The Assault on Dietary Supplements
Elected representatives Susan A. Davis (CALIF), John D. Dingell (MICH) and Henry A. Waxman (CALIF) have introduced legislation [HR 3156] before the House of Representatives, 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.
Previous FDA Warning Eliminated One Dietary Supplement
Here is why HR 3156 poses such a threat to the availability of dietary supplements. 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 could result from the passage of HR 3156.
Guilt by assumption
This legislation was written without adequate prior evidence that vitamin, mineral or herbal products pose a mortal or serious risk to humans. HR 3156 requires the public and their physicians to report to federal health authorities within 15 days of the onset of any serious adverse reaction. This legislation assumes the industry is hiding product hazards that have escaped normal monitoring.
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 association 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 with 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!
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, onerous reporting requirements would be mandated by HR 3156. The dietary supplement industry has nothing to hide. These reporting requirements 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.
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? Relatively troublesome drugs like Vioxx and Bextra have been returned to pharmacy shelves with black box warnings that put the burden on consumers to check for potential side effects.
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?
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.
* 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 * Find out the status of this bill. * Read the bill. * Contact your elected representative.
by Bill Sardi