TGA Consults on Andrographis Delisting; US Congress Proposes Mandatory Supplement Listing

London, United Kingdom — 27 April 2026

Australia's Therapeutic Goods Administration (TGA) has opened a consultation regarding the potential removal of Andrographis paniculata from its list of low-risk ingredients for listed medicines, including health supplements. This action follows a sustained increase in reported anaphylaxis cases linked to the botanical since 2019. The TGA's safety review concluded that existing risk mitigation measures have not adequately reduced the ingredient's risk profile for its continued inclusion in listed products. Products containing Andrographis, primarily marketed for immune health and cold/flu relief, are widely available in Australian pharmacies, supermarkets, and health food stores.

Concurrently, in the United States, a new legislative proposal, the 'Dietary Supplement Listing Act of 2026', has been introduced in the House of Representatives by Representative Maxine Dexter, M.D. (OR-03). This bill mandates that dietary supplement manufacturers list their products with the Food and Drug Administration (FDA). Key requirements include submitting product names, comprehensive ingredient lists (including proprietary blend details), electronic label copies, allergen statements, and all health and structure/function claims. The legislation aims to establish a public database within two years of enactment, assigning a unique 'Dietary Supplement Listing Number' to each product. Non-compliance would result in products being designated as 'misbranded'.

The mandatory product listing proposal has divided the US industry. The Natural Products Association (NPA) argues it would divert resources from research and innovation, while the Council for Responsible Nutrition (CRN) supports the concept, viewing it as a pragmatic framework to enhance FDA oversight while maintaining feasibility for responsible manufacturers.

Furthermore, the Centre for Nutraceuticals at the University of Westminster, UK, is advocating for a significant increase in clinical research involving women, particularly within sports nutrition where female participation in studies is as low as 4-13%. Dr Helena Tiekou Lorinczova and Dr Stephanie Ho Yi Chan highlighted that hormonal fluctuations in women present challenges but underscore the critical need for gender-specific data to address women's distinct nutritional requirements.

What this means for Australia

Australian brand owners utilising Andrographis in listed products must submit feedback to the TGA by 30 April 2026. A delisting could necessitate immediate product reformulation, increased compliance costs, and potential stock write-offs. This regulatory shift will likely favour brands with diversified ingredient portfolios or those employing ingredients with more robust safety profiles. Procurement teams should begin assessing alternative immune support ingredients, ensuring they meet TGA listing requirements and market acceptance to maintain category presence and avoid supply chain disruption.

What this means for United States

US supplement manufacturers must monitor the progress of the 'Dietary Supplement Listing Act of 2026' closely. If passed, it will necessitate substantial investment in data compilation and submission infrastructure. Brands should prepare for new operational overheads associated with FDA registration and the ongoing maintenance of product information. This regulation will likely increase barriers to entry for new market participants and could force smaller brands with limited regulatory budgets to consolidate or exit the market, leading to increased market concentration among larger, better-resourced players.

Brand owners increasingly rely on contract-manufacturing partners such as Supplement Factory to navigate these requirements.