I just do not understand

The FDA had a scientific opinion about ephedra? For that they would need a dose-response trial, and research into the biochemical causes of adverse results, which I never heard about during the ephedra controversy. What I did hear about was a small number of weeping relatives begging for “something to be done”. So they banned it to score PR points. It looks a lot like the silicone implant debacle.

My strong suspicion is that ANY sympathomimetic amine given in large uncalibrated doses will have exactly the same side effect profile as ephedra, including fatalities. A subset of people are simply hypersensitive to pressor amines, and tend to also have substantially reduced monoamine oxidase activity. Pressor amines can get these folks into real trouble. (Says the man who felt horribly bad after taking pseudoephedrine, went into atrial fibrillation after repeated doses of phenylephrine, and gets migraine attacks from MSG. If I took a big dose of any pressor and went to baseball practice, I would expect to die.)

That was the judge’s point. We KNOW the whole class of drugs has a narrow (in some cases nonexistent) therapeutic window. It is entirely possible that ephedra adverse reactions resulted from a lack of dose calibration, in which case the FDA’s statutory authority would only extend to those doses. (In exactly the same way that they limited OTC potassium tablets to 100 milligrams.) The FDA could have prevented this by asking the judge to wait a few hours while the scientific results were emailed, and then presenting them in court. Either the ban was unscientific, or the FDA didn’t bother to read its own science reports in a life-and-death matter. Whatever happened, the FDA screwed up.

this judge’s decision was not about the safety of ephedra. rather, it was what is the fda required to demonstrate in order to keep a non-pharmaceutical product off the shelf. the statuory language of the food drug and cosmetics act has different requirements for non-pharmaceuticals and pharmaceuticals.

this judge is not making a scientific judgment that ephedra is safe – far from it, in fact. rather, the judge ruled that the fda did not follow its own statutory requirements when pulling ephedra.

Who is to say that Ephedra is “dangerous”???? Think about ALL the available products out on the shelves that are not “safe” when you take too much of it. When are people going to grow up and accept personal responsibility for what they put into their bodies? I am tired of hearing about the “baseball player” that died from ephedra. Who in their right mind would take more than the recommended dosage and then exercise in blistering heat? An IDIOT! Thats who! I could die if I take too much cold medicine and wash it down with a beer. I could die if I take too much tylenol-or at least I would shut my kidneys down-and yet these medicines are still widely available. There are plenty of things out on the shelves that are not safe and can cause reactions in certain people. Every product that contained ephedra had a warning on the label. It is up to the consumer to heed that warning. I applaud the Judge. How many more choices are we going to let the government make for us?