Published online Sep 29, 2021.
https://doi.org/10.52361/fsbh.2021.1.e36
Study on the Measure for Improving the Review System for the Individually Approved Health Functional Food
Abstract
Health functional foods have contributed to reducing national medical expenses and improving the quality of life through disease prevention and health promotion. Recently, the health functional food industry has been newly included in the bio-health industry. Therefore, health functional food industry can be supported by the government both administratively and financially, just like the already included medical product industry that produces drugs and medical devices. Currently, for the medical product approval review system, the government is implementing a policy to support the entire process from the planning stage to the product approval. Since the health functional food industry has already included in the bio-health industry, the review system for individually-approved health functional food must be prepared like that for the medical product approval. However, it is not easy to establish such a system in a short period of time. Therefore, even if it takes time, we should be benchmarking the approval review system for medical products first and operate the our current “pre-review system” under the guidance of private specialized agencies and the Ministry of Food and Drug Safety. From this, if sufficient experience and know-how are accumulated, we can prepare the system that can be implemented effectively and also get a chance to be supported from the government. In this study, I will propose a way to reach this goal.
Health functional foods improve people's nutritional status by supplying nutrients that can easily be insufficient in daily diet due to irregular eating habits of modern-day life, nutritional imbalance, and the super-aging population. It influences the function and structure of the human body by providing valuable functional components and helps to promote public health and improve the quality of life.
In addition, the health care paradigm is shifting from the post health management method with a focus on curing the disease to preventing the risk of disease in advance and managing health on a daily basis to significantly reduce national health expenditure.
In Kim et al.,1 health functional foods have been found to be effective in reducing national health expenditure by preventing disease and managing health.
This research shows that 86.0% of people take health functional foods and the medical expenses reduction due to health functional food intake was 49,598 won per person, about 2.02 trillion won in the private sector, about 6.75 trillion won in the public sector, and about 8,952 billion won in total medical costs.
The global market size of the health functional food industry2 was $143.2 billion in 2019 and $639.4 billion (prediction) in 2020, showing an annual market expansion rate of about 6%. The US holds 48.9 billion (34%) of the global market followed by China at $21.6 billion (15%) and Japan at $11.3 billion (8%). The Korean market however, despite its continuous growth, has a global market share of only about 2% due to its domestic-centered market and sluggish exports.3
The Korean domestic market size has grown by 12.1% year on year to 4.1753 trillion won in 2020 and rapidly growing at 13.7% on average for the recent 5 years according to the Ministry of Food and Drug Safety (MFDS). The health functional food industry in Korea is a high value-added industry with increasingly high growth potential.
As mentioned above, while the demand and market for health functional foods are rapidly expanding, the market size is still insignificant, therefore it is time to consider special government support policies for market expansion.
The industry's first priority is to expand the market for individually approved functional ingredients and products through the rational and efficient improvement of the regulatory science system of the individually approved health functional food review system.
Recently, the health functional food industry was newly included in the bio-health industry, to receive government support along with similar industries such as pharmaceuticals and medical devices.
Given that, this study is to propose a plan for developmental institutional improvement at the global level so that the current health functional food scientific evaluation and approval systems can be transformed into a business support-oriented operation management system in terms of R&D regulatory science development strategy through a comparative study of the individual approval review system of health functional foods and that of the similar industries.
General facts regarding the health functional food industry and an individual approval type of approbation
The Health Functional Food Act defines health functional foods “Foods that are consumed for the purposes of control nutrients for the structure and function of the human body or to obtain meaningful health effects, such as physiological reaction.” and have predetermined the manufacturing standards for each raw material, daily intake, and cautions for ingestion according to their safety, functionality, standards and specifications evaluation results. It is also stipulated to consume the health functional food within its daily intake.
In addition, functional ingredients for health functional foods are classified by the MFDS's announcement of ‘Standards and Specifications for Health functional foods' (Codes of Health functional foods) into notified functional ingredients that anyone can use and individually approved2 ingredients that can only be used by the businesses that received the approval of the MFDS through its approval process. As for the notified functional ingredients, 28 kinds of nutrients (vitamins, minerals, dietary fiber, etc.) and 68 kinds of raw materials including red ginseng, aloe, and lactic acid bacteria are listed in the Codes of Health functional foods.4, 5
The notified functional ingredients accounts for 2.671 trillion won of actual output of the health functional food of 3,325.3 billion won, which is an increase of 11.2% from the previous year. Particularly, the individually approved products amount to 654.3 billion won, demonstrating a high growth rate of 19.3%.
In the top 10 health functional food market, individually approved products ranked second with a market share of 19.7% or 654.3 billion won after red ginseng with 1.09 trillion (31.9%) won of market share and are showing continuous growth. The 3rd place is held by probiotics with 525.6 billion (15.8%) won, 4th by vitamins/minerals with 298.8 billion (9%) won, 9th by protein 40.5 billion (1.2%) won, and 10th by propolis extract 35.2 billion (1.1%) won. The top 10 items accounted for 88.8% of the total market with 2.9526 trillion won.6, 7
According to the MFDS, total 647 individually approved ingredients were reported from 2004 to 2020, with 203 (31.4%) domestic materials and 444 (68.6%) imported materials (Table 1).
Table 1
Individually approved health functional food approval status (2004–2020)
In the early stages of enactment of the Health functional food Act (2002) and enforcement of the law, 9 ingredients including sardine peptide, the first individually approved ingredient, were began to be approved and in 2009, record 97 ingredients received approval. Along with the reinforced regulation due to the cases involving foreign agents in Cynanchum wilfordii, the approval cases decreased significantly to 31 cases in 2015, 21 cases in 2016, and 6 cases in 2017, but recently the figure is being recovered to 31 cases in 2019 and 15 cases in 2020.7
The number of individual approval cases by year for domestic and imported materials was respectively 43.4% and 56.6% showing a low trend in domestic materials from 2004 to 2016. However, from 2017, the number of domestic material approvals has gradually increased, and in 2020, it is reported that domestic ingredient approval rate is significantly ahead of imported ingredients with the rates of 69% and 31% respectively.
The number of functional ingredient review applications over the past five years shows that domestic material applications (27-69 cases) have continuously increased since 2017 and the figure is twice greater than that of imported material cases (22-38 cases), showing that domestic R&D and functional ingredient approval applications are being done actively.
Among the functional ingredients approved from 2004 to 2020, the most approved functionality was body fat reduction (98 cases), followed by joint/bone health (66 cases), eye health (52 cases), and memory improvement (48 cases), and skin health (46 cases).
Comparative study on the review system of health functional foods and similar industries such as pharmaceuticals and medical devices
Health functional foods go through a series of scientific evaluation processes such as in vitro tests, animal tests, toxicity tests, and experiment on human volunteers to standardize the functional ingredients and prove the food's safety and functionality. They are thus controlled by the government's management system equivalent to drugs recognized by the MFDS.
In the case of individually approved health functional foods, the MFDS has been implementing ‘group discussion’ since 2010 to support civil petitioners to facilitate the development of functional ingredients and receive accreditation. This system is a meeting of the appealing person and public officials to exchange opinions on documents submitted and plans for experiment on human volunteers in the research and development stage or accreditation application stage for approval of functional ingredients.
The pre-review system, which is recently being implemented in parallel with the group discussion, minimizes trial and error in the development process by consulting on the data prepared in accordance with the relevant regulations before the appealing person applies for individual approval functional ingredients. The system also supports the level of completion of the submitted data and expedite evaluation. However, the group discussion and pre-review do not have the same legal ground and force as the pre-review system of pharmaceuticals, and are operated at a level of autonomously presenting an exchange of opinions at the level of prior consultation.
In the case of medical products, in order to reduce trial and error in the research and product development processes and promote commercialization, a pre-review system was put in place for pharmaceuticals (implemented on June 8, 2012) and medical devices (implemented on October 8, 2011). In the meantime, the pre-review system has been individually operated as a separate provision notified by the MFDS in the ⌜Regulations on the Pre-review of Drugs, etc.⌟ and ⌜Regulations on the Operation of Pre-review of Medical Products⌟ in accordance with Article 35 (2) of the ⌜Pharmacist Act⌟ and Article 11 of the ⌜Medical Device Act⌟. In 2021, the MFDS enacted the “Regulations on the Operation of Pre-review of Medical Products” (‘21.2.22.) to integrate regulations related to pre-review of medicines and other medical devices and operate them in a systematic and consistent manner.8
The pre-review system is a system that can be used to accelerate the commercialization period by receiving the evaluation of the data that should be reviewed at the item approval stage stipulated as legal complaints in the Pharmaceutical Affairs Act and the Medical Device Act rather in advance in the product development stage.
Prior to the appealing person's application for product approval·review, for the purpose of facilitating the development and accelerating the commercialization of pharmaceutical products, pre-review on the standards for preparing safety and efficacy review data required for product approval·reporting or clinical trial plan approval of a medical product under development is being implemented.
In the field of medical products, the pre-review and pre-consultation systems are put in place side by side. Though the pre-review and pre-consultation systems look similar, there are evident differences between the two.
The pre-review system has legal force, so if the data are prepared, the period of the authorization(approval) process can be shortened by using the pre-review data. The pre-consultation system has no legal force, but is characterized by its ability to receive specific and diverse opinions by examining various possibilities and methods.
The MFDS is supporting swift commercialization from the initial stage of pharmaceuticals and other medical product development to safety management after commercialization by communicating systematically with implementing the “Official Communication Channel Operation Guideline for Medical Product Authorization and Review”.
The MFDS has operated diverse channels including integrated consultation reservations for visitors who have made an advance reservation in relation to medical product approval and review, communication on the E-people (a website where people can voice their complaints) website and with the head of the department, consultations on commercialization support operated by business departments (Pharm Navi, Priming water, Approval assistant), phone calls, e-mails, and in-person visits.
The official communication channel systematically records and stores (meeting minutes) the appealing person's consultations results and manages consultation history on “Integrated pharmaceutical information system (nedrug.mfds.go.kr)” and “E-petitioning window (emed.mfds.go.kr)”. In order to provide a comprehensive and consistent answer, the communication window is the “person in charge of the pre-review department” in the development stage's pre-review, and “Item manager of the authorization department” in the in-person review in the approval·review stage.
In addition, the MFDS stipulates that the attached pre-review notification must reflect the pre-review result when applying for authentication·certification·report·approval of drugs and medical devices.
Efficient improvement plan of the review system of individually approved items, which is health functional food R&D regulatory science
According to a survey of 250 health functional food companies by the Korea Health Functional Food Association (January 1, 2021 to March 1, 2021), it was found that a total of 1.2 billion won is expensive and takes a long time to obtain and commercialize one functional material. (Table 2)
Table 2
Cost and time for each phase in health functional food development
Unlike general foods, the individually approved functional ingredients of health functional foods need to meet high safety and functionality standards. Therefore, encounter many difficulties due to a strict evaluation system that requires scientific evidence from R&D and product development to commercialization.
The health functional food industry is an industrial structure centered on small and medium-sized enterprises, and most domestic industries do not have enough R&D investment capacity, thus the expenses for in vitro tests, animal tests, toxicity tests, and experiment on human volunteers for scientific evaluation of health functional foods are an excessive burden on the industry.
Despite the need for long-term and exorbitant cost, the number of applications for individual approval is continuously increasing due to the fact that the MFDS's functional ingredients approval and approved products provide a monopoly status and evident consumer confidence to individual companies to obtain a market advantage and success. Therefore, the demand for R&D investment expansion of the health functional food industry is continuously increasing (Fig. 1).
Fig. 1
Costs for individually approved health functional foods' scientific approval procedure.
In order to overcome the shortcomings of high cost, long-term, and low success rate due to the functional ingredients' scientific evaluation system of the current health functional foods' individual approval system, we suggest a system improvement by introducing a new pre-review system of health functional food, benchmarking the pre-review system of medical products and devices with evaluation systems with the scientific evaluation system at a rational and efficient regulatory science level. Through this, we expect that it can reduce the time required for scientific evaluation and review and minimize trial and error of the industry by connecting experts and specialized institutions at each stage required by the company and providing one-stop support for all stages of R&D, safety and functional evaluation.
The common problems of the scientific evaluation process and review system of medical products and health functional foods complained by the businesses are excessive time consumption in processing, uncertainty in review results, and lack of consistency in review results. This is because it is difficult to conduct scientific evaluation requiring a high degree of expertise with a limited number of people due to the lack of the government's budget, organizational and human resources support.
In a situation where it is difficult to realistically expect a significant increase in manpower and budget due to the nature of the government organization, in order for the review agency to conduct scientific and professional review along with the current individually approved health functional food pre-evaluation group discussion and pre-review, it is desirable to integrate with the pre-review.
The MFDS's pre-consultation function and role will be shifted in the short term through a system of mutual cooperation with external private specialized agencies, and the autonomous pre-review system, centered on supporting the appealing person without legal force, will be implemented first. At this time, it is necessary to complement the system to prevent delay in evaluation and minimize uncertainty through establishing a connected review system by documenting all processes such as roadmaps, timelines, and regulations discussed in the consultation and review process with mandatory pre-review record reports. In the long run, it is considered that the progressive regulatory science of the pre-review system operated by the MFDS, which has long-term legal effects such as medical products, needs to be implemented step by step.
In addition, it is necessary to implement an efficient system that operates with a cooperative body of the industry, academia, and government experts with a pre-review system for advice and policy adjustments such as review of the latest technology and scientific evaluation related regulations and guidelines when evaluating functional ingredients.
In conclusion, the global health industry policy is shifting its paradigm from disease treatment to prevention, and the health functional food industry continues to advance into a high value-added industry that will be the core industry in the future while contributing to improving the quality of life by reducing national health expenditure and promoting health by preventing disease.
In order for the health functional food industry to develop continuously with its recent recognition as part of the bio-health industry, it is necessary to establish an innovative scientific evaluation system for the entire process of R&D, product development, and commercialization of functional ingredients, along with the government's policy and economic support for R&D regulatory science. Also, promoting the pre-consultation support policy of functional ingredient evaluation data will help secure competitiveness of the domestic industry in the international arena and domestic functional ingredients and products to become a driving force to enter the global market.
Disclosure:The author has no potential conflicts of interest to disclose.
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