A new manufacturing standard has been established for health supplements containing the functional ingredient "Garcinia cambogia extract," which is known to help reduce body fat. This measure follows reports of abnormal cases such as vomiting, jaundice, elevated liver levels, and indigestion. The key point is that this ingredient should not be manufactured with other functional ingredients that have body fat reduction functionality, nor should it be consumed alongside other body fat reduction functional health supplements.
Additionally, "Reishi mushroom fruiting body extract" has been excluded from functional ingredients due to the lack of confirmed effectiveness.
The Ministry of Food and Drug Safety announced on the 6th the results of reassessing the safety and functionality of nine functional ingredients used in health supplements. The nine functional ingredients subject to this reassessment are ▲ Garcinia cambogia extract, ▲ soy isoflavones, ▲ guava leaf extract, ▲ evening primrose seed extract, ▲ lecithin, ▲ Haematococcus extract, ▲ mucopolysaccharides and proteins, ▲ Reishi mushroom fruiting body extract, and ▲ collagen peptides.
A Ministry official explained, "Last year, abnormal cases such as vomiting, jaundice, elevated liver levels, and indigestion were reported, necessitating a safety and functionality assessment of Garcinia cambogia extract and another ingredient. We comprehensively reviewed the safety and functionality data at the time of their recognition and any relevant information that surfaced over the 10 years since their approval. The soy isoflavone, which has been recognized for 10 years, was among the seven ingredients subjected to this review."
Based on the reassessment results, additional precautions will be added for manufacturers or consumers of Garcinia cambogia extract to ensure they do not manufacture or consume it alongside other "body fat reduction" functional ingredients.
Furthermore, the manufacturing standards for materials and supplies such as "lecithin" and "mucopolysaccharides and proteins" will be changed in accordance with the results of functionality and safety evaluations. The daily intake ranges for "soy isoflavones," "lecithin," "Haematococcus extract," and "mucopolysaccharides and proteins" will be rerouted.
The standard for lecithin's materials and supplies will be changed from the previous "soybeans, egg yolk" to "soybeans," deleting egg yolk. The materials and supplies for mucopolysaccharides and proteins will be changed from the previous "cartilage tissues from cattle, pigs, sheep, deer, horses, rabbits, donkeys, sharks, poultry, squid, crabs, and shellfish" to "cartilage tissues from pigs, chickens, and sharks."
The daily intake for soy isoflavones will be rerouted from the previous 24-27 mg to 37-45 mg. Lecithin will change from the previous 1.2-18 g to 18 g, Haematococcus extract will adjust from astaxanthin 4-12 mg to 6-12 mg, and mucopolysaccharides and proteins will change from the previous 1.2-1.5 g to 2 g. Additionally, in order to strengthen the management of harmful substances, the lead standard for "lecithin" will be reinforced from 2.0 mg/kg or less to 0.5 mg/kg or less.
The Ministry also stated that to strengthen the management of abnormal case reports for the functional ingredients reassessed this time, a phrase will be required on products instructing consumers to "stop consumption and consult a professional in case of abnormal cases," and additional precautions will be included. For example, guava leaf extract must state, "children, pregnant women, and nursing mothers should avoid consumption," and mucopolysaccharides and proteins must state, "those with allergic constitutions may exhibit hypersensitivity reactions, depending on the individual."
Since 2017, the Ministry of Food and Drug Safety has conducted annual reassessments of functional ingredients in health supplements. By last year, a total of 82 ingredients have been reassessed, resulting in amendments to standards and specifications for 81 ingredients, continuously managing their safety and functionality.