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----- Original Message ----- From: Citizens for Health

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Sent: Tuesday, May 06, 2003 9:41 AM

Subject: Act today to support better health at a lower cost! Take action at www.citizens.org

URGENT ACTION ALERT!Act today to support better health and a lower cost. Visit Citizens for Health at www.citizens.org and take action now!

Your input is needed today to support better health at a lower cost:** Support efforts to require reporting of adverse events for dietary supplements, food additives and all drugs.** Oppose legislation that restricts health choices and increases the costs of health care.

New legislation promises to protect consumers, but the details reveal plans to: 1) increase health care costs and decrease consumer choices; 2) single out dietary supplements and hold them to a higher standard of scrutiny than many over-the-counter medications and food additives, even though supplements have proven to be safer; and 3) provide unnecessary additional regulatory authority to the FDA, fueling the healthcare cost crisis and fundamentally altering the Dietary Supplement Health & Education Act (DSHEA), the regulatory framework demanded by millions of consumers in 1994 and responsible for bringing dietary supplements to a wide market and providing consumers with the information and products for better health at a lower cost.

Support Full and Fair Information ReportsSB722 mandates dietary supplement manufacturers to report serious adverse event reports (SAER) to the FDA. This is not required for many over-the-counter drugs or for food additives, categories with a track record of serious side effects in at risk consumers for ex ceding those of nutritional supplements. Information obtained by the government can only be useful if collected for all regulated substances in ways that allow for comparing apples to apples. Singling out supplements and using different information sources to make critical decisions is not the best approach to managing public health, but may be part of an overall plan to limit consumers access to these beneficial products.

Tell Congress that you support reporting of serious adverse event reports across the board for all regulated products. And stress that the same standards for information collection and disclosure of all products are critical for accurate analysis and sound decisions.

And most importantly, tell Congress that the FDA does not require additional legislation to mandate reporting of adverse event reports. FDA has ample legal authority to require adverse event reporting under existing law, and we encourage them to fully implement the law.

Promote low-cost health care alternativesSB722 potentially subjects all vitamins, minerals, herbs and other supplements to an intense level of scrutiny unwarranted by the safe track record supplements have. The bill calls for unprecedented and costly clinical evaluation of all products classified as "stimulants"-defined as "any ingredient that…increases metabolism, increases heart rate, causes the body to release adrenaline or constricts blood vessels." These requirements are unnecessary, prohibitively costly and reduce consumer access to safe and beneficial products by unnecessarily expanding FDA’s authority.

What is especially troubling is that any change in FDA's legislative authority would fundamentally undermine the Dietary Supplement Health and Education Act (DSHEA), which is the law under which supplements are regulated, and applies to all vitamins, minerals, herbs and supplements. The end result could be a significant loss of choice in your own health care decisions by hindering access to and increasing the cost of supplements. Given the FDA’s slow implementation of the existing law, any change in the law can only add confusion and further delays on weeding out the few bad players, giving consumers less protection rather than more.

Millions of consumers, possibly you among them, contacted Congress in 1993/94 urging support for the regulatory framework, the Dietary Supplement Health & Education Act (DSHEA) in order to provide important health information and products to consumers and to ensure the safety of these products. The unanimous passage of the law reflected the overwhelming number of constituents - citizens like you -- demanding access to nutritional supplements. As a result, Congress unanimously passed DSHEA, which is a good law and gives the FDA all the power it needs to ensure safe and effective products when enforced, including the power to require reporting of adverse event reporting.

Today, strong, mainstream research is emerging to support the important positive impact diet and supplements are having on maintaining and improving health outcomes. There is overwhelming evidence to support better health at a lower cost through supplements and other low-tech approaches.

The nation is facing an unprecedented health care crisis. At a time when over 100,000 Americans die per year from FDA approved drug products used as directed, more than 1 out of 4 Americans are suffering from FDA approved drug-side effects, and the costs of today’s high-tech health care is devouring the nation’s resources…our decision makers should be embracing rather than debunking the use of dietary supplement products that have hundreds of years of safe and effective use and cost substantially less than their pharmaceutical alternatives.

It is imperative that consumers -every person concerned about access to a wide variety of safe, cost effective and beneficial health care solutions-contact their Senators and Representatives today. Reaffirm your support for better health at a lower cost. Send a strong message to Congress to pursue, not denigrate natural, safe and cost-effective health care approaches.

Send your letter directly by visiting www.citizens.org.

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