{"id":876173,"date":"2026-10-09T10:06:15","date_gmt":"2026-10-09T10:06:15","guid":{"rendered":"https:\/\/www.newsbeep.com\/us\/876173\/"},"modified":"2026-10-09T10:06:15","modified_gmt":"2026-10-09T10:06:15","slug":"usfdas-gummy-study-australias-rules-on-andrographis-in-regulatory-round-up","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/us\/876173\/","title":{"rendered":"USFDA\u2019s gummy study, Australia\u2019s rules on andrographis in regulatory round-up"},"content":{"rendered":"<p><img decoding=\"async\" data-chromatic=\"ignore\" alt=\"The mature dietary supplement market has been drawing increasing scrutiny from regulators, inspectors and legacy supplement brands.\" src=\"https:\/\/www.newsbeep.com\/us\/wp-content\/uploads\/2026\/10\/1791540373_436_LW2V53AT5NGNXALH4VWP3JGBNQ.jpg\" loading=\"lazy\"\/>The mature dietary supplement market has been drawing increasing scrutiny from regulators, inspectors and legacy supplement brands. (Colorsandia \/ Getty Images)<\/p>\n<p class=\"c-paragraph b-article-body-skinny\">The USFDA has been keeping an eye on functional gummies, concerned that the popular dietary supplement format may not always be delivering what it says it is.<\/p>\n<p class=\"c-paragraph b-article-body-skinny\">In a perspective published in The Journal of Dietary Supplements, a team of scientists from the Office of Dietary Supplement Programs (ODSP) at the FDA explored the quantitative formulation, manufacturing and analysis challenges in the gummy production process. <\/p>\n<p class=\"c-paragraph b-article-body-skinny\">For instance, certain ingredients can degrade during matrix heating, the sticky finished product form can complicate analytical testing, and higher water activity may increase microbial susceptibility. <\/p>\n<p><img decoding=\"async\" data-chromatic=\"ignore\" alt=\"Parma, Italy - July 13, 2014: Efsa, headquarters, European food safety authority.\" src=\"https:\/\/www.newsbeep.com\/us\/wp-content\/uploads\/2026\/10\/3MEUNZR77ZCPZDTNK6YAYIVTXI.jpg\" loading=\"lazy\"\/>The report focuses on how EFSA will keep pace with food system innovation, policy change and systemic pressures, while maintaining robust, faster risk assessment. (Giorez\/Getty Images)<\/p>\n<p class=\"c-paragraph b-article-body-skinny\">The European Food Safety Authority (EFSA) has published a roadmap for European food regulation over the next decade. <\/p>\n<p class=\"c-paragraph b-article-body-skinny\">The roadmap outlined how food safety risk assessments should evolve in response to innovation, climate change and emerging technologies.<\/p>\n<p class=\"c-paragraph b-article-body-skinny\">EFSA published the position paper ahead of its Safe Food, One Future conference in September 2027, where it will launch the new strategy. <\/p>\n<p><img decoding=\"async\" data-chromatic=\"ignore\" alt=\"Trade association Natural Health Products New Zealand (NHPNZ) believes that allowing export-only health supplements to make therapeutic claims and not restricting them to local New Zealand labeling and composition rules would unlock an additional NZ$500m in revenue for the sector.\" src=\"https:\/\/www.newsbeep.com\/us\/wp-content\/uploads\/2026\/10\/JOZO6CY6Y5C2HBLDRQRT2JIIKI.jpg\" loading=\"lazy\"\/>Trade association Natural Health Products New Zealand (NHPNZ) believes that allowing export-only health supplements to make therapeutic claims and not restricting them to local New Zealand labeling and composition rules would unlock an additional NZ$500m in revenue for the sector. (Iskandar Zulkarnaen\/Getty Images)<\/p>\n<p class=\"c-paragraph b-article-body-skinny\">New Zealand\u2019s Food Safety Minister Andrew Hoggard has proposed loosening requirements for dietary supplements meant for export\u2014a move that the local industry believes would be a game-changer. <\/p>\n<p class=\"c-paragraph b-article-body-skinny\">In his <a href=\"https:\/\/www.beehive.govt.nz\/release\/improvements-proposed-level-playing-field-dietary-supplements-exporters\" target=\"_blank\" rel=\"nofollow noopener\" title=\"https:\/\/www.beehive.govt.nz\/release\/improvements-proposed-level-playing-field-dietary-supplements-exporters\">Sept. 23 announcement<\/a>, Hoggard <a href=\"https:\/\/www.mpi.govt.nz\/dmsdocument\/72733-Targeted-improvements-to-the-Dietary-Supplements-Regulations-1985-Cabinet-Paper\" target=\"_blank\" rel=\"nofollow noopener\" title=\"https:\/\/www.mpi.govt.nz\/dmsdocument\/72733-Targeted-improvements-to-the-Dietary-Supplements-Regulations-1985-Cabinet-Paper\">introduced updates<\/a> that would allow New Zealand\u2019s dietary supplements exporters to make therapeutic claims in line with the requirements of importing countries. <\/p>\n<p class=\"c-paragraph b-article-body-skinny\">Exporters will also be exempt from New Zealand\u2019s compositional requirements for food additives and the maximum daily dose of vitamins and minerals.<\/p>\n<p><img decoding=\"async\" data-chromatic=\"ignore\" alt=\"From Sept. 17. 2026, Andrographis paniculata-containing supplements sold in Australia will only be available through the registered medicines regulatory pathway, the TGA announced.\" src=\"https:\/\/www.newsbeep.com\/us\/wp-content\/uploads\/2026\/10\/CVM5H3H2WNBZ7J7QLPNMBNUOEE.jpg\" loading=\"lazy\"\/>From Sept. 17. 2026, Andrographis paniculata-containing supplements sold in Australia will only be available through the registered medicines regulatory pathway, the TGA announced. (nutoeizuza \/ Getty Images)<\/p>\n<p class=\"c-paragraph b-article-body-skinny\">Australia\u2019s health supplement and herbalist associations, along with a leading botanical research expert, have voiced disappointment over the Therapeutic Goods Administration\u2019s (TGA) decision to remove Andrographis from listed medicines.<\/p>\n<p class=\"c-paragraph b-article-body-skinny\">Complementary Medicines Australia (CMA), for instance, questioned why the government did not explore implementing stronger front-of-pack warnings as a more moderate approach rather than an outright ban.<\/p>\n<p class=\"c-paragraph b-article-body-skinny\">Jon Wardle, professor of public health at Southern Cross University and foundation director of the university\u2019s National Centre for Naturopathic Medicine (NCNM), believes there is a cause for further regulatory action and investigation, but completely removing Andrographis from listed medicines is unwarranted. <\/p>\n<p><img decoding=\"async\" data-chromatic=\"ignore\" alt=\"Indian-supplier-details-immune-cell-mechanisms-for-Andrographis-extract.jpg\" src=\"https:\/\/www.newsbeep.com\/us\/wp-content\/uploads\/2026\/10\/UQEJQ43HLZOX5J736TT2ZGFMDE.jpg\" loading=\"lazy\"\/>\u00a9Getty Images &#8211; rungniran ramolsan (rungniran namolsan\/Getty Images\/iStockphoto)<\/p>\n<p class=\"c-paragraph b-article-body-skinny\">Andrographis paniculata is no longer allowed in new listed medicines sold in Australia, starting from Sept. 17, 2026, the local regulator, the Therapeutic Goods Administration (TGA), announced. <\/p>\n<p class=\"c-paragraph b-article-body-skinny\">Sponsors of existing Andrographis products will be receiving recommendations from the TGA to either voluntarily cancel their products\u2019 ARTG listing or recall their products. <\/p>\n<p class=\"c-paragraph b-article-body-skinny\">The move comes after the <a href=\"https:\/\/www.nutraingredients.com\/Article\/2026\/04\/21\/andrographis-could-be-removed-for-use-in-health-supplements-in-australia\/\" target=\"_blank\" rel=\"nofollow noopener\" title=\"https:\/\/www.nutraingredients.com\/Article\/2026\/04\/21\/andrographis-could-be-removed-for-use-in-health-supplements-in-australia\/\">TGA\u2019s safety review consultation with targeted industry stakeholders in April<\/a>, where it raised concerns about anaphylaxis associated with Andrographis supplement use. <\/p>\n","protected":false},"excerpt":{"rendered":"The mature dietary supplement market has been drawing increasing scrutiny from regulators, inspectors and legacy supplement brands. 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