Study highlights importance of quality and potency of saw palmetto extracts in prostate health supplements
Flomentum, powered by USPlus® and guided by our parent company, Valensa, is proud to share groundbreaking news about the importance of quality in saw palmetto extracts – revealing the standards that we passionately uphold in every softgel.
Only 7 products out of 28 studied truly deliver on clinical effectiveness in relieving lower urinary tract symptoms affecting millions of men. Flomentum was the ONLY product that met the standards AND is 3rd party veriﬁed by USP
EUSTIS, FLA. – A new study published in the Journal of Urology Open Plus reveals that 7 saw palmetto products met the identity and potency standards to effectively address urinary tract symptoms associated with an enlarged prostate. According to the lead author of the study, Dr. Bilal Chughtai, who is a board-certified urologist, of the 28 supplements included in the study, only six of the lipid extracts and one multi-active product were found to have the appropriate dosage of 320 milligrams of saw palmetto extract and the minimum 80% fatty acids clinically shown to address inflammation and improve symptoms that nearly all men will experience in their lifetime, like increased urination, sudden urgency, weak stream and disrupted sleep.
The study included some of the popular saw palmetto retail products, which consumers find in stores and online platforms like Amazon, including berry powders, extracts, blends and multi-actives. The blinded study was performed at Eurofins Food Chemistry Testing, Inc., Madison, WI. Total fatty acid content ranged from 0.796% for a berry powder product to 89.923% for a lipid extract product. None of the berry powders met the criteria for clinical efficacy. Lab tests confirmed that Valensa USPlus®, which is the active ingredient in Flomentum, was unique in meeting the criteria established in the US Pharmacopeia monograph for standardized saw palmetto extracts (min. 80% total fatty acids), met the lipid profile for an authentic product, and was found to contain the clinically effective dose of 320 mg.
“Only concentrated extract of mature saw palmetto berries has been found to inhibit the biological process by which testosterone gets converted to DHT, which leads to benign prostate enlargement,” said Dr. Bilal Chughtai. “This study not only confirms the rampant variability of saw palmetto products, but also highlights the need for physicians and industry to verify the quality of the supplements they’re recommending to patients and consumers to ensure the best results possible.”
Saw palmetto is a wildcraft plant native to remote areas of the southeastern U.S. Among increased demand of saw palmetto, there has been widespread misrepresentation, blending and dilution of saw palmetto extracts with less expensive plant oils like coconut, canola, olive and sunflower or use unripened berries that do not provide clinical benefit.
Flomentum, powered by Valensa’s USPlus®, is the first and only USP verified ingredient that is a lipidosterolic extract of saw palmetto berry, also known as Serenoa repens. As per the newly-published study, only one of the 28 products met United States Pharmacopeia criteria for a standardized lipidosterolic extract, defined as total fatty acid content ≥80% and a fatty acid profile indicative of authentic Serenoa repens based on the ratios of the lauric acid concentration to 9 other individual fatty acid concentrations.
Valensa’s USPlus® rigorous quality-control process ensures the product contains only mature, wild-harvested, Fresh from Florida® saw palmetto berries that are sourced using sustainable harvesting practices. Valensa USPlus is able to provide this uncompromising quality through a proprietary ultrahigh pressure extraction process that delivers a standardized lipidosterolic extract of saw palmetto for clinical effectiveness.
“Without studies like this to bring quality issues to light, it’s very difficult for consumers to know if they’re taking a supplement full of ‘sawdust’ that doesn’t do anything or a quality saw palmetto product that promotes your prostate health,” said Stephen Hill, Vice President of Quality and Regulatory of Valensa International. “By understanding the role that high-quality saw palmetto extract can play in men’s health, millions of men can benefit from this safe and natural solution to maintaining prostate health and possibly prevent or delay the need for more serious medical interventions down the line.”
Benign prostatic hyperplasia, or an enlarged prostate, affects about 50 percent of men between the ages of 51 and 60 and up to 90 percent of men older than 80. Valensa USPlus is the first and only USP Verified saw palmetto extract ingredient available to men to support lower urinary tract symptoms with no sexual side effects.*^
USP, the United States Pharmacopeia, is a 200 year old non-profit scientific organization that sets standards for drugs and dietary supplements. USP helps protect patient safety and improve the health of people around the world.
Learn more about Valensa USPlus’s harvest to bottle quality control standards and patented extraction process here: https://www.youtube.com/watch?v=JGddboRQdjk
*Adapted from: Carraro JC, et al. Prostate. 1996;29:231-240; Debruyne F, et al. Eur Urol. 2002;41:497-506; Latil A, et al. Prostate. 2015;75:1857-1867; Pytel YA, et al. Adv Ther. 2002;19:297-306; Zlotta AR, et al. Eur Urol. 2005;48:269-276
^These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.
About Valensa International USPlus®
Located in Eustis, FL, Valensa International USPlus is the first and only USP Verified saw palmetto oil extract in the world. Learn more at www.Valensa.com/USPlus/.