USPlus® Pure Lipidosterolic Extract of Saw Palmetto, derived from Valensa’s GEMS Supply Chain Excellence Program, delivers an effective product and enables brands to meet emerging Amazon requirements
ORLANDO, Fla. (April 5, 2021) — Valensa International announced today that for a third consecutive year the company’s USPlus® Pure Lipidosterolic Extract of Saw Palmetto, is the only saw palmetto extract to be verified under the United States Pharmacopeia (USP) Ingredient Verification Program for Dietary Ingredients (IVP-DI). This certification demonstrates Valensa’s product and process deliver the quality, potency, and purity as recommended by the independent scientific experts at USP. The company’s efforts set the gold standard for consumer trust and transparency amid new standards from Amazon and key retailers.
Valensa pioneered the Saw Palmetto industry 20 years ago and initiated a GEMS™ Supply Chain Excellence Program in 2019. The program substantiates the company’s commitment to providing a clinical-strength lipidosterolic extract of saw palmetto and to give customers confidence in a market proliferated by out-right fake and adulterated products.
The GEMS Supply Chain Excellence Program specifies the quality of saw palmetto berries harvested to ensure the resulting extract meets the USP monograph. ” said Larry McCarty, Valensa’s Head of Manufacturing and Supply Chain. “GEMS focuses on creating positive outcomes for the supply chain including landowners, harvesters, drying companies and the environment, through education and standards.”
The outcome GEMS strives for include: traceability, sustainability, purity and responsibility — four attributes that many saw palmetto purveyors ignore, McCarty added. “Unfortunately, the market continues to allow unripe green berry powder supplements, or adulterated oil versions that do not meet the clinically-proven profile of a pure lipidosterolic extract.”
To obtain USP verification, Valensa undergoes rigorous third-party auditing of its Supercritical CO2 extraction process for cGMP compliance. Each batch of USPlus® Pure Lipidosterolic Extract is also tested to ensure that it consistently meets the USP monograph. According to Steve Hill, VP of Product Management and Technology, “Valensa’s commitment to providing an effective product is demonstrated by the verification that USPlus® delivers exactly what’s promised in the nutritional profile.”
The power of Saw Palmetto lies in the full spectrum of a pure lipidosterolic extract with a specific ratio of 85-90% total fatty acids and other phytonutrients as per USP. In the U.S., saw palmetto is regulated as a dietary supplement, but in Europe, a pure lipidosterolic extract of saw palmetto is sold, and regulated as an herbal medicine at a recommended daily dose of 320 mg.
Having earned the IVP-DI status from USP, Valensa International continues to be listed on USP’s website, a resource for finished product manufacturers seeking ingredient manufacturers who have earned the right to use the 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 in the United States.
Click here for more information about USP’s IVP-DI Program and the process by which Valensa International earned this certification.
About Valensa International
Valensa International is a leading innovator of pure, science-based, clinically effective nutraceutical solutions proven to benefit health and wellness. For 20 years, Valensa has partnered with nutraceutical, food and pharmaceutical companies to bring condition-specific solutions for human and companion animal well-being to market. Our commitment to safety, quality and the environment is represented by the United States Pharmacopeia (USP) Dietary Ingredient Verification Program, FDA Good Manufacturing Practice compliance and sustainability practices. Valensa is headquartered in Orlando, Florida, near a protected saw palmetto grove. Learn more at valensa.com.
About USP
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.
Media Contact: David Jahr, (805) 452-4180, davidjahr@mac.com, Valensa International, Media Relations
