The ABC-AHP-NCNPR Botanical Adulterants Prevention Program (BAPP) has published a new Laboratory Guidance Document (LGD) on saw palmetto (Serenoa repens) extracts, which have been shown to improve symptoms related to benign prostatic hyperplasia (BPH) in human clinical trials.
 
Products containing saw palmetto berries and/or their extracts are among the top-selling botanical dietary supplements in the U.S.—ranking 11th in the mainstream market (supermarkets, drug stores, grocery stores, etc.) and 14th in the natural foods channel with a combined $35 million in sales for both channels, according to the latest HerbalGram Herb Market Report for 2018.

Poor harvests from 2016 to 2018, and possibly the introduction of new permitting requirements by the Florida Department of Agriculture and Consumer Services, have led to a situation where the saw palmetto berry supply cannot keep up with the demand. Consequently, prices for saw palmetto berries, which grow only in the southeastern U.S., mainly in Florida, increased substantially in 2018.

While admixture or substitution with berries from related species of the palm family appears to be infrequent, the substitution or dilution of saw palmetto extracts with vegetable oils or designer fatty acid blends from plant or animal sources to attempt to mimic saw palmetto’s fatty acid composition is more commonplace. Routine analytical methods using gas chromatography (GC) for fatty acids are not suitable to detect adulteration if the method measures only the total fatty acid content. A combination of various analytical methods including an organoleptic (color, taste, etc.) inspection of the liquid, determination of the acid value (pH), and GC for measuring fatty acid, fatty alcohol, and phytosterol profiles provides a more robust approach to ensure saw palmetto extract authenticity.

The new LGD was written by Stefan Gafner, PhD, chief science officer of the American Botanical Council (ABC) and technical director of BAPP. The LGD evaluates the usefulness of 34 published analytical methods to detect saw palmetto berry and berry extract adulteration, and summarizes the main advantages and disadvantages of each method regarding suitability for use in a quality control laboratory. In addition to the assessment of the analytical methods, the document details the chemical composition of saw palmetto and many of the known adulterants. The saw palmetto LGD was peer-reviewed by 25 experts from third-party contract analytical laboratories, nonprofit scientific organizations, and the herbal industry, and follows the publication of version 3 of the Saw Palmetto Botanical Adulterants Prevention Bulletin by BAPP in October 2018.3

Dr. Gafner explained: “Complete substitution of saw palmetto with vegetable oils is readily detected by organoleptic and chemical assays. However, fraudulent suppliers have become increasingly sophisticated in producing low-cost materials that are chemically similar to authentic saw palmetto. Therefore, a set of methods is now needed to determine if an extract labeled to be saw palmetto is actually authentic.”

Mark Blumenthal, ABC founder and executive director and BAPP founder and director, added: “There appears to be no depth to how low some fraudsters in the global botanical extract market are willing to go to make an illicit profit. For years we’ve known that some unethical ingredient suppliers have been selling fraudulent ‘saw palmetto’ extracts containing lower-cost oils from other plants. And recently, reports have been published in reputable medicinal plant journals that fraudsters have begun to add fatty acids produced from animal fats to so-called ‘saw palmetto’ extracts. This is not only unfair to consumers but also to the reputable companies that produce and market authentic, reliable saw palmetto ingredients and products made from them.”

The saw palmetto LGD is the ninth publication in the series of LGDs and the 53rd peer-reviewed publication published by BAPP. As with all publications in the program, LGDs are freely accessible to all ABC members, registered users of the ABC website, and all members of the public on the BAPP website (registration required).