THE FDA IS MARCHING
By Byron J. Richards, CCN
October 16, 2007
The United States Health Freedom Assembly met October 12 � 14, 2007 at the William Mitchell College of Law in Saint Paul, MN, a gathering of many of the top state, federal, and international health freedom advocates, organizations, and industry. The meeting took on a tone of extreme importance as the FDA has issued policy and obtained broad new regulatory authority over health freedom in the past 12 months.
The FDA is seeking to undermine the law known as DSHEA (Dietary Supplement Health and Education Act of 1994), the cornerstone of health freedom in America. Emboldened by its new powers the FDA is now poised to trample the first amendment rights of companies and Americans who seek to explain or understand how nutrition can support health. The FDA campaign has begun.
Just as the Health Freedom Assembly got under way the FDA announced its latest assault on a dietary supplement company that sought to explain how an herbal product, backed by considerable science and many years of traditional medical use, could be of help to diabetics. At the request of the FDA, U.S. Marshals seized approximately $71,000 of goods from FulLife Natural Options, Inc., of Boca Raton, Fla., which marketed and distributed Charantea Ampalaya Capsules and Charantea Ampalaya Tea. The case highlights interference of the FDA in the dissemination of scientific information that supports natural health options, a clear violation of the first amendment � as well as the absurd use of federal police power against a well-meaning U.S. company.
The double standard is obvious. On September 27, 2007 President Bush signed the FDA Reauthorization Bill into law, ushering in sweeping changes at the FDA that now allow massive conflicts of interest, permitting the FDA to act as a pseudo drug company. During debate on this bill Congressional leaders had seriously considered a ban or severe restriction on direct to consumer drug ads, as most often the adverse side effects of drugs are seldom understood when a drug is first approved (like Vioxx). However, the media came to the defense of Big Pharma fearing they would lose billions in ad revenue. Media lawyers and lobbyists successfully lobbied Congress to block any significant restrictions on direct to consumer ads, arguing that such restrictions would violate the first amendment rights of Big Pharma!
We now have a bizarre situation in this country that is considered �law.� Under first amendment protection Big Pharma can actively promote extremely dangerous drugs in glitzy ads in order to turn a new drug into a blockbuster � even though the risks are unknown and often include death. That�s right, deaths from drugs have doubled in the last five years mostly due to new drugs and FDA incompetence in tracking these drugs. On the other hand, dietary supplement companies cannot promote safe alternatives to these dangerous drugs even when backed by legitimate science, violating the first amendment rights of dietary supplement companies and consumers.
Drug company executives, often hiding known risks, are never personally held accountable (someone should file involuntary manslaughter charges). Dietary supplement company executives have their businesses shut down for trying to help people safely improve their health. Legislation proposed by presidential candidate Ron Paul, known as the Health Freedom Protection Act, would rectify this matter. However, without broad consumer support it continues to languish in committee, as Big Pharma interests are trying to prevent it from ever seeing the light of day.
The Health Freedom community also faces new challenges from CODEX (meeting next month regarding dietary supplements), the illegal collusion of the FDA with Mexico and Canada known as the Trilateral Cooperation Charter, the failure of the Supreme Court to hear the ephedra case (meaning the FDA has legal precedent to treat dietary supplements as drugs), the creation of the Reagan-Udall Foundation for the FDA (a law enabling the FDA to predict possible �danger� based on its opinion and remove any dietary supplement it wants), and needlessly cumbersome Adverse Event Reporting legislation and manufacturing guidelines (which the FDA states will drive up the cost of supplements and run small businesses out of business.)
Central to these FDA efforts is increased power of the federal government, especially the delegation of power to unelected bureaucrats who are then able to trample the rights of American citizens and companies. A key FDA theme is to treat dietary supplements as drugs � giving the FDA the power to remove anything it wants from the market as it desires. The FDA campaign is based on spreading fear under the false pretense of protecting the consumer � while at the same time allowing dangerous drugs to seriously injure millions and kill a hundred thousand citizens each year. The FDA threat to your health and your health freedom is very real.
Meeting against this backdrop of tyranny leaders in the Health Freedom community unanimously adopted three key resolutions to strengthen American sovereignty, current American law, and prevent the FDA from abusing its power:
The First Resolution
Citizens Supporting the Sovereignty of American Law
We support the sovereignty of American Law, and the right of the American people to govern themselves through elected representative government; rather than having American agencies and courts following the rulings, standards, and guidelines of international institutions or foreign governments.
Among other things, the sovereignty of American Law is in jeopardy in the following ways with respect to threats to Health Freedom:
BE IT THEREFORE RESOLVED that U.S. executive and independent agencies shall not bypass the U.S. Congress by adopting or enacting into domestic law those regulations, guidelines, and standards from international institutions or foreign governments.
The Second Resolution
We oppose any law or any interpretation of law that will determine the safety of food and/or dietary supplements based on drug-related, risk-benefit analysis models.
The Third Resolution
With the exception of industrial chemicals added to the food or drug supply, the burden of proof of safety or the lack thereof for any product regulated by the FDA should rest with the FDA.
Americans Take Note
The Health Freedom community has put the FDA on notice. The FDA is not your friend or operating in your best interests. It is a police force bully used to stamp out competition to Big Pharma, who now pays the FDA hundreds of millions of dollars a year in �approval fees.� It will be up to the American people to defend the sovereignty of their country, their first amendment rights, their right to choose how to take care of themselves, and their right to have access to a wide range of natural products and healing modalities. Nobody can do it for you. Together we can win.
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Byron J. Richards, Founder/Director of Wellness Resources, is a Board-Certified Clinical Nutritionist and nationally-renowned health expert, radio personality, and educator. He is the author of Mastering Leptin, The Leptin Diet, and Fight for Your Health: Exposing the FDA's Betrayal of America.
Richards encourages individuals to take charge of their health, stand up for their health rights, and not blindly succumb to propaganda from the vested-interests who profit from keeping Americans sick. As founder of Wellness Resources, Inc. of Minneapolis, MN, an independently-owned fine-quality dietary supplement company since 1985, he has personally developed 75 unique nutraceutical-grade nutritional formulas. www.wellnessresources.com
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The New York Times outlines several horror stories of individuals stuck in an unscrupulous system, as well as the near total lack of FDA oversight.