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.

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