TGA Bars New Andrographis Listings Over Anaphylaxis

Australia's Therapeutic Goods Administration has removed Andrographis paniculata — a herbal ingredient common in cold-and-flu supplements — from the list of ingredients eligible for self-certified "listed" (AUST L) medicines, effective 17 September 2026. Existing listed products can keep being sold for now, but TGA is telling sponsors to act: it says it will assess from mid-October 2026 whether to compel recalls or ARTG cancellations for anyone who has not voluntarily done so.

What actually changed

Australia runs two tiers for over-the-counter and complementary medicines. "Listed" (AUST L) medicines enter the ARTG through sponsor self-certification against a Permissible Ingredients Determination — TGA does not review the specific product's safety or efficacy before it reaches shelves, though it can audit compliance afterward. "Registered" (AUST R) medicines, by contrast, undergo full TGA pre-market assessment of safety, quality and efficacy before sale. TGA's amendment removes Andrographis paniculata from the permissible-ingredients list that makes the listed pathway available, effective 17 September 2026. That closes the low-friction route for new Andrographis products; it does not, on its own, ban the ingredient outright, since a sponsor could in principle still pursue the higher-bar registered pathway. TGA said delaying the change would likely pose an imminent or serious risk of injury to consumers, the justification it uses for immediate-effect determinations.

The safety case

TGA's underlying safety review, finalized earlier in 2026 and updated with data through 31 December 2025, recorded 287 reports of anaphylaxis associated with Andrographis-containing medicines. Reporting has climbed sharply in recent years, and the review includes a report of a fatal anaphylactic reaction, received by TGA in June 2024, in a person who had used an Andrographis-containing product — an adverse-event report, not an independently adjudicated cause-of-death finding, but the case TGA cites as central to the urgency of the action. TGA had flagged the possibility of this change months earlier, running a consultation before finalizing the removal in September.

What sponsors are supposed to do now

Existing listed products containing Andrographis are not automatically pulled from the ARTG or from sale by the 17 September change. TGA's stated approach is to press for voluntary compliance first: sponsors are expected to work with manufacturers to halt production, recall affected stock, and cancel their own ARTG listings. TGA says it will assess from mid-October 2026 whether any sponsors who have not taken what it calls timely voluntary action need to be compelled — through mandatory recall or cancellation of their listing. That gives affected sponsors roughly a month's window from the effective date to act on their own terms before TGA considers using its compulsory powers.

Industry pushback

Complementary Medicines Australia, the industry body, publicly criticized the decision as disappointing, arguing TGA moved to remove the ingredient before trying a mandatory, standardized, prominent front-of-pack warning across the product category — the kind of control used to manage other rare-but-serious risks, comparing it to how paracetamol, antibiotics, and common allergens are handled through labelling rather than market removal. The dispute is a familiar one in complementary-medicine regulation: whether a low but real anaphylaxis signal is better managed through consumer warnings that keep a product available, or through removing the ingredient's easiest path to market. TGA's determination reflects the latter judgment; the CMA's public response makes clear the industry has not conceded the point.

• Action: Andrographis paniculata removed from TGA's Permissible Ingredients Determination, closing the self-certified AUST L listing pathway to new products.
• Effective: 17 September 2026.
• Basis: 287 anaphylaxis reports as of 31 December 2025, including a fatal case reported June 2024.
• Compliance deadline: TGA will assess from mid-October 2026 whether to compel recalls or ARTG cancellations for sponsors that have not voluntarily acted.
• Not affected: the AUST R registered-medicine pathway, which requires full TGA pre-market assessment, remains technically open to the ingredient.
• Industry reaction: Complementary Medicines Australia says a mandatory warning label should have been tried first.

Frequently asked questions

What did TGA change, and when?

Effective 17 September 2026, TGA removed Andrographis paniculata from the Permissible Ingredients Determination, closing the self-certified AUST L listed-medicines pathway to new Andrographis-containing products.

Are existing Andrographis products pulled from sale immediately?

No. TGA is strongly recommending voluntary cancellation or recall now, and will assess from mid-October 2026 whether compulsory action is needed against sponsors who have not acted.

Why did TGA act?

A safety review recorded 287 anaphylaxis reports linked to Andrographis-containing medicines as of 31 December 2025, including a fatal case reported in June 2024; TGA said delay would likely pose an imminent or serious risk of injury.

Is Andrographis banned outright?

No. The change closes the lower-bar listed (AUST L) pathway. The higher-bar registered (AUST R) pathway, requiring full pre-market TGA assessment, remains technically available.