{"id":829239,"date":"2026-11-09T17:12:11","date_gmt":"2026-11-09T17:12:11","guid":{"rendered":"https:\/\/www.newsbeep.com\/uk\/829239\/"},"modified":"2026-11-09T17:12:11","modified_gmt":"2026-11-09T17:12:11","slug":"loren-israelsen-on-ods-drug-preclusion-mandatory-listing-and-more","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/uk\/829239\/","title":{"rendered":"Loren Israelsen on ODS, drug preclusion, mandatory listing, and more"},"content":{"rendered":"<p class=\"c-paragraph b-article-body-skinny\">The Office of Dietary Supplements (ODS) \u2013 not to be confused with the Office of Dietary Supplement Programs at the FDA \u2013 was created by the Dietary Supplement Health and Education Act (DSHEA) in 1994 to provide a scientific focus on supplements within the NIH.<\/p>\n<p class=\"c-paragraph b-article-body-skinny\">\u201cIt was decided right after DSHEA by NIH to put it into the office of the director, where there would be more ability to decide where the value of the office could assist other parts of NIH,\u201d said Israelsen during an interview at SupplySide Global 2026. <\/p>\n<p class=\"c-paragraph b-article-body-skinny\">To move it to the ONR would do a couple of things, said Israelsen. Firstly, it\u2019s seen as a demotion in many people\u2019s minds, but more importantly, the architects of DSHEA worked liked crazy to avoid the word \u2018nutrition\u2019 in the law. <\/p>\n<p class=\"c-paragraph b-article-body-skinny\">\u201cIt had to be dietary, and it just doesn\u2019t fit over nutrition. What about all the non-nutrients? The growing perception would be this office deals with vitamins and minerals, etc. So, we think it confuses and it misleads all parties as to what the role and purpose of the office is.\u201d<\/p>\n<p>Drug preclusion<\/p>\n<p class=\"c-paragraph b-article-body-skinny\">Israelsen also addressed a couple of other regulatory issues facing the industry currently, including drug preclusion, which is the subject of a recent bill by Congresswoman Diana Harshbarger (R-TN) called the <a href=\"https:\/\/www.nutraingredients.com\/Article\/2026\/09\/12\/new-bill-seeks-to-fix-drug-preclusion-provision-to-boost-dietary-supplement-innovation\/\" target=\"_blank\" rel=\"nofollow noopener\">Dietary Supplement Innovation Act<\/a> (Harshberger was re-elected to Congress during the 2026 midterms). <\/p>\n<p class=\"c-paragraph b-article-body-skinny\">\u201cAssuming that drug preclusion is on the agenda for next year, and assuming the Democrats are controlling the House, this will be on their agenda. Hence, it\u2019s important,\u201d said Israelsen. <\/p>\n<p class=\"c-paragraph b-article-body-skinny\">The bill divided the industry, with the American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA), and the Council for Responsible Nutrition (CRN) voicing their support and the Natural Products Association (NPA) expressing concerns. <\/p>\n<p class=\"c-paragraph b-article-body-skinny\">\u201c[The bill was] well thought out, well crafted, and it took a hell of a long time to get to that point to bring the trades within alignment,\u201d said Israelsen. \u201cAnd not all the trades agreed. We [UNPA] decided to remain neutral on the view that if it plays out a bit further, we could be another voice as the issue matures and felt that there was there was a good reason just to sit tight. <\/p>\n<p class=\"c-paragraph b-article-body-skinny\">\u201cIt\u2019s a very complicated issue, one of the toughest there is [\u2026] There\u2019s no easy mechanism to fix this problem, and we knew that when DSHEA passed that at some point we\u2019ll run into this. We did not anticipate we would keep slamming into it as many times as we have.\u201d <\/p>\n<p class=\"c-paragraph b-article-body-skinny\">Mandatory product listing is another issue that keeps arising. A long-time objective of Senator Dick Durbin (D-IL), some industry observers expected the topic to fade away with the veteran lawmaker\u2019s retirement at the end of the current Congress. <\/p>\n<p class=\"c-paragraph b-article-body-skinny\">\u201cSenator Durbin has been the lead voice on mandatory product listing, and he does retire,\u201d said Israelsen. \u201c It\u2019s my sense that he has asked his Democratic colleagues to carry the issue on, and as a courtesy, they will. Whether they will bring the same enthusiasm to try and move it remains to be seen.\u201d <\/p>\n<p>Recognizing Trish Knight and Peter Reinecke<\/p>\n<p class=\"c-paragraph b-article-body-skinny\"><a href=\"https:\/\/www.nutraingredients.com\/Article\/2026\/06\/30\/unpa-to-sunset-at-the-end-of-2026-with-israelsens-retirement\/\" target=\"_blank\" rel=\"nofollow noopener\">With news that UNPA is sunsetting this year<\/a>, Israelsen also paid tribute to two of his long-time collaborators: Trish Knight and Peter Reinecke. <\/p>\n<p class=\"c-paragraph b-article-body-skinny\">\u201cWell, of all the people that were involved in DSHEA, Peter and Trish \u2013 and Steve McNamara \u2013 those three were the most important people,\u201d said Israelsen. \u201cPeter was the health policy staff director for Senator Harkin; Trish, health policy staffer for Senator Hatch. Democrat and Republican. The fluidity and the collegiality of the relationship between Peter and Trish and their bosses is something that we long for in the Congress today, and they were so committed to this bill because their bosses were, but they personally were too. <\/p>\n<p class=\"c-paragraph b-article-body-skinny\">\u201cAnd the amount of time and attention they gave it, and just a relentless, relentless, we will not let this go, which is also their bosses\u2019 personalities, I consider to be central, and they ran the command control, and they told people what to do and what not to do, and we followed their lead. <\/p>\n<p class=\"c-paragraph b-article-body-skinny\">\u201cI\u2019ve received more than my due share of credit, I believe. And it\u2019s high time that Peter and Trish and a number of other people be recognized for their tremendous contributions.\u201d<\/p>\n<p class=\"c-paragraph b-article-body-skinny\">Watch the video for the full interview. <\/p>\n","protected":false},"excerpt":{"rendered":"The Office of Dietary Supplements (ODS) \u2013 not to be confused with the Office of Dietary Supplement Programs&hellip;\n","protected":false},"author":2,"featured_media":829240,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[45],"tags":[8421,49093,41668,101346,33453,20619,5237,164373,7552,7553,164374,20733,29366,102,86734,3247,7554,11620,105,6591,164375,6636,75911,14143,305,306,38973,9479,56,54,55,17706,4884,151995],"class_list":["post-829239","post","type-post","status-publish","format-standard","has-post-thumbnail","category-nutrition","tag-america","tag-approval","tag-building","tag-certification","tag-clinical-trials","tag-drug","tag-drug-development","tag-exterior","tag-fda","tag-fda-approval","tag-fda-approved","tag-federal","tag-food-additives","tag-health","tag-health-and-human-services","tag-health-care","tag-hhs","tag-landmark","tag-maryland","tag-medication","tag-naval-ordnance-laboratory","tag-nutrition","tag-outdoor","tag-park","tag-policy","tag-regulation","tag-restricted-area","tag-trees","tag-uk","tag-united-kingdom","tag-unitedkingdom","tag-urban","tag-vaccine","tag-vaccine-development"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/posts\/829239","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/comments?post=829239"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/posts\/829239\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/media\/829240"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/media?parent=829239"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/categories?post=829239"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/tags?post=829239"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}