Korea removes spirulina’s skin health claim, adds caution statement to nine raw materials

The authority said spirulina could not make functional claims related to skin health as there was a lack of human clinical data.

The MFDS conducted a re-evaluation of raw materials that have been accredited as functional health food raw material a decade ago.

The purpose is to reconfirm their safety and functionalities.

Nine raw materials have been re-evaluated. They include spirulina, propolis extract, oil containing gammalinoleic acid (GLA), psyllium hull dietary fibre, polydextrose, red yeast rice, chlorophyll containing botanicals, and coleus forskohlii extract.  

With the revision, all nine functional raw materials are required to indicate the caution statement “if an adverse event occurs, stop taking it and consult a specialist.”​

There are also new requirements, such as changes to the daily intake level, to some of the raw materials.

“The Ministry of Food and Drug Safety will continue to re-evaluate the safety and functionality of functional ingredients based on the latest scientific literature and information so that consumers can purchase health functional foods with confidence. ​

“In addition, we will continue to disclose the results of health functional food re-evaluation for transparency in the health functional food re-evaluation process and predictability of future standard changes,” ​the MFDS said.  ​

The following is the list of additional changes introduced.

Spirulina ​

Although spirulina can no longer make claims related to skin health, it can still make functional claims related to its antioxidant properties and the lowering of blood cholesterol level.  

As an antioxidant, the daily intake of total chlorophyll from a spirulina product should be between 10mg and 80mg.

For lowering of blood cholesterol, the daily intake of total chlorophyll should be between 40mg and 80mg.

The revised requirements are lower than before, where the maximum permitted daily intake of total chlorophyll was 150mg.

Propolis extract​

The daily intake of total flavonoids from propolis extract has been increased from between 16 and 17mg to between 20 and 40mg.

There is no change to its functional claims, which are related to its antioxidant and antibacterial properties.

Psyllium hull dietary fibre ​

The daily intake requirement has been increased from 5.5g to 6.0g for claims related to the lowering of blood cholesterol and up from 3.9g to 5g for facilitating bowel movement.

Coleus forskohlii extract ​

This is a botanical that can claim to reduce body fat with a daily intake of 500mg.

The MFDS has added a new caution statement “consult healthcare professional if taking or are blood pressure control medications or if having low blood pressure” for products containing this raw material.

Red yeast rice ​

New warning statements were added, cautioning children, pregnant women, and lactating women to avoid consumption of products containing this raw material.

Individuals suffering from liver disease and those taking hyperlipidemia medications are also cautioned to avoid the product.