Your right to have free access to safe and highly effective dietary supplements is under an intense multi-pronged FDA attack. On May 14, 2007 the Supreme Court sided with the FDA by deciding not to hear the case of Nutraceutical v FDA, letting stand a federal appeals court ruling that permits the FDA to use drug-related risk/benefit analysis to determine if a nutrient is safe. This is the exact same point the FDA is trying to get put into law through Senate bill S.1082 and HR.1561, which consumers have flooded the Senate on over the past few weeks. And it is the same point the FDA is seeking to help implement on an international basis through Codex. The Supreme Court denial to hear this case is a dramatic turn of events that means there is very little time left to act to preserve free access to dietary supplements. The first part of this article explains this issue in depth so that Americans can understand what is taking place. The second part explains the steps Americans need to take to preserve their health freedom.
Leading health freedom attorney, Jonathan Emord, has been handling the Supreme Court petition for Nutraceutical Corporation. He has also been helping us prepare amendments to neutralize the threat posed by current FDA reform legislation (S.1082/HR.1561). On May 11, 2007 I received an email from Mr. Emord explaining the significance of the Supreme Court case:
“In particular, FDA for the first time in its history now holds a dietary ingredient or dietary supplement adulterated at every dose level if at some dose level it can be shown to present even an infinitesimal risk if it concludes there to be no substantial health benefit from the supplement. Because all dietary ingredients, dietary supplements, and foods present a risk to health at some level of ingestion, the FDA’s new position permits the agency to declare any dietary ingredient or dietary supplement adulterated at its whim or caprice.”
This abhorrent FDA strategy is now the prevailing legal precedent in the land. The FDA has also launched a sneak attack on dietary supplements through Senate bill S1082, seeking to slip wording into the bill that would allow this exact strategy to become law. Language within the bill allows the FDA to use drug-related risk assessment to brand dietary supplements as unsafe, overturning fundamental principles of food and drug law.
Under current law, it is up to the FDA to show that a food, food ingredient, or dietary supplement is adulterated and poses a risk to human health. The FDA is seeking to redefine the term “adulterated.” Please take the time to read and understand the substance of these issues – the future of health freedom in America depends on enough people understanding what is at stake. Within 1-2 weeks the House is likely to take up the same legislation that the Senate recently passed (S.1082). We must be ready to take action.
Basic Food Adulteration
It is rather easy to understand that a food or food ingredient that is contaminated by bacteria, parasites, fungal toxins, lead, or other chemicals may pose a risk to human health and therefore be adulterated. One example is the infectious E. coli that caused the recall of spinach last summer.
Industries constantly lobby the EPA and the FDA to ensure that various levels of chemicals, whether used as pesticides (like organophosphate nerve toxins) or found in the water (like perchlorate or PCBs) will be acceptable at certain levels in the food supply. Natural health advocates argue that not only are many of the government-sanctioned levels of toxins acutely detrimental to health, but the bio-accumulation of these poisons over the course of a lifetime is a primary cause of obesity, cancer, and heart disease.
Government regulatory agencies invariably side with the profits of industry, and when they don’t industry files ridiculous law suits that tie issues up in court forever – all at the expense of human health. More insidiously, the FDA even acts to promote adulteration of food to support the economic priorities of the White House and its industry friends, as is the case with genetically modified crops wherein a toxin is now in every single cell of the genetically altered food. It is FDA management’s opinion, whose employees are a revolving door with the industries they regulate, that such toxins in food are safe. The FDA shocked many people last fall when they approved an industry-favorable cocktail of live viruses be added to the food supply. Thus, the EPA and the FDA do a poor job of establishing criteria for and managing even obvious adulteration of food and food ingredients, a problem that has been part of FDA culture since its inception 100 years ago.
On an international basis, the FDA-supported Codex Alimentarius is seeking to set international standards for food adulteration so low, including the elimination of true organic standards, that many contaminants that are adverse to health (such as the level of mycotoxin allowed in food) will be sanctioned as legal for the purpose of international trade. While Codex is a United Nations group, the members concocting these international guidelines are typically responding to the wishes and financial interests of multi-national corporations.
Adulteration of Food Itself
Another aspect of adulteration is the food or dietary supplement ingredient itself, as different from some type of contamination. For example, certain mushrooms are poisonous in small amounts and are thus unsafe. In general, food and food ingredients are considered safe unless proven otherwise. Indeed, courts in the United States have recognized time and again that food and food ingredients are inherently safe. Under current law it is up to the FDA to prove that a specific ingredient poses a risk, based on a preponderance of evidence – not based on FDA opinion. This is much different than drug safety law, wherein the drug company must prove that the benefit of a drug, which is inherently toxic, outweighs the risk.
The recent Supreme Court case involves the herb Ephedra, wherein a high dose may have adverse cardiovascular side effects. However, there is no evidence that lower doses cause any harm at all. The herb has been in traditional use for several thousand years. The FDA has no proof that it poses any harm whatsoever in smaller amounts. By using drug-related risk/benefit analysis the FDA stated it had the authority to remove Ephedra at any dose – thus overturning basic fundamentals of food and drug law. As long as this case stands the FDA has the legal precedent to do this with any herb or vitamin it chooses.
The FDA’s next step is to make this type of risk analysis into actual law. The language in S1082 is cleverly worded so that food and food ingredients (and thus dietary supplements) are lumped into the same category as drugs for safety review purposes. The FDA is slyly seeking to change existing law so that if the FDA determines even a small risk in any dietary supplement ingredient it can brand the ingredient as unsafe, even if the commonly consumed dose poses no threat to safety at all.
Let’s take water as an example. We now know that too much water can kill athletes or those in military training when consumed at an amount greater than 1 ¼ gallons over a two hour period. Under the new wording in S1082, if the FDA, IN ITS OPINION, decided that the benefits of water were not adequate to warrant this risk, it could remove water from the market (even a sip of water). This is based on drug-related risk/benefit analysis. While it is unlikely FDA would ever try to remove water from the market, this same ludicrous logic can be applied to any dietary supplement ingredient – thus gutting the law known as DSHEA that gives Americans access to natural health options.
In recent days many Americans flooded the Senate with objections to this language and a proposed amendment to correct the problem, which Senator Enzi refused to place into the bill. Some progress was made in that Senators Hatch, Harkin, Kennedy, and Enzi went on record insisting that bill S1082 will not affect dietary supplements or alter DSHEA (Dietary Supplement Health and Education Act of 1994). However, the problematic language remains in the version of the legislation passed by the Senate. The battle now moves to the House. If this language becomes law the FDA will gain new regulatory power to remove dietary supplements based on highly-opinionated risk assessment (toxicology) criteria. It has long been a goal of the FDA to have dietary supplements regulated as drugs, against the wishes of the great majority of Americans.
The Critical Path Initiative and the Reagan-Udall Foundation for the FDA
The FDA would implement this draconian dietary supplement strategy using highly advanced technology being developed by the Critical Path Initiative. In order to fully understand the threat to dietary supplements it is necessary to understand this approach. The Critical Path Initiative is the FDA’s attempt to invigorate the sagging pharmaceutical industry. Its purpose is to modernize drug development and bring new drugs to the market with less cost and significantly less testing for safety or effectiveness. The Critical Path Initiative utilizes cutting edge science relating to genes (genomics), proteins (proteomics), and cells. The technology is on the one hand exciting, as well as unproven and very risky. The Critical Path Initiative is being driven by multiple forces (Wall Street, the next wave of drugs, and the dream of treating untreatable diseases). The FDA is gambling that the Critical Path Initiative is the future. FDA Commissioner Andrew von Eschenbach, M.D. has stated that this initiative is the top priority of the FDA for many years to come. The recently promoted second in command at the FDA, Janet Woodcock, has focused on the Critical Path Initiative from its inception several years ago.
From a practical standpoint of drug safety today, wherein several million Americans are injured each year requiring medical attention and over 100,000 Americans die from drug errors and side effects, the Critical Path Initiative is a pie-in-the-sky pipe dream. Proponents of it promise to solve these existing drug safety issues by turning the practice of medicine over to FDA computers.
The goal of the FDA is to use the Critical Path Initiative to radically change the drug approval and monitoring process from one based on extensive human clinical trials to one based on biomarkers. A biomarker is like a signpost. Some biomarkers indicate toxicity (risk assessment and analysis technology) and other biomarkers indicate a positive change in a cell or a defined clinical event (like tumor shrinkage). The FDA has undertaken a massive campaign, including the development of its own software, to analyze biomarkers and set up standards for drug development and disease treatment.
This means that the current safety and effectiveness testing based on rigorous clinical trials will be replaced. It also means that a physician’s clinical judgment will be of secondary importance compared to FDA supercomputers (doctors will soon be lining up to join the health freedom movement). Simply because a biomarker looks good in a computer does not mean that a positive change is being produced or will be produced in the individual – especially in the long term. The focus of drug development will shift to drugs that target biomarkers as compared to drugs that demonstrate they improve human health.
Many cellular proteins and protein-related pathways play both a positive and negative role in cell chemistry – depending on what the cell is trying to do. Thus, using risk assessment for biomarkers is incredibly complex and fraught with potential error – simply because we are still in our infancy of knowledge in terms of understanding how signaling pathways in cells work. The net result is that new and powerful biological drugs will come to the market faster with much less human testing for safety or effectiveness, and then the FDA will monitor the drugs as they are being used by patients and try to figure out if they are safe or not. Both Kennedy and Von Eschenbach make wild claims that this unproven technology will help drug safety, which at this time is nothing but unsubstantiated propaganda.
Under the Clinical Path Initiative patients entering the doctor’s office for the “best possible care” will instead receive the latest FDA/Big Pharma drug experiment with extremely expensive biotech drugs. As Von Eschenbach stated on May 1, 2007 patients should be happy about this because this new science will “explore the unique genetic and biologic features of individuals that will determine how he or she responds to treatment.” Translated to English that means your DNA will not only be profiled, it will be in a government-controlled supercomputer in order for you to receive medical care.
The purpose for creating the Reagan-Udall Foundation for the FDA in bill S1082 is to facilitate a collaboration between Big Pharma, Big Biotech, academic research, and the FDA to get the funding for and carry out the extensive research required to move the Critical Path Initiative forward. The foundation will be under the direction of the FDA and will hold patents and licenses relating to the drugs or devices that are developed. This concept is being patterned after a smaller Critical Path operation known as C-Path, wherein the FDA works with Big Pharma to develop drugs. FDA Commissioner Andrew von Eschenbach has been heavily and financially involved with Big Biotech companies for many years (leading the elder President Bush’s C-Change). It is no secret that the FDA is now headed by a biotech representative who has a top priority of bringing drugs to the market faster and a documented history of conflicts of interest. No person in the civilized world should be duped into thinking this means improved safety.
Von Eschenbach will argue that the cost and complexity of developing the next generation of drugs and standardizing the drug development is far too costly for any one drug company – which is true. This is the main reason Von Eschenbach took the top job at the FDA, to push the Big Biotech plan known as Critical Path (not because his passion or experience is in food or drug safety). One main problem with the Critical Path Initiative is that the FDA becomes a drug company with an important stake in the success of the drugs it approves and licensees for use. This creates major conflicts of interest in multiple ways, with true safety and effectiveness left as large question marks.
If this is what Americans want in the name of progress then that should have been what Senators openly debated and voted on. This could have lead to truly adequate safeguards being built into the law. Senators spent no time at all debating the Reagan-Udall Foundation for the FDA and its major safety and discrimination implications. Instead, this part of S1082 was rubberstamped. It is quite likely that 90% of the Senators do not understand what I have just explained. It doesn’t take a crystal ball to realize that Senators’ ignorance is likely to result in increased injuries and deaths and will eventually require the “Biomarker Fraud Act of 2012.”
Never Underestimate the FDA’s Desire to Attack Natural Health
A great concern is that language written into S1082 gives FDA new regulatory power that can be used to attack dietary supplements. The problematic language in S1082 occurs in Subtitle B – The Reagan-Udall Foundation for the Food and Drug Administration, as follows:
(b) Purpose of Foundation- The purpose of the Foundation is to advance the mission of the Food and Drug Administration to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.
(c) Duties of the Foundation- The Foundation shall--
Earlier versions of S1082 did not contain the food and food ingredient language, nor does the current companion bill sitting in the House (HR 1561) – although now that the Senate has passed S1082 it is likely that the House will take up the full Senate version and work from there. My point is that sneaking the words food and food ingredients into this legislation is a recent change.
`(1) taking 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 postapproval, of devices, including diagnostics, biologics, and drugs, and the safety of food, food ingredients, and cosmetics;
In January of 2007 the FDA issued a press release on the Critical Path Initiative. The FDA now wants to use the Critical Path risk assessment technology to help determine adulteration of food and food ingredients, such as identifying bacterial contamination (a valid use) AS WELL AS ASSESSING THE SAFETY OF FOOD AND FOOD INGREDIENTS (a use that can be used to frivolously attack dietary supplements with drug-based risk/benefit analysis). The FDA is trying to expand the role of the Critical Path Initiative from a new drug development initiative into new regulatory tools. The FDA states:
“The Critical Path Initiative is not limited to the sciences that support human medical product development. Scientific advances hold the potential to improve the tools FDA uses to evaluate the safety and efficacy of human and veterinary products as well as the safety and nutrition of food and food ingredients (e.g., new rapid tests for biological and chemical contamination of animal-derived foods, technologies for detecting and mitigating the microbial contamination of food, analysis technologies [i.e., drug based risk/benefit analysis] for assessing the safety and nutritive value of foods and food ingredients).”
Based on the recent additions of “food” and “food ingredients” to the S1082 legislation and this FDA document it can be seen that FDA wants to use the Critical Path Initiative technology to not only look for contamination of food (a good use) but also to evaluate safety of food and food ingredients. As I explained in the preceding sections, this technology is based on risk assessment and analysis (toxicology) using biomarkers and will fall heavily on FDA OPINION using drug-related risk/benefit analysis.
There are two very important questions: What biomarkers will be used? and, How will biomarkers be set up to determine the level that is toxic? Unfortunately, the answer to the second question is based primarily ON THE OPINIONS OF WHOEVER IS SETTING THE STANDARDS, which is in this case the FDA.
For example, let’s say you developed an invention to test the volume level of a stereo. In this analogy “volume” is a biomarker. You can plainly test for various volume levels, ranging from soft to loud. At what level is the volume a problem? Do we set the level based on shattering ear drums? What you think is nice? What a neighbor thinks is correct? In others words, the threshold for a “toxic” volume level is easily influenced by opinion or government policy – not science.
Now remember, biomarkers are changes in proteins at the cellular level. Food, food ingredients, and dietary supplements obviously change proteins at the cellular level and will thus change a wide variety of biomarkers. Dietary supplements are indeed powerful changers of biomarkers. In a normal and sane world, this ability to see what dietary supplements do would be used to help individuals prevent and treat disease. In the anti-competitive FDA police-force world this same technology will be used to get competition off the market. The FDA can set the “volume” knob for health-related biomarkers based primarily on opinion and say “we only allow soft music, everything else requires a prescription.”
Let’s take a specific example. NF KappaB is a protein that operates within a cell – in reality it is the brain of a cell that manages cellular stress. NF KappaB levels go up and down and do various things – all towards the goal of maintaining healthy cellular function. Many nutrients directly modulate NF kappaB, which is how they work to help a cell repair itself, reduce inflammation, and maintain normal healthy function. In almost every type of cancer, NF KappaB is hijacked and the cell’s natural defense system is taken over – like a terrorist attack. In this case, the volume knob on NF KappaB is now set in such a way that the music sounds like a loud blaring rock station and the excessive NF KappaB is the actual force driving the cancer process.
Drugs are designed to knock out this hyped-up NF KappaB signal, resulting in death to cancer cells. The problem is of course that most drugs are not specific only to cancer cells, and interruption of NF KappaB in healthy cells also results in healthy cell death. Surviving cancer treatment is often a race between killing enough cancer cells before killing too many healthy cells. Along comes green tea. Green tea polyphenols, like many nutrients, change NF KappaB. Mother Nature has empowered green tea with wisdom that no drug possesses. Green tea can tell the difference between a cancer cell and a healthy cell. Green tea will take its best crack at turning off excessive NF KappaB in a cancer cell and thereby help induce the cancer cell to die. Amazingly, green tea will not bother the NF KappaB in a healthy cell, other than to assist it in normal and healthy cell function. This does not mean that green tea is a cure for cancer or even a treatment for cancer – but it sure won’t hurt someone who takes it who has cancer.
It will be easy for the FDA to say, with the new powers proposed in S1082, that green tea is unsafe because it changes biomarkers related to cancer. The statement is factual. It is the OPINION of the FDA that the change is a problem. The language in S1082 gives the FDA the regulatory power to make that opinion stick, thus setting back natural options for health fifty years.
You may find it hard to believe that the FDA would follow this path when so many people are in need of natural and safe health options. Yet, the FDA is already working with Codex on an international basis to help establish risk analysis (toxicology) for dietary supplements. FDA scientists are heavily involved with the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU). In the upcoming meeting in Germany in Nov 2007 an FDA-supported plan will be presented in an effort to help establish the application of risk analysis to guide CCNFSDU to set “Safe Upper Limits” for dietary supplements. Safe Upper Limits, as currently viewed by Codex, are a public health scam; they are a politically correct strategy for branding dietary supplements as drugs based on drug-related risk analysis technology. The FDA and Codex goal is to remove therapeutically useful dietary supplements from the free market so they don’t compete with drugs. Another goal is to make all useful nutrients into prescriptions to give Big Pharma a total monopoly on all health options.
We must educate our legislators and get them to help us preserve our right to have free access to helpful dietary supplements.
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