Listed medicines at risk of containing safrole

Safrole is a naturally occurring substance that may pose health risks to consumers. Studies in animals and laboratory settings have shown that it can cause genetic damage and may increase the risk of cancer. As such, limits have been placed on the amount of safrole allowed in listed medicines to ensure safe use, especially in products that may be at risk of containing this substance. 

Listed medicines must contain no more than 0.1% of safrole when they are for internal use, and no more than 1% when they are for topical application.

In 2020, we initiated targeted reviews to assess compliance of listed medicines that were at risk of containing safrole (e.g. medicines containing rosemary oil, nutmeg dry, nutmeg oil, camphor oil white, Myristica fragrans and Cinnamomum camphora). 

What we asked sponsors

We selected 31 oral and topical listed medicines that contained rosemary oil, nutmeg dry, nutmeg oil, camphor oil white, Myristica fragrans and Cinnamomum camphora. Some medicines were selected randomly while others were selected on the basis of regulatory intelligence. We asked the sponsors of these medicines to provide evidence in relation to monitoring and controlling the content of safrole in their finished products.

What we found

The sponsors of all 31 medicines (100%) responded to our request for information. Following assessment of the information provided by the sponsors:

• we did not identify any safety-related issues for 10 (32%) medicines.
• we found that for 8 (26%) medicines sponsors did not have documentation to support their certification that the medicines complied with quantity limits for safrole, and other substances including cineole, camphor and oxedrine. 
  However, subsequent testing indicated that the quantity of safrole and these other substances in the medicines was within the permissible limits and unlikely to pose a safety risk to consumers. Nevertheless, we issued educational letters to these sponsors outlining the issues with their medicines and reminding them of their regulatory responsibilities.
• we were not able to determine the compliance status of the remaining 13 (42%) medicines as they had either never been marketed or had not been supplied within the last 4 years (at the time).

The compliance review results for each medicine has been published on the Listed medicine compliance reports database. Search for ’safrole’ in the search bar to view the results.

Information for sponsors

If you are a sponsor of listed medicines, you should:

• be aware that it is your responsibility to ensure that your medicines are safe for the purposes for which they are to be used.
• review the ingredients used in your medicines to ensure that any requirements outlined in the Therapeutic Goods (Permissible Ingredients) Determination and the Poisons Standard are complied with. You are also expected to maintain appropriate records for demonstrating your medicine’s compliance with the relevant regulatory requirements, and providing this information to us, when required.
• be aware that being over the quantity limits or missing warning statements on medicine labels may result in market action (including recall) for the non-compliant stock.
• be aware that the requirements for ingredients in the Therapeutic Goods (Permissible Ingredients) Determination or the Poisons Standard can change from time to time. It is your responsibility to make sure that changed requirements are complied with during the transition period, if applicable.
• be aware that repeatedly failing to comply with legislative requirements could result in escalated enforcement actions, including infringement notices or other penalties.