You find a health food that sells well in Korea or elsewhere in Asia, and then comes the step of bringing it into Japan. What stops the most products at that point is ingredients. In Japan, the mere presence of a given ingredient makes the product a drug rather than a food. This is called the food–drug classification.

Judged against two lists

The Ministry of Health, Labour and Welfare publishes two lists as “examples of the treatment of ingredient substances (raw materials) in the food–drug classification”.

  • List of ingredient substances used exclusively as drugs
  • List of ingredient substances not judged to be drugs unless drug-like efficacy is claimed

Ingredients on the first list cannot be used in what are commonly called health foods. If even one is used as a raw material, the product is judged to be a “drug”. Once treated as a drug, it cannot be imported as a food.

What is treated as “exclusively a drug”

Substances judged to be exclusively drugs are those with an established record of use as drugs, or those containing ingredients equivalent to prescription drugs that need to be regulated as drugs from a public health standpoint. The criteria are the distribution reality and safety in Japan; whether the substance is sold as a food in its country of origin is irrelevant.

“It was on the health food shelf in Korea” — this fact cannot be used in determining classification in Japan.

The second list has a pitfall too

The list of substances “not judged to be drugs unless drug-like efficacy is claimed” means they can be treated as food conditionally. Read the other way, the moment efficacy is claimed, the product tips into being a drug. Rendering country-of-origin packaging or e-commerce descriptions directly into Japanese crosses that line more often than one would expect.

The ingredients themselves may be fine, and the way it is sold makes it a drug. It is closer to reality to consider that classification is determined by ingredients and claims together.

Order of checking

  1. Obtain the full ingredient list in the original language (the original, not an English translation or summary)
  2. Check it against the “exclusively drugs” list
  3. If nothing matches, confirm that the claims you intend to make do not amount to efficacy claims
  4. Only then begin preparing the food import notification

Completing this check before commercial discussions turns out to be the faster route. We carry out ingredient checking at the early stage of sourcing consideration. If a product’s status is uncertain, please raise it at the planning stage.

Primary sources referenced

※ This article summarises the outline of the system. The lists are revised over time. Individual determinations rest with the competent authority, so please confirm current primary sources.