Listed medicines containing caffeine

In 2021, we initiated targeted compliance reviews of selected listed medicines containing caffeine and caffeine-containing ingredients. 

Review process

Listed medicines may be subject to a 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. 

Caffeine and caffeine-containing materials are used as ingredients in many food products and medicines. The benefits of caffeine vary between individuals, but high caffeine intake can cause adverse effects, or even death in case of acute caffeine toxicity. In September 2019, following a safety review of caffeine, we amended the requirements for caffeine and caffeine-containing ingredients which are permitted for use in listed medicines. The new requirements include the quantity limits of caffeine in the medicine, the maximum daily dose of caffeine, and relevant warning statements on the medicine label. 

These new requirements were first included in the Therapeutic Goods Amendment (Permissible Ingredients) Determination (No. 1) 2019 - external site. To ensure compliance with the new requirements, we had a transition arrangement until 2 March 2021 for sponsors to take action on their impacted listed medicines. After this transition, all listed medicines containing caffeine or other ingredients with caffeine as a mandatory component are required to meet the revised new requirements provided in the Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2021 - external site (the Determination).

As of November 2021, a total of 328 medicines containing the ingredient of caffeine and/or herbal ingredients which are known to contain caffeine were listed on the ARTG.

What we did

We selected 44 listed medicines to review whether they met the new requirements relating to the quantity limits of caffeine and its maximum daily dose specified in the Permissible Ingredients Determination. We reviewed the in-use labels, manufacturing documents and website advertisements.

What we found

The sponsors of all 44 medicines (100%) responded to our request for information and we found that:

• 22 medicines (50%) complied with the caffeine requirements
• 11 medicines (25%) were cancelled by the sponsors after receiving TGA correspondence
• 8 medicines (18.2%) were identified with deficiencies which were corrected by the sponsors, and thus remained on the ARTG
• 1 medicine had a minor issue on the label which was not pursued in this review and 
• The compliance status of 2 medicines (4.5%) could not be determined as they were never manufactured or supplied.

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

Information for sponsors

If you are the sponsor of a listed medicine, you should:

• review the ingredients used in your medicine to ensure that any requirements and warning statements listed in the Therapeutic Goods (Permissible Ingredients) Determination are complied with
• be aware that being over the quantity limits or missing warning statements on medicine labels may result in recall of non-compliant stock
• be aware that the requirements for ingredients in the Therapeutic Goods (Permissible Ingredients) Determination can change from time to time. It is the sponsor’s responsibility to make sure that these changes are implemented to their medicine, and within the transition period if applicable and
• be aware that repeatedly failing to comply with legislative requirements could result in higher-level enforcement actions, including infringement notices or other penalties.