FDA Ban Of Vitamins, Minerals, & Herbs?

The attack against our health freedom, drug safety, and dietary supplements (vitamins, minerals, and herbs!), was launched by Senator Edward Kennedy (D-MA) with major support from Michael Enzi (R-WY).

It is called the Food and Drug Administration Revitalization Act (S1082). This legislation was planned over the past few years working hand-in-glove with the FDA's dysfunctional management and legal team - meaning this legislation was written for the profits of Big Pharma and Big Biotech at the expense of safety and human health.

The FDA and the drug companies have been very close for some time now, the bill S1082 is proposing to arrange a marriage between Big Pharma and its regulatory agency.

The new FDA business enterprise is called the Reagan-Udall Foundation for the Food and Drug Administration.

"The purpose of the Foundation is to advance the mission of the Food and Drug Administration to modernize medical, veterinary, food, food ingredients, and cosmetic product development, accelerate innovation, and enhance product safety.

The Foundation shall [take] into consideration the Critical Path reports and priorities published by the Food and Drug Administration, identify unmet needs in the development, manufacture, and evaluation of the safety and effectiveness, including post approval, of devices, including diagnostics, biologics, and drugs, and the safety of food, food ingredients, and cosmetics."

Through this foundation the FDA is seeking broad new regulatory power that it currently does not possess.

This will include the authority to attack any dietary supplement (which are food ingredients) as unsafe based on its use of "Critical Path" technology.

This means the FDA will use proteomics (the advanced study of proteins in biological systems) to assess changes in biomarkers (the change in the state of a protein at the molecular level) in order to establish whatever it wants to consider as a risk. The FDA can slant this technology, based on their own personal opinions, to make anything they want appear as a risk - including your favorite vitamins minerals and herbs that you use to stay healthy.

Under the false pretense of improved food and drug safety the FDA is re-inventing itself as a kingpin drug company. The Senate has already approved this FDA transformation. The House will bring similar legislation with a vote in the full House likely in July. The measure will then go to a conference committee to work out the differences. The final chapter in this transformation occurs when the Reagan-Udall Foundation for the FDA becomes law, which is scheduled to happen some time before September 30, 2007.

S1082 is a Trojan Horse bill that pretends to address safety issues. The bill turns the FDA into a drug development company that will expose Americans to new and dangerous biological drugs that have little testing to prove safety or effectiveness. And to top it off, the bill gives broad new regulatory powers to the FDA that can be used to frivolously attack dietary supplements, vitamins, minerals, and herbs.

Senators were bombarded by emails and letters complaining that they did nothing to revise the S1082 bill. They attempted to assure people that the bill would establish the Reagan-Udall Foundation as a non-government entity that would have no control over the FDA, industry, or consumers.

The Truth: The board of directors is composed of the Commissioner of the FDA, the Director of the National Institutes of Health, the Director of the Centers for Disease Control and Prevention, the Director of the Agency for Healthcare Research and Quality, 4 representatives from Big Pharma and Big Biotech, representatives from academia (which is funded by Big Pharma), 2 more from the FDA and NIH, 2 from consumers groups, and 1 from health care providers.

This means that the FDA/Big Pharma/Big Biotech voting block always has 13 votes - to at the most 3.

This front group foundation is run by the FDA in combination with the industry it is supposed to be regulating. This makes the FDA part of the drug business as a drug company.

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Senators also attempted to smooth over the people's concerns about the Foundation's involvement with food and food ingredients. Stating the involvement would be with food safety, and not with dietary supplements. Claiming that food safety tools are lacking, the Foundation would undertake research to help make food safer but it would have no regulatory authority.

The Truth: By law, dietary supplements are food and food ingredients. I believe everyone would be in favor of the FDA being better able to identify contamination in food that poses a risk to human health. The fact is that the technology to be used by the Foundation relies on drug risk analysis and can be used to claim that a nutrient that is not in any way contaminated is unsafe, thus undermining the very foundation of food and drug law.

The Foundation is being positioned as a major tool for the FDA to implement its opinionated use of this technology, which can easily be used to attack dietary supplements, vitamins, minerals, and herbs.

Since the Foundation is responding to the needs of the Critical Path Initiative, and that initiative is primarily about the development of new drugs, it is clear that the Foundation will not only help with drug development but it will have significant business relationships as a result.

Do not be confused by the Foundation's non-profit status, this is simply a useful vehicle that SRI International has used to coordinate collaboration, while securing patents and licenses, and then spinning off business ventures.

The FDA is trying to reduce its legal liability to the federal government by setting up the Regan-Udall Foundation as a non-profit, in case the drugs it helps design injure or kill people.

Make no mistake about it, the FDA will be fully in control of the Reagan-Udall Foundation for the FDA. Once this becomes law, as anticipated by September 30, 2007, we will enter a new era with the FDA as a drug company.

Well, the bill has passed through the Senate, and as of May 10th, it is 'sitting on the House desk'. I have checked the House daily procedings, and S1082 has not come up yet.

I believe the wording still includes 'food and food ingredients'. My Iowa Senator discussed this subject while talking about the amendment #1016 to the S1082.

Page S5491, titled Overturning DSHEA:

Mr. HATCH My office has been inundated by calls from people throughout the country who believe that this legislation, specifically the provision establishing a Reagan-Udall Institute, will overturn the Dietary Supplement Health and Education Act of 1994. That has not been my reading of the bill, but I wonder if other Senators have heard similar concerns?

Mr. HARKIN Yes, I have received a good many calls as well. And, I have to say that I would be very concerned, as I know the Senator from Utah is, if anything in the bill we are considering, S. 1082, would overturn DSHEA, a law we fought side-by-side to see enacted.

Mr. ENZI It might be helpful if I explained the provision you are discussing, as my office has received many calls as well and I believe the callers are not informed about this matter. Subtitle B of title II of S. 1028 establishes the Reagan-Udall Foundation for the Food and Drug Administration. That simple purpose of that nonprofit Foundation is to lead collaborations among the FDA, academic research institutions and industry designed to bolster research and development productivity, provide new tools for improving safety in regulated product evaluation, and in the long term make the development of those products more predictable and manageable.

Mr. KENNEDY That is exactly the purpose of the Foundation, which was included in the drug safety legislation Senator Enzi and I introduced last year. The Foundation will be financially supported by industry and philanthropic donated funds. A chief scientist at FDA will promote intramural research and coordinate it with efforts at the Foundation.

Mr. HATCH That explanation is very helpful. What, specifically, would the role of the Foundation be with respect to dietary supplements?

Mr. KENNEDY Let me make absolutely clear that the Reagan-Udall Foundation will in no way override, overturn or conflict with the Dietary Supplement Health and Education Act. Nothing in this bill would have that effect.

Mr. ENZI Yes, we took great pains to make certain there would be no conflict with DSHEA. Regarding foods, and dietary supplements are generally regulated as foods, the general directive of the Foundation is to identify holes in the evaluation of food safety and identify ways to address those deficiencies through collaborative research with industry.

Mr. HARKIN So to make this absolutely clear, what you are saying is that the bill we are debating would in no way interfere with consumers' access to dietary supplements?

Mr. HATCH To add to that point, it seems that the language could, in fact, help dietary supplement consumers, because it would allow collaboration between government and industry to conduct research on issues that might be helpful to supplement consumers?

Mr. KENNEDY Yes, that is the case.

Mr. ENZI I agree with Chairman Kennedy's assessment.

Mr. HATCH I thank you for those assurances and that clarification.

Mr. HARKIN This has been a very helpful discussion, because Senator Hatch and I could never support legislation that would interfere with DSHEA and we are glad to receive the assurances of the chairman and the ranking Republican on the committee.

So there it is people, Mr. Kennedy's and Mr. Enzi's statement that the FDA Foundation will not interfere with our access to dietary supplements.

Time will tell if this holds true.

On July 11, 2007, the U.S. House of Representatives passed HR 2900, blocking debate on the law and preventing the introduction of any amendments that might have provided meaningful drug safety protections for consumers.

Only one Congressman, Rep. Ron Paul, was attempting to introduce meaningful amendments that would protect the interests of the people and protect
dietary supplements. His efforts were blocked by Speaker of the House Nancy Pelosi.

This action demonstrates that the House of Representatives, much like the Senate, is utterly controlled by 'Big Pharma' and has abandoned any responsibility to defend the interests of the voters.

The 'People' have once again lost and been forgotten about by the Representatives they voted into office.

Drug companies now have complete control over the U.S. Congress, and through a campaign of intense lobbying and financial influence, they have managed to easily water down a law that once proposed to end the American monopoly on pharmaceuticals and ban advertising on new drugs.(S1082).

Instead of placing new restrictions on 'Big Pharma' and the increasingly dangerous power of the FDA, this new law (a combination of HR2900 and S1082, when it is hammered out in conference) grants more power to the FDA while deepening the financial ties between the FDA and drug companies.

Both the House and Senate think it is completely fine that the drug industry pay the FDA fees so that the FDA can approve new drugs faster. Indeed, the FDA and 'Big Pharma' met 112 times to work out their partnership before the FDA let Congress know what it wanted to see in HR2900 and S1082.

The law effectively surrenders the American people to a system of medical tyranny under which a criminally-operated FDA will continue to promote pharmaceuticals, censor nutritional education and discredit alternatives that threaten drug company profits.

The FDA routinely squashes the first amendment rights of American citizens to understand natural health options, and the science that explains how they can prevent and treat disease. The FDA wants to actively suppress information that will help people.

Nothing in the new law protects consumers' access to dietary supplements or natural medicine.

Provisions within the legislation that creates the Reagan-Udall Foundation for the FDA will allow the FDA to remove any dietary supplement from the market based on its whim.

This new Reagan-Udall Foundation places the FDA in charge of drug design, drug patents, drug licenses, and the creation of new marketing intities/companies. Such a relationship with private industry is an unprecedented conflict of interest.

The FDA wants to prevent citizens from suing drug companies when they are injured, thus protecting 'Big Pharma'. FDA tyranny, based on this type of power, is used to promote and protect the pharmaceutical industry while at the same time undermining the dietary supplement industry.

The House version of the bill is stronger than the Senate version in terms of drug safety issues, but these differences could easily disappear in conference, leading to a final signing of a useless, watered-down "FDA safety" bill that is actually nothing more than an FDA corruption rewards program.

This new fake "safety" legislation provides the FDA with unprecedented new power to stamp out competition to drug companies as well as expose Americans to far greater safety risks than ever before.

While the House version would require the publishing of a clinical trials database (which shouldn't even be debatable, it should be full disclosure by default) and limit the number of bribed FDA officials who can sit on a drug decision panel to 1, even these provisions are laughable in the fact that none of them actually require drug companies or the FDA to act with integrity or defend the health and safety of the American public.

Congress had the potential to pass a really good law.

A law that would have:
* ended direct-to-consumer advertising,
* banned conflicts of interest at the FDA,
* required the open source publication of drug trials,
* and ended the U.S. monopoly on pharmaceuticals.

Instead, Congress chose to do none of these things.

The House, like the Senate, will continue to allow direct-to-consumer advertising of new drugs with unknown risks; a flagrant safety risk that will cost many people their lives.

It staged a song and dance about "FDA reform" while selling out the future of America's health to a tiny but powerful group of ultra-wealthy corporations that now virtually rule this country.

Representatives Frank Pallone, Jr. (D-NJ), John Dingell (D-MI), Henry Waxman (D-CA), and others falsely proclaimed that they were doing America a favor by passing this sweeping FDA-supported legislation that grants the FDA more power and money, and even transforms it into a quasi drug company.(by the formation of the Regan Udall Foundation!)

There is nothing in the new law worth celebrating unless you are the CEO or major shareholder of a 'Big Pharma' corporation, in which case you will be stunned at just how cheaply and easily U.S. lawmakers can be bought.

Congress is for sale, cheap!

Welcome to the United States of Big Pharma.

My country has become a place where lawmakers actually bicker about how much bribery and corruption should be allowed in the FDA drug approval decision process.......... rather than simply agreeing to ban all bribery and conflicts of interest.