What led you to be so involved in this particular cause?
One reason, of course, is the state I represent. Utahans are big consumers of dietary supplements and big believers in their efficacy. We also have some of the strongest businesses in the industry located here, so Ive seen first-hand how your industry has helped millions of people improve their quality of life.
Utah is kind of the Silicon Valley of nutrition and network marketing, isnt it?
It really is. The leading companies in your industry are run by high-quality people and provide very high-quality products, and theyre no fools, either. They knew that if the FDA fully got its way, a lot of them would be out of business, or at least their products would become so expensive, because of the economic burden that all that a priori testing would create, that most people wouldnt be able to afford them.
Ive heard you say that youre a long-time user of dietary supplements yourself.
Thats true. Even aside from my position in my public life, this has always been an important matter to me. Ive taken dietary supplements since I was a young man.
And as I understand it, youre in pretty good shape, too.
As a U.S. Senator, Im expected to go through fairly frequent physical exams. Every time I see that doctor, he says, Orrin, I wish I could tell your formula to othersbecause youre always in such good shape!
Have you told him, Well, Doc, you can!
He knows Im a big believer in dietary supplements. Hes now taking them too. In fact, you can walk into any pharmaceutical company in this country and ask the people if they take dietary supplements, and theyll say, We sure do! Ive talked with some of the top scientists in the pharmaceutical industry, and thats what they say.
It wasnt that long ago that we were looked at as kind of a kooky fringe.
I dont really think so, not as a whole. Some in the industry have been looked at as kooky fringe, and some of them are. Thats one reason we created DSHEA; that act actually gave the FDA more authority than it had before, but authority applied in a direction that makes sense and supports the industry, instead of hamstringing it with overregulation.
DSHEA clarified the critical distinction that dietary supplements are not drugs, and legislated that they be regulated as foods.
DSHEA said that the Food and Drug Admin-istration had to stop playing games with supplements. The FDA cannot regulate the potency of your products. They cant trump up some crazy regulatory scheme to remove a product from the market, as they did all through the seventies and eightiesalthough they lost every case. In fact, said DSHEA, the FDA can remove a product from the market only if it is unsafeand the agency has the burden of proving that its not safe.
So just like citizens, now dietary supplements are innocent until proven guilty.
Thats essentially it. Whereas if the FDA had gotten their way, supplement producers would have to do what drugs do, which is to prove theyre safe through exhaustive testing before going onto the market. Which for a food is prohibitively burdensome.
DSHEA also said that you may provide consumers with truthful and non-misleading information about your products. Before this, FDA considered that information to be labeling and stopped you from handing it out.
These were all landmark changes in the law, and they were not easy to achieve. Our bill passed the Senate unanimously, not once but twice, and in the end, it passed the House of Representatives unanimously as well. But putting together the support it needed and reaching that end took an awful lot of effort. It was a real labor of love.
It was also a landmark example of bipartisan effort.
Thats true, and I think thats evidence of how powerful your industry is, because we were able to motivate people all over the country to get after their Senators and Congresspeople and make it very clear that these are good products and they dont want them overregulated to death.
When I talked with Jim Turner, he said this was the largest volume of letters on a single issue Congress ever received.
It was one of the big ones, all right. Labor law reform was another big one; I led that fight back in 1978. And of course Vietnam was a huge issue that provoked an immense response from the population. But this issue of dietary supplements was certainly one of the biggest ones weve ever seen, and it reflects enormous popular support.
According to our figures, over a hundred million people take dietary supplements every day. Now that is simply not something one can ignore, and I think that this was the moment, in the early nineties, when it dawned on people in Washington that this is the case.
Can you tell us a bit about your new proposed legislation that has to do with reporting adverse reactions?
In the almost twelve years since DSHEA has been enacted, the vast majority of dietary supplements have been used completely safely and have posed little cause for concern. The issue was, how do we deal with those extremely rare instances where problems do occur? Ephedra being an example.
From my perspective, the bill that Senator [Richard] Durbin [D-Illinois] was coming up with was very tough, inordinately so. But we worked together on this and eventually came to a parallel sense, which was that it would be beneficial to public health to have governmental authorities become aware of serious problems so they or the individual business could take appropriate follow-up action.
And thats the key word: serious. We defined serious adverse events as events that result in death, life-threatening experience, in-patient hospitalization, persistent or significant disability or incapacity, or even a congenital anomaly or birth defect. Or, an event that requires consideration based on reasonable medical judgment and medical or surgical intervention to prevent one of those outcomes.
DSHEA was written to protect consumers and the industry, and this new bill was written with the exact same goals. I believe the Adverse Event Reporting or AER bill will help show that the majority of supplement manufacturers are in the mainstream, as FDA-regulated entities.
So by having a mechanism for separating out the bad apples, it gives the rest of us a clearer field to do what we do well.
Thats right. As the industry matures, we need to separate out the good actors from the bad. And the AER bill is one way to show that this is a respectable mainstream industry, certainly every bit as much as, say, pharmaceuticals.
The only time weve ever had anyone die from dietary supplements was thirty or forty years ago, when a few people died from a bad batch of a product. Well, were losing about 100,000 people a year from toxicity in pharmaceuticals! But were willing to tolerate that, because of the hoped-for benefits.
Everybody knows that the vast majority of supplements are safe. And I dont anticipate a flood of AERs resulting from this bill. But the bill gives the FDA a mechanism to know quickly when theres a problem, and this will help protect consumers from serious health risks, should such risks arise.
Where is the bill now?
The Health, Education, Labor and Pensions Committee approved S. 3546, the Dietary Supplement and Non-Prescription Drug Consumer Protection Act, on June 28; we filed a comprehensive committee report on August 30. We hope the bill will pass unanimously, or as close to it as possible, before we adjourn for the elections. By the time your readers are reading these words, well know if we were successful.
Theres been a bit of opposition, yes?
Yes, its been controversial in some circles. Some organizations and well-known spokespeople have been strongly for it, and some have come out against it. The AER bill shows that the industry is far from unified.
What can I do as an individual to be aware of whats going on and help support a healthy regulatory environment?
One useful thing would be for people to push the formulation of Good Manufacturing Practices, called GMPs. One of the key components of DSHEA was that it gave the FDA the authority to write GMP guidelines specific for supplements.
Whats the significance of these GMPs to our businesses?
These are the standards we use to ensure purity, potency and all other requirements of clean, legal manufacturing. And theyre critically important because, when written and used correctly, they will assure the public that the products theyre buying live up to their labels.
Its been twelve years since we wrote the bill and got it passed, and the regulations are still not there. Senator Harkin and I have been pushing the FDA to publish them. Weve asked Michael Leavitt, the Secretary of Health and Human Services, to get engaged, and he has promised to do so; based on information I recently received, were quite hopeful that they are truly in the last stages of review, and that these GMPs will be published very soon. If this doesnt happen, then bringing consumer pressure to bear on this issue would be very helpful to the industry itself.
Another problem we face is the FDAs lack of enforcement against the bad actors in the industry.
Why would they be reluctant to do this?
Typically, FDA has said they dont have the resources to act. I think the truth is that they dont want to act. They would rather see some disaster happen, and then they could come in and take over and say they were right from the beginning.
So Senator Harkin and I have written a bill to provide them with all the funding they need to do the job. Hopefully we will get that bill passed as well.
What else can we do as individuals in this business?
Given the FDAs history, I think its crucial that we all keep our eyes on them to make sure that once they have the funding for this task, they are truly going after only the bad actors, and not reverting to their old ways of punishing the good guys as well.
Let me give you one example of how were helping the FDA with this. Two years ago, I joined with Senator Joe Biden [D-Delaware] to offer a law that made precursor steroids, such as androstenedione, federally-controlled substances that are not legally available for sale. The primary motivation in passing that bill was the fact that those steroid-like substances were being abused by young actresses, at great cost to their health.
However, the Biden-Hatch Law specifically exempted DHEA. Why? Because DHEA does not have the worrisome safety profile of the precursor steroids subject to the new law. Moreover, there is no evidence to suggest that DHEA has ever posed any health problems. In fact, it appears the product is being safely used by many Americans who recognize its potential.
So, never-ending vigilance is called for.
Thats why you need to have champions, like Harkin on the Democrat side and myself on the Republican side. The industry needs to support its champions on both sides of the political fence. This is too important to let it get eaten up in partisan politics. This is about the health and well-being of all our families, throughout the country.
How involved or informed do you see rank-and-file people in our industry being these days?
Unfortunately, a lot of the people in the industry dont get involved because they think, now that we have DSHEA, the problems all solved. And I have to say, it has been solved significantlybut that doesnt mean it will always stay solved. We have to keep the pressure on. Not to sound self-serving, but thats why you need senators like me who have a personal belief in these products that transcends the politics of the issue.
Senator, what about the Codex issue, of overseas and international regulation?
Personally, I dont think you need to be overly concerned about it. The Codex Alimentarius Commission is an international organization that provides guidelines for food safety worldwide. Their guidelines for vitamin and mineral food supplements are not going to affect our own regulation of dietary supplements in the United States unless Congress decides to adopt their provisions. And truthfully, I dont believe thats going to happen.
However, heres where we need to be careful: the Codex regulations could affect exports and our overseas businesses if other nations decided to include them in their laws. To me, they seem so radical that I doubt that most nations would do that. But its something we definitely need to watch.
I care deeply about the vitamin and herbal business, both in Utah and throughout our country, and Ive worked very hard to ensure that we have sensible, well-designed and well-enforced regulations here in our country. Assuming that Im reelectedagain, which is something well know by the time this article is in your readers handsthen if the issue of dietary supplement regulation comes before Congress, either in the context of Codex guidelines or in the form of any further proposed domestic legislation, Ill be here working to achieve a regulatory framework that best suits businesses and consumers alike.
Earlier you used the phrase as the industry matures, and that prompts a question. How do you see the role of, not nutrition or dietary supplements per se, but of network marketing as a whole, as a force in the twenty-first century?
I see it playing a very important role. The companies that have developed this marketing approach with truly high-quality products are doing a lot of good in the world.
On one level, your business model is a critically important way of helping people to use high-quality productspeople who may never want to sell them but simply want the lower price and ready access they can get by being distributors.
On another level, its also a way to give certain people an opportunity to sell those products and earn a good living from it. And we want people to make money in this business, so that they can keep developing even better, stronger and higher-quality products.
Anything in particular we need to look out for, as we grow?
Again, theres the issue of bad apples. You really want to watch out for those fraudulent, pyramid-type programs and make sure people understand the difference between them and the legitimate programs.
Keep those standards high.
Exactly, just as with dietary supplements: keep the standards high. The bad companies have got to go, and they will. And the good companies? Theyre going to be around for a long, long time.