- 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
- 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
- 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
- Would patients be in a position to report serious side
- 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
- 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: http://thomas.loc.gov/cgi-bin/query/z?c109:H.R.3156.IH:
- To read the bill: http://www.ahpa.org/05_0630_HR3156.pdf
- To contact your elected representative: http://www.house.gov/writerep/
- Knowledge of Health, Inc
- 457 West Allen Avenue #117
- San Dimas, CA 91773