Declaration Of War
To Oppose HR 3156
Bill Sardi, President
Knowledge of Health, Inc.
Be it hereby declared that the citizenry of the United States is at war with its elected officials over free access to dietary supplements without interference by federal health agencies that now distribute misinformation regarding these products.
The threat is posed by HR 3156: Dietary Supplement Access & Awareness Act
Elected representatives Susan A. Davis (CALIF), John D. Dingell (MICH) and Henry A. Waxman (CALIF) have introduced legislation, now in committee, that would virtually destroy the dietary supplement industry.
The legislation is identified as the "Dietary Supplement Access & Awareness Act," but it does not address free access and only creates a negative awareness of these products.
Guilt by assumption
That these elected representatives would write legislation, without prior evidence that vitamin, mineral or herbal products pose a mortal or serious risk to humans, and requires the public and their physicians to report to federal health authorities within 15 days of the onset of any serious adverse reaction, assumes the industry is hiding product hazards that have escaped normal monitoring.
Dietary supplements relatively safe
For many years running the American Association of Poison Control Centers has reported the mortality and morbidity associated with dietary supplements to be relatively low, with no mortality associated with multivitamins for a period of more than 8 years running. Even though dietary supplements are safer than food (food borne infection strikes millions annually), safer than table salt, and safer than many over-the-counter remedies such as aspirin, these representatives have chosen to draft legislation that would mandate onerous reporting requirements that are unjustified.
Mandates scare tactics
HR 3156 would require that millions of dollars of public money be spent to educate the public to report alleged side effects to their physicians. HR 3156 will likely result in labeling that will say "Report any serious adverse reactions to your physician." Or imagine listening to the radio and a government sponsored ad says: "If you or a loved one experience a serious side effect such as a stroke, heart attack, or even death) that you believe may be related to a dietary supplement, please notify your physician." Such efforts to label products or educate the public in this manner only serves to create doubt in the public's mind over the relative safety of these products and assumes serious adverse reactions are a major but unreported problem.
Previous FDA Warning Eliminated One Dietary Supplement
Not long ago the Food & Drug Administration (FDA) issued just a similar warning, asking physicians to report adverse reactions associated with kava kava supplements, an anti-anxiety herbal product. The public was also warned to report any side effects and the FDA warning was published in newspapers and on TV news reports. Later, published studies cleared kava kava from any suspicion, but the damage had been done. The public backed away from kava supplements based upon the bulletin issued by the FDA, and today kava farmers in the South Pacific have plowed up their fields. A $25 million product was destroyed by FDA meddling. The same destruction will result from the passage of HR 3156.
Timing of Legislation Questioned
HR 3156 appears misdirected. It comes at a time when the side effects emanating from properly prescribed and ingested prescription drugs result in the needless death of more than 100,000 Americans annually. Where is legislation that would adequately protect the public from unsafe over-the-counter or prescription drugs?
FDA inaction over unsafe drugs has prompted search for safer alternatives
Furthermore, the public has become aware the FDA has approved drugs that have not undergone adequate safety testing, and permitted pharmaceutical companies to advertise these very same drugs on television, making unsubstantiated claims of their effectiveness and safety, which resulted in the demise of thousands of Americans. This has prompted millions of Americans to search for safer alternatives to unsafe drugs, namely dietary supplements, to allay symptoms posed by arthritis, headaches, menopause and other conditions.
Dietary supplements are concentrated foods, just as table salt is concentrated sodium. Will physicians be required to report strokes induced by patients who ingest excessive amounts of salt?
Guilt by association
Every physician who treats a patient that has had a stroke, heart attack, or experienced sudden death, will now be obligated to report any dietary supplements after an adverse event. This is guilt by association.
The Dietary Supplement Information Bureau reports that six in ten Americans (59 percent) report taking dietary supplements on a regular basis. Subsequent reports will read there is an association between mortal and near-mortal events and dietary supplements. But there is little if any evidence of cause and effect.
Imagine the government commissioned a study of hit-and-run auto-pedestrian accidents and found that 95% of children hit by cars were wearing tennis shoes. Would we then mistakenly conclude that the tennis shoes caused the accidents? Such non-scientific associations would likely be aired in news reports to frighten the public away from relatively safe products.
For example, this recently occurred when researchers at Harvard Medical School published a report showing more lutein in fatty tissues of people who have heart attacks. The researchers publicly suggested this was a concern that required more investigation. But lutein accumulates in fatty tissues to protect them from turning rancid, and individuals who
have more body fat will exhibit higher concentrations of lutein in these tissues. There is simply no evidence that lutein, provided in spinach and from marigold extracts in dietary supplements, causes heart attacks!
Would patients be in a position to report serious side effects?
Pray tell, how would a patient experiencing a serious side effect (death, stroke, cardiac arrest, etc.) be in a position to even ascertain their harmful health event was related to a dietary supplement? The average older American takes 2.4 prescription drugs in addition to dietary supplements. Why are the dietary supplements being fingered for reporting and not the more hazardous drugs?
Drugs and other agents would be unreported
For example, a patient taking aspirin therapy to prevent a heart attack, and steroids to treat arthritis, estrogen replacement therapy for menopause, along with vitamin E, and experiences a heart attack, would have to disclose to their doctor they were taking vitamin E pills. Aspirin, estrogen and steroids deplete the body of vitamin C which weakens blood vessels, induces their collapse, and can result in blockage of a coronary artery that produces a heart attack. But the vitamin E might be unfairly blamed for inducing this event. The patient may also be a smoker and/or alcohol drinker, which further depletes vitamin C and increases the risk for a heart attack. But only the vitamin E pills would be reported to the FDA!
No demonstration project
Virtually all patients and their physicians would be obligated under HR3156 to report to the FDA such adverse events, at a cost of millions of dollars, with no demonstration project that proves threats to public health would be eliminated or the public welfare improved.
Launch recall efforts today!
The dietary supplement industry and the public must launch an all out effort to recall elected representatives who submit overly onerous, restrictive legislation that assumes all dietary supplements are unsafe and which will likely frighten the public away from relatively safe alternatives to problematic prescription drugs.
Therefore, and without hesitation, American health freedom fighters have resolved to launch an all out recall effort against representatives Davis, Dingel and Waxman, to begin today! Furthermore, HR 3156 shall be vigorously opposed from every quarter in American society!
Sponsor: Rep Davis, Susan A. [CA-53] (introduced 6/30/2005)
Co-Sponsors: Rep Dingell, John D. [MI-15] - 6/30/2005
Rep Waxman, Henry A. [CA-30] - 6/30/2005
To find out the status of this bill go to:
To read the bill:
To contact your elected representative:
Knowledge of Health, Inc
457 West Allen Avenue #117
San Dimas, CA 91773



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