The status of 5-ALA depends on the purpose of use and the type of product. In the medical field, 5-ALA hydrochloride has been approved in some cases as a drug used for photodynamic diagnosis in cancer. Gleolan, which is approved by the U.S. FDA, is an optical imaging agent used to make tumor tissue easier to see during surgery for malignant glioma.

On the other hand, 5-ALA supplements generally sold in Japan are treated as health foods, not as medicines. In other words, they are not approved as drugs for the treatment of diabetes. As a health food ingredient, 5-ALA is known to be contained in foods such as sake, natto, and fermented foods, and it is also present in the human body.

Therefore, at this stage, it cannot be stated that “5-ALA is a drug that cures diabetes.” A more appropriate explanation is that “5-ALA is being studied as a compound involved in glucose metabolism and mitochondrial function.” This is also because claiming that a health food can treat or prevent a disease may be considered a medicinal efficacy claim.