The two government bodies primarily responsible for food laws in Korea are the Ministry for Health, Welfare and Family Affairs (MIHWAF) and the Korea Food and Drug Administration (KFDA)—the MIHWAF provides oversight and develops laws, while the KFDA implements the law and enforces the requirements.

The principal law that governs the food industry in Korea is the “Food Sanitation Act.” This law establishes the requirements for importation, manufacture, distribution and sale of general food products, with a number of exceptions that are governed under other laws. In 2002, Korea passed the Health Functional Food Act. Under these laws, food is classified as either “general food” or “health functional food.” Depending on the classification of the product, the labeling, ingredients and business license requirements differ.

When evaluating whether a product is a “general food” or “health functional food” the ingredients must be reviewed. A product is considered a health functional food based solely on the amount of a specific ingredient and not by the claims associated with the product. All other products fall under the category of general foods.

It is important to be aware that only health functional food products can bear a “specific health” or “structure/function” claim. Accordingly, any product bearing such claims must comply with the requirements of the applicable health functional food regulation, if one exists. Failure to comply (or if no health functional food regulation exists) deems the food in violation and KFDA will take corrective action.

The Regulatory System

The Korean functional food regulatory system resembles that of the U.S. system for over-the-counter (OTC) medicines or the Canadian monograph system for dietary supplements. Once a food is deemed a health functional food, it must follow the “recipe” identified in the Health Functional Food Code (HFF Code), which includes minimum/maximum daily intake levels of ingredients as well as the permissible claims that may appear on the product. Other than these identified claims, products may not bear health or other claims. Unlike the U.S., health claims may not appear on a product unless it is specifically identified in the HFF Code. General foods may not bear health claims.

The health functional food regulations apply to all products—regardless of the form they take—that contain the functional ingredient at the specific levels and make the claims indicated in the regulation. Typical products include squalene, royal jelly and vitamin C, and they may take the form of tablets, capsules, pills, granules, liquid and powders. Health functional foods are further divided into two separate categories: (1) Listed Health Functional Food (Listed HFF) and (2) Product Specific Health Functional Food (Product Specific HFF).

The HFF Code lists those ingredients that have already been reviewed by the KFDA. The products that are made of these ingredients are called Listed HFF. Annually, the KFDA identifies a few functional ingredients to evaluate and include in the HFF Code. In 2010, the KFDA will likely include CoQ10, saw palmetto, lutein, soy isoflavones, garcinia cambogia extract and haematococcus extract in the HFF Code. If these ingredients are included in the HFF Code, any company with a manufacturing license may utilize the regulation and create a product using the ingredient so long as it meets the standards and specifications identified. This process is similar to the monograph system in the U.S.

Requirements that apply to Listed HFF are similar to those for general food products. For example, Listed HFF can be imported and sold in Korea without a formal product approval from the KFDA, as long as: (a) it is classifiable into a category in the HFF Code and meets the standards and specifications for that category, (b) approved ingredients and food additives are used and (c) labeling requirements are met.

The second category of health functional foods is Product Specific HFFs. These products are manufactured using functional ingredients not listed in the HFF Code. In this case, the ingredient must be individually approved by the KFDA. To gain approval, information regarding the safety and functionality of the relevant ingredient(s) must be submitted to the KFDA for review. Generally, the documents include peer-reviewed journals, rulings by other countries, and other scientific findings such as clinical data. Once the ingredient is approved, the company is required to develop standards and specifications for the Product Specific HFF, which then require KFDA approval. Once this process is completed, the company must comply with the entire Product Specific HFF.

For foreign companies interested in importing a novel product into Korea, the Product Specific HFF process is an essential component to the product portfolio. This process provides the company with exclusivity and the ability to be the sole provider of the product. Care and caution should be used to ensure the process is properly managed.

Finally, a business license is required to sell health functional foods. The requirements for obtaining a business license are relatively simple. In Korea, HFFs are sold in both standalone stores and at kiosks within larger department stores. As a practical matter, companies may hire a qualified dietician or nutritionist to assist with information and provide guidance about the products. This is a particularly effective marketing tool since Korean customers are accustomed to the assistance of a learned intermediary (e.g., pharmacist) when purchasing health-related products.
Although the regulatory framework for general foods and health functional foods in Korea is similar to the U.S., they present different challenges with regard to communicating the health benefits of the product to the consumer. The general approach in the U.S. has been through an advertisement that associates the product with a health benefit. In Korea, because of the limitations associated with the HFF Code, claims are limited. Therefore, new forms of marketing and communication are necessary.

For the Future

With more than 50 million people concentrated into a relatively small geographic area, Korea presents a new untapped market for dietary supplement products. Korean consumers believe strongly in the importance of health and the positive impact of dietary ingredients. Dietary supplement and nutritional product companies are only just beginning to realize the market potential in Korea and within the Asia Pacific region.