'Aspartame' in Pharmaceuticals... Even Without Major Issues, Pharmaceutical Industry Faces 'Deep Concerns'

The International Agency for Research on Cancer (IARC), under the World Health Organization (WHO), is likely to classify aspartame as a "possibly carcinogenic substance (Group 2B)" on the 14th. This has put the pharmaceutical industry in a dilemma. While keeping in mind the stance of the Korean food and drug authorities that the actual aspartame intake by Koreans is extremely low compared to the permissible amount, they are waiting, but since it is a medicine, if public anxiety increases, they will have to look for alternatives.

Aspartame, a synthetic sweetener, is used as one of the additives in medicines to reduce bitterness as much as possible because it is 200 times sweeter than sugar in the same amount. It is mainly used in uncoated pills such as cold medicine, digestive medicine, and anthelmintics, as well as in fever-reducing syrups consumed by children. According to the Ministry of Food and Drug Safety's Drug Safety Korea on the 6th, there are a total of 688 domestically approved medicines containing aspartame (472 prescription drugs and 216 over-the-counter drugs).

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The food and drug authorities judge that it is too early for the public to be anxious already. In the case of medicines with a fixed daily dosage, the aspartame content is far below the WHO recommended amount (40 mg/kg). A Ministry of Food and Drug Safety official said, "Although we will prepare measures regarding aspartame by comprehensively reviewing the WHO evaluation results and domestic and international usage status, since the daily intake of aspartame by Koreans is only 0.12% of the permissible amount, we currently do not consider safety concerns."

Nevertheless, the pharmaceutical industry is concerned. Although the risk associated with aspartame content in medicines is low, the so-called "placebo effect," where positive or negative beliefs about the efficacy of a medicine actually influence its effectiveness, cannot be ignored. A pharmaceutical industry official lamented, "Due to the nature of medicines as treatments for diseases, it is a reality that we have to consider alternatives."

The Ministry of Food and Drug Safety permits a total of 22 types of artificial sweeteners, including aspartame, and the pharmaceutical industry is considering maltitol and erythritol as alternatives to aspartame. However, maltitol and erythritol provide sweetness levels of about 90% and 70% of sugar, respectively, so they are evaluated to be significantly less effective than aspartame.

Some argue that until the Ministry of Food and Drug Safety completes its risk assessment, the IARC classification results should not be overly trusted. Group 2B, where aspartame is expected to be included, contains substances that are potentially suspected of carcinogenicity, but it also includes commonly consumed foods such as kimchi, pickled vegetables, and aloe vera. It is explained that there is no major problem if the domestic standards permitted by the Ministry of Food and Drug Safety are met. The carcinogens designated by IARC are not absolute. They classify substances based on how sufficient the evidence of cancer causation is, and if it is not Group 1, which means "definite carcinogen," it means there is no conclusive evidence. For example, coffee was included in the IARC Group 2B carcinogens in 1990 but was removed from this classification in 2016, 25 years later.

A Ministry of Food and Drug Safety official said, "Even if aspartame is designated as a Group 2B carcinogen, it is important to examine the basis on which IARC made the designation."

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