Australia’s TGA removes Andrographis paniculata for use in listed medicines
The Australian Therapeutic Goods Administration (TGA) has removed Andrographis paniculata from its list of permitted ingredients for new listed medicines, effective September 17, 2026.
The decision follows years of safety monitoring and ongoing reports of severe allergic reactions, including anaphylaxis, despite previous risk management measures such as warning labels. As of Dec. 31, 2025, the TGA had received 287 reports of anaphylaxis associated with Andrographis-containing medicines.
Andrographis is used in Indian and Chinese traditional medicine for conditions such as the common cold, flu and liver support. In supplements, it has been used to relieve common cold, flu and mild URTI symptoms. The ingredient is also often combined with other herbal ingredients, including Echinacea.
“Adverse reactions to Andrographis are unpredictable and can happen the first time someone takes it, or after taking it previously without any issue,” the TGA said. “Most people affected had no history of allergies or asthma and symptoms usually appear within 30 minutes of consuming Andrographis.”
“The TGA considers that delaying implementation of this change would likely pose an imminent or serious risk of injury to consumers,” it added. “Accordingly, an amendment made under section 26BC of the Act to remove the ingredient Andrographis from the Permissible Ingredients Determination commenced on 17 September 2026.”
Why it matters: This is one of the strongest regulatory actions taken against a widely used botanical ingredient in recent years and signals that regulators are becoming less willing to tolerate safety risks in self-selected supplement products, even when those risks are relatively rare.
Given what the industry has seen around Ashwagandha and turmeric across jurisdictions, the decision also raises questions about whether other regulators around the world will revisit the safety profile of Andrographis.
Botanical adulteration rising despite 15 years of industry action
Adulteration of botanical and herbal ingredients is a significant and persistent issues, and appears to be on the rise, exacerbated by supply chain pressures, trade wars and climate change.
That’s according to Dr. Stefan Gafner, chief science officer of the American Botanical Council (ABC), who presented data at the recent 74th International Congress and Annual Meeting of the Society for Medicinal Plant and Natural Product Research (GA) in Reims, France.
According to data from three reviews conducted by ABC, gingko showed the highest rates of adulteration at 57%, followed by black cohosh (42%), echinacea (29%), ginseng (25%), elderberry (17%) and turmeric (22%).
“If you impose a tariff on another country and the raw materials get 50% more expensive, some companies will start to take shortcuts,” said Dr. Gafner. “There’s also military conflicts. Currently, with the war in Iran, gas prices are much higher which has increased shipping costs. Fertilizer costs have massively increased, too. As raw materials get more expensive, some companies start to cheat.”
Dr. Gafner has been at the heart of efforts to combat botanical adulteration through the Botanical Adulterants Prevention Program (BAPP), a partnership between ABC, American Herbal Pharmacopoeia (AHP), and the University of Mississippi’s National Center for Natural Products Research (NCNPR).
Over 15 years, BAPP has produced over 100 peer-reviewed documents exposing the extent of botanical adulteration, and a recent survey of industry members undertaken by the ABC showed that around 90% of respondents changed their quality control procedures as a result of the council’s publications, and around half said they changed suppliers.
Despite BAPP’s best efforts, however, botanical adulteration persists.
Why it matters: Supply chain integrity remains one of the industry’s most significant vulnerabilities. As demand for botanicals grows and climate pressures affect agricultural production, companies will face increasing scrutiny over ingredient authentication, traceability and quality assurance.
Is perimenopause finally becoming its own category?
Ritual is entering the perimenopause category with a hormone-free formula that is designed to support symptoms such as hot flashes, sleep issues, mood changes and hormonal transitions.
The company argues that women in perimenopause have historically been underserved despite representing a large and growing demographic.
Ritual’s new Perimenopause Health supplement combines shatavari extract (SheVari4 by Cepham) with DIM, evening primrose oil and Vitamin B6. It was developed with OB/GYNs and the company’s Scientific Advisory Board.
Perimenopause supplements are moving away from addressing individual symptoms in isolation and toward understanding the full biological transition, according to Mastaneh Sharafi, PhD, RD, senior VP of science and innovation at Ritual.
“That is why we built Perimenopause Health to support the bigger picture,” she said. “We looked at the physiology of this transition and brought together ingredients that work through different pathways.”
Why it matters: Perimenopause is evolving from a niche concern to a mainstream consumer segment, and brands are beginning to develop products specifically for this transition period rather than addressing women’s hormonal health in broad terms.
