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In the second part of a two-part interview, Loren Israelsen tells Pete Croatto what makes DSHEA tricky to repeal and shares a memorable story about its tumultuous approval.
January 29, 2014
Click here for part one.
Supplement Perspectives: How long do you expect DSHEA to stay relevant? Will it be replaced by something that incorporates the Internet or have better definitions and timetables? Or will it be amended as time goes on?
Loren Israelsen: We dont know. We dont know. DSHEA remains very relevant as the operating framework for this industry. Having said that, after 20 years so much has changed. We have other laws that have been passed that are essentially build-ons to DSHEA designed to add structural strength, widen the roads, put up the radio tower on top of the building. [They] take into account what happens now. Things like Adverse Event Reporting, allergen labeling, Food Safety Modernization Act, steroid control legislation.
So DSHEA used to be the sole skyscraper on the horizon. If you look at it now, you see other structures, buildings, structures, communities that are the realization of how the world has changed. So the big debate, will DSHEA be repealed? I doubt it, seriously doubt it. Could it be amended? Possibly, if there was a really good reason that would strengthen DSHEA in terms of its mandates, all right lets listen to an idea. More than likely the best ideas will be as weve seen in the past. That is, take a specific issue and if we need a tune-up, lets brace that on to or next to DSHEA. That seems to work really well. Those that want to repeal or deeply amend DSHEA dont seem to appreciate that you mess with a great deal of software, operating systems, that are working day in, day out. So its not a little simple thing to do.
You change one thing and theres a great deal of downstream effect, and then you have a lot of uncertaintyusually rulemaking, policymakingthat goes on for years. We know this. DSHEA was passed 20 years ago and the rulemaking process for DSHEA is still not done. So what you end up with is an under construction sign is always up on the roads. That is not an efficient way to run laws. Ideally, its heres the law, here are the hard deadlines to have the regulatory components put into place.
If theres any observation about DSHEA is we should have built in some hard deadlines for the completion of GMPs, new dietary ingredients, policy and practice, that kind of thing. It would have helped a lot.
Supplement Perspectives: Yeah, but hindsight is 20/20.
Loren Israelsen: This is the hardest part, I guess, of DSHEA: we all look at the finished product and think, Yeah, that was great, and forget just how difficult it was. You had such deeply opposed sides in Congress. You had multiple interests within the industry itself who wanted and needed different things; the constant barrage of media dumping on this thingpro and conjust as we see right now. In the midst of the revolutionary 1994 political elections, and wow. Its hard to imagine with all of that tumult and all the game playing that this bill passed. You could fill pages with the details of how that happened. Its an extraordinary story and most people after they hear about it say, I cant believe DSHEA ever became a law. Just from the timing, the process, the intrigue. It really is a John le Carre novel.
Supplement Perspectives: Was there one obstacle or moment where you and your allies thought, Oh geez, were toast?
Loren Israelsen: There were many of those, but one really does stand out. It was May of 1994. There was a critically important Senate mark-up. So in the Senate HELP Committee, chaired by Senator Kennedy, not a friend of the bill, this was the do-or-die. Complicating the fact was that it was Nelson Mandelas inauguration day. Three members of the committee had flown to South Africa to be part of that. We didnt know how they were going to vote. Two of the three were Democrats; one was Republican.
Normally, you would give your proxy vote to the ranking member of your party, in other words, to Ted Kennedy. Which means, we assumed, that he would vote no on DSHEA. We were frantically doing the head count trying to figure out if weve got the votes. It was a very intense mark-up. Chairman Kennedy calls for a vote. We were urging Senator Hatchs staff to ask for a postponement to get these people back from South Africa. We ran the numbers and were convinced we were going to lose. If we lost this vote, that was the end of DSHEA. Well, Kennedy insisted on proceeding and long story short, we won.
Its something thats quite extraordinary and unusual is that one of the DemocratsI wont name names at this pointin South Africa gave their proxy vote to Senator Hatch, a Republican. And when that senators name was called, all eyes were on Ted Kennedy expecting nay. All of a sudden over on the right side here is Orrin Hatch saying, yea and we thought, What the hell is going on here? It appeared that Kennedy didnt know that was coming, which was a substantial breach of protocol. One more thing of that sort happened, and that gave us the two votes that we were missing. We won it by one at the end of the day. The gallery erupted into huge applause, screaming, standing on chairs. And Chairman Kennedy was so annoyedhe pounded his gavel so hard on the table that the head broke off and flew into the crowd.
Thats one of, man, I dont know 50 events of that kind, that you go through and think, Yeah, that really happened. Yeah, we got on the edge and somehow survived it. It was a bill like that. Every other week there was a drama of some sort.
Supplement Perspectives: Twenty years later, would you be willing to do it all over again?
Loren Israelsen: [Laughs] Would I be willing to do that again? I dont have the physical strength to do that again. My wife would never give me permission to do it. And I would be looking for the smartest kids in the room and say, You want to do something fun that will never be forgotten?, and send them off and be their guide and mentor. And thats what we need. We need that younger generation of folks who are willing and able to do exactly that. We want and need others to do that. They need to go prove themselves, learn the lessons, and become the leaders of the future for this industry.
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