Tight scheduling restrictions are being imposed on caffeine powders
Currently unregulated caffeine powders are to be included as scheduled medicines, after an interim decision announced by the Therapeutic Goods Administration late last week.
The TGA’s Advisory Committee on Medicines and Chemicals Scheduling decided at its November 2019 meeting to list caffeine in Schedule 6 and Schedule 4.
The decision follows increasing public concern and reporting of caffeine-related health incidents, including a fatal case in NSW linked to acute caffeine toxicity. It sees many caffeine powder products moved to the S6 Poisons schedule, except for some prescribed preparations.
The new listing states:
Schedule 6 – New Entry. CAFFEINE except:
a) when included in Schedule 4; or
b) in divided preparations for internal human therapeutic use when labelled with a maximum
recommended daily dose of no greater than 600 milligrams of total caffeine; or
c) in undivided preparations for internal human therapeutic use with a concentration of less
than 5 per cent of total caffeine and when labelled with a maximum recommended daily
dose of no greater than 600 milligrams of total caffeine; or
d) in preparations for external use; or
e) in other preparations with a concentration of less than 5 per cent of caffeine.
Schedule 4 – New Entry. CAFFEINE for internal human therapeutic use except:
a) in divided preparations when labelled with a maximum recommended daily dose of no
greater than 600 milligrams of total caffeine; or
b) in undivided preparations with a concentration of less than 5 per cent of caffeine and when
labelled with a maximum recommended daily dose of no greater than 600 milligrams of
The scheduling delegate commented that “I have considered the information provided with the application and the advice of the Committee and have made the decision to include caffeine in Schedule 4 and Schedule 6 of the Poisons Standard.
“While caffeine in food and beverages and its use therapeutically is subject to regulatory oversight, pure and highly concentrated caffeine powder, which is not packaged or labelled in a way to reduce the risk of poisoning, can be purchased in Australia without restriction via web-based vendors,” the delegate said.
“The inquest by the Coroner’s Court of NSW into a recent fatality associated with inadvertent caffeine overdose, demonstrates that the current availability of pure and highly-concentrated caffeine powder presents a clear public health risk.
While pure or highly concentrated caffeine poses a clear public health risk, it does not meet
the SPF Scheduling Factors for inclusion in Schedule 7. However, I am satisfied that reasonably
foreseeable harm to users from the known dangers of pure and/or highly concentrated caffeine can be
sufficiently reduced via a Schedule 6 listing, requiring products to include strong label warnings (i.e.
POISON) and extensive safety directions educating consumers on its potential dangers and safe use”.
The delegate added that “In light of standard doses of caffeine in food and therapeutic products, I am also satisfied that the 600 mg maximum daily dose exemptions from Schedule 4 and Schedule 6 for preparations for human internal therapeutic use are acceptable. These will continue to allow both ARTG listed and registered products to continue to be marketed without any scheduling restrictions.
Although the 600 mg cut-off is higher than the dietary 400 mg recommended by FSANZ…I am of the opinion that it is reasonable given that caffeine is being used as a medicine”.
See here for more on the latest scheduling announcements