TGA Regulating sports supplements
Whlile some sports supplements have been regulated as medicines, many sports supplements have typically been regulated as foods. The TGA has now declared that certain sports supplements are therapeutic goods. This represents a change to the regulation of sports supplements in Australia.
The declaration will only apply to those products that make claims relating to performance in sport, exercise or recreational activity and:
- contain ingredients that are higher-risk (such as those containing substances in a schedule to the Poisons Standard) or included in the World Anti-Doping Code's Prohibited List) or
- are in a medicinal dosage form of a tablet, capsule or pill.
You can read the full declaration here.
WHICH SPORTS SUPPLEMENTS ARE BEING REGULATED BY THE TGA?
There are two broad categories of sports supplements that the TGA will now regulate. These are:
1. Oral products that contain:
a. a substance in a schedule to the Poisons Standard;
b. a substance identified on the World Anti-Doping Code's Prohibited List;
c. a relevant substance that is added as an ingredient to the goods; or
d. a substance with equivalent pharmacological action to a substance mentioned above that may be an active principle, precursor, derivative, salt, ester, ether or stereoisomer
2. Products supplied in the form of a tablet, capsule or pill (other than goods containing glucose only)
if the products make therapeutic claims which include:
- gaining muscle
- increasing mental focus
- increasing metabolism
- increasing stamina
- increasing testosterone levels, reducing oestrogen levels, or modifying hormone levels
- losing weight or fat
- preparing for workout
- recovering from workout
More information is available on the TGA's website.
The TGA has also created a tool to help you determine if your sports supplement is a therapeutic good under the declaration.
WHEN ARE THE CHANGES COMING?
The TGA has provided two transition periods for these changes.
Products in category 1, that is, sports supplements that contain substances or ingredients listed in the declaration, have until 30 November 2020 to conform to the Therapeutic Goods Act 1989, reformulate to remain within the food framework, or withdraw products from the market.
Products in category 2, that is, sports supplements that are in the form of tablets, capsules, or pills, have until 30 November 2023 to conform to the Therapeutic Goods Act 1989, change the dosage form to remain within the food framework, or withdraw products from the market.
WHAT DOES REGULATION BY THE TGA MEAN FOR SPORTS SUPPLEMENTS?
Products that are included in the TGA's new regulatory framework now need to comply with the Therapeutic Goods Act 1989. This means that products will need to be listed on the Australian Register of Therapeutic Goods (ARTG).
If the products contain ingredients that are included in the Poisons Standard, these products will need to be included as registered (or high risk) medicines. These products will be assigned an AUST R number. Products that do not contain ingredients in the Poisons Standard can be listed on the ARTG. These products will be given an AUST L number.
The TGA suggests that most sports supplements will be regulated as 'listed medicines'. Among other things, this means that products will need to contain ingredients in the Permissible Ingredients Determination, only make claims that come from the Permissible Indications Determination, be manufactured in an approved facility and be eligible for listing.
You can check out our Regulation Basics to learn more about the requirements that listed medicines need to meet.
WHAT PRODUCTS ARE NOT AFFECTED?
Sports supplements that contain lower-risk ingredients that are presented as foods will not be regulated as medicines. This includes products such as protein powders, nutrition bars, and energy drinks. Other products that don't make therapeutic claims (such as claims relating to enhancing sports or exercise performance) such as artificial sweeteners will also be excluded.
CAN YOU HELP US?
Absolutely! The regulatory affairs consulting team at Avicenna Consulting has been preparing to help existing and new sports supplements suppliers to transition their products to the TGA's regulatory framework.
We can assess your sports supplement products to determine whether they are captured by the TGA's new framework. We can help you to decide whether your product should be transitioned to the new framework or whether it would be best for you to reformulate or redesign your product to ensure you remain within the food framework.
We can help you figure out if your product should be registered or listed on the ARTG and help you prepare your safety, quality, and efficacy evidence to meet the TGA requirements.
Want to learn how we can help you?
Contact us to find out more