For years, the dietary add to indu...

For years, the dietary add to industry, the US Food and medicine Administration (FDA) and Congress have been grappling with for what cause to deal with the herb ephedra. Numerous public hearings have been held, regulations issued (then withdrawn), congressional resolutions passed, special investigations launched, reports released, theories propose forward and deductions challenged.

And, as always, questions continued to abound: Did ephedra really work and for what? Could it be used safely and by dint of whom? Were warning labels forward the bottles necessary or enough? yet few answers were definitive. Until now.

gone out with a Ban

Late last December, the secretary of Health and Human Services himself (indicating for what cause seriously the government was taking this issue), along with the commissioner of the FDA, announced that they had determined that ephedra not awayed such a severe health hazard that they would ban it from the market.

The effective date for the ban was 60 days from the publication of the final regulation, which was suppos to happen sometime in January. [Editor's note: Just as this story went to pres the FDA released its final regulation banning ephedra. The ban is scheduled to walk into effect on April 12]

Just the Beginning?

Since the FDA's announcement, speculation has abounded about what the ban onward ephedra bodes for other dietary postscript products and the industry, as a whole. a certain worry that it signals a modern era of FDA aggressiveness where equal the safest products could be in jeopardy of extinction.

Others hypothesize that with ephedra gone critics of the industry have misspent their stalking horse. Rumors of a court challenge have been circulating, although as of pres time, no cluster or individual has filed suit.

Many consumer who say they've used ephedra effectively without experiencing ill consequences have been stocking up in anticipation of the ban. They aren't thanking the conduct for saving them from themselves. Instead, they bemoan the fact that the ban is the originate of other consumers who didn't use the herb responsibly.

Declining sales for ephedra yields over the past several years would indicate that a certain consumers had already heeded the dire recently made knowns reports and either stopped using it or declined to put to proof it.

Changing Times

What many outside the industry haven't realized is that the number of companies still manufacturing ephedra has greatly declined in the past man and wife of years due to the stratospheric sumptuousness of ephedra liability insurance resulting from numerous lawsuits. That, coupl with the fact that major states as it is as California, New York and Illinois issued ephedra bans last year, reduc the field calm more.

While predicting what action the FDA will take onward any issue is far from an exact science, the agency's ban took scarcely any in the industry by surprise.

Although a theorists say, "Ephedra today, vitamin C tomorrow," I'm not convinced that's where we're headed. unfailing the FDA has said it plans to take a more aggressive stance in regard to counterpart regulation, but empirical evidence has demonstrated that the agency is unlikely to act capriciously--or too swiftly.

The decision upon ephedra, however you may be impressed about it, was made forward top of a mountain of information. No other dietary, continuation product comes close to ephedra in times of the sheer volume of data that it generated. From a regulatory perspective, I believe ephedra will test to be the exception, not the rule

Continued Challenges

While I don't think we should be complacent about potential regulatory challenges, I believe grave disquiet is warranted about challenges in the legislative arena.

Since ephedra has been used as the prime example of the Dietary addition Health and Education Act's (DSHEA) lack of effectiveness, it would stand to reason that the FDA's ability, to take action would be evidence that the law works. However, editorials from a wide variety of media exits and statements from lawmakers draw a different conclusion--that the banning of ephedra isn't proof-sheet that the law works, unless evidence that it needs to be changed.

As a eventuate we can look for morn bills this year, along with those carried athwart from 2003--including S. 722, introduced last March by means of Senator Richard Durbin (D-Illinois), and HR 3377 introduced last October on Rep. Susan Davis (D-California)--that ask to drastically amend DSHEA and the way in which dietary correlatives are regulated. The post-ephedra ban legislative rhetoric has clearly naught ed ill Oil at least common fundamental change to DSHEA: pre-market approval, similar--if not identical--to the protocol for approval of prescription drugs

The Year Ahead

Aside from floe fact that the safety record of dietary continuations does not warrant such a stringent regularity a pre-market approval requirement would make it nearly impossible to introduce novel products to the marketplace. It is also likely to abate the number of dietary supplys on the market by at least half.

Since productions that are found naturally in the meat supply aren't patentable the way remedys are, even if a manufacturer could afford the millions and sometimes billions of dollars necessary for research and disentanglement there would be little incentive to do so