Probiotic Vaginal Health Claim in Korea

The South Korean Ministry of Food & Drug Safety has approved the application from a leading, global microbiology institute (Chr. Hansen) for a health claim for the specific combination of probiotic bacteria strains known as Urex. The two strains that make up the combination are: Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1, both of which have shown excellent capabilities to survive transit through the GI tract, and then transfer across to the vagina to help maintain female ‘intimate’ health.

These two strains are the same strains that are in our ‘For women’ product, which we are pleased to be launching next month. The specific strains have many clinical trials showing their efficacy at maintaining a healthy, vaginal microbiota, and alleviating the symptoms of thrush, bacterial vaginosis and cystitis. 

Marketers selling these strains in South Korea are now able to use the following health claim on both product packaging and any promotional materials: ‘Urex can help vaginal health by increasing lactic acid bacteria’; a clear health claim about women's intimate health.

Nutritional supplement companies operating within the EU are strongly regulated by the European Food Safety Association (EFSA) as to the wording they are allowed to use on product packaging and marketing support materials. Any statement that could be construed as being a ‘health claim’ can not be used, unless it has prior approval by the EFSA and the scientific claims have been validated.

Regulations on health claims vary across different countries, however in the EU they have become extremely strict. To date, the EFSA has not approved any submitted health claims for probiotic products. (To read more about the Nutritional Health Claims Regulations, click here.)

The fact that L. reuteri RC-14 and L.rhamnosus GR-1 have now been approved by the South Korean Ministry of Food & Drug safety as helping maintain vaginal health, means that a ‘scientific precedent’ has been set for them. We are hopeful that if South Korean scientists agree that these strains help with vaginal health, then European scientists at the EFSA might also agree. We have our fingers firmly crossed that ‘For women’ will be high up on the list to be one of the first probiotics to be granted an EFSA approved health claim.Watch this space......