Gone: what does the ephedra ban mean for consumers? - Dc/updates: word from WashingtonBetter Nutrition, April, 2004 by David Seckman
For years, the dietary supplement industry, the US Food and Drug Administration (FDA) and Congress have been grappling with how 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 Numerous public hearings have been held, regulations issued (then withdrawn), congressional resolutions passed, special investigations launched, reports released, theories put forward and deductions challenged.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 whom? Were warning labels on the bottles necessary or enough? But few answers were definitive. Until now.
Out with a Ban
Late last December, the secretary of Health and Human Services himself (indicating how seriously the government was taking this issue), along with the commissioner of the FDA, announced that they had determined that ephedra presented 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 supposed to happen sometime in January. [Editor's note: Just as this story went to press, the FDA released its final regulation banning ephedra. The ban is scheduled to go into effect on April 12.]
Just the Beginning?
Since the FDA's announcement, speculation has abounded about what the ban on ephedra bodes for other dietary supplement products and the industry, as a whole. Some worry that it signals a new era of FDA aggressiveness where even the safest products could be in jeopardy of extinction.
Others hypothesize that with ephedra gone, critics of the industry have lost their stalking horse. Rumors of a court challenge have been circulating, although as of press time, no group or individual has filed suit.
Many consumers who say they've used ephedra effectively without experiencing ill effects have been stocking up in anticipation of the ban. They aren't thanking the government for saving them from themselves. Instead, they bemoan the fact that the ban is the result of other consumers who didn't use the herb responsibly. Declining sales for ephedra products over the past several years would indicate that some consumers had already heeded the dire news reports and either stopped using it or declined to try it.
What many outside the industry haven't realized is that the number of companies still manufacturing ephedra has greatly declined in the past couple of years due to the stratospheric cost of ephedra liability insurance resulting from numerous lawsuits. That, coupled with the fact that major states such as California, New York and Illinois issued ephedra bans last year, reduced the field even more.
While predicting what action the FDA will take on any issue is far from an exact science, the agency's ban took few in the industry by surprise.
Although some theorists say, "Ephedra today, vitamin C tomorrow," I'm not convinced that's where we're headed. Sure, the FDA has said it plans to take a more aggressive stance in regard to supplement regulation, but empirical evidence has demonstrated that the agency is unlikely to act capriciously--or too swiftly.
The decision on ephedra, however you may feel about it, was made on top of a mountain of information. No other dietary, supplement product comes close to ephedra in terms of the sheer volume of data that it generated. From a regulatory perspective, I believe ephedra will prove to be the exception, not the rule.
While I don't think we should be complacent about potential regulatory challenges, I believe grave concern is warranted about challenges in the legislative arena.
Since ephedra has been used as the prime example of the Dietary Supplement 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 outlets and statements from lawmakers draw a different conclusion--that the banning of ephedra isn't proof that the law works, but evidence that it needs to be changed.
As a result, we can look for morn bills this year, along with those carried over from 2003--including S. 722, introduced last March by Senator Richard Durbin (D-Illinois), and H.R. 3377, introduced last October by Rep. Susan Davis (D-California)--that seek to drastically amend DSHEA and the way in which dietary supplements are regulated. The post-ephedra ban legislative rhetoric has clearly zeroed ill Oil at least one 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 supplements does not warrant such a stringent system, a pre-market approval requirement would make it nearly impossible to introduce new products to the marketplace. It is also likely to reduce the number of dietary supplements on the market by at least half. Since products that are found naturally in the food supply aren't patentable the way drugs are, even if a manufacturer could afford the millions and sometimes billions of dollars necessary for research and development, there would be little incentive to do so.
Clearly, ephedra has been the legislators' favorite tool for prying apart and remaking DSHEA. Now that ephedra's almost gone, it will be interesting to see what unfolds in Congress in 2004. We'll keep you posted.
To learn more about legislation affecting dietary supplements and the natural products industry, please visit the Advocacy Action Center on NNFA's Web site at www.nnfa.org. You can also voice your opinion by sending your senator or representative an email or letter. In addition, you can sign up to receive Advocacy Updates, which report on some of the topics covered here.COPYRIGHT 2004 PRIMEDIA Intertec, a PRIMEDIA Company. All Rights Reserved.
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