An Individual functional health claim review of MetabolAid in Korea started in December 2016.
From 2017 to 2018, The mechanism and effect were confirmed through studies that meet The Korea Ministry of Food and Drug Safety (MFDA)standards for the”weight management” registration.
From 2019 to February 2020. The clinical trials including the results of Dexa scan, which one required by MFDA was progressed and thesis registration completed.
The Korean partner NOVAWELLS who worked together in Korea for MetabolAid, prepared many documents for the functional health claim registration after a long discussion with Monteloeder about clinical data to prove the functionality and functional compound content test with validation.
The documents were finally submitted in March 2021 through those processes.
After submitting several additional documents, it was finally reviewed by MFDA in February 2022 and The final approval of the health claim has been completed.
○ Ingredient name: Extract complex of Lemon verbena and Hibiscus
○ Recognition Number: 2022-13(2022.2.24.)
○ Company or institution: NOVAWells
○ Functionality of the ingredient: May help to reduce body fat
○ Daily intake amount: 500 mg/day
The finished product in Korea aims to be launched in the autumn season 2022.
MetabolAid functions and effects have been proven all over the world, and sales are increasing rapidly during two years. So It is expected to create a huge impact in Korea too.
NOVAWells not only discussed clinical and ingredients analysis methods with Monteloeder but also prepared a number of documents and information requested by the MFDA for more than 5 years.
Therefore, I am truly thankful to Novawells as well as the people in charge of Monteloeder colleagues for their hard work for this registration of Korean Individual Health functional claim.
Receiving an Individual Functional Health Claim in Korea requires patience, cost and a lot of paperwork. The most important thing is to understand the requirements presented by the Korean MFDA guidelines for each functional claim.
Monteloeder considers it important to receive the certification of individual functional health claims for The Korea market. And has completed NutroxSun and MetabolAid certifications so far. Monteloeder will continue to review the registration of our new Brand ingredients in cooperation with Korean partners.
Clinical study (Dexa scan result included)
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7143443/
Confirmed the functional health claim registration from MFDA Korean website.
https://www.foodsafetykorea.go.kr/portal/board/boardDetail.do
For more information, please contact Jane Lee
