PACran gets UTI claim approved in Korea

The PACran powder is distributed in EU by Lallemand Health Ingredients (LHI), under exclusive license from US based company Decas Botanical Synergies.

“The approval of PACran in Korea is especially re-assuring for our efforts to assure a European-wide health claim, especially given the stringent Korean requirements for Functional Food Health Claims,”​ said Nicolai Jensen, General Manager of LHI.

The product is the first cranberry ingredient to receive a brand-specific Health Functional Food approval in Korea, and the only one authorized to carry a Urinary Health Claim, say the company.

The approved claim attached to the product is “By reducing bacteria adhesion on the urinary tract wall, it may help with urinary health.”​

In 2004, the KFDA enforced the approval system of functional ingredients for the Health Function Food market according to the law of Health Functional Food. As cranberry extract is not included in the list of 37 generic HFF products, it is considered to be brand-specific.

The extensive approval process for PACran by the KFDA took almost two years. In order to obtain approval, product manufacturer, Decas Botanical Synergies (DBS) and its Korean partner, Monature, were required to submit a complete clinical dossier including the required safety data.

Julie Rosenborg, business development manager at LHI told NutraIngredients.com that PACran was sold in limited quantities in Korea before the approval but without a claim on the product it was hard to get sales going. "Decas expect a strong impact on sales, as their partner in Korea can now use a much wider range of marketing activities to promote their product," ​she added.

She said that Decas was not currently planning to seek approvals for PACran in other countries within Asia but that partners in the region are very excited about the Korean approval as she said that it sends a strong signal to the market of the viability and quality of PACran:

“There is s spill-over effect from an approved health claim in Korea similar to the situation in Europe where products are sold in Germany and Italy carrying the French health claim wording.” ​

PACran is standardised to a minimum of 1.5 per cent PACs. In 2006, a randomised double-blind clinical study showed that daily consumption of 500 mg PACran for 90 days was able to significantly reduce the presence of uropathogenic E. coli in patients.

The cranberry powder is suitable for any type of delivery, including capsules, soft gels and confectionery.