Seeking acceptance: Taiwan FDA drafts GMP to help locally-made supplements gain global recognition
The draft released on Sep 4, is open for public consultation for 60 days.
There are in total 10 chapters in the draft, which covers a range of topics, such as the organisational chart, where the responsibilities of key personnel are defined; and specifications of the production and storage areas.
It also covers specifications for the entire production process, starting from the raw materials, semi-finished products, finished-products, and packaging final products.
Other details will touch on the labelling of ingredients and dosage on containers, the premises, facilities, and equipment of the production lines.
“The primary objective of GMP of health supplements manufacturer is to ensure that quality assurance (QA) system can include GMP and quality control (QC) mechanism,” the draft stated.
Adherence to the GMP guidelines is on a voluntary basis.
Boosting global competitiveness
The introduction of GMP guidelines is seen as a significant development for the local health supplements industry, as it plays a role in boosting product competitiveness.
According to the Taiwan FDA’s official notice, the GMP guidelines are introduced to “satisfy the unique demands of the country’s health supplements industry and raise the level of the industry’s global competitiveness.”
On the other hand, Taiwan FDA Risk Management Division section chief Tsai Luen Lue previously told NutraIngredients-Asia that with the administration-backed GMP certification, it was hoped that export challenges of health supplements could be reduced.
This is because these GMP certificates will bear the logo of Taiwan FDA – a symbol of official government recognition.
At present, health supplements made in Taiwan can go through Taiwan Quality Food Association (TQF) certification – which is the equivalent of GMP – but exports faced issues such as rejection due to a lack of official government recognition.
Direct sellers’ haven?
A Euromonitor report released in February this year highlighted that direct selling firms were some of the best performers in the dietary supplement space.
Amway maintained the leading position last year, although the second-placed Grape King Enterprises was catching up.
“Amway’s network of direct selling agents is its strongest asset and its leading position is largely attributable to the close personal relationships formed between its agents and their clients
“Direct selling remains the leading distribution channel for dietary supplements in Taiwan. This is reflected in the Amway’s leadership of the category, while other successful direct selling companies present in dietary supplements include Nu Skin Enterprises, Herbalife and Avon,” said the report.
It added that the dosage formats would likely be a “key battleground” for the leading brands as “consumers continue to move away from tablets and capsules, and towards RTD tonics and other formats.”