If you look up the word “health food” in Wikipedia, you will find an entry for “handling herbal medicines”. The following is its citation.
Treatment of crude drugs
In Japan, some of the indigenous herbal medicines used in Kampo and other medicine are recognized as pharmaceuticals, while Western herbs (crude drugs) are distributed as health foods.
Western herbs have been distributed as dietary supplements in the U.S. and as pharmaceutical products (herbal medicines) in the EU, but in Japan, they can be distributed and sold as health foods because of the deregulation of the U.S. on the form of herbs in 1998 due to foreign pressure.
On June 24, 2003, the Ministry of Health, Labor and Welfare also held a meeting on these Western herbs at the “Study Group on the Examination of Herbal Drug Preparations (Including Western Herbs) as OTC Drugs”. The following comments were received
Some have medicinal effects that require caution, but because they are food, they cannot be labeled.
As direct OTC, they can only be reviewed at the level of synthetic drugs, which is difficult to get approved.
Furthermore, the approval system differs between Japan and EU countries. In EU countries, such existing herbal medicines need only to be tested on animals to confirm their safety, whereas in Japan, they need to undergo regular clinical trials that are expensive and require several years or more to complete. (For more details, see the section on “Clinical Trials.”) Because crude drugs cannot be patented, businesses cannot conduct clinical trials because they are unprofitable.
This study group did not meet a second time.
On March 22, 2007, the Evaluation and Management Division of the Pharmaceutical and Food Safety Bureau of the Ministry of Health, Labour and Welfare approved the use of overseas data for Western herbs and other herbal medicines that had been distributed as health foods because of difficulties in obtaining approval in Japan, thus reducing the burden of drug approval applications in the future.
Since July 2007, a “Study Group on Ensuring the Safety of Health Foods” has been in place.
In other words, even if the crude drug “Indigo naturalis” were to be used as a specific medicine for ulcerative colitis, it would not be marketed as a drug as it is. In Japan, it would not be profitable.
I heard that Dr. Amano of the Hiroshima Clinic is working with a pharmaceutical company to develop a drug based on the active ingredients of Chinese herbal medicine, but perhaps they are trying to sell it as a drug in such a way because it is effective in its crude form but they cannot secure profits?
If they are forced to market it as a drug even though it is effective in its “Indigo naturalis” form, a tremendous amount of health insurance premiums will be spent on the patent fees for the new drug.