Valensa International, Eustis, FL, has sent communications to thought leaders, marketers and retailers of saw palmetto cautioning them about widespread improper use of the botanical ingredient in support of prostate health.

The potential for improper use stems from consumers confusing clinically unproven powdered saw palmetto capsules containing saw palmetto berry powder with similar-sized capsules containing clinically proven oil extract. The communication cited a series of clinical trials that show a daily dose of 320 mg of saw palmetto oil extract mitigated the common effects of benign prostatic hyperplasia (BPH) in middle-aged and elderly men who were suffering from frequent urination and other common manifestations of BPH.

Saw palmetto oil extract is the only form of the product used in every successful saw palmetto BPH clinical trial to date. Saw palmetto powders are usually sold in 320 to 500 mg capsules that mimic their oil extract counterparts in size. These powder-form products contain about 10-12% of the oil extract that has been studied in all of the successful clinical trials. At this rate, users would need to consume between 7 and 10 capsules a day to ingest the 320 mg oil extract dose supported by the trials.

Typically, dosage recommendations for these powder-form products are only 1 capsule per day. It is estimated that 50% of the sales of saw palmetto in the U.S. are related to these powder-form products. Powder-form saw palmetto is virtually unknown in Europe, where the botanical is regulated as a drug in some countries and sold as a supplement in other countries.

According to Dr. Rudi Moerck, president & CEO of Valensa, there is a great potential for consumers to miss out on the benefits of saw palmetto extract supplementation if they follow the recommended dosage levels with the powder-form products.

“There is a solid body of evidence based on a number of clinical trials that show the 320 mg per day dosage of pure saw palmetto oil extract offers support to men experiencing the common effects of BPH,” he said. “There have been no studies done on similar levels of the powder-form products. Just because both product forms start with saw palmetto berries, it doesn’t mean they are equivalent when it comes to achieving the result we expect from saw palmetto oil extracts. Both a car and a bicycle can get you from Chicago to St. Louis—I just wouldn’t recommend the bicycle to anyone I cared about. At the end of the day, we should be recommending the oil extract form of the product for supporting prostate health, because the science says it works and it is easier and less expensive for consumers to get the levels required.”