Japan is possibly the first country that implements the dietary supplement management regulation. Regulation for health food is definitely required. In USA, they have Nutrition Labeling and Education Act (NLEA) as a federal law. The law gives FDA authority to require nutrition labeling of most foods regulated by the Agency. Also, nutrient content claims and health claims format has been set up. With the same standards, the regulations became effective for health claims, ingredient declarations on food and dietary supplements. Consumers can obtain essential information on ingredients.
Next, I will introduce the process of health food development in Japan, USA, Taiwan, and China. Japan is possibly the first country which implements the dietary supplement management regulation Regulation for health food is definitely required. In 1989, Ministry of Welfare in Japan includes the specific dietary supplements into the regulation for special nutritious food. With same dietary supplement product, different countries have different regulations towards this specific product. So regulation differ from country to country. Here are two icons. They are the approval mark from Japan government If you go to Japan’s drugstore, you can find these two marks on the dietary supplements. The one on the left is what we call specific healthcare food. There is human shape inside this mark.
The right one is release mark by Japan Health and Nutrition Food Association. The image is a hand holding a star. Products with these two marks represent they are certificated. In China, they use Blue Hat Sign. Taiwan is now working towards this same direction of the mark system. We will see Taiwan’s little gree man mark in later slides. In the USA, regulation in dietary supplement management is not as strict as in Japan. In 1982, USA FDA highlighted in the report that health food is hard to define. Any manufacturer wants to sell this kind of products without legal approval can be prosecuted by violating drug safety regulations. Consumers have very high demand on dietary supplements.
In 1990, there were several famous cases a person took great amounts of amino acid in order to have deep sleep. This amino acid contained harmful elements and was not labeled clearly. It was also sold to the consumer in the category as food instead of dietary supplements. This life-threaten accident arose FDA’s awareness and started to incestigate. Related law and regulation had also been established. In 1994, a famous proposed law was passed. It was law related to dietary supplement and health education. Dietary components and dietary supplements ingredients were clearly defined since then. More importantly, a complete and safe protective system to protect consumer’s right and interest has to be established before these dietary supplements products hit on markets.
Several important regulations were made during the process There must be a clear food ingredients and food nutrition composition label presented to the consumer. GMP standard to ensure food quality has also become an important standard. After the announcement was published in 1994, manufacturers started to actively consider whether they can bring the dietary supplement to another level. In 1997 if I remember it right, under the economic Clinton Government, nutrition contents information was requested more specifically to present to consumers. A bill has been approved. Nutrition Labeling and Education Act (NLEA) becomes a United States Federal law.
The act defines nutrition labeling of most foods regulated by the Agency; The law gives FDA authority to require nutrition labeling of most foods regulated by the Agency. Also, nutrient content claims and health claims format has been set up. With the same standards, the regulations became effective for health claims, ingredient declarations on food and dietary supplements. Consumers can obtain essential information on ingredients. Whether functional food or dietary supplements, a clear description is crucial. We can see from this diagram. Nutrients can be made into capsules or caplets. It can also become Food Additives as a way to add nutrients. One thing to mention, different format of dietary supplements and functional food can be classified in different category.
As a result, the regulation from FDA can be different. The relationship between food and medicine has been changed during past 30 years. In 1982, food and medicine was very different and had no connection in terms of category. After 1997, the FDA set up regulations for food and authorized health claims regulation. Later, Dietary supplements have changed this relationship gradually. For example, calcium tablets. calcium tablet can help retain bone mass and avoid osteoporosis happened. Calcium can be used as food additives, like high-calcium milk. Drinkging high-calcium milk is a way to prevent loss of calcium in bone. Milk is categorized as food. Calcium can also be made into caplets. Then it will be categorized as dietary supplements. Caltrate is a famous example.
When the public has higher demands for health pursuit, these nutritional supplement products start to raise the public’s attention. More and more people took nutritional supplements out of health pursuits.
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