‘Foundation for success’: Korean regulator to expand manufacturing standards for five more FSMP

It said that it would set the manufacturing standards for FSMP catered to patients suffering from 1) hypertension 2) pneumonia 3) liver disease 4) inflammatory bowel disease (IBD) and 5) dehydration and electrolyte imbalance.

The draft standards will be announced within this year after the MFDS has consulted the industry’s opinion. The aim is to introduce the finalised standards by year 2026. By then, there will be standards in place for 12 types of FSMP.

Currently, FSMP in South Korea can be classified into three broad categories for seven health conditions.

The three categories are 1) standard nutritional supplements, 2) customised nutrition supplements, and 3) meal-type management products. The first two could be made into liquid and powder products while the last could be made into lunch box or meal kits.

The seven health conditions, which already have the relevant FSMP manufacturing standards set in place are for 1) general patients, as well as those suffering from 2) diabetes 3) kidney disease 4) cancer 5) intestinal disease 6) caloric and nutritional deficiency and 7) dysphagia.

Increasing the manufacturing standards for more FSMP meant that the industry could cater to the needs of more patients, as well as strengthening the industry’s competitiveness in the global market as part of the ‘Food and Drug Administration Innovation Plan.’

The plan, announced in July, is aimed at supporting the entry of domestic industries in the fields of new bio and digital health technology into the global market.

“This plan not only improves the quality of life by expanding patients’ food choices and helping them in the treatment and recovery process, but also lays the foundation for producing a variety of food for patients, and helping the industry to thrive,” ​the MFDS said in a statement.

Last December, the MFDS introduced a set of nutritional standards​ for specialised foods meant for the elderly and cancer patients.

Why these five FSMP? ​

The MFDS said the five aforementioned areas were selected after considering the market demand.

For instance, hypertension has now become the most common chronic disease in South Korea. Therefore, FSMP could be designed to manage their blood pressure.

Secondly, due to COVID-19, pneumonia has garnered a higher attention and FSMP could be formulated to lower their respiratory burden.

Thirdly, IBD is seeing rapid increase among young people due to stress and other factors.

As for liver disease, the regulator said that it could come with anorexia and muscle loss due to poor nutrient metabolism. In this case, FSMP for these patients could focus on supplying calories and branched chain amino acids (BCAA).

This is because BCAA such as valine, leucine, and isoleucine, could serve as a source of energy without having to go through liver metabolism.

Lastly, FSMP for dehydration and electrolyte imbalance could be catered to individuals suffering from high fever or diarrhoea.