An Overview of Women’s Health Nutrition Supplement Products in South Korea

The South Korean market for women’s nutrition products is rapidly growing, fueled by high disposable incomes and increasing consumer awareness. This sector caters to health-conscious consumers, particularly younger individuals willing to invest in premium supplements. Approximately 43% of Korean adults use dietary supplements, highlighting the substantial interest in enhancing health through supplementation.

The Importance of Women’s Nutrition Supplement Products in South Korea

Women have unique nutritional needs at different life stages. During pregnancy and lactation, women require nutrients like folic acid, iron, and calcium. Menopausal women benefit from calcium and vitamin D for bone health, while aging women need supplements for joint health, cognitive function, and overall well-being. Supplements help bridge dietary gaps and address specific health concerns such as skin aging, immune support, and hormonal balance.

Market Trends for Dietary Supplements in South Korea

The South Korean nutrition and supplement market is projected to grow at a Compound Annual Growth Rate (CAGR) of 9.5% from 2022 to 2030, reaching $11.52 billion by 2030. This growth is fueled by government initiatives for promoting health and increasing consumer awareness as well as strict regulations established by the Ministry of Food and Drug Safety (MFDS), which ensure product safety and efficacy.

Popular Women’s Health Nutrition Supplement Products in South Korea

Popular women’s health nutrition products in South Korea include a variety of supplement products tailored to specific health and wellness needs:

• Red Ginseng: Known for its overall health benefits.
• Probiotics: Widely used for gut health.
• Collagen: Sought after for skin health and its anti-aging properties.
• Hyaluronic Acid: Popular for skin hydration and joint health.
• Multivitamins: Essential for overall health.

Regulations for Women’s Health Nutrition Products

The Ministry of Food and Drug Safety (MFDS) regulates the sale of health supplements in South Korea. The Korean Health/Functional Food Act, which has been effective from January 2004, mandates that health supplements must be sold in measured doses (e.g., pills, tablets, capsules, and liquids). The MFDS ensures the safety, efficacy, and proper labeling of these products.

Specific Labeling Requirements

The Ministry of Food and Drug Safety (MFDS) has implemented specific labeling requirements to ensure transparency and accuracy of food and dietary supplements:

• Country-of-origin Labeling: This applies to nutrition supplements for the elderly (aged sixty-five [65] and above). It includes labeling for the six (06) functional raw materials used in health supplements and three (03) primary raw materials used in product formulation.
• Nutritional Information Labeling: Effective from July 01, 2023, it has been mandatory for manufacturers to include detailed nutritional information on labels, including calories, sodium, carbohydrates, sugars, fats, trans fats, saturated fats, cholesterol, and protein. The MFDS outlines a ten (10)-step plan to ensure compliance with these guidelines.

General Advertising Regulations

• Truth in Advertising: The Korean Health/Functional Food Act requires health supplements to be sold in measured doses, thereby ensuring the safety, efficacy, and labeling of Health Functional Foods (HFFs).
• Combating False Advertising: Manufacturers often use misleading marketing claims, which can harm the credibility and market growth of their product. The MFDS regulates these practices to maintain consumer trust and ensure food safety.
• New Labeling Regulations: As of July 01, 2023, new regulations mandate the inclusion of specific nutritional information on labels of new food and beverage products, thus ensuring transparency and compliance.

The Role of the Market Authorization Holder (MAH)

The Market Authorization Holder (MAH) plays a vital role in registering women’s health nutrition supplements in South Korea, ensuring compliance with the Ministry of Food and Drug Safety (MFDS)’s regulations. The MAH handles product registration, safety, quality, labeling, advertising, cosmetic claims, and customs clearances. Their responsibilities include:

• Registering health supplements with the respective Regulatory authorities.
• Ensuring that all the food safety and quality standards are met.
• Overseeing accurate labeling and compliant advertising.
• Managing customs clearances for the import and distribution of food products.

Steps for Registering Women’s Health Nutrition Supplements in South Korea

• Product Development: Develop a product that complies with the South Korean regulations and standards.
• Labeling and Packaging: Ensure that the product’s labeling and packaging meet the requirements of the Korean Health/Functional Food Act.
• Registration: Submit the product for registration with the MFDS, including all the required documentation.
• Approval: Obtain approval from the MFDS.
• Marketing and Sales: Launch the product in the South Korean market, in alignment with the advertising and marketing regulations.

Post-marketing Activities for Women’s Health Nutrition Supplements

Post-marketing activities for women’s health nutrition supplements in South Korea ensure product safety, quality, and Regulatory compliance, which are crucial for enhancing consumer trust and public health. The key activities include:

• Adverse Event Reporting: Promptly reporting any side effects associated with nutraceutical products.
• Quality Control and Testing: Routine testing of ingredients, formulations, and product integrity.
• Labeling Compliance: Ensuring accurate labeling as per the MFDS’s guidelines.
• Market Surveillance: Monitoring product safety and quality.
• Good Manufacturing Practice (GMP) Inspections: Verifying the manufacturing standards.
• Regulatory Updates: Adapting to new guidelines and standards.
• Import and Export Monitoring: Ensuring compliance with international trade regulations.
• Enforcement Actions: Implementing recalls, withdrawals, fines, or penalties for non-compliance.
• Collaboration with Industry: Promoting mutual understanding and adherence to regulations.

Legal Consequences of Non-Compliance

Manufacturers and distributors face significant legal consequences if they fail to comply with South Korean regulations. Some of the major outcomes are:

• Fines and Penalties: Non-compliance can result in monetary penalties.
• Product Recall: The MFDS can mandate a product recall if it is deemed unsafe or non-compliant.
• Criminal Charges: Severe violations can lead to criminal charges.

To conclude, the market for women’s nutrition supplement products in South Korea is thriving, driven by increasing health awareness and a willingness among consumers to invest in premium products. The MFDS plays the central role in ensuring product safety and efficacy. Manufacturers and distributors must adhere to the MFDS’s regulations to avoid legal issues and maintain consumer trust.  The Market Authorization Holder (MAH) also plays a critical role in this process, handling product registration, safety, quality, labeling, and customs clearances. Consulting our regulatory experts, who specialize in MAH license holding, can help you seamlessly navigate the complex landscape of the MFDS and facilitate the launch of your women’s health supplements in the South Korean market. Contact Freyr now!

Written By Shriya Sandeep Marathe-
Senior Associate, Consumer Food and Dietary Supplements

Shriya is a Regulatory professional with seven (07) years of experience in Food Quality Control, Quality Assurance, and Food Safety. She has spent four (04) years working with Indian food companies. Her core competencies include expertise in food safety certification requirements and documentation with the US FDA, FSSAI, HACCP, FSSC 22000, ISO 9001, ISO 14001, ISO 45001, WHO GMP, Halal, and Kosher. She also possesses in-depth knowledge of human resource and safety requirements for SMETA 6.1 certification. A food technologist by profession, Shriya is a certified Food Safety Supervisor under the FSSAI FoSTaC certification program for both Basic Manufacturing and Advanced Manufacturing.