Complementary Medicines Australia has outlined its case as to why the Therapeutic Goods Administration (TGA) should extend the consultation period warning “we will see many of the smaller retailers going out of business on the back of 40 to 50 per cent of products being removed from the shelves”.
Carl Gibson of the CMA said it’s not just industry but consumers who will be impacted because they “won’t have access to their favourite products”.
“We as an industry association are saying to the Government and the TGA just stop a minute, we just need to understand the impact that those orders will have across the whole of the sector.”
THE CMA DESCRIBES WHAT THE TGA IS PLANNING TO DO:
“The medicines regulator, the Therapeutic Goods Administration (TGA) is looking at reclassifying many of the sport supplements as therapeutic goods, so currently they are classified as foods and they are regulated as foods so the transiting over to therapeutic goods has a lot of knock-on effects and a lot of implications for those sport nutrition products, anything from pre workout to post workout mixes as well so whilst you might be used to seeing pill and formulas as therapeutics, this actually affects 40 to 50 per cent of all current sport nutrition products, so it’s not a small consultation, it’s a massive consultation with a huge impact as well.”
WHAT’S AT STAKE?
“We are trying to respond on behalf of the industry to actually alert the TGA: It’s affecting the whole of the supply chain and the whole of the industry, and it has possible unintended consequences of actually removing 40 to 50 per cent of all products from the shelves and what that essentially means is that you are giving consumers less choice rather than more choice.”
WARNING FOR CONSUMERS:
Consumers will go overseas or online and buy illegal products and that is only going to perpetuate the problems with safety because if you are buying products from overseas retailers, you are not sure about the quality and you are putting yourself at risk, so it’s actually having the unintended consequence of having the worse effect, rather than moving it to a more safer regime.
“My fear is consumers who won’t have access to their favourite products will look elsewhere for them, they will look online, they will import them and they don’t have the ability to test them so won’t know what the iodine level, caffeine level is or if it’s going to harm them.
“We just want action on those illegal products coming in and work with the Government and the regulator and the rest of sector on which ones need to be regulated.”
IMPACT ON INDUSTRY:
Moving a product to a therapeutic regime means that product will have to be listed on the Australian Register of Therapeutic Goods, and not all the sport supplement products qualify for that registration because it might be a different dosage, it might be ingredients – there’s a lot of criteria that have to be completed so you actually find quite a lot of product won’t actually be able to make it on to the register so they can’t be listed.
“An analogy is that if you are currently making a cake that requires three eggs, the TGA says you are only allowed now to use one egg because of the dosage limits.”
WHAT ABOUT MANUFACTURING:
Manufacturing at the moment is under Food Standards, but manufacturing under Therapeutic Goods is a different level of standard and that has to be under Pharmaceutical Standards which are regulated and audited by the TGA.
To get to a TGA standard manufacturing can take you 12 to 18 months to upgrade the facility and millions of dollars and many people won’t be able to do that and also the existing manufacturing capacity we have in Australia won’t be able to cope with the increase in demand so you are going to move you manufacturing offshore.
CALL FOR EXTENSION TO CONSULTATION:
“We have asked for a longer consultation period as this is one of the shortest, I’ve seen.” Mr Gibson said.
“We’ve asked the TGA to extend consultation and do a Regulatory Impact Assessment so we can understand the huge negative impact it is going to have across the whole sector – but we haven’t been able to secure an extension of that consultation.
“While the TGA might want to install their new orders as quickly as they possibly can, the reality is that the process and system aren’t there yet to support it.”
“We all want to see a sports nutrition sector that is safe and of the highest quality, so consumers have access to products that are safe.
“We need to make sure consultation is there so the sector is viable going forward.”