의약품 또는 건강기능식품으로 오인·혼동할 우려가 있는 정제·캡슐 형태의 일반식품에 대한 법·정책적 개선 방안

초록

Recently, as the number of general foods in the form of tablets and capsules has increased, the possibility of consumers mistaking or confusing them for medicines or health functional foods has increased. Currently, foods that can be labeled with functionality include health functional foods and foods with functional labels, and unlike health functional foods, foods with functional labels cannot be manufactured in capsule or tablet form. In addition, general foods that claim functionality by exploiting loopholes in regulations are rapidly increasing, so it can be said that systematic management is necessary for consumer protection. Article 2 of the Food Code, Common Standards and Specifications for General Foods, Article 2. Manufacturing and Processing Standards 11) stipulates that “Foods cannot be manufactured in the form of capsules or tablets. However, confectionery, candies, chewing gum, chocolate, soy sauce, seasoned foods, processed sugar products, beverages, and processed fruits and vegetables may be manufactured in tablet form, and edible oils and fats may be manufactured in capsule form. However, in this case, they must be manufactured so that there is no risk of mistake or confusion with medicines or health functional foods.” Thus, in principle, the manufacturing of general foods in the form of tablets or capsules is prohibited. However, the above food code regulations are only regulations to guarantee the consumer's right to know and establish a sound trade order, which are the legislative purposes of the Food Labeling and Advertising Act, and it is difficult to view them as regulations to protect and promote the health of the people, so it can be seen as an excess of the limits of delegated legislation. Although this regulation appears to be targeting general foods in the form of tablets and capsules that may be easily mistaken for or confused with medicines or health functional foods, what this regulation targets is labels or advertisements that may be mistaken for or confused with medicines or health functional foods. Therefore, the provisions of the Food Code, which stipulate the manufacturing and processing standards for general foods in the form of tablets and capsules, are subject to regulation of labeling or advertising that may cause confusion or misunderstanding of general foods in the form of tablets and capsules as medicines or health functional foods. Therefore, it can be said that this is a regulation that goes beyond the limits of delegated legislation, as the Commissioner of the Ministry of Food and Drug Safety stipulated in a public notice content that could not be stipulated in a public notice from the beginning, considering the legislative purpose of the legal provision and the content of the provision. On the other hand, general foods in the form of tablets or capsules are beneficial to consumers in many ways. In other words, since general foods in the form of tablets or capsules are beneficial to consumers, unlike what the Food Code stipulates, it is necessary to broadly (in principle) allow the manufacturing and processing of general foods in the form of tablets or capsules, if possible. Of course, even in this case, it is necessary to consider revising (legislating) the Food Code to prohibit the manufacturing and processing of general foods in the form of tablets or capsules that may be mistaken or confused with medicines or health functional foods, taking into account “consumer safety (protection and promotion of national health).” That is, within the scope of the purpose of delegated legislation of the Food Sanitation Act, it is necessary to consider revising Article 2 of the current Food Code, Common Standards and Specifications for General Foods, Article 2. Manufacturing and Processing Standards 11) to “Foods containing functional raw materials for medicines or health functional foods cannot be manufactured in the form of capsules or tablets.” And in cases where general food in the form of tablets or capsules is clearly labeled or advertised in a way that can be mistaken or confused with a medicine or health functional food, it can be punished for violating the Food Labeling and Advertising Act. However, in the case of labeling or advertising general food in the form of tablets or capsules, there are cases where it borders on violating the Food Labeling and Advertising Act, or although it is not a case of violating the law in terms of preventive measures for national safety, it is necessary to supplement it to some extent as a policy for the purpose of protecting and promoting national health. In other words, as one way to prevent consumers from mistaking or confusing general foods in tablet or capsule form for medicines or health functional foods and general foods that do not contain functional raw materials for medicines or health functional foods and that do not fall under the “unfair labeling or advertising practices” stipulated in the Food Labeling and Advertising Act, it is necessary to consider, from a legal and policy perspective, the establishment of a regulation requiring that the “food type” be displayed next to the “product name,” which is one of the labeling items on the main display screen, so that anyone can easily see it.

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