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FDA Celebrates Hundred Years of Pretense












By Byron J. Richards, CCN

July 7, 2006

The FDA has conveniently used the excuse of looking out for consumer safety to increase their perverse regulatory power, undermine free speech, disrupt commerce, and generally get in the way of helping people improve their health. The �half-truth� of the safety issue is used as a ploy to reduce the rights of Americans, one freedom at a time. Once again, the FDA is seeking more police power to intimidate supplement companies. This is one step in an overall FDA master plan to eliminate therapeutic nutritional supplements from the free market. Those who lose are the American public.

The newest piece of supplement-harassing legislation is the brainchild of vitamin-hating Senator Richard Durbin (D-IL), perennial attacker of the supplement industry. S 3546, Dietary Supplement and Nonprescription Drug Consumer Protection Act, is known as Adverse Event Reporting (AER) legislation. It was introduced in the Senate on June 21, 2006, by Senator Orin Hatch (R-UT), former supporter of the supplement industry now turned gutless compromiser. It is backed by large supplement industry spin groups like the Council for Responsible Nutrition (CRN) and the National Nutritional Foods Association (NNFA). CRN and NNFA have been infiltrated by Big Pharma and march to the drum of globalization and the New World Order. Like Hatch, these groups have placed themselves in a position of speaking for the supplement industry. Unfortunately, they are rapidly taking on the colors of the enemy.

The PR spin suggesting a �need� for this legislation is to protect consumers and give consumers confidence in the supplement industry. The only reason for any lack of consumer confidence is due to a relentless and fraudulent persecution of supplements by the controlled media acting on behalf of the sickness industry. It is an attempt to divert public attention from the real safety issue of dangerous drugs that kill several thousand Americans per week. Big Pharma is terrified that the American public will flock to natural health options instead of options that have death as a side effect.

Under the proposed legislation supplement manufacturers and distributors would be required to report to the FDA serious adverse reactions such as death or inpatient hospitalization. Such requirements seem plausible to any person with common sense; however, it is already a simple matter to file an adverse event report for any drug, medical device, or dietary supplement. The FDA�s MedWatch program offers a toll free number. Forms for filing complaints are readily available on their website. Furthermore, supplements are so safe such reactions are very infrequent. Why is legislation needed for a nonexistent problem?

The way the legislation is written a person could blame vitamins for almost anything, even if they are on multiple drugs or have pre-existing serious health problems. While the legislation states that the need to file a serious adverse event report is not an admission of guilt, some feel it will lead to frivolous law suits.

If AER legislation becomes law, the FDA will need to issue regulations. It is easy to predict that:

1. The FDA will charge supplement companies user fees for AER functions (as they currently do with drug companies).
2. The FDA will use supplements as a scapegoat for adverse effects that are caused by drugs.
3. Agreeing to such legislation implies there is an actual need for it. This shifts the burden of proof from government to supplement companies, undermining free commerce, citizen�s rights, and existing legislation that protects consumer access to health options (DSHEA).
4. The legislation will be a springboard for future FDA efforts to regulate supplements as prescription drugs and implement draconian Codex supplement guidelines, plunging alternative health for Americans into the Dark Ages.

If all that isn�t bad enough, tucked into the legislation is a requirement for supplement companies to keep records of any adverse event reported to them for the past six years. The bill says, �The term adverse event means any health-related event associated with the use of a dietary supplement that is adverse.� This is far different than a serious adverse event. In another words, any symptom a person associates with taking a vitamin that in their opinion is improper will need to be recorded as an adverse event. Such reports need to be open for FDA inspection at any time. This legislation is nothing more than an FDA harassment vehicle.

As the owner of a nutritional company, Wellness Resources, and a clinician with twenty years of experience working with supplements, I can tell you that such a requirement is absolutely absurd.

The number of variables associated with the possible cause of a symptom is staggering: the pre-existing health and fitness of the individual, current medications, changes in weather, emotional stress, junk food consumption, food poisoning, a lack of sleep � the list is almost endless. It is drugs that kill at least 100,000 Americans per year and send 1.6 million people to the hospital with true adverse reactions. Drugs are poisons that require physician dispensing and monitoring. Rarely do supplements cause any type of significant adverse reaction. There is a huge difference. Due to stringent production standards, supplements are far safer than food!

Take the simple fact that half of Americans have digestive problems. The overuse of antibiotics and sugar-laden diets make us the world leaders in gas, bloating, indigestion, and constipation. No country in the world can beat us in antacid and laxative use.

One example is the common problem of Candida albicans (a digestive yeast infection) occurring after antibiotic use, especially recurring antibiotic use. This issue is at epidemic levels in America, a problem caused by incompetent medical care. It can ruin lives, sending people down a path of chronic problems with digestion, sinuses, allergies, thyroid function, autoimmune problems, depression, and fatigue. In small children it can easily cause a life of asthma or lead to serious learning, developmental, immunological, or mental disorders.

Since doctors appear virtually incapable of recognizing the problem or helping a person recover, and they typically create the problem in the first place, patients frequently turn to alternative health. Thankfully for many, the proper use of vitamins and diet can restore health and prevent what may otherwise be a lifetime of misery.

Under current FDA repression of free speech, we aren�t supposed to tell someone what their problem is or how supplements can help them. Those with MDiety syndrome deny the problem even exists! People with Candida frequently have various symptoms that come and go and could easily be considered adverse, both because of the problem itself and due to the process of normal recovery (which can be likened to pulling weeds out of a lawn, wherein the lawn is the digestive tract).

Under the proposed legislation, if a person gets nauseous or a headache after taking a supplement (which is referred to as �die off� and a relatively common occurrence), and complains about it, we would have to record it as an adverse event. Soon, the supplements that truly help people would be gone. Of course, individuals with Candida get headaches and nausea from eating sugar, consuming artificial sweeteners, or drinking alcohol. In this case, these substances are actually making them worse. Shouldn�t the entire food industry have to keep track of �adverse� events?

As a supplement company I will incur costs trying to explain to people what their symptoms mean so as to prevent having to file an adverse event report, keeping track of symptoms in a six year file, and defending myself from FDA harassment. The burden of proof for the safety of supplement products will shift from the government to the supplement companies, counter to existing law. Needless cost will be passed on to the consumer. Much worse, truly helpful supplements will be targeted for removal from the market so as to eliminate competition for drugs (the true FDA intent).

Sooner or later I will be asking myself, why should I bother trying to help anybody? And that is exactly what the FDA would like me to think. The FDA does not want useful supplements as a health option for the American public. Candida albicans is one of many similar issues, like fibromyalgia, depressed immunity, and chronic fatigue. Tens of millions of Americans are suffering at the hands of the inept medical care of the sickness industry. In many cases, high quality nutrition offers a true option for a return to health.

The pharmaceutical companies that make garbage synthetic vitamins and seek to mass-market their junk to the American public have nothing to worry about. Their products are so useless they don�t produce a health effect of any kind. It is only the companies that are truly helping people that will be harassed. Many of the large pharmaceutical-linked companies that comprise CRN and NNFA want this legislation. Its costs will place all the small and innovative nutritional companies at a serious disadvantage.

The FDA is actively engaged in a series of steps to take away useful nutrition as a health option for Americans. All the FDA plans to leave on the market is watered-down trash. The useful supplements will become prescription items of Big Pharma. I fully explain and document this FDA plan in Fight for Your Health. [Read "Fight For Your Health"]

Adverse event reporting is addressing a non-existent problem. It is seeking to shift the legal burned of proof to supplement companies. It is targeted to harass small and truly helpful nutritional companies. It plays on the false need for improved safety as the excuse to gain further regulatory control of the supplement industry. It is a ploy by the FDA and various bought-off members of Congress to further harass supplement companies, setting the stage for Codex implementation and overturning U.S. law that gives consumers access to a wide variety of supplements.

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The FDA has a one-hundred year history of promoting and protecting drug sales, while stamping out competition. Congress should make the FDA do its real job, that of protecting the American public from the dangerous use of drugs and cleaning up the massive adulteration of our food supply. Congress should quit behaving like a pawn in the FDA/Big Pharma game. The FDA is the group in need of a total makeover. Senator Durbin is in need of retirement (2008 if we are lucky). Senator Hatch needs to look in a mirror and find his soul. Our government needs to quit attacking the good guys and impeding safe and effective health options for Americans.

Call your Senators today (202-225-3121). Tell them no on S-3546.

� 2006 Byron J. Richards - All Rights Reserved

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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, educator, and author.

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. " Author of Mastering Leptin and Fight for Your Health. Richards is now joining forces with health freedom leaders in the U.S. and throughout the world. " Independent journalist and health blogger. "

As founder of Wellness Resources, Inc. of Minneapolis, MN (since 1985), he has personally developed 75 unique pharmaceutical-grade nutritional formulas. "Charter Member of the International and American Associations of Clinical Nutritionists (IAACN) (since 1991)" Intriguing Health Speaker - Richards has presented hundreds of educational classes to health professionals and individuals who want to take charge of their health!












The FDA is actively engaged in a series of steps to take away useful nutrition as a health option for Americans. All the FDA plans to leave on the market is watered-down trash. The useful supplements will become prescription items of Big Pharma.