spoon.)

We’re supposed to believe that unelected bureaucrats at FDA who we have ZERO political leverage over actually give a damn what we think about anything, and you’re actively distracting supplement consumers from communicating with the only people who we DO have leverage over: our ELECTED officials in Congress. There are two GENUINE issues which NSF (interestingly) isn’t doing ANYTHING about:

1. The FDA’s Trilateral Cooperation Charter With Canada & Mexico:

Wherein FDA is illegally deconstructing America to harmonize our food and drug laws with Canada’s and Mexico’s as a prelude to harmonizing us to Codex.

http://www.thepetitionsite.com/takeaction/373269232#body

2. S.1082- The FDA Revitalization Act- Which Creates a Pharmaceutical Company Inside FDA & Which Hands FDA Broad New Powers to Attack Dietary Supplements- The bill is scheduled to be Voted on on the Floor of the Senate on Monday April 30th
http://www.lef.org/featured-articles/consumer_alert_042707.htm

General- If the 145,541 people who wasted their time and energy sending your form letter to the unelected bureaucrats at FDA regarding this Guidance document had instead signed this petition
http://www.thepetitionsite.com/takeaction/373269232#body
directed to ELECTED OFFICIALS in the Oversight & Investigations Subcommittee of the House Commerce committee we might actually be doing something REAL.

IAHF and Allied Groups conduct a Triage Assessment of all alleged threats currently facing us. We realize that to have a chance get an oversight hearing on FDA’s Trilateral Cooperation Charter we’ll have to overcome the flood of Pharma PAC donations pouring in to members of the Oversight & Investigations subcommittee- and the only chance we have to do that is via sheer numbers of people.

There are two possibilities here: one is that NSF has simply failed to properly surveil the terrain and so has simply not recognized where the true threats in fact are, or else NSF is intentionally attempting to distract the public.

If we’re dealing with the former, NSF will immediately change course and start working with IAHF and Allied Groups. If we’re dealing with the latter, NSF will continue to attempt to whip the public into a frenzy over a non existent issue in an attempt to distract people.

DOES FDA’s CAM GUIDANCE DOCUMENT POSE AN ACTUAL THREAT?OR IS IT BEING CYNICALLY USED BY NSF AS A DISTRACTION FROM FAR MORE REAL THREATS?

The National Health Federation was established in 1955. It is the oldest, most experienced grass roots health freedom organization in the world. Lee Bechtel, their DC lobbyist, has years of experience working directly on Capital Hill. He collaborates closely with Scott Tips, JD, NHF’s Legal Counsel, a man who has been attending all important Codex meetings since 2000 on behalf of dietary supplement consumers and who’s reports from Codex meetings can be seen here:
http://www.thenhf.com/codex.html

Here is what Lee Bechtel has to say about the FDA’s Guidance Document:

“MUCH ADO ABOUT NOTHING: LETS GET THE FDA/CAM ISSUE PUT TO REST”
http://www.thenhf.com/newsflash.html

Hmmmmm. Seems Natural Solutions Foundation suddenly has a HUGE credability problem. You’ve got the public all whipped up into a FRENZY and moving against a NON ISSUE, General! Is that due to sheer incompetence, or is it by DESIGN???

To excerpt from NHF’s analysis: Currently, several groups - other than the NHF - are circulating news about the "end" of dietary supplements and ability of medical professionals, State-regulated or not, to practice Complementary and Alternative medical (CAM) professions, as we currently know it to be the case.

What is being consistently lost in the issue translation in these messages is what the proposed Guidance really means, to CAM providers and consumers, the intent of the Guidance, and the federal and State medical regulatory processes in place that will not mean the "end of the world" as we know it.

The Guidance as drafted does not prevent access to CAM providers. It does not prevent the use of supplements/herbs etc. by medical professionals in their practice, with limitation, nor does or would it directly impact consumers/patients. It would not prevent the use of healthy foods in a diet recommended by a doctor.

What the Guidance does do is present current FDA thinking on how CAM fits within the current context of FDA food and drug regulation. Again, Guidance is not a regulation, nor is it a law. It confers no legal impact on the FDA or the public. Guidance specifically relates to FDA thinking on the design, production, labeling, promotion, and manufacturing of regulated products. In this case, products related to CAM medical practice. This includes FDA-regulated drugs, supplements, and potentially foods, with severe restrictions.

IS THERE A PATTERN HERE?

HAS NSF ENGAGED IN OTHER EITHER INCOMPETENT OR MISLEADING ACTIONS?

I’ll let the readers of this open letter make that determination for themselves after:

A) Examining NSF’s actions after receiving this open letter which I’m sending directly to General Stubblebine to see whether or not NSF begins to do the right thing or not after receiving it.

B) Reading this article by Paul Anthony Taylor at the Dr. Rath Health Foundation:

A Modern Major General Exposed?
http://www4.dr-rath-foundation.org/THE_FOUNDATION/Events/codex-moderngeneral....

C) Reading this section on the IAHF website about controlled opposition groups:

http://www.nocodexgenocide.com/page/page/3312735.htm

D) Reading the Chapter in Jon Ronson’s book The Men Who Stare at Goats titled “The General” which is about Stubblebine’s apparent sincere belief in his ability to walk through walls. You can read a review of this interesting book here:
http://books.guardian.co.uk/reviews/politicsphilosophyandsociety/0,6121,13558...

General Stubblebine: I was prompted to send this open letter to you after reading your grandiose message titled “The First Principle of War” in which you stated:

The critical importance of defining the objective clearly
The absolute necessity in staying focused on the agreed direction lest you inadvertently wander off course and find yourself in the swamp up to your arm pits in the muck and mire of confused defeat instead of on the sky line drive of Victory with a magnificent view and the world at your command."
Seems like NSF is trying to STEER US over a CLIFF by trying to make us FOCUS on NON ISSUES.

Frankly sir, I have no reason to trust the alleged “vision” of a man who sincerely believes himself to be capable of walking through his office wall and who created a military program at Fort Bragg wherein you ordered men to stare at goats wanting to see if they could make their hearts stop.
http://books.guardian.co.uk/reviews/politicsphilosophyandsociety/0,6121,13558...

I remain offended that when IAHF and Allied Groups attempted to defend American Sovereignty by trying to kill the Central American Free Trade Agreement, recognizing the tie in between it and CODEX by virtue of the SPS language it contains that NSF cynically generated no less than 7 spin pieces against our message while simultaneously misinforming the public claiming that a (non existent) “Miracle” had occurred at Codex.

This lie was ably exposed in Paul Taylor’s article, cited above. If you wish to refute what he said in that article, please do so publicly.

I remain VERY offended that when IAHF and Allied Groups have been attempting to get badly needed congressional oversight on the FDA’s Trilateral Cooperation Charter and on the North American Union, NSF has done absolutely nothing to call attention to these issues.

Our country is being deconstructed, General. You swore an OATH to defend it, but you're NOT defending it. In the face of this information:
http://www.stopthenorthamericanunion.com/TreasonAbounds.html
and all concerns expressed above, all of your attempts to impress with talk about the German’s successful effort to breach the French perimeter by going around the Maginot Line rings very empty and hollow. At a time when our country is under clear and very obvious attack, and where Codex is clearly being ushered in via regional harmonization, you are still trying to con people into believing its possible to stop codex AT codex (while making no effort to get congressional oversight on the FDA's Trilateral cooperation charter which you distract from via a non issue.)

I’d like to see you and Rima attempt to spin your way around this:
http://www.stopthenorthamericanunion.com/videos/EuropeanUnion.html
and
http://www.youtube.com/watch?v=3tg8suvwS3o&mode=related&search=

Codex is being forced on us via Regional Harmonization,but you’re well aware of that aren't you General?

I still have grave difficulty trusting anyone who is as much a cog in the military industrial complex as you appear to be and want to know the complete details of your being on the Board of Canadian Sub
http://www.canadiansub.com/Board.html
and am very curious about this AEGIS “Homeland Security” private initiative that you’re involved with? Is that the same as this effort
http://www.aegiscorporate.com/
to tighten up the police state we’re living in under the guise of "protecting us" from terrorists?

Does your involvement with that have anything to do with your total silence about the threat posed by the so called “Security and Prosperity Partnership of North America”
http://www.spp.gov
to expand NAFTA to the point of destroying our country ostensibly in order to “protect us from terrorists”?

We have zero pull with unelected bureaucrats at the UN’s Codex Alimentarius Commission who NSF seems to think it can influence. FDA refuses to provide their internal documents re the Trilateral Cooperation Charter per the Freedom of Information Act which is forcing IAHF to file a lawsuit in Federal District Court. FDA intends to harmonize our food and drug law with Canada's and Mexico's as part of an ongoing effort to deconstruct our nation. This is a full frontal attack on DSHEA.

If we want to defend ourselves from Codex, our only chance is to defend US Sovereignty, sir. From this point Forward, if Natural Solutions Foundation continues to make no effort to do that, the reason why will become abundantly clear, and in my opinion, you will be seriously urinating on your Constitutional Oath.

For Health Freedom,

John C. Hammell, President

International Advocates for Health Freedom

jham@iahf.com

For Health Freedom, John C. Hammell, President International Advocates for Health Freedom 556 Boundary Bay Road Point Roberts, WA 98281-8702 USA
http://www.iahf.com
jham@iahf.com 800-333-2553 N.America 360-945-0352 World

--------------------------------------------------------------------------------

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Re: THANKS FOR SORTING THIS OUT - GO... #19934 17 y 8,002

#19934

This is a reply to # 858,794

I have commented to legislators on the Codex thing via IAHF already, and so this is a good re-focusing on the issues. Thank you for your post!

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Re: Also to ponder... #19934 17 y 7,879

#19934

This is a reply to # 858,977

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This is also something to ponder:

THE LAW LOFT

Who Says Whatever Happens at Codex

Does Not Affect US Law and

Why Do They Say It?

A journalist looks back to help you look forward

by Suzanne Harris, J.D.

Copyright © 2005 The Law Loft

I was struck recently by an article appearing in the NNFA Today magazine, Volume 18, No.11 entitled "International Products Regulation Q&A: What Affect do They Really Have on the U.S.?" While some parts of the article were good, a number of the questions and answers struck a discordant note including the following:

"However, according to a U.S. Department of Agriculture official, the United States has never changed its laws or regulations to conform to any standards or guidelines adopted at Codex. He noted further that the United States does not, as a matter of practice, officially accept, accept in part, accept free distribution, or accept standards or guidelines adopted by the Codex Commission. Therefore, it doesn't appear that any changes to U.S. law or regulations would likely occur as a result of any adoption by the Commission of the vitamin and food supplement guidelines." [emphasis added]

It was the therefore that really bothered me. If NNFA asked that unnamed bureaucrat about acceptance of guidelines, then it really asked the wrong question. The U.S. generally doesn't accept Codex guidelines nor do other countries. The Codex Secretariat hasn't received a notice of acceptance in the last 10 years. The better question is whether Codex standards and guidelines act as a template or containment within which countries must then write their laws and regulations or face enormous political and legal pressure. To this latter question the answer is clearly yes — write laws within the acceptable field set forth by the applicable Codex standard or guideline or be prepared to accept the consequences, including the risk of cross-sector trade sanctions if you don't.

Why are Codex guidelines and standards a containment, a template, within which nations must then operate or face a host of nasty consequences? Partly because since the creation of the World Trade Organization and its internal operating agreements, every member nation knows that its laws and regulations can become the object of a WTO ruling and the object of political pressure to harmonize. Back in 1997, I watched as the realization dawned on Codex delegates that they had entered into a new era of food law harmoninzation.Too late to cry now was the essence of the message delivered to them by the counsel from WTO.

A few months later, I was dining in Washington with another group of food regulators fresh with the kind of know-it-all arrogance that strikes people who have been around the block at Codex once or twice, and I said: "You know, it's really fascinating to watch how regulations that affect us here at home start out at international meetings."

"No, they don't," intoned a voice from the other end of the table. "They start with decisions by industry. I was at a trade meeting where a new form of packaging was unveiled. Not too long thereafter, the same idea was presented at Codex. That's the way things are done now. And you would do it that way too. Why run around from country to country seeking the regulations you want when you can do it all in one shot at Codex?" The speaker, whom I have paraphrased, was a bureaucrat from the Department of Agriculture.

Was he right? Is Codex the place where the templates for new world-wide regulations are written after business interests have agreed to them?

Through all the years of meetings I have attended since, the answer has come through loud and clear. Yes, he was right, but the pathways can be complex. It works like this: big business and bureaucrats get together and agree on how to write new international regulations in private meetings. When they agree, their agreements then surface as working projects, draft guidelines, or proposals at Codex. In some cases the pathway is very, very clear. In others it is not. In the dietary supplements case, a series of meetings were held by business and bureaucrats who agreed on some issues, went forward on those at Codex, and then agreed on others now contained in the draft guideline on vitamin and mineral supplements now at Step 8.

The real key to how things work at Codex is contained in the phrase in Article 1 of the Statutes of the Codex Alimentarius Commission where it says: the purpose is - "(b) promoting the coordination of all food standards work undertaken by international governmental and non governmental organizations;" What is so significant about this phrase are the words promoting the coordination of ... international governmental and non governmental ... What that means in the real world is taking the work of international industrial lobbying groups and then cloaking that work with legitimacy and now real binding legal and political force by feeding their agreements through Codex, an international governmental entity. The more jaded among you will say, 'Well, how is that any different from the way things have worked in Washington for decades?' The answer is it is different because decisions are made by bureaucrats and the actions are offshore. With a truly domestic piece of legislation you have a chance of overcoming industrial pressure with grassroots pressure on the people you elected. With an international guideline, by the time it's done you have almost no chance to win. You can't bring pressure to bear in all the right places. The real damage was done long ago and long before you felt it.

Would some bureaucrat in Washington deliberately mislead anybody? You bet.

Again and again in a variety of contexts, I have heard bureaucrats tell unwary consumers and reporters tall tales filled with half truths. At the end of a meeting in Washington last Fall, a Washington-based attendee slipped me his card and said "If you ever get a straight answer out of these folks let me know."

When I started to catch on to the game myself, I began changing the way I prepared for meetings and the way I asked questions. I hunted for evidence of these meetings and premised my questions accordingly. The results were startling. Bureaucrats knew months, sometimes years ahead, what was going to happen next, and they told me. I knew, for example, over two years ago that the German risk assessment for vitamins and minerals was being built — long before others 'discovered' it in January.

But they do still try to con you even if you know the game. More recently in Europe an EU bureaucrat I was interviewing said, "Of course, it is different for the FDA. They can't regulate food supplements the way we do because of DSHEA."

"Did someone tell you that?" I replied. "You have been misinformed. DSHEA contains a huge escape clause 'substantial or unreasonable risk of ... ' " I didn't get to finish my sentence. He did it for me, ' ... of illness or injury.' "You could drive a whole herd of camels through that language. Do you know any bureaucrat who wouldn't?" I said. A huge grin covered his face like a Cheshire cat smile. I had caught him and he knew it.

Why aren't they telling the truth and the whole truth? Because it is a truth they do not want you to hear.

No one in this game internationally or in Washington wants you to know that the upcoming Codex guideline will circumscribe what Congress does. It's a little game they all play now — decide offshore what to do, write a standard or guideline, tell the elected representatives: find a problem at home, launch a PR campaign, pretend you are writing new legislation to fix the problem.

Indeed, the concept of gamesmanship is now so imbedded in the bureaucratic mind that it is hard to shake out even when half truths won't work. I saw another real life demonstration of this mentality when a consultant told a room full of bureaucrats, "Half truths won't work here. They know what you are doing." The assembled bureaucrats reacted by suggesting that yet another study on how to 'disinform' the public needed to be done. A meeting organizer expressed disappointment that I was there to witness this. "We thought nobody from the press would come. We had buried the notice so deep in our website," he commented.

What are they really doing? Building blocks for global regulations through 'consensus.'

The name of the game here is convergence and harmonization, to build regulations and laws in each country that fit together with those written in other countries and at places like Codex so that trade (with a hugely expanded definition of trade) moves seamlessly. The mantra of the hour is 'approved once, accepted everywhere.'

Can this be overcome? Is it too late? No, not if just the right steps are taken right now. Otherwise, we can all look forward to a harder fight with less chance of success in Washington in the future.

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