The Ministry of Food and Drug Safety (MFDS) said on Tuesday (Sep 23) that the warning “in rare cases, it may cause harm to the liver, and alcohol consumption should be avoided during intake” will be added to Garcinia cambogia products.
This is the second time that MFDS has implemented controls on Garcinia cambogia products in this year alone.
Since January, the regulator has stopped companies from formulating Garcinia cambogia extract with other ingredients that similarly have body fat reduction functions.
The recommended daily intake of Garcinia cambogia extract was also reduced from 750-2,800 mg/day to 750-1,500 mg/day.
The MFDS said that new warnings were added followed two recent cases of adverse events – specifically acute hepatitis – were found to be related to the use of Garcinia cambogia supplements.
The affected cases were said to have taken a Garcinia cambogia supplement marketed under the brand Dr. Bear+ made by South Korean firm Natural Way Co., Ltd and distributed by Daewoong Pharmaceutical Co. Ltd.
Based on the product packaging, the product claims that it “may help to reduce body fat by inhibiting carbohydrates from being synthesized into fat. Daily intake amount is 750mg as total (-)- hydroxycitric acid.”
Based on South Korea’s Health Functional Food Standards and Specifications, a product needs to contain a total hydroxycitric acid content of at least 600 mg/g in order to make the above functional claim.
Elsewhere in Australia, the Therapeutic Goods Administration is requiring health supplements containing Garcinia cambogia or other ingredients that similarly contain hydroxycitric acid (HCA) to warn consumers of liver harm risks on the product labelling from March 1 this year.
Product recall
The Dr Bear+ Garcinia cambogia product has been under recall since September 23, after the authorities have determined “a very high possibility of a causal relationship between the adverse events and the product in question.”
The two cases of acute hepatitis were reported on August 25 and 27, with the MFDS recommending the business operator to temporarily suspend sales of the product on August 28, and the business operator conducting a voluntary recall on the next day.
On September 16, the Health Functional Food Review Committee was convened to assess causality of the product and adverse events, based on safety information analysis, expert advice, patient medical records, and other data.
It gave the product a rating of five – the highest in the causality scale.
Based on the committee’s judgement, a causal relationship is said to be “highly probable” for a level five rating.
In this case, “symptoms are severe and numerous similar adverse events have been reported, necessitating immediate public notification.”
On the other hand, the two cases suffering from acute hepatitis were hospitalized and have since been discharged.
