Recall elected representatives who submit overly onerous, restrictive
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
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
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!
Rep Davis, Susan A. [CA-53] (introduced 6/30/2005)
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: