Format innovation opportunity: South Korea to allow VMS to be made into jelly, film, and disintegrating tablets
The Ministry of Food and Drug Safety (MFDS) announced that said such new products could hit the market as early as next year.
Currently, the permitted dosage formats for VMS are powder, granules, capsules, effervescent tablets, chewable tablets, pills, troche, syrup, and liquid solution.
In its announcement, the MFDS also explained how VMS made in the new formats should be consumed.
For instance, disintegrating tablets can be taken with or without water, while oral dissolving films can be taken without water.
“These revisions were intended to promote the manufacturing of OTC products and expand consumers’ options of OTC products through the [new] specifications, [including] new formulations, new ingredients, and increasing the maximum dose per day [for certain ingredients],” the MFDS said.
Elsewhere in China, the authorities have also approved new dosage formats for health foods earlier in June.
In the case of China, health foods containing ingredients listed in the Health Food Raw Material Directory can be made into gummies and powder, aside from the usual tablet and capsule formats.
New ingredients and dosage
On the other hand, VMS in Korea can now include new ingredients such as taurine and other forms of vitamin B12.
For taurine, the maximum permitted amount per day is 2,000mg for individuals age 15 and above.
Mecobalamin and cobamamide, which are both active forms of vitamin B12, are also newly approved for use. There is a maximum permitted dosage of 1,000μg per day for both ingredients.
Prior to the announcement, the permitted forms of vitamin B12 are hydroxocobalamin, hydroxocobalamin acetate, and cyanocobalamin.
Of which, the maximum permitted dosage of cyanocobalamin has been increased from 1,000μg to 1,500μg per day.
The permitted dosage amount of other ingredients has also increased.
For example, the maximum permitted dosage of folic acid per day has increased from 500μg to 1,000μg for adults over the age of 19.
This is also the case for chondroitin sodium sulfate – which has increased from 600mg to 800mg, L-cysteine – up from 120mg to 160mg, and ursodeoxycholic acid – up from 30 to 60mg for adults 19 years old and above.
Caution statements
The MFDS also said that caution statements and potential side effects should be stated for products containing taurine and sodium chondroitin sulfate.
For taurine, individuals with hyperproteinemia – high blood protein, diabetic hyperlipidemia, abnormal fat metabolism, pregnant, lactating women, and senior citizens should consult the doctors before using products containing the ingredient.
In addition, it should also be stated that taurine-containing formulations could cause side-effects such as diarrhoea, abdominal discomfort, constipation, anorexia, and rash.
For sodium chondroitin sulfate, the potential side effects are nausea, vomiting, constipation, diarrhoea, anorexia, erythema, hives, eczema, rash, maculopapular rash, itch, edema, and water retention.
