Regulatory review: USFDA’s gummy study, Australia’s rules on andrographis and more

Find out the latest regulatory updates regarding Asia-Pacific's nutraceutical industry.
Find out the latest regulatory updates regarding the Asia-Pacific and global nutraceutical industry in this round-up. (Getty Images)

The U.S. Food and Drug Administration’s (USFDA) assessment of gummy supplements production, Australia’s stricter rules on andrographis use and New Zealand’s upcoming revisions to its natural health products export policies are some of the latest updates in this regulatory news round-up.

Sticky situation: FDA weighs in on gummy dietary supplements

The mature dietary supplement market has been drawing increasing scrutiny from regulators, inspectors and legacy supplement brands.
The mature dietary supplement market has been drawing increasing scrutiny from regulators, inspectors and legacy supplement brands. (Colorsandia / Getty Images)

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.

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.

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.

EFSA sets out scientific priorities for food safety, innovation and AI

Explore related questions

Parma, Italy - July 13, 2014: Efsa, headquarters, European food safety authority.
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)

The European Food Safety Authority (EFSA) has published a roadmap for European food regulation over the next decade.

The roadmap outlined how food safety risk assessments should evolve in response to innovation, climate change and emerging technologies.

EFSA published the position paper ahead of its Safe Food, One Future conference in September 2027, where it will launch the new strategy.

Kiwi government proposes new rules for supplement exports, industry voices support

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.
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)

New Zealand’s Food Safety Minister Andrew Hoggard has proposed loosening requirements for dietary supplements meant for export—a move that the local industry believes would be a game-changer.

In his Sept. 23 announcement, Hoggard introduced updates that would allow New Zealand’s dietary supplements exporters to make therapeutic claims in line with the requirements of importing countries.

Exporters will also be exempt from New Zealand’s compositional requirements for food additives and the maximum daily dose of vitamins and minerals.

Industry, research experts surprised, disappointed at TGA’s Andrographis removal

From Sept. 17. 2026, Andrographis paniculata-containing supplements sold in Australia will only be available through the registered medicines regulatory pathway, the TGA announced.
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)

Australia’s health supplement and herbalist associations, along with a leading botanical research expert, have voiced disappointment over the Therapeutic Goods Administration’s (TGA) decision to remove Andrographis from listed medicines.

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.

Jon Wardle, professor of public health at Southern Cross University and foundation director of the university’s 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.

Andrographis no longer allowed in new listed medicines sold in Australia

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©Getty Images - rungniran ramolsan (rungniran namolsan/Getty Images/iStockphoto)

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.

Sponsors of existing Andrographis products will be receiving recommendations from the TGA to either voluntarily cancel their products’ ARTG listing or recall their products.

The move comes after the TGA’s safety review consultation with targeted industry stakeholders in April, where it raised concerns about anaphylaxis associated with Andrographis supplement use.