Valensa International, a leading provider of Fresh from Florida saw palmetto extract, has announced that the company’s USPlus Saw Palmetto extract is the first and only of its kind to successfully reaffirm its status with the United States Pharmacopeia (USP) Ingredient Verification Program for Dietary Ingredients (IVP-DI) for meeting identity, quality, potency and purity standards.
“USP is pleased to recognise Valensa International as the first company to have a saw palmetto extract successfully complete the Ingredient Verification Program for the second year in a row,” said John Atwater, Senior Director of USP Verification Services.
“Qualifying for this programme is an accomplishment that demonstrates Valensa International’s commitment to quality and operating GMP quality systems for the manufacture of dietary ingredients in compliance with officially recognised requirements."
"It also provides manufacturers of finished products with the ability to easily identify and qualify Valensa International’s supercritical carbon dioxide extract of saw palmetto, known to much of the industry as USPlus, as a quality dietary ingredient they can trust.”
Valensa International pioneered the commercialisation of standardised saw palmetto extract in the US market back in 2001. USPlus Saw Palmetto extract is derived from an ultrahigh pressure, supercritical carbon dioxide extraction process that starts with mature dried saw palmetto berries that have been sustainably harvested by hand.
Native to Florida, saw palmetto (Serenoa repens) berries contain a phytonutrient profile rich in important fatty acids and sterols. Clinical studies conducted around the world indicate that saw palmetto is effective in controlling the most common urinary flow problems observed in nearly all men beyond the age of 50 when taken at the efficacious dose of 320 mg daily.
In vitro tests further confirm that its mechanism of action is based on it ability to inhibit 5-alpha reductase mediated transformation of testosterone to the more potent hormone dihydrotestosterone whose abundance has been linked to poor urinary flow in older men.
The power of saw palmetto extract is with its specific ratio of fatty acids that cannot be imitated. More than 50 clinical studies have successful clinical results using a quality saw palmetto extract. USPlus is also available in a powdered extract or microencapsulated form.
“Achieving USP Verified status again is a testament to Valensa’s commitment to quality, from the extraction process through delivery of a quality extract to our customers,” said Umasudhan Pal, CEO of Valensa International.
“I believe this third-party verification is important to building consumer trust, especially with saw palmetto where there are unethical efforts to push adulterated products labeled saw palmetto.”
USP IVP-DI helps ingredient manufacturers ensure compliance with GMP requirements and reduce risk, while also providing them with a way to differentiate their dietary ingredients in an increasingly competitive global market.
USP’s IVP-DI tests and verifies dietary ingredients, audits manufacturing practices, and reviews documentation before the manufacturer earns the use of the USP Verified Mark.
Having received recognition from USP, Valensa International was also added to USP’s website, a resource for finished product manufacturers to identify ingredient manufacturers who have earned the right to use the USP Verified Mark.