CONTACT YOUR CONGRESSMAN
Dear Health Enthusiast:
Health Freedom Advocates OPPOSE S1082/H1561 Subtitle B: Reagan-Udall Foundation S1082/H.R. 1561 sets up a non-profit corporation called the Reagan-Udall Foundation that would give the FDA a new and expanded role to be part of a Foundation with the purpose of implementing goals of the FDA in the area of new drug development. This means that the same organization that will be developing drug evaluation technology is also enmeshed in the agency that regulates the drug approval process, thus creating a situation that could potentially reduce the safety of the drugs and products made available to the public.
In addition to being focused on drug assessment technology development, the Senate added language to the bill which jeopardizes health freedom. The Senate version now includes foods, safety. The inclusion of food safety amendments, and the inclusion in the original bill of foods and dietary supplement assessment in the purpose of this non-profit is completely unacceptable to freedom advocates because it could mean down the road that foods, dietary ingredients and dietary supplements would be at risk for being treated like drugs when evaluated by the FDA with their new tools. Foods and dietary supplements in the U.S. are not currently regulated as drugs, but are regulated as foods under DSHEA. Foods and dietary supplements are considered nutrients generally regarded as safe and the evaluation of their safety is based on whether they cause a significant risk of harm as opposed to being evaluated under the toxic drug risk/benefit assessment. Because of this assumption of safety, with the burden of proof on the government to show harm rather than risk/benefit, we have a wide variety of foods and supplements in the marketplace.
If foods and dietary supplements were ever to be evaluated as drugs with technology developed for drugs, instead of as natural nutrients with complex natural processes, we run the risk of natural products being incorrectly assessed as harmful and taken off the market, and losing access to many wonderful foods and nutrients that we currently use.
Foods and dietary supplements should continue to be treated as food (DSHEA) and evaluated under food standards and technology instead of with toxic drug risk/benefit assessment tools. To accomplish this, an amendment must be added to the current bill.
The following amendments are being recommended:
Proposed amendment to S 1082 and HR 1561:
The bills are hereby amended to prohibit the Foundation or Institute from evaluating the health benefit or efficacy of foods, dietary ingredients, and dietary supplements and to limit review of foods, dietary ingredients and dietary supplements to a determination of whether they are safe. In assessing whether dietary ingredients and dietary supplements are safe, the Foundation or Institute shall not compare product risks with health benefits or efficacy. Instead, the Foundation or Institute shall determine whether the product presents a significant risk of illness or injury under conditions of use recommended or suggested in labeling, or if no conditions of use are recommended or suggested in labeling, under ordinary conditions of use.
This bill passed the Senate and is now in the House. We need as many people as possible to email, write or call your legislators to demand that the above amendment be added.
Diane M. Miller J.D.
Director of Law and Public Policy
National Health Freedom Action
PMB 218, 2136 Ford Parkway
St. Paul, MN 55116-1863
Phone: 651-690-0732
http://www.nationalhealthfreedom.org"target=blank
Health Freedom Advocates OPPOSE S1082/H1561 Subtitle B: Reagan-Udall Foundation S1082/H.R. 1561 sets up a non-profit corporation called the Reagan-Udall Foundation that would give the FDA a new and expanded role to be part of a Foundation with the purpose of implementing goals of the FDA in the area of new drug development. This means that the same organization that will be developing drug evaluation technology is also enmeshed in the agency that regulates the drug approval process, thus creating a situation that could potentially reduce the safety of the drugs and products made available to the public.
In addition to being focused on drug assessment technology development, the Senate added language to the bill which jeopardizes health freedom. The Senate version now includes foods, safety. The inclusion of food safety amendments, and the inclusion in the original bill of foods and dietary supplement assessment in the purpose of this non-profit is completely unacceptable to freedom advocates because it could mean down the road that foods, dietary ingredients and dietary supplements would be at risk for being treated like drugs when evaluated by the FDA with their new tools. Foods and dietary supplements in the U.S. are not currently regulated as drugs, but are regulated as foods under DSHEA. Foods and dietary supplements are considered nutrients generally regarded as safe and the evaluation of their safety is based on whether they cause a significant risk of harm as opposed to being evaluated under the toxic drug risk/benefit assessment. Because of this assumption of safety, with the burden of proof on the government to show harm rather than risk/benefit, we have a wide variety of foods and supplements in the marketplace.
If foods and dietary supplements were ever to be evaluated as drugs with technology developed for drugs, instead of as natural nutrients with complex natural processes, we run the risk of natural products being incorrectly assessed as harmful and taken off the market, and losing access to many wonderful foods and nutrients that we currently use.
Foods and dietary supplements should continue to be treated as food (DSHEA) and evaluated under food standards and technology instead of with toxic drug risk/benefit assessment tools. To accomplish this, an amendment must be added to the current bill.
The following amendments are being recommended:
Proposed amendment to S 1082 and HR 1561:
The bills are hereby amended to prohibit the Foundation or Institute from evaluating the health benefit or efficacy of foods, dietary ingredients, and dietary supplements and to limit review of foods, dietary ingredients and dietary supplements to a determination of whether they are safe. In assessing whether dietary ingredients and dietary supplements are safe, the Foundation or Institute shall not compare product risks with health benefits or efficacy. Instead, the Foundation or Institute shall determine whether the product presents a significant risk of illness or injury under conditions of use recommended or suggested in labeling, or if no conditions of use are recommended or suggested in labeling, under ordinary conditions of use.
This bill passed the Senate and is now in the House. We need as many people as possible to email, write or call your legislators to demand that the above amendment be added.
Diane M. Miller J.D.
Director of Law and Public Policy
National Health Freedom Action
PMB 218, 2136 Ford Parkway
St. Paul, MN 55116-1863
Phone: 651-690-0732
http://www.nationalhealthfreedom.org"target=blank
posted by Karen Herrmann-DeSantis, Herb Specialist, Natural Health Educator | 7:25 AM
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