Insights

What evidence does an AUST L listed medicine actually need? This guide maps TGA, FTC, and ACCC substantiation thresholds by claim type — from traditional use to establishment claims.

Whether a brainwave app or sleep tool needs TGA approval depends on one thing: what the manufacturer claims it does. This post explains the SaMD classification line, what Class IIa and IIb mean in practice, and the question every health software founder should answer before launch.

Most pet supplements in Australia can avoid APVMA registration by qualifying as END products, but the four-test framework hinges on claims wording, and the ACCC still applies to every claim you make.

Three Victorians arrested, a Sydney telehealth sold for over a billion, and the MJA calling it a public health challenge. Inside Australia's strangest boom.

Australia's R&D Tax Incentive now returns up to 48% of clinical trial costs, and the 2026 Budget just made it more attractive. Here's what biotech founders need to know before committing.

Gummies are the fastest growing supplement format in 2026 — but most brands cite clinical evidence conducted at doses their gummy products can't physically deliver. Here's why that matters.

Australian and US health brands are legally responsible for health claims made by their influencers, even content they didn't write or approve. Here's what the law actually says.

From TGA to MoCRA, INCI to HRIPT, a plain-English glossary of regulatory, claims and safety acronyms for personal care, wellness and supplement brands.

The GLP-1 supplement market is worth $4.1B and growing fast — but most brands haven’t thought through their claims. We break down what’s defensible, what’s exposed, and what evidence you need.