Skip to comments.Maker's request to disallow ban rejected
Posted on 04/12/2004 11:32:19 AM PDT by hchutch
NEWARK, N.J. -- A federal judge allowed a nationwide ban on dietary supplements containing ephedra to take effect Monday, turning aside a request by two supplement makers.
U.S. District Judge Joel Pisano refused to grant a temporary restraining order sought by the two manufacturers that would have prevented the U.S. Food and Drug Administration from banning the products.
Pisano's decision does not affect medicines containing ephedra, such as prescription or over-the-counter cold remedies.
The New Jersey manufacturer of a popular diet supplement had hoped to head off the nationwide ban on the herbal stimulant, arguing the main ingredient in its product is safe if used as directed.
NVE Pharmaceuticals Inc. of Newton maintains that the FDA lacks proof that ephedra is dangerous if used as directed, and its lawsuit argues that the agency simply reacted to the emotion of high-profile deaths like Baltimore Orioles pitcher Steve Bechler.
The FDA argued that it amassed sufficient proof of ephedra's dangers from thousands of side-effect reports and scientific studies that proved the herb's stimulant-like effects.
Ephedra sales already had plummeted because of publicity about the risks, which peaked after Bechler's ephedra-related death a year ago. Three states -- New York, Illinois and California -- prohibited the stimulant on their own.
The data on adverse events were drawn from clinical trials and case reports published in the literature, submitted to the FDA, and reported to Metabolife, a manufacturer of ephedra-containing supplement products. The strongest evidence for causality should come from clinical trials; however, in most circumstances, such trials do not enroll sufficient numbers of patients to adequately assess the possibility of rare outcomes. Such was the case with our review of ephedrine and ephedra-containing dietary supplements. Even in aggregate, the clinical trials enrolled only enough patients to detect a serious adverse event rate of at least 1.0 per 1,000. For rare outcomes, we reviewed case reports, but a causal relationship between ephedra or ephedrine use and these events cannot be assumed or proven.
"The enumeration in the Constitution of certain rights, shall not be construed to deny or disparage others retained by the people."
The "people" have the "retained" right to consume the chemical of their choice, in the quantity of their choice, for the reason of their choice.
The FDA "power," delegated to it by the Congress, to ban the consumption of any chemcial from use by free people, is blatantly and unambigously unconstitutional.
Congress can delegate the power to the FDA to investigate the safety and advertised claims of benefits from manufacturers of chemicals made for human consumption for accuracy and report that information to the citizens for the purpose of assisting citizens make intelligent decisions to consume such chemicals. That action would be constitutional.
Rush Limbaugh could use the same constitutional argument in his case.
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