Japan Proposes to Revise the Directory Distinguishing Food and Drug Ingredients

On May 16, 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) successively released two draft amendments to the Directory Distinguishing Food and Drug Ingredients. These two amendments both focus on the Non-drug List, which outlines substances (raw materials) not considered pharmaceuticals, provided no claims of medicinal efficacy or effects are made. Public comments may be submitted via the e-GOV public comment platform until June 16, 2025.

Background

Under Japanese law, products (taken by mouth) are classified into two categories: "pharmaceuticals" and "foods." The Pharmaceutical and Medical Device Act (PMD Act) applies to pharmaceuticals, while the Food Sanitation Act governs foods. Due to regulatory differences between countries, imported health food products may be classified as "pharmaceutical products" if they contain ingredients recognized as drugs in Japan.

To help determine whether an ingredient is classified as a pharmaceutical, the Ministry of Health, Labour and Welfare (MHLW) considers factors such as its history of medicinal use, toxicity, and narcotic-like effects. As a practical reference for these judgments, MHLW publishes the Directory Distinguishing Food and Drug Ingredients, which consists of two lists:

Drug list

The substances (raw materials) listed on the Drug list cannot be used in so-called health foods. However, when the substance is used as a food additive for coloring or fragrance, and the additional amount is not enough to produce a pharmacological effect, it can be exempted from being considered as a pharmaceutical ingredient.

Non-drug list

This list includes substances that are not regarded as pharmaceuticals, provided that no medicinal efficacy or effects are claimed. However, inclusion in the Non-drug List does not automatically mean that the ingredient is permitted for use in all foods, it may still be subject to restrictions under the Food Sanitation Act or relevant food additive regulations.

Additionally, substances not listed in either the Drug List or the Non-drug List have not been formally classified, and their regulatory status remains uncertain. The absence of a listing does not imply that the substance is not a drug. For clarification, businesses should consult the local pharmaceutical affairs division with relevant data.

Key Revisions for Non-drug List

1. Added substances

Substance	Alias	Part	Remark
Ocimum tenuiflorum	Holy basil, tulsi	Leaf	/

2. Removed substances

No.	Substance	No.	Substance
1	Lactobacillus acidophilus.	26	Billberry
2	Indian sweet tea	27	Terminalia bellirica
3	Impetiginosus	28	Bamboo
4	Cassis	29	Tabebuia
5	Kashutou	30	Evening primrose oil
6	Pollen	31	Tilleul
7	Kyusetsucha	32	Touhokuougi
8	Kinsengren	33	Juniperus communis
9	Gluten	34	Dog rose
10	Clove	35	Nansho yam
11	Black rice	36	Elm
12	Keishi	37	Malt
13	Brown rice embryo	38	White tea
14	Koukaganshou	39	Honey
15	Euphrasy	40	Gymnema
16	Kojin	41	Bush tea
17	Succinite	42	Black plum
18	Rice starch	43	Blackberry
19	Rice bran	44	Bryonia
20	Comfrey	45	Bael
21	Sakyo	46	Taraxacum albidum Dahlst
22	Capsicum frutescens	47	Marrubium vulgare
23	Camphor	48	Mint
24	Citrus sinensis	49	Gall
25	White willow	50	Dioscorea L.

3. Revised substances source range

A total of 70 substances are revised in the draft amendments, mainly concerning clarification or modification of their source range. Among them, the source range has been narrowed for eight substances, meaning that certain parts that were previously permitted may now be excluded under the updated classification.

The following substances are among those whose source range has been restricted:

Substance	Part (before)	Part (after)
Psidium guajava L.	Fruit /fruit peel/leaf	Fruit /leaf
Zanthoxylum piperitum (L.) DC.	Fruit /fruit peel/root	Fruit /root
Aralia chinensis L.	Root /root bark/wood	Root /wood
Sarcandra glabra (Thunb.) Nakai	Whole plant	Aerial parts
Capsicum annuum L.	Fruit /fruit peel	fruit
Alibertia patinoi (Cuatrec.) Delprete et C.H.Perss.	Fruit /fruit peel /seed	Fruit /seed
Salix sp.	Entire woody plant	Aerial parts
Thamnolia vermicularis (Sw.) Schaer.	Aerial parts	Thallus

4. Others

The format of the list has been updated to include a new column for scientific names, providing clearer identification of substances. In addition, some entries have been further subdivided for greater taxonomic precision. For example, the previous listing for hawthorn has been split into Crataegus pinnatifida Bunge and Crataegus cuneata Siebold et Zucc.