A Regulatory Turning Point
Australia’s reputation for high-quality complementary medicines rests on a rigorous regulatory framework. In 2026, the Therapeutic Goods Administration (TGA) is intensifying its oversight with a proactive, risk-based enforcement model that will fundamentally reshape how herbal, organic, and supplement products are marketed and sold.
The Shift from Passive to Proactive Enforcement
Historically, Australia’s listed medicines pathway allowed sponsors to supply low-risk products without pre-market approval, relying on post-market surveillance. That model is evolving. The TGA’s Compliance Principles for 2026 and 2027 signal a sharper focus on product claims, advertising, evidence substantiation, quality systems, and post-market compliance. In January 2026, the TGA released its updated compliance framework, setting out a proactive approach to enforcement across all regulated sectors.
Digital Marketing Under the Microscope
Social media, influencer partnerships, and online advertising have created significant regulatory exposure. The TGA has made listed medicine advertising a priority focus area, using proactive digital advertising scrutiny and online monitoring. Sponsors remain fully responsible for ensuring all promotional claims are accurate, evidence-based, and compliant—even when third-party influencers are involved. A sponsor promoting a herbal product through influencer partnerships may face compliance risks if promotional statements imply unapproved therapeutic benefits.
Permissible Ingredients and Labelling Reforms
Regulatory changes are also affecting product formulations. The Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2026 updated the list of ingredients permitted in listed medicines, with new requirements for warning statements and label compliance. Notably, Andrographis paniculata was removed from the list of ingredients allowed in new listed medicines from 17 September 2026, following a high-moderate risk assessment. Additionally, from May 1, 2026, all complementary medicines containing vitamin B12 in mecobalamin form must reflect only the name ‘mecobalamin’ on product labels.
Evidence and Lifecycle Compliance
The era of “set and forget” evidence files is over. The TGA now expects sponsors to maintain robust evidence files, routinely review promotional materials, and ensure product claims remain supported throughout the product lifecycle. Companies must continuously review evidence, monitor scientific developments, and maintain quality systems to stay compliant.
What This Means for the Industry
The complementary medicines sector is forecast to grow by 18% over the next five years, driven by demand for vitamins, probiotics, and personalised health products. However, this growth will be increasingly concentrated among brands that combine strong compliance with clear communication. Consumer trust—already at 84% confidence in the safety and quality of complementary medicines—will favour evidence-backed brands that prioritise transparency and regulatory rigor.
Enforcement in Action
The TGA’s enforcement capabilities are expanding. In 2025, Marvel Health (Australia) Pty Ltd was fined $13,320 for alleged failure to comply with an information notice related to a complementary medicine. Consequences for non-compliance now include cancellation from the Australian Register of Therapeutic Goods (ARTG), financial penalties, and civil or criminal proceedings.
