⚖️ The Critical Fork in the Road: Food vs. Medicine

The single most important decision is product classification. A product sold in Australia or New Zealand must be either a food or a medicine—it cannot be both. Its classification dictates everything from ingredients and claims to manufacturing requirements.

1. Formulated Supplementary Sports Foods (FSSFs)

• Regulation: These are regulated as foods under Standard 2.9.4 of the Code. They are formulated to help sports people achieve specific nutritional or performance goals.

• Key Format: Typically, products sold as powders, bars, or ready-to-drink beverages are classified as foods.

• Compositional Hurdles: Standard 2.9.4 sets strict limits on the addition of various vitamins, minerals, amino acids (like $\beta$-alanine, which is limited to $1.2\text{ g}$ per one-day quantity), and other substances. Furthermore, many substances common overseas (like certain high-level botanicals or drugs) are prohibited from being included in any food.

2. Therapeutic Goods (Complementary Medicines)

• Regulation: Products that are intended for a therapeutic purpose—like preventing or curing a disease, or influencing a major physiological process—fall under the TGA.

• Key Format: Products presented in tablet, capsule, or pill form are nearly always regulated as therapeutic goods, regardless of their ingredients.

• Manufacturing: They must be manufactured in facilities compliant with Good Manufacturing Practice (GMP) and must be listed (AUST L) or registered (AUST R) on the Australian Register of Therapeutic Goods (ARTG).

The Supplab Advantage: We eliminate the guesswork. Our formulation team understands the fine print of the FSANZ Food Standards Code, allowing us to structure your ingredient profile and dose size to successfully remain compliant as an FSSF, avoiding the costly and time-consuming burden of TGA regulation.

🔑 Crucial Compliance Pillars

Even once classified as a food (FSSF), a product must adhere to stringent standards.

🍎 Safety and Composition (The Ingredient Guardrail)

Every ingredient must be expressly permitted and safe. For an FSSF, this means:

• No Prohibited Substances: Ensuring ingredients do not appear on the schedules of prohibited plants or substances in the Code.

• Limit Compliance: Adhering to the specific maximum permitted amounts for fortifying nutrients and other added substances, as detailed in the relevant Standards (e.g., limits for amino acids and specific vitamins).

🏷️ Labelling and Claims (The Communication Constraint)

FSANZ tightly controls what can be stated on a food label and in marketing.

• Mandatory Statements: FSSFs require specific warning statements, such as being 'Not suitable for children under 15 years of age or pregnant women'.

• Claim Substantiation: All Nutrition Content Claims (e.g., "high protein") and Health Claims (e.g., "contributes to muscle growth") must meet the rigorous scientific evidence requirements of the Code. Critically, there are specific prohibitions in Standard 2.9.4 against making claims related to enhanced athletic performance or beneficial physiological effects for many types of sports foods.

✅ Partner with Supplab for Certainty

The consequences of non-compliance—ranging from product recalls and seizure of stock to significant fines—are simply too high to risk.

At Supplab, our expertise is your peace of mind. We specialise in:

• FSANZ-Focused Formulation: Crafting ingredient lists and serving sizes that adhere strictly to Standard 2.9.4 and the broader Code.

• Compliance Review: Rigorously auditing labels and marketing copy to ensure all nutrition and health claims are permissible and substantiated for your FSSF.

• Navigating the Review: Keeping abreast of the ongoing FSANZ Proposal P1010 review of FSSFs to ensure your product remains compliant in a changing landscape.

Don't let regulatory hurdles stifle your innovation. Partner with Supplab to develop a best-in-class, high-impact supplement that is fully compliant and ready to dominate the market.

Ready to launch your compliant, cutting-edge supplement? Contact Supplab today to discuss your next formulation project and gain clarity on your path to market.