resources

24-Aug-2006
Valensa International, a leading producer of nutraceutical grade saw palmetto extract for supplemental nutrition, has announced that it is now offering free analysis and product profiling to nutraceutical producers interested in ensuring the quality of the saw palmetto extract they use. The analysis will be done on saw palmetto extracts at Valensa’s laboratories in Eustis, Florida and the profiling will be based on the United States Pharmacopeia’s (USP) monograph on saw palmetto extract.

Tests for saw palmetto quality have often been based on total fatty acid content that does not give an accurate assessment of the identity and quality of the extract. The method used by Valensa is the USP monograph published standard for total fatty acids, fatty acid profile, total fatty alcohols and phytosterol levels. It also provides the ratio of the concentration of lauric acid to the concentration of constituent fatty acids, giving what is essentially a ‘genuine saw palmetto fingerprint’.

According to Sid Hulse, Vice President of Sales and Marketing for Valensa, the motivation behind the program is to protect the image of saw palmetto in the mind of consumers and to ensure that bogus, ineffective or adulterated product does not reach the marketplace. "Saw palmetto is one of the top three nutraceuticals by sales in the North American market. Maintaining its image of quality and efficacy is important, not only to Valensa a leading provider of Florida saw palmetto, but to the nutraceuticals industry as a whole. That’s why we initiated this program to any marketer of saw palmetto, regardless of whether they buy from Valensa or not," he said.

A wildcrafted product of Florida, USA

Saw palmetto presents some challenges to manufacturers and marketers because of its natural origins. The saw palmetto plant grows mainly in the State of Florida and in the southeast United States. Saw palmetto is wildcrafted, meaning that it is not farmed or cultivated in any way. It grows throughout the state of Florida and in southern portions of Georgia, Alabama and South Carolina, but is commercially harvested mainly in the State of Florida, USA. During the harvesting season, extractors and wholesalers of saw palmetto berries contract with groups in Florida to provide berries. Harvesting season typically runs from mid-to late-August through the end of October, based on when berries become ripe. Berry ripeness is the single most important determinant of the effectiveness of the final saw palmetto extract. Berries harvested before they are ripe have lower oil content which often does not meet USP specifications. Berries harvested before they are ripe have limited or no value as a nutraceutical. The clinical trials that have shown positive effects of saw palmetto supplementation on the symptoms of benign prostrate hyperplasia have been conducted with saw palmetto material produced from fully mature berries that met the USP monograph specifications.

As with any natural product, nature has an impact on the size and quality of the crop in any given year. The saw palmetto crop was substantially diminished two years ago when four major hurricanes went through Florida, damaging saw palmetto groves throughout the state. This had the effect of increasing prices substantially on saw palmetto extract. It also sent producers scrambling for ways to meet market demand.

Effective testing, fast turnaround
The testing program will be conducted on saw palmetto extracts only, and not on standardized powdered saw palmetto extract or dried ground berry powders, which offers a number of quality testing issues. Participants can contact the company and send in numbered samples. Testing will be done using a variety of methodologies including gas chromatography when required. Results will be delivered within ten days of the sample receipt at Valensa’s labs.

Quality: the proof is in the profile
When it comes to quality in saw palmetto extract, Hulse says there are a few basic questions that buyers should ask. "You should always ask where your berries come from. We can say with certainty that saw palmetto does not grow in China. You should ask when they were harvested. If the answer is July, you should steer clear. You should be concerned about chain of custody – where have those berries been and have they been mixed with other, younger unripe berries. And you should ask whether your saw palmetto extract has been mixed with other fatty acids and whether you are getting pure saw palmetto extract," he said.

Ultimately says Hulse, the proof is in the profile when it comes to saw palmetto. "There is an objective standard for saw palmetto that is based on years of studying the makeup of mature saw palmetto berries and their extracts, the only saw palmetto product that has been shown to be safe and effective in dealing with the symptoms of BPH. If we want consumers to take us seriously about the issue of quality, we should use this objective standard," he said. "The science exists to ensure the quality of the product. With this new free program, there is no reason not to deliver the best product to consumers," he added.