{"database": "press", "table": "releases", "rows": [["https://www.hatch.senate.gov/public/index.cfm/releases?ContentRecord_id=2f70eb3b-2175-4306-b78c-cc4d2e9961c5", "Hatch Marks 20th Anniversary of the Dietary Supplement Health and Education Act (DSHEA)", "2014-10-27", "2014", "2014-10", "Republican", "House", "UT", "Orrin Hatch", "H000338", "www.hatch.senate.gov", null, null, "legacy", "Sen. Orrin Hatch, former Chairman of the Labor and Human Resources Committee and current member of the Senate Health, Education, Labor, and Pensions (HELP) Committee delivered a speech marking the 20th anniversary of the signing of the Dietary Supplement Health and Education Act (DSHEA) into law this weekend.\u00a0\r\nAccording 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% annual compound growth.\u00a0 By 2017, national sales are expected to reach just under $50 billion.\u00a0 In Utah, it is an almost $7 billion industry annually.\r\nIn his speech to leaders of the dietary supplement industry Hatch stated: \u201cDSHEA was a remarkable achievement.\u00a0 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.\u00a0\r\n\u201cThe 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.\u201d\r\nThe Senator\u2019s full remarks are below:\r\nThank you for that kind introduction and for having me here today.\u00a0\r\nI am so honored to be speaking here today in front of a crowd of longtime friends and supporters.\u00a0\r\nYou 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.\r\nI 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.\u00a0 \u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\r\nThat\u2019s why I\u2019m so proud that this week we celebrate the twentieth anniversary of DSHEA - the Dietary Supplement Health and Education Act of 1994.\r\nWhy DSHEA?\r\nAs you all know, DSHEA established a rational framework for the regulation of dietary supplements.\u00a0\r\nIn the early nineties, a national dialogue on improving health care was underway.\u00a0 Numerous studies indicated at least 100 million Americans regularly used vitamins and minerals to improve diet and health.\r\nUtah was a key part of this dialogue, in part because of the concentration of supplement companies located here, but also because of our state\u2019s affinity for freedom and resentment of unnecessary federal intrusion.\r\nOver 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.\u00a0\r\nOne of the most notable examples was FDA\u2019s 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.\r\nForging a Compromise\r\nThat\u2019s why I came together with my colleagues in the Senate to change the law.\u00a0\r\nAnd, in fact, this was not a partisan issue.\u00a0 It was about fairness and about allowing the American public access to these products and information about their benefits.\r\nI worked very hard and methodically to build support.\u00a0\r\nSenator Harkin and Congressman Richardson worked with me to make the case to our colleagues.\u00a0 In the end, two-thirds of the Senate and over half the Labor and Human Resources Committee were cosponsors.\u00a0\r\nI\u2019ll never forget when we crossed the halfway mark in committee.\r\nSenator Jeff Bingaman was crucial to the effort.\u00a0\r\nHe was from New Mexico, the same state as Congressman Richardson and was considered to be a rational and thoughtful Senator on the Committee.\u00a0 He said he had talked to the FDA and was convinced they weren\u2019t being fair on this issue. \u00a0So, he came on board with DSHEA and put us over the halfway mark in the Labor and Human Resources Committee \u2013 what\u2019s now called the HELP Committee.\r\nI hounded Senator Kennedy \u2013 who chaired the committee \u2013 to move the bill forward.\u00a0\r\nTed, I need a hearing, I said.\u00a0\r\nAnd to his credit, he gave me one and allowed me all the time I needed to question the witnesses.\u00a0\r\nTed, I need a markup, I said.\r\nHe put the bill on the agenda \u2013 even though his own compromise legislation only got five votes.\u00a0\r\nTed, I need the bill brought up in the Senate, I said.\r\nAnd he allowed it to go forward.\r\nPerhaps most importantly, there was unprecedented grassroots support.\u00a0 I have many of you here today to thank for that.\u00a0\r\nThe mail was crushing.\u00a0\r\nAnd, if you visited any health food store, you were confronted with a petition to Congress.\u00a0 It was an amazing outpouring.\r\nUtahns, of course, were very interested in this bill.\u00a0\r\nI really valued the input from Utah and the real-world perspective.\u00a0 And I\u2019m not just talking about manufacturers.\u00a0 I\u2019m talking about consumers, and health food store owners and staff, naturopaths, and others.\u00a0\r\nI 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.\u00a0\r\nWaxman, Dingell, Richardson, Hatch, Harkin \u2013 we were all there at the table in Richardson\u2019s Capitol office \u2013 the very last day of Congress in 1994.\u00a0 It went right down to the wire, as I knew it would.\u00a0\r\nThe success of this effort that produced a tremendous win for consumers was that the bill passed by unanimous consent in both bodies.\u00a0 It was brought up by Chairman Waxman himself in the House, and I was gratified to bring it up in the Senate.\r\nDSHEA was a remarkable achievement.\u00a0\r\nThe 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.\r\nDSHEA Highlights\r\nDSHEA accomplished a number of things to promote public health.\u00a0\r\nThe 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.\u00a0\r\nInstead 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.\r\nThat 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.\r\nDSHEA also authorized good manufacturing practice guidelines specific to dietary supplements, which were phased in over time \u2013 although it shouldn\u2019t have taken 10 years for those guidelines to be implemented.\r\nAnd, 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.\r\nThe 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\u2019s long-standing bias against these products.\r\nA Rational Framework for Regulation\r\nSince the passage of DSHEA, critics have asserted that dietary supplements are \u201cunregulated\u201d or that DSHEA ties the Secretary\u2019s hands from acting.\u00a0 Clearly, nothing could be further from the truth.\r\nI want to be clear about my views on enforcement: DSHEA established a rational framework for FDA regulation of dietary supplements.\u00a0 It did not shield bad actors from prosecution.\u00a0 Nor should they be shielded.\r\nIn fact, the FDA has abundant authority to remove unsafe products from the marketplace.\u00a0 FDA has seizure, injunction, and criminal prosecution authority.\u00a0 The agency can issue warning letters, seek recalls, issue civil monetary penalties, and use the power of publicity.\r\nSo when critics of the law say dietary supplements are unregulated, or protected by the Hatch/Harkin law, they are just plain wrong.\r\nBut I know the majority of dietary supplement companies are good actors who want to be regulated within a clear and well established framework.\u00a0 That is certainly true in Utah.\r\nThe 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.\u00a0\r\nSpiked Products\r\nI am committed to protecting this industry and the integrity of its products.\u00a0 One continual thorn in the side of responsible dietary supplement manufacturers is reports that illegally spiked products are being sold as dietary supplements.\u00a0\r\nThese are, for example, weight loss products that illegally contain unapproved drugs.\u00a0\r\nIn some cases, responsible manufacturers are unknowingly receiving tainted ingredients.\u00a0 That is why testing and quality controls have to be an important component of manufacturing.\r\nBut, 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.\u00a0\r\nThis should be a major target of FDA\u2019s enforcement.\r\nAdditionally, 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.\u00a0\r\nThat is why we have worked for several years to pass \u201cDASCA\u201d \u2013 or the Designer Anabolic Steroid Control Act.\u00a0 We are coming closer than ever to enactment \u2013 the bill under the leadership of Subcommittee Chair Joe Pitts passed the House in the middle of September and I\u2019m hopeful it will pass the Senate this year.\r\nOther Issues\r\nI\u2019m committed to advocating for your industry in other areas of concern, including possible guidance from the agency regarding new dietary ingredients.\r\nSince 1994, sales of dietary supplements have evolved into a very sophisticated marketplace with products sold worldwide.\u00a0 At times, though, the industry has faced barriers to sales overseas.\u00a0\r\nAs 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.\r\nAs 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.\u00a0 This, of course, is an unfortunate trend that should be reversed.", 1, "2026-03-30T12:14:52Z", "2026-03-30T12:14:52Z"]], "columns": ["url", "title", "date", "year", "month", "party", "chamber", "state", "member_name", "bioguide_id", "domain", "scraper", "source", "date_source", "text", "has_text", "collected_at", "updated_at"], "primary_keys": ["url"], "primary_key_values": ["https://www.hatch.senate.gov/public/index.cfm/releases?ContentRecord_id=2f70eb3b-2175-4306-b78c-cc4d2e9961c5"], "units": {}, "query_ms": 1.6477939207106829, "source": "dwillis/congress-press", "source_url": "https://github.com/dwillis/congress-press", "license": "MIT", "license_url": "https://github.com/dwillis/congress-press/blob/main/LICENSE"}