Listed medicines containing fennel requiring warning statements

In 2022, we initiated targeted compliance reviews for listed medicines that require warning statements on the label based on their inclusion of the herbal ingredients Foeniculum vulgare (fennel), fennel bitter seed dry, fennel sweet seed dry and/or fennel oil.

What led to this review?

Listed medicines may be subject to a post-market compliance review at any time while they remain on the Australian Register of Therapeutic Goods (ARTG). This allows us to determine the compliance of these medicines with relevant regulatory requirements. Listed medicines are only permitted to contain low risk ingredients from an approved list at certain quantities. This list of approved ingredients can be found within the Therapeutic Goods (Permissible Ingredients) Determination. Although these ingredients are considered low risk to the general adult population, some may still pose a risk during pregnancy, breastfeeding, or to children.

One tool that we use to ensure the safety of listed medicines for specific population groups, such as children and pregnant/breastfeeding women, is mandating the inclusion of warning statements on the medicine label and advertising materials. There are over 150 ingredients approved for use in listed medicines which may require a warning statement about pregnancy, breastfeeding and/or children. For example, medicines containing the herbal ingredients Foeniculum vulgare (fennel), fennel bitter seed dry, fennel sweet seed dry and/or fennel oil are required to include the following warning statements on the label and certain advertising material:

• ‘Use in children under 12 years is not recommended’
• 'Do not use if pregnant or likely to become pregnant (or words to that effect)', and
• 'Do not use while breastfeeding.'

The absence of these warning statements for medicines that contain these ingredients may result in the unsafe use of the medicine and the increased possibility of adverse events.

What did we do?

We identified 11 listed medicines containing either fennel or fennel oil ingredients which were at high risk of non-compliance with the required pregnancy, breastfeeding and child warning statements. We asked the sponsors of these medicines to provide the labels in use to review the compliance with this requirement.

What did we find?

The sponsors of all 11 medicines responded to our request for information and we found that:

• 5 medicines included the required warning statements on the labels
• 4 medicines were missing the required warning statements from the labels and were therefore recalled: see Database of Recalls, Product Alerts and Product Corrections (DRAC). The label of one of these medicines was updated by its sponsor and it remained on the ARTG. The other 3 medicines were cancelled from the ARTG by their sponsors
• 1 medicine was missing the required warning statements from the label but was not recalled because there was no stock within expiry on the market. The sponsor updated the label of the medicine and it remained on the ARTG
• 1 medicine had not been supplied for multiple years and was cancelled from the ARTG by the sponsor.

The results of the compliance review for each medicine are published on the page Listed medicine compliance reports.

Information for sponsors

If you are the sponsor of one or more listed medicines, you should review the ingredients used in your medicines to ensure that:

• any requirements and warning statements mandated by the Therapeutic Goods (Permissible Ingredients) Determination are adhered to with respect to your medicine
• the presentation and advertising of your medicine, including your website and any related social media, also meet any requirements related to ingredients specified in the Therapeutic Goods (Permissible Ingredients) Determination.