This review could potentially have the biggest impact to the nation’s health food and wellness sector since the introduction of the Therapeutics Goods Act in 1989.
The supplement industry in Australia, is already, we believe the most regulated of its kind in the world, however we welcome any reforms which could make it safer.
This could mean updating compliance to cater for changes in the international marketplace, cross borders, personal importation and the worldwide web that have been introduced since the FSANZ/TGA created the industry standards in 1989.
But in light of the TGA’s consultation document on Sports Supplements (Proposed clarification that certain sports supplements are therapeutic goods), there is widespread concern regarding the implications to the Australian manufacturing and retail industry and the flow-on effects for support industries (transport, construction, equipment engineers, farmers, etc).
Furthermore, the industry believes that the proposed changes will not improve quality nor safety of the sports supplement industry but rather increase risk.
We are disappointed with the tight turnaround for consultation on this critical review, with submissions due to close at 5pm on December 3.
This review follows concerns raised by the Federal Health Minister after two consumer deaths – one from using a pure caffeine powder, and another from a protein powder used by a consumer with an underlying renal protein condition.
However, the TGA paper indicates that the two so-called ‘problem’ items of protein and caffeine DO NOT form part of this proposed TGA clarification.
The TGA is targeting foods that have ‘an equivalent pharmacological action’ to an array of ingredients, or those products that are in pill/capsule/tablet form.
We believe this would potentially greatly reduce the market and therefore restrict the consumer’s right of choice, forcing them to import the products from unregulated overseas providers, decreasing safety – which is what the TGA is actually trying to improve.
With more consumers ordering on-line, the TGA proposal will also reduce the number of jobs in the industry. Qualified in-store staff, who have the potential to guide consumers safety, will disappear.
Australian retailers also have boundaries around advertising and claims to comply with FSANZ and TGA, but there is no control over buying direct from overseas.
TGA notes that many products in the market are adulterated with banned substances or contaminants. However, it is believed that these products are imports as Australian food and sport supplement manufacturers are unable to buy/import these raw ingredients. TGA’s idea to manage imports is to check labels for banned substances, however many times the ingredient is not on the label (undeclared ingredients).
TGA Regulation and Manufacture Status.
Everyone agrees, we want the safest industry possible – acknowledging the rules, regulations and testing is already in place to ensure this is already happening.
Perhaps the TGA looks at the Generally Recognised as Safe (GRAS) system, recognised in both the EU and the US.
We are calling for extensive consultation with industry (retailers, manufacturers (FSANZ, TGA and cosmetics), distributors of finished goods and raw materials, regulatory affairs consultancy, universities conducting trials, agricultural industry, naturopaths, dieticians, CMA, and associated services (local and international courier companies, freight forwarders, border security.
A Regulatory Impact Statement must be created, and an approved strategy implemented because the economic impact of these changes will be unprecedented, and the Australian economy will not be able to absorb the cost burden and loss of revenue.
Supplements likely to be impacted: