[Edaily Reporter KIM SAE-MI ] Caregen Co.,LTD.(214370)CareGen is delaying its application for domestic “individual recognition” status as a health functional food ingredient for “ProGsterol,” a blood sugar management product that has completed the U.S. Food and Drug Administration (FDA) New Dietary Ingredient (NDI) process. Although there were initial plans to submit the application to the Ministry of Food and Drug Safety around June or July of this year to secure approval by the end of the year, as of October, it remains unclear whether the application has been filed.

“Deglusterol,” the active ingredient in ProGsterol, has a history of failing to clear the Ministry of Food and Drug Safety’s approval process once before in 2022. Although it completed the FDA’s New Dietary Ingredient (NDI) process in the U.S. that same year, approval as an individually recognized ingredient in Korea has yet to be granted, even four years later.

An Ingredient Reportedly in Development for 5 Years: MFDS Rejected It in 2022

According to a comprehensive report by E-Daily on the 2nd, Caregen Co.,LTD. is preparing to apply for domestic “individually recognized” ingredient status for three types of oral peptides, starting with Progestrol, followed by “Myoki” and “Korglutide.” Caregen Co.,LTD. had already announced last May its plan to pursue MFDS registration for these three ingredients under the “individually recognized” category.

The first product scheduled for application is Progesterol. To date, Caregen Co.,LTD. has not separately announced that it has completed its application for Progesterol with the MFDS. Regarding the delay in the application, a Caregen Co.,LTD. representative explained, “As we are striving to effectively explain the peptide substance, the review of additional materials may cause the process to take longer than originally anticipated.”

What is noteworthy is that this application is, in effect, a second attempt. Previously, in January 2022, the MFDS Health Functional Food Deliberation Committee issued a decision to reject “Corntide,” the raw material for Progesterol. Corntide is a synthetic peptide ingredient developed by Caregen Co.,LTD. to regulate blood sugar levels; it is a substance linked to diglusterol, which is currently used as the key ingredient in Progesterol. At the time, Caregen Co.,LTD. sought individual ingredient approval for Corntide.

According to the “Results of the First 2022 Health Functional Food Deliberation Committee Meeting” released by the Ministry of Food and Drug Safety in February of that year, committee members raised concerns regarding both the safety and functionality of Corntide.

Regarding safety, they pointed out the need to verify whether the manufacturing process for the synthetic peptide raw material—produced in a laboratory—could actually be applied in a GMP production facility. They also deemed the data insufficient regarding the food-grade suitability and removal of resins and catalysts used in the manufacturing process, as well as impurities that could arise during synthesis. Furthermore, they determined that there was insufficient data to support the recommended daily intake.

It also failed to meet the threshold for functional evaluation. The Review Committee determined that it was difficult to recognize the product’s functionality because there were no significant differences between the intake group and the control group in human clinical trials. It also pointed out that the rationale for additional analyses—excluding participants in certain age groups—was not valid. The meeting results explicitly state, “There were no changes in blood glucose levels, and the evidence for additional analyses was insufficient.” Ultimately, the Review Committee did not recognize either the safety or the functionality of Contide.

Jeong Yong-ji, CEO of Caregen Co.,LTD., said, “The decision stated that the safety and functionality of the ingredient ‘Contide’ could not be recognized,” adding, “We plan to actively implement additional measures to address safety concerns through separate consultations with the Ministry of Food and Drug Safety.” At the time, Caregen Co.,LTD. explained that Contide was the active ingredient in “Diglusterol,” a functional food for blood sugar control, and noted that Diglusterol was a product developed over a period of five years.

However, about two months later, the situation changed in the United States. On March 21, 2022, Caregen Co.,LTD. announced that Diglusterol had completed the FDA’s NDI process. Subsequently, Myoki completed its NDI registration in February 2025, and Coglutide completed its NDI registration this past January. Caregen Co.,LTD. has referred to these developments as “FDA approval” in various public disclosures and investor relations materials, emphasizing the safety and commercial viability of its oral peptides.

Different Thresholds for FDA NDI and the Korean Ministry of Food and Drug Safety… Have the Reasons for Rejection Four Years Ago Been Addressed

? However, the nature and scope of the review process differ between the U.S. NDI and Korea’s “individual recognition” system for ingredients.

According to the FDA, NDI is a prior notification system requiring manufacturers to submit evidence demonstrating that a product containing a new dietary ingredient is reasonably expected to be safe under the intended conditions of use at least 75 days before the product is marketed. The FDA’s response does not imply “approval” of the ingredient’s safety or functionality. In principle, the FDA does not pre-review and approve functional claims for dietary supplements.

In contrast, for ingredients approved under Korea’s “Individual Recognition” system, the Ministry of Food and Drug Safety (MFDS) evaluates not only the safety but also the functionality of a new ingredient before deciding whether to grant recognition. The statutory processing period for new ingredients is 120 days. Therefore, the mere fact that the NDI procedure has been completed in the U.S. does not guarantee that the ingredient will be recognized under Korea’s Individual Recognition system.

The key issue is the extent to which Caregen Co.,LTD. has supplemented the evidence regarding safety and functionality—which the Ministry of Food and Drug Safety (MFDS) did not accept in 2022—over the past four years. Although the company has been selling Progesterol overseas and accumulating data from human clinical trials during this time, it is now postponing its schedule ahead of the domestic application, citing the need to review additional data.

The delay with Progesterol could also affect the schedule for follow-up products. Caregen Co.,LTD.’s plan is to first submit the application for Progesterol, followed by applications for Mioki and Coglutide in the order they become ready. A company representative previously stated, “We will proceed with Progesterol first, and then move on to whichever product—Mioki or Coglutide—is ready sooner.” No specific target dates for submitting applications for these two follow-up products have been set yet.

Although all three products have completed FDA NDI registration overseas, their entry into the domestic market has effectively been blocked starting with the very first product. This is why attention is focused on whether Progestrol will be able to overcome the safety and efficacy hurdles pointed out by the Ministry of Food and Drug Safety four years ago, and when the application will be submitted.