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Botanical Adulterants Prevention Program Publishes Saw Palmetto Berry Extract Laboratory Guidance Document

ISSUE:
Page:
18-19

The ABC-AHP-NCNPR Botanical Adulterants Prevention Program (BAPP) recently published a new Laboratory Guidance Document (LGD) on saw palmetto (Serenoa repens, Arecaceae) fruit extract.1

In human clinical trials, saw palmetto extracts have been shown to improve symptoms related to benign prostatic hyperplasia (BPH). Products containing saw palmetto are among the top-selling botanical dietary supplements in the United States — ranking 11th in the mainstream market (supermarkets, drug stores, mass-market retailers, etc.) and 14th in the natural channel in 2018, with a combined $34.7 million in sales for both channels, according to HerbalGram’s 2018 Herb Market Report.2

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

While admixture or substitution with berries of related species in 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 it summarizes the main advantages and disadvantages of each method regarding suitability for use in a quality control laboratory. In addition, the document details the chemical composition of saw palmetto and many of its known adulterants. The LGD was reviewed by 25 experts from third-party contract analytical laboratories, nonprofit scientific organizations, and the herbal industry, and follows the publication of the third version of the Saw Palmetto Botanical Adulterants Prevention Bulletin in October 2018.3

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, said: “For years, we’ve known that some unethical ingredient suppliers have been selling fraudulent ‘saw palmetto’ extracts containing lower-cost oils from other plants. Recently, reports have been published in reputable journals that fraudsters have begun to add fatty acids 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 of 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).

About the ABC-AHP-NCNPR Botanical Adulterants Prevention Program

The ABC-AHP (American Herbal Pharmacopoeia)-NCNPR (National Center for Natural Products Research) Botanical Adulterants Prevention Program is an international consortium of nonprofit professional organizations, analytical laboratories, research centers, industry trade associations, industry members, and other parties with interest in herbs and medicinal plants. The program advises industry, researchers, health professionals, government agencies, the media, and the public about various issues related to adulterated botanical ingredients sold in commerce. To date, more than 200 US and international parties have financially supported or otherwise endorsed the program.

References

  1. Gafner S. Saw Palmetto Extract Laboratory Guidance Document. Austin, TX: ABC-AHP-NCNPR Botanical Adulterants Prevention Program; 2019. Available at: http://cms.herbalgram.org/BAP/LGD/SawPalmettoExtractLabGuidanceDoc.html. Accessed September 25, 2019.
  2. Smith T, Gillespie M, Eckl V, Knepper J, Morton Reynolds C. Herbal Supplement Sales in US Increase by 9.4% in 2018. HerbalGram. 2019;123:62-73. Available at: http://cms.herbalgram.org/herbalgram/issue123/files/HG123-HMR.pdf. Accessed September 25, 2019.
  3. Gafner S, Baggett S. Botanical Adulterants Prevention Bulletin: Adulteration of Saw Palmetto (Serenoa repens). Version 3. Austin, TX: ABC-AHP-NCNPR Botanical Adulterants Prevention Program; 2018. Available at: http://cms.herbalgram.org/BAP/pdf/BAP-BABs-SawPalmetto-CC-102018-v2.pdf. Accessed September 25, 2019.

—ABC Staff