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The regulation of caffeine in Foods and Therapeutic Goods in Australia

09 Jul 2019 4:48 PM | Anonymous member (Administrator)

This report is in response to the tragic death of a young man who overdosed on caffeine taken in the form of an unknown powder. https://7news.com.au/news/health/young-mans-death-prompts-fathers-bid-to-ban-caffeine-supplement-powder-c-204573

The article reports on the substance being banned in the US last year after similar deaths occurred, while ready access is still available in Australia. Products regulated in other jurisdictions as dietary supplements are considered in Australia as either Foods or Therapeutic Goods; there is no separate dietary supplement category. It is not clear what type of product the caffeine powder product was, the article alludes to it as being a Food and as a Therapeutic Good, but this is not clear.
The Australian Register of Therapeutic Goods (ARTG) does not include any products considered to be pure caffeine powder supplements.


Caffeine in Australian Sports Foods

The Food Standards Code restricts how much caffeine can be added to cola-type soft drinks and energy drinks. Foods containing added caffeine must also have a statement on the label that the product contains caffeine. In terms of a food, the caffeine content is usually from guarana (a South American plant with naturally high levels of caffeine). Foods containing guarana must also be labelled as containing caffeine, this is to help people avoid caffeine if they wish.


Caffeine in Complementary Medicines

The Therapeutic Goods Administration (TGA) has historically limited the quantity of caffeine in listed low risk complementary medicines (those with an ‘AUST L number’) to 100mg, approximately the amount of one cup of coffee. This has been provided that it states it was for adults only and disclosed the relevant amount of caffeine in the product. Other, higher risk ‘registered’ (AUST R) TGA medicines were only permitted to contain larger amounts of caffeine if approved by the TGA.


In 2018, the TGA provided a proposal to allow a limitation of 600mg of caffeine in listed, low risk medicines. CMA responded cautiously, providing that such a dose could only be allowed for medicines that were allowed to be self-selected from retail shelves, if additional protections were put in place for consumer safety.


After analysing international regulatory practices for caffeine products, CMA proposed that the new quantity of caffeine could only move forward if any individual dose was limited to 200mg, consistent with the European Food Safety Authority safety evaluation. Each dose must be given at least three hours apart, up to the proposed daily maximum of 600mg. CMA further proposed that there must be additional label warning statements, to protect children and pregnant consumers, as well as a label statement to tell consumers how many cups of coffee was equivalent to a certain amount of caffeine so that consumers could more easily and safely estimate how much they could safely take.


CMA has always, and continues to support the safe, quality use of foods and complementary medicines, including an appropriate level of regulation to protect consumers from any harmful or tragic consequences from consuming unregulated products.


The safety of consumers

The CMA strongly advises consumers who are contemplating buying medicines in retail outlets around Australia or over the internet, to look for either the Australian listing number (AUSTL) or Australian registration number (AUSTR) on the product label. This way, they can be sure that the TGA regulates the products. Products available for purchase over the internet including from overseas-based internet sites without an AUSTL or AUSTR number are not Australian regulated medicines and may not be subject to the same level of quality, safety or efficacy control as medicines regulated for sale in Australia by the TGA.


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