SALT LAKE CITY — Sen. Orrin Hatch delivered a speech marking the 20th anniversary of the signing of the Dietary Supplement Health and Education Act into law this weekend.
According to the United Natural Products Alliance, the industry has grown from a $9 billion industry in 1994 when the bill passed to $35 billion in 2013 with a 7.5 percent annual compound growth. By 2017, national sales are expected to reach just under $50 billion. In Utah, it is an almost $7 billion industry annually.
“Dietary Supplement Health and Education Act was a remarkable achievement,” Hatch said in a speech to leaders of the dietary supplement industry. “The solid compromise has had relatively few problems in two decades, and there has not been a major amendment to its structure in the last 20 years. The law created a crystal clear definition for dietary supplements and made clear they would be regulated as foods. DSHEA provided the FDA with abundant authority to protect public health through a defined safety standard and new safety authorities.”
The Senator’s full remarks are below:
Thank you for that kind introduction and for having me here today.
I am so honored to be speaking here today in front of a crowd of longtime friends and supporters.
You all know that I am very fond of the dietary supplement industry, and I am so proud to have watched this industry continue to grow and flourish in the state of Utah.
I am personally invested in ensuring that the companies represented here today are able to reach consumers, grow their business, and improve the health of millions of Americans by developing their products and expanding their capacity to fill the demand for dietary supplements.
That’s why I’m so proud that this week we celebrate the twentieth anniversary of DSHEA – the Dietary Supplement Health and Education Act of 1994.
As you all know, DSHEA established a rational framework for the regulation of dietary supplements.
In the early nineties, a national dialogue on improving health care was underway. Numerous studies indicated at least 100 million Americans regularly used vitamins and minerals to improve diet and health.
Utah was a key part of this dialogue, in part because of the concentration of supplement companies located here, but also because of our state’s affinity for freedom and resentment of unnecessary federal intrusion.
Over the previous several decades, the FDA had been rather heavy-handed with this industry, trying repeatedly to create new restrictions on both the labeling and content of dietary supplements.
One of the most notable examples was FDA’s opposition to folic acid as a dietary supplement. The CDC recommended pregnant women take folic acid to prevent birth defects, but the FDA refused to allow supplement manufacturers to use this information.
Forging a Compromise
That’s why I came together with my colleagues in the Senate to change the law.
And, in fact, this was not a partisan issue. It was about fairness and about allowing the American public access to these products and information about their benefits.
I worked very hard and methodically to build support.
Senator Harkin and Congressman Richardson worked with me to make the case to our colleagues. In the end, two-thirds of the Senate and over half the Labor and Human Resources Committee were cosponsors.
I’ll never forget when we crossed the halfway mark in committee.
Senator Jeff Bingaman was crucial to the effort.
He was from New Mexico, the same state as Congressman Richardson and was considered to be a rational and thoughtful Senator on the Committee. He said he had talked to the FDA and was convinced they weren’t being fair on this issue. So, he came on board with DSHEA and put us over the halfway mark in the Labor and Human Resources Committee – what’s now called the HELP Committee.
I hounded Senator Kennedy – who chaired the committee – to move the bill forward.
Ted, I need a hearing, I said.
And to his credit, he gave me one and allowed me all the time I needed to question the witnesses.
Ted, I need a markup, I said.
He put the bill on the agenda – even though his own compromise legislation only got five votes.
Ted, I need the bill brought up in the Senate, I said.
And he allowed it to go forward.
Perhaps most importantly, there was unprecedented grassroots support. I have many of you here today to thank for that.
The mail was crushing.
And, if you visited any health food store, you were confronted with a petition to Congress. It was an amazing outpouring.
Utahns, of course, were very interested in this bill.
I really valued the input from Utah and the real-world perspective. And I’m not just talking about manufacturers. I’m talking about consumers, and health food store owners and staff, naturopaths, and others.
I think a big key to the success of the final bill was that it was negotiated directly by the principals, working off the Senate draft.
Waxman, Dingell, Richardson, Hatch, Harkin – we were all there at the table in Richardson’s Capitol office – the very last day of Congress in 1994. It went right down to the wire, as I knew it would.
The success of this effort that produced a tremendous win for consumers was that the bill passed by unanimous consent in both bodies. It was brought up by Chairman Waxman himself in the House, and I was gratified to bring it up in the Senate.
DSHEA was a remarkable achievement.
The solid compromise has had relatively few problems in two decades, and there has not been a major amendment to its structure in the last 20 years.
DSHEA accomplished a number of things to promote public health.
The law created a crystal clear definition for dietary supplements and made clear they would be regulated as foods. DSHEA provided the FDA with abundant authority to protect public health through a defined safety standard and new safety authorities.
Instead of assuming all companies are making unsafe products, the law operates on the assumption that most products are safe, and the burden of proof is on the agency to prove otherwise.
That safety authority was subsequently enhanced through a Hatch-Durbin law requiring reporting of serious adverse events, and through recall authority in the Food Safety Modernization Act.
DSHEA also authorized good manufacturing practice guidelines specific to dietary supplements, which were phased in over time – although it shouldn’t have taken 10 years for those guidelines to be implemented.
And, the law explicitly allowed certain third-party literature to be provided in conjunction with a sale and for statements of nutritional support, or structure or function claims.
The law also established the Office of Dietary Supplements at the National Institutes of Health, to foster independent scientific research about the benefits of supplements, given FDA’s long-standing bias against these products.
A Rational Framework for Regulation
Since the passage of DSHEA, critics have asserted that dietary supplements are “unregulated” or that DSHEA ties the Secretary’s hands from acting. Clearly, nothing could be further from the truth.
I want to be clear about my views on enforcement: DSHEA established a rational framework for FDA regulation of dietary supplements. It did not shield bad actors from prosecution. Nor should they be shielded.
In fact, the FDA has abundant authority to remove unsafe products from the marketplace. FDA has seizure, injunction, and criminal prosecution authority. The agency can issue warning letters, seek recalls, issue civil monetary penalties, and use the power of publicity.
So when critics of the law say dietary supplements are unregulated, or protected by the Hatch/Harkin law, they are just plain wrong.
But I know the majority of dietary supplement companies are good actors who want to be regulated within a clear and well established framework. That is certainly true in Utah.
The fact is that the vast, vast majority of dietary supplements are safe products that over 150 million Americans use each year in order to maintain a healthy lifestyle at an affordable cost.
I am committed to protecting this industry and the integrity of its products. One continual thorn in the side of responsible dietary supplement manufacturers is reports that illegally spiked products are being sold as dietary supplements.
These are, for example, weight loss products that illegally contain unapproved drugs.
In some cases, responsible manufacturers are unknowingly receiving tainted ingredients. That is why testing and quality controls have to be an important component of manufacturing.
But, in other cases, these illicit marketers know exactly what they are doing and they are hoping sell a lot of products before they are caught.
This should be a major target of FDA’s enforcement.
Additionally, Senator Whitehouse and I have been concerned that athletes, and particularly young athletes, have been able to purchase steroid look-alikes that perform much like steroids, but because of legal loopholes cannot be banned by the Drug Enforcement Administration.
That is why we have worked for several years to pass “DASCA” – or the Designer Anabolic Steroid Control Act. We are coming closer than ever to enactment – the bill under the leadership of Subcommittee Chair Joe Pitts passed the House in the middle of September and I’m hopeful it will pass the Senate this year.
I’m committed to advocating for your industry in other areas of concern, including possible guidance from the agency regarding new dietary ingredients.
Since 1994, sales of dietary supplements have evolved into a very sophisticated marketplace with products sold worldwide. At times, though, the industry has faced barriers to sales overseas.
As the ranking Republican on the Senate Finance Committee, which has jurisdiction over international trade, my office has worked with many of you to give advice on specific country issues and we will continue to make this a priority. Whenever there are trade barriers to supplement sales overseas, we will work to see these barriers eliminated.
As the role of social media continues to evolve for dietary supplements, as with other FDA-regulated products, the trend seems to be toward regulators holding companies responsible for what third parties are saying on social media such as Facebook or Twitter. This, of course, is an unfortunate trend that should be reversed.
I don’t need to tell you there has been a massive turnover in the Congress in recent years. About three-quarters of the Senate was not here in 1994 when DSHEA was enacted.
And, I don’t need to tell you that one of your biggest champions, my friend Tom Harkin, will be leaving the Senate at the end of the year. We will all miss him.
I encourage you to continue this dialogue with your representatives in Washington and to remember that the current Congress is not as well-versed in your issues as it was in 1994.
Stay in close contact with legislators and make certain you participate in the in the political process.
I look forward to continuing to work with you on many issues of critical importance to an industry that is playing such a positive role in helping Americans lead healthy lives.
Thank you, once again, for having me here today.
God bless you all.
Submitted by the Offices of Sen. Orrin Hatch
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