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Botanical Adulterants Program Publishes Bulletin on Adulteration of Saw Palmetto
Low-cost vegetable oils used to adulterate saw palmetto extracts
AUSTIN, Texas (February 1, 2017) — The ABC-AHP-NCNPR Botanical Adulterants Program announces the publication of a new Botanical Adulterants Bulletin (BAB) on saw palmetto (Serenoa repens) berry and berry extracts.
Saw palmetto extract is a popular ingredient in dietary supplements used for normalizing prostate function and relieving lower urinary tract symptoms (e.g., inability to void urine) related to benign prostatic hyperplasia. The 2015 HerbalGram Herb Market Report ranked saw palmetto products among the 20 top-selling herbal supplements in both mainstream and natural retail outlets in the United States.
Reports of the addition of undeclared vegetable oils (e.g., palm oil, canola oil, or coconut oil) to saw palmetto extracts for financial gain appeared in the early 2000s. Since these vegetable oils contain some of the same components as ripe saw palmetto berries, the detection of this type of adulteration is not always straightforward. Even more difficult is the determination of the proper amount of saw palmetto in a finished product, since vegetable oils almost always are added (and appropriately declared on the label) as part of the semi-liquid formulation of the saw palmetto extract (e.g., in softgel capsules). Unscrupulous suppliers have taken advantage of these analytical challenges to pass vegetable oils as saw palmetto extracts entirely and/or to dilute saw palmetto extracts with the lower-cost vegetable oils.
The goal of the Botanical Adulterant Bulletins is to provide accounts of ongoing issues related to botanical identity and adulteration, thus allowing quality control personnel and lab technicians in the herbal medicine, dietary supplement, cosmetic, conventional food, and other industries where botanical ingredients are used to be informed on adulteration problems that are apparently widespread and/or that may constitute safety problems. As with all publications in the Program, the Bulletins are freely accessible on the Program’s website to all American Botanical Council (ABC) members, registered users of the ABC website, and members of the public.
The saw palmetto Bulletin was co-authored by Scott Baggett, PhD, an analytical methods consultant for the natural products industry, and Stefan Gafner, PhD, ABC chief science officer and Botanical Adulterants Program technical director. Besides information on production, supply sources, and the market importance of saw palmetto and its extracts, the Bulletin provides information about known adulterants and analytical approaches to detect adulterants. Ten expert peer reviewers provided input on the saw palmetto Bulletin.
“The saw palmetto plant is known to grow and produce fruit (called ‘berries’ in the trade) only in the southeast United States, mainly Florida,” said Mark Blumenthal, founder and executive director of ABC and founder and director of the Botanical Adulterants Program. “We have heard concerns for many years from ethical, responsible members of industry of the presence of ostensible saw palmetto extract containing low-cost vegetable oils as an adulterant. This creates unfair competition and reduces the potential health benefit to men who use saw palmetto to help manage urinary conditions.”
“There are high-quality saw palmetto extracts in the world market that are the subject of numerous published clinical trials demonstrating their safety and potential benefits in prostate health,” Blumenthal continued. “Consumers should be able to purchase these and other saw palmetto supplements with a sense that they contain appropriate amounts of true, authentic saw palmetto.”
Gafner added: “The sale of adulterated extracts is known to the reputable manufacturers of authentic saw palmetto extracts and to many responsible manufacturers of saw palmetto dietary supplements, but there is a lack of reliable data on the extent of the problem in the peer-reviewed scientific literature. Of particular concern are raw materials labeled as ‘saw palmetto extract’ that are imported from China, where saw palmetto is not known to grow. We hope that this Bulletin will help to raise awareness of this adulteration issue and ultimately increase the number of high-quality products in the market.”
The saw palmetto Bulletin is the eighth publication in the relatively new series of Botanical Adulterants Bulletins. Also available are Bulletins on adulteration of arnica (Arnica montana) flower, bilberry (Vaccinium myrtillus) fruit extract, black cohosh (Actaea racemosa) root and rhizome, goldenseal (Hydrastis canadensis) root and rhizome, grape (Vitis vinifera) seed extract, skullcap (Scutellaria lateriflora) herb, and St. John’s wort (Hypericum perforatum) herb.
About the ABC-AHP-NCNPR Botanical Adulterants Program
The American Botanical Council (ABC)-American Herbal Pharmacopoeia (AHP)-National Center for Natural Products Research (NCNPR) Botanical Adulterants Program (BAP) 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 the various challenges related to adulterated botanical ingredients sold in commerce. To date, more than 180 US and international parties have financially supported or otherwise endorsed the Program.
The Botanical Adulterants Program plans to release additional Bulletins in the coming months. These include a Bulletin on grapefruit (Citrus x paradisi) seed extract, rhodiola (Rhodiola rosea) root and rhizome, and saw palmetto (Serenoa repens) berry. In addition, the Program has just published an article in ABC’s peer-reviewed journal HerbalGram on adulteration of pomegranate (Punica granatum), specifically the undeclared addition of synthetic ellagic acid.
To date, the ABC-AHP-NCNPR Botanical Adulterants Program has published six extensively peer-reviewed articles on the history of adulteration, the adulteration of the herbs black cohosh and skullcap, adulteration of bilberry fruit extract, the history of ginseng (Panax spp.) taxonomy, nomenclature, and trade as basis for understanding ginseng adulteration, and the sale of synthetic antimicrobial compounds labeled to contain so-called “grapefruit seed extract.” In addition, the Program has published three Laboratory Guidance Documents reviewing and evaluating analytical methods to authenticate and detect adulteration of bilberry extract, black cohosh, and skullcap. The Program also publishes a quarterly e-newsletter, the Botanical Adulterants Monitor, that highlights new scientific publications related to botanical authenticity and analysis to detect possible adulteration, recent regulatory actions, and Program news. All of the Program’s publications are freely available to ABC Registered Users and Members on the Program’s website.