Registration of Food Supplement in Australia

Products marketed as food supplements in other jurisdictions are often regulated as complementary medicines in Australia where they meet the definition of a therapeutic good under the Therapeutic Goods Act 1989. Products that do not meet this definition may instead be regulated as foods under the Food Standards Australia New Zealand (FSANZ) framework. Determining a product's intended purpose, ingredients, and claims is therefore essential to identifying the correct regulatory pathway.

Regulatory Authority

Therapeutic Goods Administration (TGA)

Regulatory Website

https://www.tga.gov.au/

License Validity

5 Years

Registration Timeline

45 to 210 days

Most Complementary Medicines Are "Listed," Not "Registered"

Most complementary medicines are included in the Australian Register of Therapeutic Goods (ARTG) as Listed Medicines (AUST L), based on the sponsor's certification that all applicable legislative requirements have been met. Certain complementary medicines with intermediate-level indications may instead be included as Assessed Listed Medicines (AUST L(A)), where the TGA evaluates the evidence supporting the permitted indications before inclusion. Higher-risk complementary medicines requiring full evaluation of quality, safety, and efficacy are included as Registered Medicines (AUST R).

What Listed (AUST L) Status Actually Requires

Listed medicines must comply with the requirements of the Therapeutic Goods Act 1989 and associated legislative instruments. Products may only contain permitted ingredients, use permitted indications, comply with Good Manufacturing Practice (GMP) requirements, and meet all applicable labelling and advertising obligations. Sponsors certify compliance when applying for ARTG inclusion, and the TGA may conduct post-market compliance reviews at any time.

The Permissible Ingredients Determination: A Living Document

The Therapeutic Goods (Permissible Ingredients) Determination specifies the ingredients that may be used in listed medicines, together with any applicable restrictions, maximum quantities, mandatory warning statements, or conditions of use. As this legislative instrument is updated periodically, manufacturers should always verify their formulation against the latest published version before preparing a submission.

Complementary Medicine

Complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.

In Australia, the TGA oversees regulating  pharmaceuticals and other therapeutic commodities. Before higher-risk medications can be supplied lawfully in Australia, they evaluate them for efficacy, quality, and safety. The question of whether a product performs as promised is known as its efficacy. 

Lower risk medications’ safety and quality are regulated by limiting their use to pre-approved low-risk substances and pre-approved low-risk or minor medical problems, as well as by enforcing high manufacturing standards. If they perform a formal compliance review of the medicine, the commercial sponsor is also obliged to have proof that their product is effective, and they are obligated to furnish the TGA with this proof.

The strategy used by the TGA lowers the price of approving low-risk medications. Should we evaluate every low-risk product for effectiveness prior to allowing it on the market, the extra expenses would be transferred to the end user.

Vitamins are controlled as either prescription drugs or complementary medications, depending on the vitamin and dosage. Most vitamins are classified as low-risk supplementary medications, which means that the TGA solely oversees their quality and safety.

Pre-market evaluations by the TGA of low-risk medications and supplemental vitamins entail items that satisfy certain requirements:

• Only components from a pre-approved list that the TGA has previously evaluated for quality and safety may be found in the product.

• The product’s commercial sponsor is required to select a use from a pre-approved list that is limited to minor health issues. Claims about serious and life-threatening conditions are not allowed on products.

• The product needs to be produced in an approved facility that satisfies quality requirements.

• The product’s sponsor is required to provide proof that the product performs as promised.

Manufacturing Standards Apply Regardless of Listed vs. Registered Status

Good Manufacturing Practice (GMP) requirements apply to both Listed and Registered complementary medicines. Although Listed medicines are not routinely evaluated by the TGA before inclusion in the ARTG, manufacturers must still comply with applicable GMP requirements and all relevant legislative obligations throughout the product lifecycle.

The TGA does not review the final product and its label for low-risk medications, nor does it assess the commercial sponsor’s proof of product efficacy prior to the product’s release onto the market. Nonetheless, we reserve the right to review any product as part of our sporadic and focused examination of items available for purchase. In this way, we evaluate several hundred goods annually.

We have the authority to revoke a sponsor’s approval to distribute a product in Australia if a TGA review determines that the sponsor does not have enough proof of the product’s effectiveness. Cancellation may also result from other non-compliance, such as incorrect or unsuitable labeling. On the TGA website, we frequently post lists of canceled items.

The labels of all medications that the TGA has approved for distribution have one of two numbers: AUST R or AUST L.

• AUST R codes are assigned to registered medications whose safety, efficacy, and quality have been assessed by the TGA.
• The TGA exclusively regulates low-risk listed medications for safety and quality, such as the majority of vitamin supplements, under AUST L codes.

It’s possible that medications lacking these codes won’t be permitted for sale in Australia. This is particularly problematic for products that are offered online because they can include unlisted, potentially harmful substances.

Advertising Restrictions Apply Here Too

Manufacturers must comply with the Therapeutic Goods Advertising Code and must not imply that inclusion in the ARTG represents a recommendation, endorsement, or approval by the TGA. ARTG inclusion indicates regulatory compliance with the applicable legislative requirements and should not be presented as a government endorsement of the product.

How This Differs From "Food Supplement" Regulation Elsewhere

Unlike many jurisdictions where food supplements are regulated under food legislation, eligible complementary medicines in Australia are regulated by the Therapeutic Goods Administration (TGA) under the Therapeutic Goods Act 1989. As a result, manufacturers must comply with therapeutic goods requirements relating to manufacturing, labelling, advertising, and post-market compliance.

How OMC Medical Can Help

OMC Medical manages TGA complementary medicine registration through both the Listed and Registered pathways, confirms formulation compliance against the current Permissible Ingredients Determination, and evaluates whether specific health claims push a product from the lighter Listed pathway into the more demanding Registered evidentiary requirement.

Frequently Asked Questions

Are food supplements regulated by a food safety authority in Australia, like they are in the EU?

No, they're regulated as complementary medicines under TGA's therapeutic goods framework, the same overarching system governing prescription drugs and medical devices.

Do all complementary medicines require individual TGA evaluation before sale?

No. Most complementary medicines are included in the ARTG as Listed Medicines (AUST L) based on sponsor certification of compliance. Some complementary medicines are included as Assessed Listed Medicines (AUST L(A)), while higher-risk complementary medicines requiring full evaluation of quality, safety, and efficacy are included as Registered Medicines (AUST R).

Does Listed status mean lower manufacturing standards apply?

No — GMP certification requirements apply equally to both Listed and Registered products; only the pre-market evaluation step differs.

How often does TGA update its permitted ingredients list?

The TGA updates the Therapeutic Goods (Permissible Ingredients) Determination periodically. Manufacturers should always consult the latest published version before preparing or updating a listed medicine application to ensure all ingredients and conditions of use remain compliant.