ACTION TO TAKE
Please contact your Senators and Representatives, by phone. fax, or e-mail, expressing your strong opposition to the Durbin bill S1310, which could potentially severely limiting the availability of nutritional supplements. Public outcry has stopped many intrusions onto the supplement industry in the past, and we can do it again, but it takes pressure, and effort, and energy.
In addition, please notify your elected representatives of your opposition to draconian new regulations proposed last week by the FDA, which if enforced to the letter could, along with the Durbin legislation, significantly restrict supplement availability.
You can reach your Senators at http://senate.gov/ and your Representatives at http://www.house.gov/
In your contacts with your elected officials, express your opposition to the Durbin bill and the new proposed FDA regulations. You can also reach the FDA at http://www.fda.gov/
-- FDA already has sufficient power to regulate supplements, their labeling, as well as food additives and to remove harmful supplements from the marketplace.
-- The FDA has a long history of antagonism toward any form of alternative medicine and the over-the-counter sale of supplements and for decades has sought to restrict severely their availability.
-- The FDA has a long history of working hand-in-hand with the drug industry to restrict supplements in favor of prescription drugs
-- Properly designed and properly utilized supplements - such as vitamin D - have been proven repeatedly to offer enormous benefit in terms of general health and protection against diseases such as cancer.
-- Responsible alternative practitioners require a variety of nutritional supplement to provide their treatments, and the removal of these products will effectively eliminate such practices, to the detriment of thousands and thousands of Americans who want and depend on these legitimate approaches.
-- The Durbin bill and the proposed FDA regulations could force all Americans to accept the drug model of medicine for treatment of their health issues, a model which many of us rightfully and appropriately reject
-- Many people need the supplements that could be taken off the market should FDA have expanded regulatory powers.
-- No one wants dangerous products in the marketplace, but the safety record of dietary supplements compared to FDA-regulated drugs is very high.
Over the years we have all witnessed many serious threats to supplements proposed by members of Congress and the FDA, always presented in the guise of consumer protection. Invariably the proposed legislation or regulations have been onerous, repressive, and apparently intended to eliminate or seriously curtail the availability of most nutritional products. These intrusions seem designed to force the US into a European style situation where nutritionals are either forbidden (as in Norway) or become prescription items, and as a result, to the benefit of pharmaceutical companies, their drugs become the primary option. In the past, we here in the US have been able to mobilize to stop such prosposals, such as the ill-conceived McCain bill of a year ago. But once again, the anti-nutrition forces have organized and mobilized, in ways more threatening than ever before.
The first threat is Senator Durbins Senate bill S1310, the "Dietary Supplement Labeling Act," ostensibly prompted because of a recent episode of melatonin tainted brownies. Senator Durbin has long been an aggressive, vocal opponent of supplements and their availability as over the counter products. He has supported a strong FDA as well as the pharmaceutical industry. In any event, this bill would give the FDA a new set of powers that could easily be used to badger honorable, honest supplement manufacturers providing legitimate and useful products. The FDA needs no new authority in terms of labeling, because it already has enormous power to regulate additives to food, and remove harmful or dangerous supplements from the marketplace. Furthermore, the FDA has already mandated very stringent "Good Manufacturing Practice" regulations that promote standards and require manufacturers of nutritional supplements to provide the highest quality, legitimate products to consumers. This new legislation appears to be part of a concerted effort to add a new intrusive set of regulations that could eliminate legitimate health-promoting nutritionals.
Senator Durbin presented his legislation on the Friday before the July 4th weekend, presumably hoping that no one would notice. But the Alliance for Natural Health learned of the bill almost as soon as it was available, and sent out a much needed warning to begin mobilizing against it.
About the same time Senator Durbin proposed his legislation, the FDA itself announced its plans to enforce an entire new set of rules on supplement manufacturers that are so onerous, we doubt few if any companies could remain in business. In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA), which in once sense did protect nutritional supplements available at the time and their suppliers from FDA over-regulation and overt FDA harassment. However, the bill also gave the FDA enormous power over any new supplements that might be developed after 1994, with the authority to require the expensive, and time consuming process normally reserved for synthetic pharmaceuticals before these new supplements could be approved and made available to consumers. Basically, if implemented, supplements would remain stuck in 1994, with manufacturers unable to provide new products in response to ongoing research in the field.
Furthermore, by enforcing this provision in DSHEA, the FDA could require supplements available prior to 1994 that have undergone any change whatsoever to undergo re-assessment, with the possibility that these products might be removed from the market until the lengthy review was completed. Apparently, even if the particle size of a supplement has changed since 1994, the manufacturer would be required to petition the FDA for approval of the product. Experts we have consulted who have read the new, complicated regulations feel that, in their opinion, any supplement manufacturer might be at risk and few could financially survive should the FDA enforce to the letter the regulations that it presented last week.
Nutritional supplements, because of the concern and integrity of the great majority of manufacturers, are extraordinarily safe and the FDA knows this. Currently, all supplements in the US must be manufactured in compliance with the strict FDA Good Manufacturing Practices. The FDA already has the power it needs to "protect" the consumer. These regulations are unnecessarily onerous and unreasonable.
FOR FURTHER INFORMATION
For further information about the Durbin bill and the new FDA regulations we suggest you consult the following website: http://www.anh-usa.org/
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