Sirio unveils nutritional gummies compliant with Australian regulations

Sirio Pharma is launching seven gummy concepts at this week’s Complementary Medicines Australia (CMA) Innovation Day 2026 in Sydney, Australia (May 21). The company notes these gummies are compliant with regulatory standards set by Australia’s Therapeutic Goods Administration (TGA) for health products. 

The gummies include a Glowing Skin Collagen, Probiotics Vitamin C, Omega-3 Kids Brain Support, and Coenzyme Q10 100 mg gummies. 

According to Sirio, Australia’s nutritional gummy market is expanding, but there is a gap in TGA-compliant gummies, as there are limited manufacturing facilities that can make those.

Supplements marketed in the country can be regulated as a food or a therapeutic good (medicine), depending on aspects like ingredients and product claims.

For example, TGA says it considers crushed garlic in a bottle a food, as there is a tradition of using the spice as food in that form in Australia. However, if a company extracts compounds from garlic, concentrates them, and markets the product in a capsule with claims that it can be used to “relieve cold and flu symptoms,” it could be considered a medicine.

Lewis Liu, head of R&D at Sirio APAC, explains: “All technologies must comply with the TGA regulatory framework, with ingredients, claims, and stability meeting defined requirements.”

This includes aligning ingredients with TGA permitted lists, ensuring claims meet evidence standards, and creating dosage formats that remain stable in the country’s climate, where high temperatures can affect a product’s shelf life and ingredient stability.

Regulatory standards

Sirio notes that successfully marketing products in Australia depends on regulatory alignment, evidence-supported claims, and manufacturing that is compliant with Good Manufacturing Practices (GMP).

The company details that it operates under a GMP system that complies with TGA standards for various product formats, including tablets, powders, gummies, and softgels.

Successfully marketing products in Australia depends on regulatory alignment, evidence-supported claims, and GMP-compliant manufacturing.Jayne Schnitzerling, Australia and New Zealand (ANZ) sales lead at Sirio, comments: “Achieving TGA GMP certification reflects our ability to meet one of the most stringent regulatory standards globally.” 

“It assures our partners that every product we deliver is developed, tested, and manufactured to the highest levels of safety and quality expected in Australia.”

Sirio also highlights that regulatory updates have increased scrutiny on evidence substantiation and monitoring, especially in categories like immune and mental health, as these are “prone to overstatement.”

Sirio has included several concepts that support immune function in its TGA-compliant range, such as a Zinc Multivitamins gummy with 5 mg of zinc and 27.5 mcg of selenium per gummy.

Moreover, its Omega-3 Kids Brain Support gummy combines omega-3, omega-6, and omega-9 fatty acids to support healthy cognitive function, healthy brain, and neurological development.

Room for innovation

In addition, the company cautions that successful products in other markets cannot be transferred to Australia without substantial modification.

“You cannot copy a formula into Australia,” says Even Zhang, head of Product and Solution at Sirio APAC. “Products must be redesigned within the regulatory and environmental context.”

Ingredient innovation is limited by regulatory approval pathways, states the company. Therefore, competitive advantage shifts to formulations, delivery systems, and optimizing bioavailability.

According to Sirio, consumers increasingly seek new delivery formats in Australia, as in the rest of the world. Nutrition Insight previously spoke with the company about “how to go gummy,” where its brand and consumer engagement director unpacked formulation challenges behind this format.

Schnitzerling, the company’s ANZ sales lead, notes that format innovation is increasingly linked to consumer experience and differentiation.

“We have reimagined traditional powder-based supplements into gummies, making them more enjoyable for consumers while also pioneering new concepts such as gelatin-free collagen gummies and alternative delivery formats.”

At a manufacturing level, Sirio offers TGA-aligned production across different dosage forms, with technologies like probiotic stability systems, high-load encapsulation, and advanced gummy formats.

Moreover, the company supports brands to “match format with function,” while ensuring stability, efficacy, and compliance. Before formulation, it assesses if a product can exist within the TGA framework, considering ingredient eligibility, claims, and manufacturing feasibility.