By Len Monheit |
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Eyes have been on Washington the past few days, as a House subcommittee investigates ephedra and its safety, and the possibility that companies knowingly withheld information or even worse, misrepresented original safety studies in the early 90’s.
The targets are lined up: Metabolife, Cytodyne and NVE Pharmaceuticals, along with, by power of association, much of the dietary supplements industry. One company takes the fifth amendment, another cites its scientific data (after a quick company name change), and the other admits, according to the New York Times, that he has “twice been convicted of federal crimes ….and that his company had never employed a doctor or chemist in creating the ingredient formulas for its products.” Certainly a ringing endorsement and testimonial, painted as representative of the larger industry body.
David Seckman, executive director of the National Nutritional Foods Association is quoted by the Associated Press, “"A wealth of scientific information, expert testimony and consumer input already exists, including reports commissioned by the FDA itself, that the agency can use to determine once and for all whether ephedra presents a hazard to public health.”
But that’s not the only issue on the table now. It’s merely the appetizer.
The surface issue may be whether FDA should use its powers to ban ephedra, but lurking behind this central issue is the threat of Bill S. 722 proposedto require mandatory adverse experience reporting, pre-market approval for supplements containing ‘stimulants’ and a mechanism for dealing with steroid precursors. And with the stance industry members have taken by defending ephedra, they have opened a huge window of opportunity for lawmakers to use media pressure, obvious cover-ups relating to ephedra itself, and a track record of, if not gross misconduct,at the very least, a pursuit of short term gain through hyper-marketing activities. This effort has now painted much of the dietary supplements industry as cheap, unprofessional, likely guilty of irresponsibility and certainly in need of expanded regulation.
Opponents of DSHEA have been presented with a golden opportunity to begin its dismantling. They have chosen the battleground, (ephedra), have pointed out deficiencies in the law and have staked their program on product safety. Many, even those within the industry) agree that ephedra with other stimulants can pose a health threat, especially if abused. Although these same individuals may agree that abuse may happen, they also admit the excesses and abuse unscrupulous marketers heap on trusting consumers. Recent FTC and FDA actions against these companies and the resulting association with an irresponsible industry incapable of keeping its own house in order has paved the way for Senator Durbin and his supporters to first ban ephedra, and basking in the light of that success in protecting consumer safety, further assure this safety with Bill S. 722- a very logical next step The final step strategically may be to prove that, 1) since ephedra needed to be banned, and that 2) consumer safety needed to be protected through S. 722, then 3) DSHEA is not only inadequate, it is a deformed piece of legislation forced through by an irresponsible industry who would turn the law to advantage at the expense of consumers for the sake of immediate and personal gain.
Industry protests that DSHEA, if properly enforced, gives FDA authority to do everything required in order to ensure safe and effective products only are on the market. That argument only works in a proactive strategy and the Industry right now is in no position to be proactive. It is totally on the defensive and can only react to the strategy being implemented by political and media masters, ironically enough, using ammunition the industry has graciously provided.
Several weeks ago, I commented on the lost opportunity to make a statement of responsibility and strategic withdrawal with ephedra. This past week at the Newport Summit, using the interactive polling technology, executives in the room were asked whether we would see an ephedra-free industry by 2004. 63% of respondents said ‘no’. I would have been interestedto see what the response would have been had the question been “Should this be an ephedra-free industry?” My fear (and my own mini-polling) suggests the number would have been exactly the same, much to my dismay.
I realize that I don’t have a vested capital interest in the category, and certainly can’t argue with the legal minds guiding companies in the space, but from a business and industry strategy point of view, I just don’t get it. It seems that we’re being outmaneuvered everywhere, despite excellent presentation and representation by the trade associates and industry champions.
I realize it’s very easy to criticize from afar. I know organizations such as the Healthy Foundation and others help to place the industry in a much more responsible position and the tireless activities of associations such as CRN and NNFA have prevented disaster and mobilized much support. The reality is that we’re on a battlefield that is not of our own choosing, and one that won’t get any better or any easier after the current pressures (ephedra and S.722) are dealt with.
The next battlefield is DSHEA. We now have the opportunity to choose how that battle is fought. Very soon, we may not.
Perhaps the new Canadian regulatory environment should be examined to determine if the principles of DSHEA can be embraced within this model. Perhaps an industry task force should be struck to begin examining DSHEA clause by clause in two scenarios, 1) if Bill S.722 does not pass and 2) if Bill S. 722 is successful.
And for all of our sakes, let’s not give anyone more ammunition.