BH15 Jul 2025 09:38
Just think how attractive FF will be to major companies in China. At the moment to gain Blue Hat approval, companies have to submit their end-product, along with clinical trial details (or alternative supporting evidence) etc to prove the efficacy and safety of the product. If they require clinical trials, it can cost them a significant amount of money and take ages, then the submission itself costs quite a bit and there is no guarantee that it will be approved. Now Fruitflow will be in a totally unique position where the FF ingredient is essentially pre-approved for the Platelet Aggregation claim and nobody else can make that claim for 5 years, so any companies that are using a standard dose (150mg) of FF-II SD will not need to do a clinical trial for the platelet aggregation claim. When they submit for Blue Hat, it will just be the more routine aspects that will need approval, safety, stability, manufacturing quality, labelling compliance etc. This massively speeds things up, reduces cost and reduces risk. FF will be the only pre-approved health claim ingredient in China.
Then there is a chance that SAMR may speed up Blue Hat approvals, as BH are rolling this out to specifically target a risk highlighted in the HC2030 policy. Not sure that will happen though, as they don't seem to be speeding up the FF approval. It is the kinda thing they do.
To-date we know of no other ingredient that has been submitted under the New Health Claims approval process, so it looks like this unique position will held for some time.
So when it was reported in industry news that BH have agreements from a large number of multi-national supplement and food/beverage companies to commercialise FF in China, it's easy to see why they would all be so interested. They can fairly easy get a scientifically backed, Blue Hat approved product into shops and chemists in a relatively short period of time without huge cost outlay and risk, that also aligns with HC2030.
China has amongst the most restrictive health claims regulations. If Globals, the likes of Nestle (Nature's Bounty) launch new FF products in China, it is easy to see how they would then roll that product out to other countries if it were successful, which it likely would be given it's uniqueness and lack of competition.
Come on SAMR.