Spotting “Sham” Palmetto: Based on the USP Monograph, Valensa Tests Reveal Rampant Adulteration

Scientists analyzed nutritional profiles of products labeled “Saw Palmetto extract,”  finding little, if any, of the key fatty acids necessary to support prostate health;  FREE report available 

ORLANDO, Florida (April 28, 2021) – Scientists from Valensa International tested market samples labeled as ‘Saw Palmetto extract’ from different suppliers and found that all the samples were masquerading as authentic extract derived from ripened saw palmetto berries, as published in a recent report released today (available here). The tests were carried out using the United States Pharmacopeia (USP) monograph testing protocols.  

Saw palmetto (Serenoa repens) is among the best-selling ingredients in the world for maintaining normal prostate function and relieving some lower urinary tract symptoms associated with aging men. The saw palmetto is indigenous to Florida and annually produces a fruit (commonly called a ‘berry’).  The ripe, dried berries are processed by Valensa with supercritical CO2 to isolate the lipidosterolic extract. But as the scientists found, not all of the extracts on the market are legitimate. 

The analyses evaluated the chemical profiles of four dietary supplement ingredients, one of which was USPlus® by Valensa, which for a third consecutive year is the only saw palmetto extract to be verified under the United States Pharmacopeia (USP) Ingredient Verification Program for Dietary Ingredients (IVP-DI). 

“Our findings were troubling, but not altogether surprising,” said Stephen Hill, Vice President, Product Management and Technology, and a saw palmetto expert. “We know that un-ripe saw palmetto berries which are crushed into a powder and encapsulated are not an effective supplement for men’s health, because they simply don’t have the correct concentration of fatty acids, but imitation extracts present the same issue in the marketplace.” 

Therefore, Hill said this study focused on other brands claiming to be lipidosterolic extract. “Among the extracts studied, only USPlus contained the complete fatty acid, phytosterol and long-chain alcohol profile meeting the USP monograph, which we fully disclosed in our analysis. We found each of the adulterated versions to contain undeclared lower-cost oils.” 

However, rather than naming the brands, Hill offered the following tips for spotting “sham” palmetto: 

  1. Look for the USP Verification logo, or find verified saw palmetto products on the USP website https://www.usp.org/verification-services/ingredient-verification-program/company-participants 
  2. Look for “Made in U.S.A.” or “Fresh from Florida”. Saw palmetto berries grown anywhere else are not likely to be legitimate. 
  3. Look for Extract or Powdered Extract, Not Milled Berry Powder. Saw palmetto capsules containing milled berry powders do not have the concentration or dosage power to provide the same benefit as an authentic extract. 
  4. Look for Price — If the price seems too good to be true, then it’s probably not 100% saw palmetto extract.    

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 fake or 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. To obtain USP verification, Valensa undergoes rigorous third-party auditing of its supercritical CO2 extraction process and quality systems for cGMP compliance. Each batch of USPlus® Pure Lipidosterolic Extract is also tested to ensure that it consistently meets the USP monograph. 

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