Women's health supplements: developing one in Australia

The claims a women's health product can make

A listed medicine can only carry indications from the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2025. Its tables are grouped by body system, and two matter most here:

• The reproductive system (Part 10). Indications for reproductive health.
• Pregnancy (Part 17). In 2025 the pregnancy indications moved out of the reproductive table into a Part of their own. They can't be combined in a sentence with other indications. Our prenatal and postnatal guide covers them, with the warnings a prenatal carries.

Indications can be qualified by population, time of use or tradition, and the explanatory statement gives "In females" as one population qualifier. A label can reword or combine indications without changing their meaning, but it can't imply that the product treats a serious form of a disease, ailment, defect or injury, or that it prevents or cures one. More in our guide to permitted indications.

Where the line on serious conditions sits

Many women's health conditions are diagnosed and managed by a doctor. A claim that refers to a serious form of a disease, condition, ailment or defect, one that requires "a health professional to diagnose, follow-up or treat", is a restricted representation under the Therapeutic Goods Advertising Code. It can only be used with the TGA's prior approval, or under a permission the TGA has granted. So the brief has to place the product clearly: support for normal health in a life stage, not treatment of a condition. Our TGA advertising guide covers restricted and prohibited representations, and the rules on testimonials and influencers that apply to every women's health brand marketing online.

Evidence in the right women

The sponsor holds the evidence for each indication. The TGA's Listed medicines evidence guidelines expect the medicine's target population to be consistent with the population studied, unless the difference is justified. For a women's health product, that means studies in women of the right age or life stage, at the dose and in the form the product uses. A clinically studied branded ingredient can carry much of that evidence, if its studies match (branded ingredients).

EverLeanBody's capsule shows the approach: it is built around affron®, a clinically studied saffron extract, with L-theanine, lemon balm and active-form B vitamins.

Hair, skin and nails

Many women's health ranges include a beauty supplement. A product labelled or promoted for cosmetic purposes, such as improving the appearance of skin, hair or nails, is a declared medicine when it is taken by mouth, so it needs a listing like any other. Our beauty supplements guide covers the claims and ingredients.

Building for every life stage

• Preconception and fertility. Arxi's female preconception capsule: the formula, the claims evidence, the TGA listing, the label and a 24-month stability program, with a 7-day sample pack added later.
• Pregnancy and after birth. Prenatal and postnatal formulas, covered in depth in our prenatal and postnatal guide.
• Perimenopause and menopause. EverLeanBody is a founder-led women's wellness brand for perimenopause and menopause, built around an engaged online community. Its first product is a daily capsule for women 35 and over, built to a set retail price.
• Hormonal health across a range. Ora, our founder's own brand, includes a women's hormonal health range, with every formula therapeutically dosed, plant-based and backed by evidence.

From our records

• EverLeanBody: a four-ingredient capsule built around affron®, a clinically studied saffron extract, with L-theanine, lemon balm and active-form B vitamins. We ran the brief workshop, designed the formula, built the claims evidence, secured the TGA listing, drafted the label and set up a 24-month stability program. 5.8 months from signed brief to dispatch, and a second product, built on Eriomin®, now in development with us.
• Arxi's preconception supplement: a TGA-listed female preconception capsule from a fertility brand founded by a fertility dietitian and a clinical nutritionist. Three production orders since 2024.
• Mother Daily's postnatal supplement: six formula versions, an evidence package covering eight key ingredients, and one of our largest first production runs.
• Ora: around 19 products across healthy longevity, women's hormonal health, gut health, and sleep, stress and recovery, recommended by naturopaths, herbalists and functional medicine practitioners.