What are the proposed changes?
- Click this link to view the original consultation paper (dated October 2019).
- Note: The decision tree for whether a product is classified as a therapeutic good has already been updated. (see image below)
Summary (in layman’s terms):
- For the most part, Sports Supplements are classified as “Foods” as per Food Standards Australian and New Zealand. To be specific “Formulated Supplementary Sports Foods”.
- The TGA believes that some of these supplements should be classified as “therapeutics goods” due to claims and/or ingredients and form (capsules & tablets).
Who/what will this effect the most?
- Any supplements that contain WADA or ASADA non-compliant ingredients.
- All Australian manufacturers.
- All products that make therapeutic claims.
- Changes are to be put before parliament circa May 2020.
Why is this change required (as put forward by the TGA)?
- The TGA believes that for the greater good of the population , there needs to be greater regulation, in relation to the claims made by “formulated supplementary sports foods”.
- Extreme example 1 – an Australian consumer stops taking their medically prescribed anti-depressants because they purchase a cortisol reducing product from a supplement store
- Extreme example 2 – an Australian consumer stops following their doctors advice to treat their allergies because they have purchased a gut health correcting product at a pharmacy.
- Extreme example 3 – an Australian consumer fails an ASADA test because they were unaware that a pre-workout contained a WADA non-compliant item in the ingredient listing.
- “All claims” will classify products as therapeutic = MYTH. Example – if you use the term “muscle building” in your product, it will be banned. This is not true.
- Any Caffeine product with high levels of caffeine will be classified as therapeutic = MYTH. In fact, the TGA proposals have had nil changes on caffeine added to beverages and or powdered products (Schedule 29) that FSANZ has always had in place.
Questions that were not answered or still to be answered:
- How is the TGA going to enforce a level playing field for goods coming into the country from international online retailers. Is it possible that they can stop every pill, tablet and pre-workout that arrives in the country to check for compliance. The TGA responded with words to the effect that their responsibility is to protect the “greater population” (https://www.tga.gov.au/role-tga).
- Will these changes allow “large pharmaceutical companies” to create monopolies over certain ingredients in the Australian market place, due to their ability and resources to register said ingredients with the TGA (circa $25k per ingredient plus preparation costs).
- Method of delivery manipulation; Example – what if the product instructions say to “open the capsule and pour it over your cereal”. Does that become a food and not a therapeutic good?
- Why wasn’t FSANZ FSSF Schedule 29 revamped (20 years old) prior to these changes being made?
- Why are we the first country in the world to incorporate WADA (a foreign legislation body) into our legislation. Extreme example – but what if WADA made avocados illegal, would we have to make it illegal as well?
- How quickly will lead times be from WADA registration to TGA enforcement (example “synephrine” is on the WADA watch list ; so if it becomes illegal, how many days/months would retailers have to get it off their shelves)?
How will this affect VPA products?
- As it stand, the proposed TGA changes will not effect VPA products in their current formulations.
- Capsules and tablets will be assessed on a line by line basis to assess the ROI that they provide in relation to the registration costs . Depending on this assessment, capsules may or may not be removed from the product range. We advise to purchase your favourite capsules or tablets now to avoid missing out.
Why are all tablets/capsules/pills classified as therapeutic?
- The TGA proposes that the “man on the bondi tram” believes that something in capsule form is medicinal in nature. VPA agrees somewhat or more accurately doesn’t have a counter argument/study to propose otherwise.