The Ministry of Food and Drug Safety (MFDS) announced the above last month on December 16th.
It will be introducing guidelines to assess the efficacy of ingredients that claim to “relieve leg discomfort (swelling) caused by maintaining a fixed posture for a long time” or “relieve intestinal discomfort”. Examples of intestinal discomfort would include abdominal pain and bloating.
Currently, there are already methods in place to evaluate the efficacy of functional ingredients that claim to support certain aspects of intestinal health - such as supporting smooth bowel movements, proliferation of beneficial bacteria and the inhibition of harmful bacteria in the intestines.
The MFDS has drafted guidelines on how to evaluate functional ingredients used to support leg swelling and abdominal discomfort.
For instance, it has set in place guidelines for human clinical trials used to evaluate the efficacy of functional ingredients, including the criteria for selecting or excluding trial participants, the biomarkers to measure, and the study period.
The regulator said it was responding to the industry demands for methods to evaluate functional ingredients used to support different health needs.
“This guideline reflects the industry’s recent demands for the establishment of new functional evaluation standards and includes matters to be considered when designing human trials,” said the MFDS.
It also hopes to speed up new product commercialisation by allowing the use of new health claims.
“The Ministry of Food and Drug Safety expects that this guideline will increase the industry’s understanding of the evaluation of functional raw materials for health functional foods and help with rapid commercialisation and plans to support the development of the health functional food industry by continuing to prepare new functional evaluation techniques and indicators,” it said.
To drive industry development, the MFDS last year also came up with manufacturing guidelines to support the development of slow-release health supplements.
Slow-release health supplements are designed to deliver active ingredients in the body for a sustained period.
As slow-release products can be made using microencapsulation and multi-layer delivery technologies, there are therefore opportunities for companies to develop products in novel formats at the same time.
