Prenatal and postnatal supplements: developing one in Australia

The rules for pregnancy claims

A listed medicine can only carry indications from the TGA's list, the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025 (permitted indications). Pregnancy indications have their own Part of it, and a pregnancy indication can't be combined in a sentence with other indications.

The sponsor holds the evidence for each indication. The TGA's Listed medicines evidence guidelines (version 4.0, June 2022) expect the medicine's target population to be consistent with the population studied, unless the difference is justified. For a prenatal, that means studies in people who are pregnant or planning a pregnancy, at the dose and in the form the product uses (branded ingredients covers the same test for a single ingredient).

The warnings a prenatal carries

Warnings come from the ingredients, and a prenatal has many. In a 2022 review the TGA counted over 80 ingredients approved for listed medicines that may require a warning statement about pregnancy. The requirements are set in the Therapeutic Goods (Permissible Ingredients) Determination, which lists the ingredients a listed medicine can use and the conditions on each, and in the Poisons Standard for some ingredients (permissible ingredients).

Other statements come from the Therapeutic Goods (Medicines Advisory Statements) Specification 2021, whose schedule is the Required Advisory Statements for Medicine Labels (RASML No. 6):

• Folic acid. In a preparation indicated for reducing the risk of having a child with spina bifida or a neural tube defect, the label carries "Do not exceed the stated dose except on medical advice." and "If you have had a baby with a neural tube defect/spina bifida, seek specific medical advice."
• Pregnancy categories. A medicine for oral use with an active ingredient in category B1, B2, B3 or C of the TGA's Prescribing medicines in pregnancy database, and no other pregnancy warning, carries "If pregnant or likely to become pregnant, consult a pharmacist or a doctor before use" or words to that effect.

The TGA consulted on changes for a RASML No. 7 from 27 July to 4 September 2026; until a new instrument is made, No. 6 applies. Where each statement goes on the pack is in our labelling guide.

Taste, format and the daily dose

A prenatal carries a long list of vitamins and minerals at meaningful doses, for someone who may feel sick at the smell of it. From our records:

• The smell. B vitamins and selenium are bitter and smell strongly, and vitamin C fizzes in liquid. For Arxi's prenatal we traced the main odour to one selenium form and removed it.
• The format. Arxi's prenatal started as a liquid drop that trials showed wasn't stable and whose taste couldn't be masked. A liposomal liquid was tested, then the product moved to a two-a-day chewable with Rocoat® coated B vitamins to tame the taste (capsules, tablets and softgels).
• The label. Our label review on the same product caught two errors before print.
• Plant powders. One prenatal was built as much as possible on plant powders, over three versions of the formula, with quotes from three manufacturers. We also sourced a replacement supply of its lead plant ingredient.
• Stability. Arxi's preconception capsule has a 24-month stability program behind it (stability testing).

Evidence for every key ingredient

A prenatal or postnatal formula is only as strong as the evidence behind each ingredient. Mother Daily's postnatal supplement needed evidence behind every key ingredient, and the first formula wasn't right: it took six versions, with an evidence package covering eight key ingredients. The plant-powder prenatal's evidence package covered 13 or more ingredients.

From our records

• Arxi's preconception supplement: a TGA-listed female preconception capsule, with the claims evidence, the listing, the label and a 24-month stability program. We later added a 7-day sample pack for events and sampling. Three production orders since 2024.
• Arxi's prenatal chewable: a full prenatal vitamin and mineral dose in a two-a-day chewable with Rocoat® coated B vitamins, after a liquid that wouldn't hold. In production, due for dispatch in late October 2026.
• A prenatal built on plant powders: a TGA-listed capsule with an evidence package covering 13 or more ingredients, three formula versions and the stability protocol. The brand launched in 2025.
• Mother Daily's postnatal supplement: six formula versions, evidence on eight key ingredients, the nutrition panel and label press proofs, and a first production run of 4,935 units, one of our largest, shipped in 2024.