PRESS RELEASE
NHF MISSION: STOP FDA FROM
TREATING SUPPLEMENTS LIKE DRUGS
By the National Health Federation
September 7, 2007
Much has been made about the threat posed by the food-safety provisions contained in the FDA Revitalization legislation now pending before Congress (S.1082 and H.R.2900) and the yet-to-be-finalized decisions on this legislation. House and Senate Conferees will be appointed when Congress returns from its August recess in the next few days.
These threats circulating in the community were also long ago recognized by the National Health Federation (NHF), which is following up on its previously successful lobbying efforts to get a pro-supplement colloquy on the floor of the U.S. Senate about this legislation. While some – who, interestingly enough, previously denigrated the colloquy – are now claiming sole credit for it through their letter-writing campaign, they forget that without the NHF’s lobbying connection to actually get Harkin and Hatch to do the colloquy and “close the loop,” the letter-writing campaign, which was directed to another goal anyway, would not have been successful.
Now, the NHF is using the FDA Revitalization legislation as an opportunity to prevent future Food and Drug Administration actions that really could go against the core of our health-freedom beliefs. In this case, it means putting controls on how an otherwise-unaccountable FDA, conducts any future actions to ban supplements based on its own illegitimate bureaucratic misinterpretation of the DSHEA law.
The Ephedra-Ban Problem
Earlier this year, the United States Supreme Court denied the Writ of Certiorari sought by a plaintiff company, in the case of Nutraceutical Corp vs. Eschenbach. Thus, the 2004 FDA action (banning the sale of supplements containing ephedrine alkaloids at all dosage levels as adulterated foods, and FDA’s application of a post-market, drug-based risk standard for determining the safety of supplements), which initiated this case, became final. For more information on this issue, go to:
http://www.thenhf.com/government_affairs/ephedra/ephedra_issues_011.html .
In applying this drug-like standard to a dietary-supplement product, the FDA clearly overstepped its authority under the Dietary Supplement Health and Education Act of 1994 (DSHEA), which Act prohibits the FDA from applying a risk-benefit analysis to supplements. Yet, when the Supreme Court refused to hear the Nutraceutical Corp case, it allowed a 10th Circuit Court of Appeals decision to stand that sanctions the FDA’s violation of DSHEA.
The Sky’s the Limit
Today, there are no limitations to what action the FDA could take to ban any dietary supplement currently being sold to consumers. Because all food products – even water – are toxic at some dosage level, and since the 10th Circuit Court sanctioned the FDA’s power to remove any supplement that is harmful at any dosage level, the Court basically handed the FDA a blank check.
Without restriction or clarification, who knows what the FDA will target next? Will it be an entire class of supplements or simply individual dietary supplements? Will it be some natural product that competes with those of FDA’s paymasters? Whichever way, it is still arbitrary, unchecked power.
This is a serious threat to our access to safe and beneficial supplements.
Time to Pin the FDA Down
The NHF believes that it is time to pin the FDA down. What is needed is a Congressional directive to the FDA forcing the FDA to go on record with Congress as to the FDA’s future intentions concerning supplements and to clarify that the FDA will not use a drug-based standard to ban supplements, such as it did with ephedra. Both Congress and the health-freedom community could then reasonably hold the FDA accountable for any future attempts in this regard to undermine DSHEA.
The NHF is lobbying Congress to include such language in the final FDA Revitalization legislation. We are working with congressional members to draft legislative wording requiring the FDA to report to Congress on the FDA’s use of a "risk-benefit" scientific standard as the basis for its decision to ban the sale of ephedra supplements as adulterated foods. The language would also instruct the FDA to review the ephedra ban and its application, in light of the new Adverse Event Reporting (AER) law for supplements.
Our goal is also to force the FDA to restrict or eliminate its future application of a drug-like “safety” standard to nutritional foods and dietary supplements, and to explain to Congress what, if any, impact the new AER law has on the FDA’s understanding and future implementation of DSHEA.
At present, there is no regulatory or Congressional legal clarification that bars the FDA from this dangerous and arbitrary type of action. The NHF lobbyist has and is contacting key Members of Congress and their staff to include protective language in a final FDA bill.
To this end, your help with our lobbying efforts is needed, so that we can correct this significant injustice, now and for the future. Grassroots advocacy – coupled with effective personal lobbying – will spell success in this effort. This is focused on a direct – not an indirect – threat to supplement and dietary-supplement consumers being posed by unaccountable FDA bureaucrats, as well as the larger drug trade groups that are always involved. We hope that other organizations in the health-freedom community will pick up our cause as well.
As a community, we collectively know and collectively need to prevent any future ephedra-style applications of a drug-based risk standard against individual supplement products, or classes of products, by unaccountable FDA bureaucrats.
The FDA opened the door and the Supreme Court did not resolve the issue. We must close it. Until there is clarification on the reach of the FDA to "reinterpret" DSHEA, directed from Congress, all of the work done over the years to protect DSHEA, and our health freedoms, is in substantial peril.
To help with this cause, please use the links below to let your voice be heard. Contact your representatives now.
To view the sample petition letters, click these links:
Sample House of Representatives Petition Letter
To send your petition now click here
Click on this address to find your U.S. Senators: http://www.senate.gov
Click on this address to contact your Congressperson in the U.S. House of Representatives: http://www.house.gov/writerep
Click on the following links below for individual mailing addresses for
letter writing and other contact info for Congress Members:
Senate
House of Representatives
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.
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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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