Tuesday, July 31, 2007

Trip to DC: Congress, Liberty Coalition, FDA bill...

I caught the 6:36 AM train from Metropark to DC Monday, for a day of meetings with congressional aides. Training passed New Brunswick I remembered many other train trips there in the '60s, returning to Rutgers from weekends... and I remembered Henry Adams' autobiography where he was taking the same trip to DC, expecting to influence post-Civil War policy. He expected to be embraced; after all, both his father and grandfather had been presidents. He learned that Washington is a hard town to take by storm...

As I walked through the refurbished Union Station I was remembering other trips to DC in the '70s mostly to protest the fiasco in VietNam... Later for NTU and libertarian events... And again in '93 to lobby for the passage of DSHEA (Kathy and I brought our then 5 year old son)... An amazing city: magnificent monuments; awesome buildings; beautiful parks... the might of empire displayed. Surely, not even ancient Rome or Babylon could rival it. Would this place become like them... All I could think of were Shelly's lines:

"'My name is Ozymandias, king of kings:
Look on my works, ye Mighty, and despair!'
Nothing beside remains.
Round the decay
Of that colossal wreck, boundless and bare
The lone and level sands stretch far away."

Such musings ended as I met Charles Frohman, Natural Solutions Foundation's DC agent. He took me to a congressional staff meeting with about 100 conservative and libertarian congresspeople represented and then around to a half dozen congressional offices involved in the so-called FDA Revitalization Act (S.1082 - HR.2900), including Senator Harkin's office, where we were assured that Congress had heard us and the DSHEA protective language, Section 608, will remain in the final bill.

What they heard was a strong protest mounted by NSF and the Liberty Coalition a non-partisan right/left coalition of pro-freedom groups. The letter hand-delivered to the appropriate committee charis, signed by dozens of groups and individuals, reads:

Dear Messrs. Chairman,

The purpose of this letter is to alert Congress to the opportunity it has to protect the health of the American people by protecting a certain section in the "Food and Drug Administration (FDA) Revitalization Act" (S. 1082 and HR 2900), and overriding recent FDA Guidance threatening consumer access to natural therapies.

While the sponsors of the FDA Revitalization Act spoke on the Senate floor that the bill holds harmless natural supplements, Senator Durbin’s Food Title (VI) does include an explicit Section (608), “Rules of Construction,” authored by Senators Hatch and Harkin, protecting nutrients and natural supplements already regulated by the 1994 Dietary Supplement Health and Education Act (DSHEA). If Title VI is retained in the Conference Report for the underlying FDA bill, we respectfully request that Section 608 remain in the final bill. This is necessary as the FDA consistently interprets enactments contrary to clear Congressional intent that supplements are to be regulated like foods, not drugs.

This, however, is not the only problem facing consumers of Dietary Supplements. Recently FDA issued two draft Guidance’s: the so-called “CAM Products” (Docket No. 2006D-0480) and “Health Claims” (Docket No. 2007D-0125) that also impact DSHEA products. The first tries to create a new regulatory category - without Congressional approval while the second places a heavy burden on proof of health claims. The FDA Guidance’s could have dire and deadly health and freedom consequences since high potency nutrients are a well-demonstrated health protection strategy, which lowers morbidity, mortality and health costs. The undersigned organizations, representing in the aggregate millions of voters, are deeply concerned about the important health freedom assaults facing the people. We urge Congress to take immediate action to reverse these dangerous and potentially lethal regulations. One immediate step would be to adopt the Health Freedom Protection Act, HR 2117, mandating FDA approval of Health Claims that have scientific substantiation.

Signed, Natural Solutions Foundation et. al.
(to see 3 page list of co-signers, please go to

We also brought along a Natural Solutions Foundation Congressional Briefing Document to the staff meeting and offices, giving out 100 of them. The Briefing reads:

From the Desk of Major General StubblebinePresident, Natural Solutions Foundation
Re: Congressional Choice: Health Freedom or Health Tyranny
To the Members of the 110th Congress and National Decision Makers:

During the past three months supporters of the Natural Solutions Foundation – http://www.healthfreedomusa.org/ - have sent over a half million messages to Congress, the USDA and the FDA about health freedom issues. Of these, 197,000 individual messages went to the FDA regarding its recent "Guidance" about complementary and alternative healthcare modalities (docket 2006D-0480). Hundreds of thousands of health freedom supporters have signed onto the Natural Solutions Foundation's Health Freedom Alert and are ready to make their voices heard to agencies and to their congressional representatives "at the drop of a mouse..."

The House and Senate are currently conferencing the so-called "FDA Revitalization Act" - HR 2900 and S 1082. This legislation is not likely to solve the problems of the Food and Drug Administration; throwing more money and more bureaucracy at the problems caused by bureaucracy hardly ever does, but this new law is likely to further erode Americans’ access to wholesome nutrition and natural remedies.

Because hundreds of thousands of citizens made their views known to their Senators, the Senate, without dissent, added language to S 1082 protecting products already regulated under the Dietary Supplement Health and Education Act (DSHEA) from certain provisions of the act. The House did not adopt similar language. We strongly support the retention of Section 608, the DSHEA protection language, whether or not Section 6, on food safety, remains in the final bill. Better yet would be the adoption of the Health Freedom Protection Act, HR 2117, which would assure Americans that we could receive truthful health claims information from nutrient purveyors, despite FDA efforts to prevent that exercise of free speech.

Natural Solutions Foundation's supporters have further concerns. Today the Liberty Coalition is delivering a letter to the chairmen of the health committees of both houses of Congress, signed by organizations representing millions of citizens. That letter supporting the retention of Section 608 states, in part.

"Recently FDA issued two draft Guidances: the so-called “CAM Products” (Docket No. 2006D-0480) and “Health Claims” (Docket No. 2007D-0125) that also impact DSHEA products. The first tries to create a new regulatory category - without Congressional approval, while the second places a heavy burden on proof of health claims. These FDA Guidances could have dire and deadly health and freedom consequences since high potency nutrients are a well-demonstrated health protection strategy which lowers morbidity, mortality and health costs."

The Natural Solutions Foundation, seeking to educate Washington decision makers, has criticized both of these guidances. We agree with Dr. Ron Paul who called the CAM guidance "...an abuse of FDA power..." and call for further protections for nutrients and natural remedies. HR 2117 would make the Health Claims guidance moot and enhance consumer access.

Just as Congress did unanimously in 1994, when DSHEA was adopted, Congress needs to intervene and really reform the FDA. The bills that passed this session, assuming they survive conference, will not accomplish meaningful reform, especially in the area of foods. It is time to re-evaluate the entire structure of the FDA. It may very well be that a mistake was made in 1938 when the FDA was empowered, combining oversight of foods with that of drugs in a single agency. The combination led to a confused and confusing bureaucracy which under values the role of food in health and is far too supine to the interests of the hugely powerful pharmaceutical industry.

A good first step to real reform would be the adoption of HR 2117, supporting free speech in health claims. In the leading case of Thompson vs. Western States, 2002, Justice Sandra Day O'Connor stated: "If the First Amendment means anything, it means that regulating speech must be a last - not first - resort ... 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."

The FDA is conducting the world's largest experiment on the American people, without either their knowledge or consent. In the absence of any safety testing or review, it permits genetically modified (GM or "Frankenfood") in America's food supply and explicitly refuses to allow it to be labeled as such since it says that the truth would "mislead" consumers who would not eat GM food if they had a choice about it. GM food safety has been questioned scientifically; however, be that as it may, by withholding truthful information on what is, and what is not genetically modified, the FDA is simultaneously adulterating America's food supply and taking away the right of Americans to choose whether they want to be part of an experiment for which they have not signed up and which may, in the long run, cost them their lives, the right to have children, give them cancer and poison the environment for all future generations - we just don't know yet. The same reasoning applies to the FDA position on irradiation of foods without notice to the consumer; or to the USDA's recent decision to permitting 38 non-organic ingredients while still allowing purveyors to label the products (sic) "organic." Not only are these agency biotech-friendly decisions dangerous, they are also illegal since withholding this information is against the law in this country. These are yet more abuses of FDA power and the power of the other national and international agencies involved.

Americans understand that government agencies increasingly invade personal decisions, taking custody of children away from parents who do not want to vaccinate or medicate them and forcing drugs on the elderly and other vulnerable populations. They resent secret government access to their medical records under HIPPA and homeland security provisions which allow the government to invade their lab results and other records, checking up on diabetic's blood sugar levels, for example and identifying doctors who do not prescribe potentially dangerous drugs as "practicing substandard care" while paying them less money for their supposedly "substandard" treatment.

Americans are angry that the FDA and EPA have canceled their right of informed consent about human experimentation for certain powerless populations (e.g., prisoners, children in foster care) and whole populations (as long as there is secret notification of local police forces 30 days before exposing Americans to radiological, biological, frequency chemical or other experimental hazards).

Health Freedom is an issue that is supported by a majority of Americans; they want a new pro-freedom policy at the FDA, USDA, EPA and other government agencies which are currently threatening both the health and the freedom of Americans. Protection by Congressional enactment would mean that Americans would no longer be forced into compliance with international agencies, such as the Codex Alimentarius (World Food Code) serving corporate agendas, and denigrating organic standards, allowing increased levels of toxins in the international food supply in the process. We would, by adopting HR 2117 and similar laws, declare our independence from Codex and similar international mandates and, once again, lead the world toward greater personal choice in health care by the example of the freedoms our people will enjoy.

This process is what the Natural Solutions Foundation calls "The Codex Two Step." Codex Alimentarius - the World Food Code - is a UN agency under WHO and FAO. It sets international food standards and guidelines regarding food safety and food trade. The guidelines are, under the Codex Statute, advisory only. Many health conscious countries want to support standards that are stricter than Codex might allow; others want to defend traditional foods and remedies; some countries may want to allow their citizens more freedom of choice in what they eat and how they care for their own health.

However, Codex rules are enforced through the World Trade Organization (WTO) which says Codex rules are "presumptive" evidence of the standards for decisions. Nonetheless, the WTO has refused to make Codex the sole rule of decision. In the event of a WTO dispute, if a country has not designated another standard, Codex applies. So, what is the Codex Two Step? It is the legal strategy Natural Solutions Foundation has devised to protect health friendly nations’ traditional foods and remedies and American's freedom of choice.

How does the Two Step work? A country adopts its own food and health guidelines that may vary from Codex. That country then adopts science-based law enforcing its own guideline (somewhat like the US has done with DSHEA... but for a little snag we will discuss later...) - Natural Solutions Foundation has prepared model guidelines and laws for countries to use. What happens, then, if there is a dispute in the WTO involving foods and health? Since one of the countries has adopted its own guidelines and law, the WTO presumption regarding Codex standards and guidelines does not apply. Instead, the WTO judges by the science behind the dispute and each country will be judged based upon its own science-based law - a country cannot be penalized if its science is as good as the complainant's science.

The snag in US regulation is that the FDA declared, in a October 11, 1995 Federal Register announcement (60 FR 53078) that it would "harmonize" US law and regulation with international standards... and Congress and the people be d-----d! So, except for a very limited extent through 19 U.S.C. 3512 (the Uruguay Round anti-harmonization act) we are not protected from forced harmonization and only Congress can act to close the loophole in US health sovereignty.

And that is why the "FDA Revitalization Act" is not going to satisfy the American public. Congress must use the opportunity presented by HR 2117 to protect the health of the American people and that is our message to Congress today. The final adoption of the FDA Revitalization Act should be delayed; hearings should be held and careful consideration should be given to HR 2117, The Health Freedom Protection Act and other measures to protect the health freedom of Americans.

July 30, 2007

Maj. Gen. Albert N Stubblebine III (US Army, Ret.)
President, Natural Solutions Foundation
By: Ralph Fucetola JD, Foundation Counsel & Trustee
© 2007
I left the city that evening with the sense that I'd be back soon.

Saturday, July 28, 2007

Ron Paul's Health Freedom Plank

Over the past few days the Ron Paul 2008 Campaign has been consulting with us; within the past hour the Campaign posted a powerful statement regarding Health Freedom on their Issues web page:

http://www.ronpaul2008.com/issues (bottom issue on the right)

The text reads:

"Health Freedom

Americans are justifiably concerned over the government’s escalating intervention into their freedom to choose what they eat and how they take care of their health.

The Food and Drug Administration (FDA), in order to comply with standards dictated by supra-national organizations such as the UN‘s World Food Code (CODEX), NAFTA, and CAFTA, has been assuming greater control over nutrients, vitamins and natural health care providers to restrict your right to choose the manner in which you manage your health and nutritional needs.
I have been the national leader in preserving Health Freedom.

I have introduced the Health Freedom Protection Act, HR 2117, to ensure Americans can receive truthful health information about supplements and natural remedies.

I support the Access to Medical Treatment Act, H.R. 746, which expands the ability of Americans to use alternative medicine and new treatments.

I oppose legislation that increases the FDA‘s legal powers. FDA has consistently failed to protect the public from dangerous drugs, genetically modified foods, dangerous pesticides and other chemicals in the food supply. Meanwhile they waste public funds attacking safe, healthy foods and dietary supplements

I also opposed the Homeland Security Bill, H.R. 5005, which, in section 304, authorizes the forced vaccination of American citizens against small pox. The government should never have the power to require immunizations or vaccinations."

With this strong pro-Health Freedom statement, Dr. Paul once more shows himself to be a true friend of every American. He clearly challenges the statist assumptions of the federal political establishment and further sets himself apart from their failed policies. As someone recently remarked, "This country is sick and needs a good doctor... not another d----d lawyer..."

Thank you Dr. Paul!

Friday, July 20, 2007

Current Health Freedom issues

Since the last days of 2006 there have been a series of challenges to Health Freedom

* Adverse Event Reporting Act [signed late December 2006]

* FDA CAM Draft Guidance [Fed Reg. Notice on 02/26/07]

* USDA & Codex: Organic Standards Diminished

* Codex: Raising Toxic Levels, Mandating Irradiation

* Codex: GM (Genetically Modified) Labeling Failures

* FDA GMPs (Good Manufacturing Practices for Dietary Supplements) [Late June 2007]

* Senate & House adoption of FDA enabling bills [S.1082 & HR.2900] [Only S.1082 contains DSHEA protection language]

* Failure of US House to consider Health Freedom Protection Act – HR.2117 [Although over 100,000 messages to Congress demanded such protection]

Now the FDA has directly challenged HR.2117 with a new draft guidance, “Evidence-Based Review System for the Scientific Evaluation of Health Claims” [07/02/07]

Citation: http://www.cfsan.fda.gov/~dms/hclmgui5.html

This draft guidance document represents the agency's current thinking on

1) the process for evaluating the scientific evidence for a health claim,
2) the meaning of the significant scientific agreement (SSA) standard
3) credible scientific evidence to support a qualified health claim. …

Ron Paul’s Health Freedom Protection Act (HR.2117) -

Citation: http://www.govtrack.us/congress/billtext.xpd?bill=h110-2117

Health Claims must be allowed unless the FDA determines that –
(i) there is no scientific evidence that supports the claim;
(ii) the claim is inherently misleading and incapable of being rendered non-misleading through the addition of a disclaimer

The distinction between the Constitutional system of Freedom of Speech -proposed by its champion, Dr. Paul, and the FDA's bureaucratic illegal desire to impose "prior restraint" could not be clearer.

The opportunity should be clear: support HR.2117 - the Health Freedom Protection Act. While we need further protectio with language addressing each of the pending challenges noted above, this is a good start.

“It is all within our grasp, the restoration of the republic and our sovereignty … federalism, free enterprise, peace, prosperity, and the kind of future we all want for our families, ourselves, and our fellow Americans. The dream can be a reality … Instead of wars and inflation and spying and poverty, we can have peace and freedom and the blessings for our children and grandchildren of doing better than we have, of secure retirements and childhoods. No more theft -- of our savings or our liberty.” - Ron Paul at Google on 07/13/07

Tuesday, July 17, 2007

New FDA Draft Guidance: “Evidence-Based Review System for the ScientificEvaluation of Health Claims”

New FDA Draft Guidance: “Evidence-Based Review System for the Scientific Evaluation of Health Claims” - http://www.cfsan.fda.gov/~dms/hclmgui5.html

Following closely after the FDA draft anti-CAM guidance, this new draft guidance, just published, continues the FDA’s policy of more closely regulating the natural products industry. There is a 60 day comment period that should run until the end of August. Says the introduction:

“This draft guidance document represents the agency's current thinking on 1) the process for evaluating the scientific evidence for a health claim, 2) the meaning of the significant scientific agreement (SSA) standard in section 403(r)(3) of the Federal Food, Drug, and Cosmetic Act …and 3) credible scientific evidence to support a qualified health claim. …

"This guidance document describes the evidence-based review system that FDA intends to use to evaluate the publicly available scientific evidence for SSA health claims or qualified health claims on the relationship between a substance and a disease or health-related condition… This guidance document explains the agency's current thinking on the scientific review approach FDA should use and is intended to provide guidance to health claim petitioners …

"The specific topics addressed in this guidance document are: (1) identify ingstudies that evaluate the substance/disease relationship, (2) identifying surrogate endpoints for disease risk, (3) evaluating the human studies to determine whether scientific conclusions can be drawn from them about the substance/disease relationship, (4) assessing the methodological quality of each human study from which scientific conclusions about the substance/disease relationship can be drawn, and (5) evaluating the totality of scientific evidence.”

This guidance attempts to impose a high standard on Health Claims.

Dr. Ron Paul’s pending bill, the Health Freedom Protection Act - HR.2117 - addresses this further FDA power grab by imposing the standard commercial substantiation requirement instead.

Essentially Dr. Paul's bill shifts the burden of proof onto the FDA whenever the agency wants to deny the public the benefit of health claims information about Dietary Supplements. It provides that reasonable health claims, with proper disclosure language, shall be allowed "unless the Secretary determines that -- `(i) there is no scientific evidence that supports the claim; and `(ii) the claim is inherently misleading and incapable of being rendered nonmisleading through the addition of a disclaimer."

Thus, even "a scintilla" of scientific evidence would allow the making of nonfraudulant claims that Dietary Supplements may be of benefit to individuals. The requirements of the bill are consistent with the law that already governs the agency's position, announced in 2004, "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'.''

The text of the bill, reintroduced on May 7, 2007, can be found at: http://www.govtrack.us/congress/billtext.xpd?bill=h110-2117

This latest FDA Guidance needs further analysis and comments will need be addressed to the FDA recommending that Dr. Paul’s approach be substituted for the overly bureaucratic approach favored by the Agency. If not, Congress needs to act fast to protect our alternatives!

Saturday, July 14, 2007

Road Trip

This blog is about a quick road trip to DC, but first... 

Earlier this week the House passed its version of the FDA enabling act, HR.2900, without the Dietary Supplement protective language (the "Durban Amendment") that the Senate had added to its version, S.1082, passed last month. 

The bill was brought before the House under a "special rule" which means the House leadership allowed only limited debate and NO amendments. Since the versions of the bills passed were not the same, the two houses of Congress have to either convene a conference committee or one house or the other has to pass the other house's version. 

Or, of course, Congress could do nothing, which, in this case would be the best thing to do. The original Senate bill was flawed in many ways, not the least, in the bizarre notion that what Dr. Ron Paul has characterized "...abuse of FDA power..." can be cured by giving the FDA more power to abuse! If the bills do not just die without further congressional action, it is time to pressure Congress to make sure that protective language even stronger than the Durban Amendment is in the final bill. 

That Amendment merely protected Dietary Supplements from enhanced FDA power; what is needed is language protecting all health claims for dietary supplements, natural remedies and alternative modalities. Knowing all that, on Thursday I met Dr. Rima Laibow and Gen. Bert Stubblebine, the leaders of the Natural Solution Foundation (I'm a member of the NSF Board). 

They were just returning from attending the Codex Commission meeting held in Rome this year. The World Food Code (Codex) Commission continued with its globalist agenda of degrading organic standards, allowing higher levels of toxins in the food supple, attacking supplements and natural remedies... all the usual politics of the "Bigs" -- Big Pharma, Big Chema, Big Agra, Big Government, etc. But you can read about that in detail at Dr. Rima's blog on www. globalhealthfreedom.org -- where you can also sign up for the NSF eAlert system, allowing you to join hundreds of thousands using the Internet to bring pressure on Congress to leave our alternatives alone.

We need your email contact to alert you when and how to contact Congress to have the best effect; and, of course, our online system makes it easy to do. We did a "new media" online radio interview (Dr. Annette's show on http://www.bbsradio.com/ from Las Vegas and then drove together from the NY metro area to Washington for several important meetings. The nest day, Friday the 13th, we met several Washington "insiders" and visited friendly congressional offices on the Hill. I was really impressed by the commitment to Health Freedom expressed at Congressman Ron Paul's. There is a growing congressional caucus with upwards of thirty members who are seriously concerned with alternative modality, health freedom issues. 

There will be serious efforts over the next couple months to bring forward more comprehensive protective legislation. We finished the trip with the taping of an expanded NSF video on The Codex Two Step and an appearance on consumer advocate Jim Turner's PRN program, Consuming Interests - http://turner.progressiveradionetwork.org/ All-in-all an excellent road trip! 

 PS - many thanks to Will, Drew and Millie for the driving, photos and entertainment!

Monday, July 9, 2007

A message to the House Leadership on FDA reform

The following emails made today's rounds...

To: Natural Solutions Foundation eList

Hello! This message is from Ralph Fucetola, JD., one of the trustees of the Natural Solutions Foundation. Dr. Laibow and Gen. Stubblebine are boarding a plane in Europe just about now and they asked me to convey this message to you.

This morning I received an urgent email message from Congressman Ron Paul'sWashington, DC office. The bottom line: a newly introduced bill, HR.2900 should now be a focus of health freedom activities.

We need your help in getting a message through to the House leadership. Please reference HR.2900 and ask that HR.2900 be "brought up under a regular order" to be considered by the House WITH amendments.

The bill is expected to be moved on Tuesday, so this is an URGENT matter.

Speaker Pelosi's office in DC is: (202) 225-4965

Email her at: AmericanVoices@mail.house.gov

Email the following message:
"I urge the House leadership to allow HR.2900 to be brought up under a regular order so it can be fully debated and amended. I support Ron Paul's Health Freedom Protection Act, HR.2117."

Currently the bill is scheduled for 40 minutes of debate and NO amendments, which means Ron Paul's important Health Freedom Protection Act, HR.2117 or other amendments, such as that proposed by attorney Jonathan Emord, would not be allowed to become amendments to this bill. HR.2900 is the House companion bill to S.1082, the FDA "revitalization" bill that breezed through the Senate last month. That Senate bill was amended to protect Dietary Supplements and we want to make sure the House bill will also be amended to protect supplements and natural remedies.

To do that, HR.2900 must be "brought up under a regular order" so it can befully debated and amended. Please forward this widely.

Ralph Fucetola JD

PS - and remember to support Natural Solutions by shopping thoughwww.organics4u.org

------ Original Message ------
Received: Mon, 09 Jul 2007 08:34:21 AM EDT
From: "Singleton, Norman" <Norman.Singleton@mail.house.gov>
To: "'Ralph Fucetola JD'" <ralph.fucetola@usa.net>
Subject: RE: Now 82,918+ messages supporting Ron Paul

HR 2900 (FDA Reform) is on the SUSPENSION calendar tomorrow. It might be helpful if people called Pelosi, Hoyer, Bonner, and Blunt to see if it can be pulled and brought up under a regular order.
Norman Kirk Singleton
Legislative Director
Congressman Ron Paul
203 Cannon
Washington, DC 20515

Liberty "...will win eventually because it and only it is compatible with thenature of man and of the world. Only liberty can achieve man's prosperity, fulfillment, and happiness....libertarians now propose to fulfill the American dream and the world dream of liberty and prosperity for all mankind." - MurrayRothbard

-----Original Message-----
From: Ralph Fucetola JD [mailto:ralph.fucetola@usa.net]
Sent: Tuesday, June 26, 2007 9:30 PM
To: Singleton, Norman; McAdams, DanielCc: Bailey, Jennifer; releyes@gmail.com
Subject: Now 82,918+ messages supporting Ron Paul

Natural Solutions Foundation's supporters have now generated 82,918 messages to the House supporting Ron Paul's HR.2117 or opposing HR.1561 and urging that HR.2117 be added to it by way of amendment. Which Committee and Subcommittee should we direct our supporters to contact to move HR.2117?

Ralph Fucetola, JD
The Vitamin Lawyer.com Consultancy
All Rights Reserved . . .

Tuesday, July 3, 2007

Natural Solutions Foundation Analysis - Summer of Decisions: Health Freedom 2007

Natural Solutions Foundation Analysis
Summer of Decisions: Health Freedom 2007

A series of international and US government actions at the end of 2006 and beginning of 2007 have put Health Freedom of Choice -- with regards to Organic Standards, Nutrients, Traditional Remedies and Leading Edge Alternatives -- in greater jeopardy than any time since the adoption of the Dietary Supplement Health and Education Act of 1994 (DSHEA). Thus, the Summer of 2007 has become a Summer of Decision for health freedom activists.

Codex Alimentarius is the least known, the most impactful and potentially the most dangerous threat to health and health freedom. Most threats to health freedom are local (e.g., a State goes on a rampage against physicians practicing drug free medicine), national (e.g., the US FDA decides to articulate the law inaccurately setting the stage for draconian "enforcement" of a regulatory structure which deems all health aides to be untested drugs, like cherries if used for arthritis, or untested devices, like hot rocks to sooth painful muscles). Codex, because it is a UN project
which sets standards and guidelines controlling the international trade of all foods and nutrients, not only determines what is available internationally (with all the market pressure that implies) but also becomes the domestic law for those countries which, like the United States, have decided to "Harmonize" with Codex standards and guidelines. The US announced its intention to do just that on October 11, 1995 in the Federal Register when it stated that it would give preference to international standards over US regulation and, as it has turned out, US law as well.

Codex is a mechanism for moving the entire world rapidly towards an industrialized, nutrient poor diet. Under Codex, dangerous, expensive and health-damaging changes in the global food supply are being implemented. Organic standards are being degraded, permitted heavy metal residue levels are being increased, Codex permits astonishingly high levels of dangerous industrial drugs, chemicals, pesticides, toxic veterinary drugs and other poisons in the food supply. Maximum Residue Levels (MRLs) for many pesticides are being removed so that there is no upper limit whatsoever to the amounts of these systemic poisons which can be introduced into foods (and into the bodies and environments of the farmer, his family and his land). Others are being increased dramatically. Organic standards are being lowered, so pure, unadulterated food can be expected to vanish globally, since the terminology will be maintained but the reality will be degraded beyond recognition to meet the needs of industrial farming. At the same time, high potency (dose) nutrients are being prohibited since they are treated as if they were toxins (severely limited, unlike most true toxins) and "assessed" by "Risk Assessment" to be present at no more than, for vitamins and minerals, for example, 115% of the amount found in untreated foods. High potency nutrients will become unavailable in any country which "HARMonizes" with Codex" (eg., the US) or adopts Codex texts as its domestic laws (most of the developing world).

In effect, Codex standards and guidelines mandate unparalleled levels of toxicity plus global under-nutrition, the very same condition to which the World Health Organization (WHO), one of Codex's parent organizations (Food and Agriculture Organization, or FAO, is the other) attributes the global epidemic of non-communicable diseases of under nutrition: cancers, cardiovascular diseases, stroke, diabetes and obesity. These diseases are the principle killers in the developed world (after "properly" used pharmaceuticals) and are rapidly becoming the principle killers in the developing world as well. These preventable diseases are also major profit centers for industries that depend on illness for their profits: the pharmaceutical and medical industries.

At this year's Codex Alimentarius Commission (CAC) meeting (FAO Headquarters, Rome, July 2-7, 2007) the procedure has been radically altered. In previous years, standards and Guidelines proposed by the various Codex Committees and regional associations were discussed (at least to some extent) by the national delegates to the annual CAC. Unjust, dangerous, unwise or unhealthy Codex texts were opposed by countries whose self interest or public health was harmed by the text under consideration. If the standard or Guideline was not approved or needed to be revised, it would either be killed or sent back to Committee for revision, often along with specific instructions to that body. When ready, the text would return to CAC for further consideration, advancement to another level of acceptance or rejection.

That has changed dramatically. I have written that the anticipated date for implementation and globalization of total control of the world's food trade appeared to be dramatically off track. Things were not moving very rapidly despite the near-desperate efforts of Committee chairpersons like the German Rolf Grossklaus, MD, of the Codex Committee for Nutrition and Foods for Special Dietary Uses (CCNFSDU) and the Canadian Ellen Mackenzie, Ph.D. of the Codex Committee for Food Labeling, to rush decisions, curtail discussion and gallop through their view of the agenda at a dizzying pace. Of course, pro-health options like the WHO's Global Strategy on Diet, Physical Activity and Nutrition (mandated for implementation by Codex by both WHO and FAO) somehow never seemed to garner adequate time for meaningful discussion leaving implementation strategies in the dust and in the dark.

This year at CAC not only has the Natural Solutions Foundation been prevented from mingling, eating or talking with the Codex Delegates (by security guards on several occasions!), but the delegates have been prevented from discussion of the standards and Guidelines they are advancing! It is strikingly reminiscent of the US Senate being handed sealed copies of the Patriot Act weeks after 9/11, assured that their security clearances were not high enough to read the law but being instructed to vote on it anyway. If you recall, 99 US Senators did. Robert Bryd of Virginia was the sole member of the Senate to refuse to buy that pig in that poke, and Dr. Ron Paul of Texas one of the very few in the House to vote "No" to protect the republic whose founding we celebrate this week.

At CAC, the Chair now urges members to adopt whatever texts have been brought forward, whether they agree with them or vehemently disagree. Texts and amendments to them are presented "en bloc" for approval en mass without a single word of discussion, if the Chair can bully the delegates into it. When delegates try to overcome this de facto gag rule, either they are told that they are getting in the way of the good work of the CAC (shame) or that they are making it impossible for the CAC to complete its work (guilt).

Those few delegates who try to clarify the irregularities of the process or the dangers of the standards or Guidelines are told that they are getting in the way. Since Codex refuses to define "consensus" and the Chair's agenda is set before the meeting, the Chair does whatever the Chair had intended to do in the first place. An example: today new standards were authorized for a whole group of dangerous industrial chemicals (Pesticides) whose MRLs were simply evaporated by the Chairman's administrative fiat. This means that there is no upper limit to the amount of these metabolic poisons which may be incorporated into your food.

At least one country understands what is happening. China routinely "intervenes" with one simple comment: It is China's position that this matter is within its national competence. The Chinese delegates apparently understand the Codex Two Step Process.

Critical health freedom choices this summer mean making sure that your country does not harmonize with Codex Alimentarius and that your national scientists and legislators follow the Codex Two Step Process to make pro-health choices where Codex makes pro-industry ones and to protect your right to clean, unadulterated and healthy food. If you are a United States citizen, that also means signing the Natural Solutions Foundation Citizens Petition to force the US Government to comply with US law, rather than Codex standards and Guidelines with reference to vitamins and minerals.

In the last days of the past year the President signed the Adverse Event Reporting Act that requires supplement sellers to report reactions to their products; we view this law as potentially beneficial to consumers. At the same time the Food and Drug Administration - the FDA - issued a draft "CAM" Guidance (complementary and alternative modalities) that Congressman Ron Paul, MD, called "an abuse of FDA power..." This is an attempt to grab power over our remedies traditionally overseen by state law, by an agency that has show itself unable to effectively implement its confused and contradictory authority over foods and drugs.

The FDA issued the draft Guidance on December 26th, but did not bother to give the public notice until February 26, 2007. Then the public had its turn to comment. Nearly two hundred thousand people did so, telling the FDA to leave our alternatives alone. This same grassroots movement has swelled the ranks of NSF supporters. We've joined Dr. Paul in condemning this blatant power grab and have called for meaningful reorganization of the FDA. The FDA needs to focus on its core mission of protecting the public from dangerous, side-effect causing, prescription drugs that, these days, have much more in common with chemical toxins than natural materials. To do that, the agency's food jurisdiction should be shifted to the US Agriculture Department or other existing agencies.

Every Federal agency, however, is capable of causing great harm to the public and the USDA is no exception. Early June, the Department approved the addition of 38 more non-organic source materials to products that can continue to mislead us by pretending to be truly organic. This continues a general and disturbing trend to dilute organic standards. The NSF supports strong organic standards and supports the disclosure of conditions, such as irradiation and genetic modification, that allow the public to make informed choices.

Late in June the FDA, 14 years after being instructed to do so by Congress, finally issued what are called "Good Manufacturing Practices" regulations to the dietary supplement industry. This 467 page document has capacity to reduce consumer access to high potency nutrients and admits that many small companies will be driven out of business as a result. We are very concerned about this increase in regulation. Just previously, the US Senate adopted the FDA “Revitalization” bill which would "solve" the problem of FDA failures by granting it more power to abuse. When the public rose up against that bill, it was amended to protect dietary supplements from its new powers. But the House must now consider it, as HR.1561, which ought to be further amended to further protect natural remedies. We note that Dr. Paul has introduced the Health Freedom Protection Act, HR.2117 that would do just that. Our Representatives need to hear from the public so they support our freedoms with Dr. Paul instead of the new restrictions proposed by Sen. Kennedy. So far, NSF supporters have generated over 87,000 messages to the House supporting HR.2117 or asking to amend HR.1561.

At the same time, various regional and international agencies continue to threaten market access to wholesome foods, natural remedies and dietary supplements. As always, the FDA's announced intent to "HARMonize" our freedoms to international rules (even where that decreases our access to safe products), operating through the North American Union, Codex and the new US/EU cooperation agreement, remains an ever present threat. Codex Alimentarius - the world food code - still remains too much a creature of big governments and big commercial interests, although a nascent alliance of health-friendly countries, inspired by information from NSF, is making inroads and this alliance recently protected healthy babies from being exposed to fluoride in their formulas.

This is an especially exciting time for the Dietary Supplement / Natural Products market. While stricter regulations seem on the way, scientific advances and ongoing clinical studies point the way to better and more effective products. The problem is not in the science or the production; the problem is in the politics. These products are generally recognized as safe when used as directed, like any food. We therefore need to reject the big government notion that tells us we will only be safe if bureaucrats have more control over us. That nostrum is provably wrong, as we see from the failure of government, with plenary power over approving drugs (as to efficacy and safety) to protect the public from what some estimate to be hundreds of thousands of unnecessary deaths each year from lawful and correctly used prescription drugs.

The wise people who wrote the Declaration of Independence told us, "But when a long train of abuses and usurpations, pursuing invariably the same Object evinces a design to reduce them under absolute Despotism, it is their right, it is their duty, to throw off such Government, and to provide new Guards for their future security..."

It is now time for people concerned with natural solutions to our health care crises to declare our independence from the failures of the bureaucratic system and to demand new freedoms to offset and correct the old failures of the regulators.

Ralph Fucetola, JD
Natural Solutions Foundation

Rima E. Laibow, MD
Medical Director
Natural Solutions Foundation


Citizens Petition: www.healthfreedomusa.org/index.php?page_id=184

HR. 2117: http://www.democracyinaction.org/dia/organizationsORG/healthfreedomusa/campaign.jsp?campaign_KEY=11754

HR. 1561: