USPlus® Saw Palmetto, which supports prostate health, successfully completes annual surveillance by USP’s Ingredient Verification Program for Dietary Ingredients, reflecting adherence to Good Manufacturing Practices (GMP) and recognized quality standards.
ORLANDO, Fla. (April 7, 2020) — Valensa International, a leading provider of Fresh from Florida™ saw palmetto extract, announced today 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.
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“USP is pleased to recognize 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 verification program 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 recognized 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 commercialization of standardized 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 320mg daily. In vitro tests further confirm that its mechanism of action is based on the 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.
Click here for more information about USP’s Dietary Ingredient Verification Program and the process by which Valensa International earned this certification.
About Valensa International
For two decades, Valensa International has partnered with nutrition, food, and pharmaceutical companies to develop patented formulations for human and companion-animal wellbeing. Headquartered near Orlando, Florida, Valensa is committed to safety, quality, and the environment, as represented by its participation in the United States Pharmacopeia (USP) Dietary Ingredient Verification Program, FDA Good Manufacturing Practice compliance, and sourcing and sustainability protocols. Valensa specializes in supercritical CO2 extraction and microalgae-based manufacturing facilities to produce clinically proven botanical solutions for prostate, joint, cardiovascular, eye, and overall health. Valensa’s product portfolio includes: USPlus® Saw Palmetto Extract, Zanthin® Natural Astaxanthin, Parry™ Organic Spirulina, Parry™ Organic Chlorella, andFlexPro MD® Joint Health Formulation. Learn more at valensa.com.
About USP’s Ingredient Verification Program
USP’s Ingredient Verification Program for Dietary Ingredients offers rigorous third-party verification services to help manufacturers achieve quality management for dietary ingredients used in the manufacture of finished drug products and dietary supplements. Companies whose ingredients meet USP’s comprehensive and stringent verification requirements are awarded a USP Verified Dietary Ingredient Certificate and use of the appropriate USP Verified Mark. The Mark can be used on the bulk label of each container of USP Verified ingredients, on the certificate of analysis, and on marketing collateral. USP is an authoritative source for quality verification services because the United States Pharmacopeia-National Formulary (USP-NF) is an official compendium of scientific quality standards for drugs, dietary supplements, and their ingredients.
USP is an independent scientific organization that collaborates with the world’s top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. Through their standards, advocacy, and education, USP helps increase the availability of quality medicines, supplements, and food for billions of people worldwide. USP Dietary Ingredient Verification Services include GMP facility auditing, ingredient quality control, manufacturing documentation review, and ingredient testing. For more information about USP, visit www.usp.org.
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Note: These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
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Valensa International, Media Relations