What are toothpaste and oral hygiene products?
Cosmetic toothpaste and oral hygiene products are used to care for the teeth and mouth. They include:
toothpastes, powders and gels
Who regulates the ingredients in toothpaste and oral hygiene products?
In Australia, toothpaste and oral hygiene products are regulated as either therapeutic goods or cosmetics, depending on:
how the product is advertised or presented for supply
the claims made by the product
the product’s intended use
the product’s ingredients
The Therapeutic Goods Administration (TGA) is responsible for regulating toothpaste and oral hygiene products that are medicines or marketed as having therapeutic effects. Toothpaste and oral hygiene products are classed as ‘therapeutic’ goods if they:
do not meet the relevant requirements of the Therapeutic Goods (Excluded Goods) Determination 2018
contain ingredients that are prohibited in cosmetic products under the Poisons Standard
make therapeutic claims
mouthwash with a label that says it stops gum disease is a therapeutic good because it claims to prevent a disease
toothpaste with a label that says it cures gingivitis is a therapeutic good because it claims to cure a disease
However, certain toothpaste and oral hygiene products — including dentifrices, mouth washes and breath fresheners — are excluded from TGA regulation under the Therapeutic Goods (Excluded Goods) Determination 2018 and are classed as cosmetics.
We are responsible for regulating the ingredients in these products as long as they meet the following criteria:
they don’t contain any substance included in Schedules 2, 3, 4 or 8 to the Poisons Standard
they’re advertised or presented for supply so that the only benefits claimed to result from the use of the product are consequential on improvements to oral hygiene, including for the prevention of tooth decay or the use of fluoride for the prevention of tooth decay
benefits in relation to other diseases or ailments, such as gum or other oral disease or periodontal condition, are not claimed to result from using the product
Australian Chemicals Introduction Scheme, 30 November 2020