PRESS RELEASE
SENATE HAS PASSED S. 1082
Durbin Food Agency Idea Dropped and Meaningless Reimportation Added
May 10, 2007
On May 9th, the Senate finished debating and voting on the FDA Prescription Drug User Fee/Revitalization legislation, S.1082. On final passage, an extensive Manager's Amendment was debated, and included a number of previously offered but not voted on amendments.
When the Senate started its consideration of S.1082, Senator Dick Durbin wanted to amend this bill and add his Food Safety Bill, S.645, to this bill. Acting on Durbin's intentions, the NHF's lobbyist contacted Senators and their staff members on the Senate HELP committee to register our objections to allowing this to occur. Subsequent pressure on Durbin by Democratic and Republican members led to Durbin having to withdraw this attempt. In its place, Durbin had to settle for a substantially reduced scope of change. This prevented yet another attempt by Durbin to have the FDA regulate supplements more like it regulates over-the-counter and prescription drugs. This victory, by the way, had absolutely nothing to do with comments sent in to the FDA over its CAM Guidance document – a separate issue. Some organizations have falsely claimed that these comments were the swaying factor - they were not.
Under S.645, all of the FDA food-regulatory functions would be transferred to a new separate federal bureaucracy, the Food Safety Administration, except that dietary supplements would remain at the FDA. The underlying food relationship with supplements would be eliminated from the jurisdiction of the FDA. Under this scenario, without statutory authority to regulate supplements under the separate but related DSHEA provisions of the FD & C law, Congress would have no choice but to change the law and include supplements under a drug-like regulatory structure under the auspicious of a recreated FDA. Instead, the Durbin amendment, which passed the Senate by a vote of 94 for and 0 against, only makes changes to the non-dietary-supplement provisions related to foods. The Durbin amendment establishes an early warning and notification system for human food, as well as pet food, establishes fines for companies that do not promptly report contaminated products, seeks to improve inspections and monitoring of imports, and provides more uniform pet-food safety standards.
Allowing Americans the right to freely import FDA-approved drugs from Canada and 19 other foreign countries, S.242, is legislation introduced by Senator Dorgan that the NHF has supported and lobbied Congress on. It was added by voice vote (no roll call vote), but only after being amended by Senator Cochran with language requiring the FDA to certify the safety and effectiveness of reimported drugs. The Cochran amendment to the Dorgan reimportation amendment was approved by a vote of 49 for and 40 against. A vote against the Cochran amendment was a vote for reimportation. Eleven Senators did not vote. This is the third time a majority of Senators from both parties have voted both ways in a meaningless exercise to show support for reimportation.
The health-freedom community's efforts to have bill language amended on the creation of the Reagan-Udall Foundation and to drop the words "food and food ingredients" apparently were not successful. This matter may have been included in the Manager's Amendment, which passed by a vote of 93 for and 1 against. However, no specific amendment or references to this were made throughout Senate debate and votes on the bill. But, already included in the Manager's package is last year's ginseng labeling bill, S.854. This requires the country of origin labeling of raw ginseng agricultural products. It would cover the importation of raw ginseng used in the production of supplement products containing ginseng. It would not prevent importation, just require country of origin labeling.
The NHF position is that there would be intermediate and longer-term negative implications related to the future activities of this non-profit, external advisory board to the FDA. The Foundation is to be composed of members appointed by the National Academy of Sciences, with 12 representatives from across the spectrum of all of the products regulated by the FDA, including academics; but in NHF’s opinion will be dominated by interests adverse to health freedom. After 2008, the Foundation is required to submit annual reports to the FDA, and to the Congress, on recommendations it has for improving FDA drug, biologic, medical device, and human and pet food safety and post-market monitoring processes. Until legislation is enacted and signed into law, there appears to be no immediate threat to the FDA's current regulation of dietary supplements, for CAM providers, for small dietary supplement and nutritional food manufacturers and sellers, or for dietary supplement consumers. However, such things could and probably would change in coming years as the Foundation gains traction.
In the end, the Senate passed S.1082 by Unanimous Consent (no roll call vote). As we have always said, final Senate passage of S.1082 is not the end of the Congressional road. It is just the beginning. Identical legislation must pass the House; and, if not, a joint Senate and House Conference will have to occur before August. If and when a final compromise bill is re-passed by each chamber and signed by the President, the FDA must issue regulations on all of the provisions contained in the new law. This includes issuing draft regulations and taking public comments before implementing any and all changes in the new law.
The health-freedom community lobbying effort on S.1082 now moves to the House of Representatives. As such, all of the aforementioned matters are still in play. NHF members and other health-freedom advocates will continue to have the opportunity to alter this legislation, which is moving forward.
While health-freedom advocates may have been unsuccessful in stopping the creation of S.1082's non-profit drug safety Reagan-Udall Foundation, and unsuccessful in getting reimportation passed by the Senate, the community does have something positive that has come out of the NHF's attention and lobbying efforts to prevent Senator Durbin's back-door attempt, once again, to alter the status-quo FDA regulatory structure for dietary supplements and nutritional foods. As the oldest and best-respected health-freedom group on Capitol Hill, the NHF continues to be the credible source of objective assessment, and proactive actions on Congressional legislation and FDA matters that have meaningful impacts upon our freedom-of-health choices and access to dietary supplements and nutritional foods.
We shall continue our efforts against the House version of S.1082 as soon as it surfaces in the House of Representatives.
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About the National Health Federation
Established in 1955, the National Health Federation is a consumer-education, health-freedom organization working to protect individuals' rights to choose to consume healthy food, take supplements and use alternative therapies without government restrictions. With consumer members all over the world, and a Board of Governors and Advisory Board containing representatives from 6 different countries, the Federation is unique is being the only consumer health freedom organization in the world to enjoy official observer status with the Codex Alimentarius Commission.
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