The TGA recently released a public consultation, proposing to classify non-food appropriate sports nutrition as therapeutic goods, potentially making them subject to same regulations as complementary medicines (supplements).
The move is to strengthen regulations on sports nutrition products as the country confronts a number of high-profile deaths arising from the consumption of non-compliant products.
Speaking to NutraIngredients-Asia, Carl Gibson, CEO at CMA, urged the regulator to assess the impact that the proposal would have on the $1bn complementary medicines industry.
“We absolutely understand the need for beefing up the regulatory actions against illegal products, but we are not sure if this is the best way of all.
“What the industry wants to see now is action taken on illegal products and a proper impact assessment to inform the consultation,” he said.
Categorising sports nutrition as therapeutic goods means that factories will need to meet GMP standards, which adds financial burden onto the manufacturers.
“The industry is concerned that there is no capacity for GMP certification…We are talking about six to nine months to go through the upgrading process and there will be a loss of manufacturing capacity during this period of time.”
He estimated that about 40% of the industry would be affected as a result.
Black market?
Gibson's fear is that if the TGA was to approve the proposal, there will be fewer manufacturers who will make the cut.
This may then open up a black market to meet consumers’ demand for products that they have been using regularly.
“There will be unintended consequences I think, which is a real worry. If you can't register a product in Australia, the unintended consequence is that it will open up a black market, which will drive illegal activities.”
He said that the CMA was willing to work with the government on perceived or identified compliance or safety issues.
It also urged for a collaborative approach, in which the affected industry, CMA, retail associations, Food Standards Australia New Zealand (FSANZ), and Austrade are involved.
The public consultation will end on Dec 3 and the CMA has asked for that to be extended.
“This time, the TGA have actually put forth the public consultation with some draft orders, so it gives the impression that they are going to act very quickly.
“Due to the impact across the whole of the sector, we are asking the government to take a step and understand the impact assessment across the whole of the sector.”
