adulteration of saw palmettocms.herbalgram.org/bap/pdf/bap-babs-sawpalmetto-cc...4 serenoa reens •...

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Saw Palmetto Serenoa repens - B o t a n i c a l A d u l t e r a n t s B u l l e t i n • October 2018 • www.botanicaladulterants.org

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Adulteration of Saw Palmetto (Serenoa repens)

Citation (JAMA style): Gafner S, Baggett S. Adulteration of saw palmetto (Serenoa repens). Version 3. Botanical Adulterants Preven-tion Bulletin. Austin, TX: ABC-AHP-NCNPR Botanical Adulter-ants Prevention Program. 2018.

Keywords: Serenoa repens, saw palmetto berry, adulterant, adul-teration

Goal: The goal of this bulletin is to provide timely information and/or updates on issues of adulteration of saw palmetto (Serenoa repens) to the international herbal industry and the extended natu-ral products and natural health communities in general.

1 General Information 1.1 Common name: Saw palmetto1

1.2 Other common names:

English: Scrub-palmetto, sabal palm, saw palmetto berry

Chinese: Ju zonglu (锯棕榈) French: Sabal, palmier nain, palmier scie

German: Sabal, Sägepalme, Zwergpalme

Italian: Palma nana, cavolo di palma

Spanish: Sabal, palma enana americana1,2

1.3 Accepted Latin binomial: Serenoa repens (W. Bartram) Small

1.4 Synonyms: Chamaerops serrulata Michx., Corypha repens W. Bartram, Sabal serrulata (Michx.) Nutt. Ex Schult. & Schult. f., Serenoa serrulata (Michx.) G. Nicholson3

By Stefan Gafner, PhDa* and Scott Baggett, PhDb

aAmerican Botanical Council, PO Box 144345, Austin, TX 78714b37148 Talbert Terrace, Fremont, CA 94536*Corresponding author: email

Saw Palmetto Serenoa repensPhoto ©2018 Steven Foster

VERSION 3 Updated: October 2018

http://abc.herbalgram.org/site/Survey?ACTION_REQUIRED=URI_ACTION_USER_REQUESTS&SURVEY_ID=3541

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1.5 Botanical family: Arecaceae

1.6 Plant part, form, and production method: Dried powdered berries; lipophilic extracts made from the commi-nuted berries (fruits) of saw palmetto; extracts are primar-ily made using water-ethanol mixtures (not less than 90% ethanol according to the European Pharmacopoeia [Ph. Eur.]), hexanes (a mixture of n-hexane and methylpentane isomers), or a supercritical CO2 extraction technique.4,5

1.7 General use(s): Saw palmetto extracts (SPE) are indi-cated for urinary problems associated with benign prostatic hyperplasia (BPH).2,6-9 According to a survey in the United States, 0.7% and 0.4% of adults in 2007 and 2012, respec-tively, reported use of a saw palmetto in the 30 days prior to the survey.10 BPH is associated with elevated concentrations of dihydrotestosterone in men.8 Specifically, extracts of S. repens fruit inhibit the conversion of testosterone to dihy-drotestosterone by 5α-reductases.11-13

2 Market2.1 Importance in the trade: According to a press release

in 2010, worldwide sales of saw palmetto supplements were approximately US $700 million, with the United States accounting for US $200 million alone.14 Data by the market research firm SPINS ranked saw palmetto in the top 16 of botanicals sold in the United States from 2010-2017.15-21 Sales in the mainstream multi-outlet channel (excluding sales at Walmart and club stores) declined from $21.6 million in 2013 to $16.8 million in 2015, but climbed back to $19.3 million in 2017. Saw palmetto sales in the natural channel (excluding sales at Whole Foods Market) remained fairly constant over the past 5 years, fluctuating between $6.4 and $7.9 million between 2013 and 2017.

2.2 Supply sources: Saw palmetto fruits/berries are harvested from mid-August to mid-November across its natural growing range. Saw palmetto grows across Flor-ida and as far north as South Carolina. It is important to note that saw palmetto is primarily a wild-harvested (wild-

crafted) botanical (E. Fletcher [Herbal Ingenuity], oral communication, June 25, 2015). According to the American Herbal Products Association’s (AHPA’s) 2005-2010 tonnage survey,22 which is the most recent data collected by AHPA, there were 680.4 metric tons (1.5 million pounds) of saw palmetto fruits harvested in 2009 and 635 metric tons (1.4 million pounds) harvested in 2010. A small amount of saw palmetto fruits were harvested from cultivated sources (998 kg in 2009, and 1,227 kg in 2010). Other estimates set the harvest volume between 4,500 and 8,000 metric tons/year, depending on the weather conditions. (G. Woodman [Euromed] email to S. Gafner, June 25, 2018). The total extract volume in 2016 was approximately 520 metric tons, valued at US $105 million prior to encapsulation.23

2.3 Market dynamics: Saw palmetto grows in a small geographical range in the Southeast United States. In most years, there is ample supply of berries to meet market demand to produce SPE. Main supply disruptions are due to environmental factors, i.e., hurricanes and heavy rains. For example, when Florida was hit by five hurricanes in 2004-2005, fresh berries were not available and the prices increased. Another potential supply problem is heavy rains during the flowering season. Heavy rains will knock flow-ers from the palm and can prevent fruit from setting. Heavy rains also provide the perfect conditions for a disease caused by the fungus Colletotrichium gloesporioides, causing lesions in flowers and fruit and leading to the dropping of prema-ture fruit.24 While less common, heavy rains (prevent-ing fruit set) have happened in the past. Keeping track of weather disruptions in the saw palmetto growing range is important to predict the likelihood of adulteration (E. Fletcher oral communication, June 25, 2015). In particular, in 2016 and 2017 when below-average harvest volumes for saw palmetto were obtained, there were low-cost materi-als, falsely labeled as saw palmetto, which appeared on the market. The situation has been exacerbated by extensive rain in 2018, which interrupted the flowering period and resulted in widespread berry drop (see above) across the state. According to the saw palmetto mid-season harvest

Table 1: Sales data for saw palmetto dietary supplements from 2012-2017.

Channel 2013 2014 2015 2016 2017

Rank Sales [US$] Rank Sales [US$] Rank Sales [US$] Rank Sales [US$] Rank Sales [US$]

Naturala 10 6,424,306 11 6,363,119 8 7,555,435 10 7,555,383 11 7,875,432

Main-stream Multi-Outletb

11 21,560,716 10 17,990,612 14 16,849,069 16 17,403,324 14 19,294,711

aAccording to SPINS (SPINS does not track Whole Foods Market sales, which is a major natural products retailer in the US)bAccording to SPINS/IRI (the Mainstream Multi-Outlet channel was formerly known as food, drug and mass market channel [FDM], possible sales at Walmart and club stores are excluded in 2013, 2014 and 2015)n/a: not availableSource: T. Smith (American Botanical Council) e-mail to S. Gafner, September 2, 2015, September 3, 2015, and June 19, 2018; K. Kawa (SPINS) e-mail to S. Gafner, July 11, 2016.

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report by the American Herbal Products Association, the price has increased rapidly based on the short supply and a need for pickers to move into more remote areas in order to harvest the berries. In the first week of September 2018, costs for the berries were reportedly about three times higher than the average price in 2017.25

It remains to be seen how the requirement to obtain land-owner permission and a permit for saw palmetto harvesters and sellers issued by the Florida Department of Agricul-ture and Consumer Services in July 201826 will impact the supply chain. Estimated price ranges for SPE varied from US$ 150-235/kg in 2016, and rose to US$ 190-275/kg in 2017. The market is significantly impacted by adulterated materials from China and India, which are priced between US$ 50-135/kg (G. Woodman [Euromed] email to S. Gafner, June 25, 2018). The substantial increase (2-3-fold) in raw material costs since 2009 has been attributed to more competition and higher costs for the labor force (Umasud-han C.P. [Valensa] oral communication, October 31, 2016).

3 Adulteration3.1 Background about extract/product: The main

components of SPE are fatty acids (70-95%), phytoster-ols (0.2-0.5%), and long-chain alcohols (0.15-0.35%).5 A number of monographs/extract definitions have been published.4,5,27 SPE can be distinguished from other plant oils based on the relative amounts of the individual free fatty acids,28 and the higher concentration of total free fatty acids in SPE. The United States Pharmacopeia (USP) monograph specifies a ratio of naturally occurring caproic, caprylic, capric, myristic, palmitic, stearic, oleic, linoleic and linolenic acids to lauric acid for authentication of SPE. A number of analytical methods for the authentica-tion of SPE have been published: thin-layer chromatogra-phy (TLC),4,5 gas chromatography (GC),29-31 and nuclear magnetic resonance (NMR) profiling.29,32-34

3.2 Known adulterants: A number of ways to adulter-ate saw palmetto extracts and dietary supplements have been described: substitution of the saw palmetto fruit with fruit from closely-related palm species, dilution of products with exhaustively extracted berry powder, the use of unripe berries to produce an extract, the addition of vegetable oils to extracts, full substitution of SPE with other vegetable oils, and/or the production of designer blends with similar fatty acid profile to authentic saw palmetto.31-33,35-37 The closest relative of saw palmetto is Acoelorrhaphe wrightii (common names include everglades palm and silver saw palm). Little and Jeanson (2013) reported that out of 29 commercial dietary supplements (purchased at retail stores in the United States or from the Internet) labeled to contain dry, cut-and-sifted saw palmetto, one contained A. wrightii instead, and another product contained an unidentified adulterant.38 Acoelorrhaphe wrightii grows in the United States, the Bahamas, Cuba, southeastern Mexico, Belize, Guatemala, Honduras, Nicaragua, Colombia, and Costa Rica. SPE adulterated with other plant oils, such as canola (Brassica napus ssp. napus, Brassicaceae) oil, coconut (Cocos

nucifera, Arecaceae) oil, olive (Olea europaea, Oleaceae) oil, palm (Elaeis guineensis, Arecaceae) oil, peanut (Arachis hypogaea, Fabaceae) oil, and sunflower (Helianthus annuus, Asteraceae) oil has been reported on a number of occa-sions.32,35,36,39 Mikaelian and Sojka31 describe possible methods of such SPE adulteration: Unscrupulous suppli-ers can dilute the initial SPE with less expensive plant oils because the price of SPE is much higher than that of any commercially-available food-based plant oils. These suppli-ers use this approach to take advantage of manufacturers that evaluate only the amount of total fatty acids rather than the free fatty acid composition. Another type of adul-teration occurs when the SPE is diluted with a specially formulated blend of lower-cost oils in an attempt to emulate the fatty acid profile found in SPE. Finally, Perini et al. reported the appearance of a particularly sophisticated type of adulterated saw palmetto oil, in which fatty acids obtained from animal fats are mixed in the same ratio that fatty acids occur in authentic saw palmetto.32 These so called “designer blends” comply with most of the specifica-tions listed in the USP and the EP monographs, and there-fore are difficult to detect by conventional analytical meth-ods such as TLC or GC.

3.3 Sources of information confirming adultera-tion: Several papers on the quality of commercial SPE were obtained that also provided analytical data on the samples.29,30,32,40,41 The investigation into the authentic-ity of commercial saw palmetto samples from the North American market by Mikaelian et al. and Perini et al.


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confirm product adulteration.30,32 In the study by Mikae-lian et al., nine of the 10 samples were correctly labeled, and one was found to be adulterated with an unidenti-fied vegetable oil based on a different pattern of free fatty acids, and an unusually low content of free fatty acids. The 2018 investigation by Perini et al. into the composi-tion of SPEs obtained from suppliers in Asia found all of the nine ingredients to be adulterated. Three samples were adulterated with vegetable oil (two samples being coconut or babacu (Attalea speciosa, Arecaceae) oil, and one case of an unidentified mixture), the other six samples were designer blends composed of fatty acids of animal origin.32 In another study from 2018, a vegetable oil, possibly coco-nut oil, was determined as the adulterant based on the results of a 1H NMR investigation of a commercial sample labeled to contain saw palmetto.33 Cases of SPE adultera-tion with vegetable oils (olive oil, palm oil, peanut oil, and sunflower oil), or with animal fat-derived blends have also been reported from quality control departments at leading suppliers of saw palmetto extract: Euromed (Mollet del Vallès, Spain), Indena (Milan, Italy), and Valensa (Eustis, FL, USA). 23,36,39,42 Two other publications suggest the dilution of SPE with various vegetable oils is commonly occurring, but the documents do not provide data to support the statements.35,37

3.4 Accidental or intentional adulteration: A distinc-tion between raw saw palmetto fruit material and fruit extract adulteration is warranted. Adulteration of saw palmetto berries with berries from A. wrightii38 may be due to harvests from the Caribbean entering the saw palmetto trade. Acoelorrhaphe wrightii grows in a differ-ent habitat than saw palmetto, and has considerably larger fruit; therefore, the two species are not likely to be confused by saw palmetto harvesters, making such an adulteration intentional (S. Foster, e-mail to S. Gafner, December 20, 2016). The addition of lower-cost vegeta-ble oils or fatty acids from animal sources to SPEs is for economic gain, either by willfully increasing profitability through the use of less expensive adulterating materials or to supplement market demands in times of shortage. As stated above, costs for authentic SPEs ranged from US $190-275/kg in 2017. Materials that are offered at consid-erably lower prices are likely adulterated. Such adulteration by unscrupulous suppliers is intentional and purposefully deceives the finished herbal product manufacturer and consumer.

3.5 Frequency of occurrence: There are no statisti-cal data available on the frequency of the overall occur-rence of saw palmetto fruit and extract adulteration. As noted above, an evaluation of 10 commercial samples, purchased in local stores in the United States and from the Internet, found that one product was adulterated.30

The nine commercial ‘saw palmetto’ extracts of Asian origin analyzed by Perini et al. were all adulterated.32 As saw palmetto is native to the United States, SPE shipments labeled to contain saw palmetto originating in Asia are

generally viewed with suspicion. There have been three known broad attempts to buy and analyze commercial saw palmetto products. Two were studies carried out by universities29,38 and one was conducted by a commer-cial consumer products testing program, ConsumerLab.com in 2003.43 Similar to the findings of Mikaelian et al. reported above, tests on 22 commercial saw palmetto products by ConsumerLab.com in 2003 revealed possible addition of an undeclared vegetable oil in one product.43 The rather comprehensive overview on the quality of saw palmetto supplements in the marketplace by Booker et al.29 also indicated a low occurrence of adulteration, since all 57 commercial products actually contained saw palmetto and the presence of additional vegetable oils was declared on the labels (most likely as appropriate excipients in soft-gel capsules). Highly variable contents in free fatty acids (40.7%-80.7%) and triglycerides (6.8%-52.2%) were also found during an investigation into the quality of 14 European saw palmetto products. The authors, however, did not hypothesize about the reason behind the differ-ences with the exception of one product known to contain 50% olive oil (which is declared on the label).41

Similar results were observed in the study by Wang et al.,40 where eight commercial samples (seven capsules and one softgel product) purchased on the Internet were analyzed by GC with mass spectrometric (MS) detec-tion. The fatty acid composition of the capsule products was consistent with authentic saw palmetto berry. The softgel product had a different fatty acid composition, with a larger amount of oleic acid due to the presence of olive oil, which was declared on the label. The use of added vegetable oils is consistent with preparation of soft gelatin capsule technology. However, since the adultera-tion rate seems to be to some extent dependent on the weather and harvest conditions in current or immediately prior seasons (see Section 2.4), a yearly fluctuation in the number of adulterated products on the market may be expected. While there is little evidence of adulteration of saw palmetto finished supplements in the current market based on published reports thus far, as shown above (see Section 3.3) unpublished analyses by suppliers of authentic SPE suggest there is some adulterated SPE present in the botanical ingredient supply chain.

3.6 Possible safety/therapeutic issues: None of the vegetable oils linked to saw palmetto adulteration is considered to be a health hazard. Similarly, the sale of designer blends made from animal-derived fatty acids does not represent a health hazard, although many coun-tries demand specific documents for the customs inspec-tion process, in particular ingredients derived from bovine origin to reduce the risk of bovine spongiform encepha-lopathy (BSE). In addition, the presence of animal-derived fatty acids may represent a moral issue for vegetarians, vegans, and/or persons of certain religious traditions,in which the undeclared presence of fats of possible porcine or bovine origin would be considered anathema. Concern-ing adulteration with berries from closely related species,

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the fruits of A. wrightii are edible according to Austin, and some parts of the plants are used as medicine in Belize.44 However, to our knowledge, no extensive review on the safety of A. wrightii has been performed.

3.7 Analytical methods to detect adulteration: There are four monographs on saw palmetto materials in the USP: Saw Palmetto, Powdered Saw Palmetto, Saw Palmetto Extract, and Saw Palmetto Capsules.5,45-47 Two of the monographs (Saw Palmetto and Powdered Saw Palmetto) include a TLC assay for authentication, and all four of them describe a method for quantification of the fatty acids by GC using a flame ionization detector (FID). For extracts, the organoleptic assessment may give a hint on the pres-ence of an adulterant: SPE has a characteristic odor; the color depends on the type of extract: ethanol extracts are of a dark greenish-brown color, the supercritical carbon dioxide extract has a yellowish-brown or orange-brown color, and the hexane extract is yellowish-green to orange-yellow. In addition, the SPE and saw palmetto capsule monographs contain a GC-FID method to determine the contents in long-chain alcohols and phytosterols (campes-terol, stigmasterol, β-sitosterol, and stigmastanol), which provides another parameter with regards to the authentic-ity of the material. The Ph. Eur. has a monograph for saw palmetto berries, which again uses TLC for authentication and GC-FID to determine the concentrations of individual fatty acids relative to lauric acid.4 In addition to TLC and GC methods, 1H NMR with subsequent statistical analysis has been used to characterize saw palmetto dietary supple-ments.29,34 De Combarieu et al. have used principal compo-nent analysis (PCA) of proton nuclear magnetic resonance (1H NMR) data to evaluate the phytoequivalence of extracts obtained with different solvents.34 In 2018, Perini et al. published a comprehensive analytical approach to authen-ticate saw palmetto, which included GC-FID, high-perfor-mance liquid chromatography (HPLC), 1H NMR and isotopic fingerprinting analysis with a subsequent statistical assessment by principal component analysis (PCA). Isotopic

fingerprinting is an analytical approach in which the ratios of stable isotopes, e.g., hydrogen (H), carbon (C), oxygen (O), strontium (Sr), and/or other chemical elements are measured. The determination of the 18O/16O, and 2H/1H ratios proved to be particularly useful, since these ratios differed substantially from those of the authentic SPEs and allowed to determine that six out of the nine commercial samples were derived from animal fats.32

Phytoequivalence is a term used to describe the similarity of the plant metabolites in extracts made from the same part of a plant species in order to determine if the same physi-ological effects can be expected. Another way to check for adulteration is to determine the lauric acid content. SPE is unique due to its high content of lauric acid. The Ph. Eur. monograph requires a minimum content of 23% lauric acid in anhydrous SPE. In addition, SPE has a very high acid value which is different from other plant oils; therefore, the acid value range of SPE is specified in the Ph. Eur.4 However, when vegetable oils are added to the product, for example in softgel capsules, and the addition of such prod-ucts is indicated on the label, it is very difficult to verify if the amount of SPE indicated on the label is accurate. For crude raw material, the DNA mini-barcode method described by Little et al. provides an additional tool to determine if species other than saw palmetto are present, though it will not satisfy GMP requirements for identifica-tion of the appropriate plant part.38 For extracts, a combi-nation of analytical methods, including the organoleptic evaluation, the determination of the fatty acid profile, the acid value, and the content of fatty alcohols should allow authenticating SPE.

4 ConclusionsSaw palmetto is an important herbal supplement. SPE

has been well characterized and phytochemical profiles for the supercritical and alcoholic extracts have been estab-lished, thus defining SPE.4,5 Multiple analytical methods (DNA barcoding, HPLC, GC, TLC, 1H NMR, and isoto-pic fingerprinting) to authenticate saw palmetto have been


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Saw Palmetto Serenoa repens - B o t a n i c a l A d u l t e r a n t s B u l l e t i n • February 2017 • www.botanicaladulterants.org

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published. In recent years, saw palmetto fruits have not been in abundant supply, since environmental conditions have adversely affected their availability. Preliminary feed-back suggests that heavy rain, and the new state permitting requirement for picking saw palmetto berries suggest that the 2018 harvest will also be negatively impacted. Manu-facturers need to be particularly vigilant in years when the harvested amount of saw palmetto berries is low, and in immediately subsequent years when possible adulterated materials may more likely be found in the marketplace. SPE ingredient specifications should be developed in a manner that will ensure the absence of adulterants. Quality control analysts should be informed of the appropriate tests that can be used to verify the authenticity of the material. Establish-ing the country of origin for a shipment of saw palmetto berries may reduce the likelihood of a substitute species being used, as authentic saw palmetto grows only in a small range in the southeast U.S. (e.g., material labeled to origi-nate from China is unlikely authentic saw palmetto since to these authors’ knowledge, there are no commercial saw palmetto cultivations in that country).

5 References1. McGuffin M, Kartesz JT, Leung AY, Tucker AO. Herbs of Commerce.

2nd ed. Silver Spring, MD: American Herbal Products Association; 2000.

2. Melzig MF, K. H, Loew D. Sabalis serrulatae fructus In: Wichtl M, ed. Teedrogen und Phytopharmaka. 6th ed. Stuttgart, Germany: Wissenschaftliche Verlagsgesellschaft mbH; 2016:572-574.

3. The Plant List. Version 1.1. http://www.theplantlist.org/tpl1.1/record/kew-298116. Accessed June 12, 2017.

4. Sabalis serrulatae extractum. European Pharmacopoeia (EP 9.0). Stras-bourg, France: European Directorate for the Quality of Medicines and Health Care; 2014:1509-1511.

5. Saw palmetto extract. USP 41-NF 36. Rockville, MD: United States Pharmacopeial Convention; 2018:4860-4861.

6. Bennett BC, Hicklin JR. Uses of saw palmetto (Serenoa repens, Arecaceae) in Florida. Econ Bot. 1998;52(4):381-393.

7. Wadsworth TL, Carroll JM, Mallinson RA, Roberts JCT, Roselli CE. Saw Palmetto extract suppresses insulin-like growth factor-I signaling and induces stress-activated protein kinase/c-Jun N-terminal kinase phosphorylation in human prostate epithelial cells. Endocrinology. 2004;145(7):3205-3214.

8. MacDonald R, Tacklind JW, Rutks I, Wilt TJ. Serenoa repens mono-therapy for benign prostatic hyperplasia (BPH): an updated Cochrane systematic review. BJU International. 2012;109(12):1756-1761.

9. Geavlete P, Multescu R, Geavlete B. Serenoa repens extract in the treat-ment of benign prostatic hyperplasia. Ther Adv Urol. 2011;3(4):193-198.

10. Clarke TC, Black LI, Stussman BJ, Barnes PM, Nahin RL. Trends in the use of complementary health approaches among adults: United States, 2002–2012. National health statistics reports. 2015(79):1-16.

11. Wilson JD. The pathogenesis of benign prostatic hyperplasia. Am J Med. 1980;68(5):745-756.

12. Pais P, Villar A, Rull S. Determination of the potency of a novel saw palmetto supercritical CO2 extract (SPSE) for 5α-reductase isoform II inhibition using a cell-free in vitro test system. Res Rep Urol. 2016;8:41-49.

13. Pais P. Potency of a novel saw palmetto ethanol extract, SPET-085, for inhibition of 5α-reductase II. Adv Ther. 2010;27(8):555-563.

14. Leading Saw Palmetto Producer Reports That Consumers May Be Using Saw Palmetto Incorrectly in Support of Prostate Health [press release]. Orlando, FL: PRNewswire, August 10 2010.

15. Lindstrom A, Ooyen C, Lynch M, Blumenthal M. Herb supple-ment sales increase 5.5% in 2012: herbal supplement sales rise for 9th consecutive year; turmeric sales jump 40% in natural channel. HerbalGram. 2013;99:60-65.

16. Blumenthal M, Lindstrom A, Ooyen C, Lynch M. Herb supplement

sales increase 4.5% in 2011. HerbalGram. 2012;95:60-64.17. Lindstrom A, Ooyen C, Lynch M, Blumenthal M, Kawa K. Sales

of herbal dietary supplements increase by 7.9% in 2013, marking a decade of rising sales: turmeric supplements climb to top ranking in natural channel. HerbalGram. 2014;103:52-56.

18. Smith T, Lynch M, Johnson J, Kawa K, Bauman H, Blumenthal M. Herbal dietary supplement sales in US increase 6.8% in 2014. HerbalGram. 2015;107:52-59.

19. Smith T, Kawa K, Eckl V, Johnson J. Sales of herbal dietary supple-ment sales in US increased 7.5% in 2015. HerbalGram. 2016;111:67-73.

20. Smith T, Kawa K, Eckl V. Herbal supplement sales in US increase 7.7% in 2016. HerbalGram. 2017;115:56-65.

21. Smith T, Kawa K, Eckl V, Morton C, Stredney R. herbal supplement sales in US increase 8.5% in 2017, topping $8 billion. HerbalGram. 2018;119:62-71.

22. Dentali S, Zimmermann M. American Herbal Products Association Tonnage Surveys of Select North American Wild-Harvested Plants, 2006–2010. Silver Spring, MD: American Herbal Products Associa-tion; 2012.

23. Minatelli J. Saw palmetto extract: Dealing with emerging adulteration in the global market [Internet]. NutraIngredients-USA William Reed Business Media; 2017 June 22. Podcast. Available from: https://www.youtube.com/watch?v=I4UEyM0Akjc

24. Carrington ME, Roberts PD, Urs NVRR, McGovern RJ, Seijo TE, Mullahey JJ. Premature fruit drop in saw palmettos caused by Colleto-trichum gloeosporioides. Plant Disease. 2002;85(2):122-125.

25. Saw palmetto berry 2018 mid-season harvest report [press release]. Silver Spring, MD: American Herbal Products Association, September 25 2018.

26. Putnam AH. Saw palmetto harvest fact sheet. Gainesville, FL: Florida Department of Agriculture and Consumer Services; 2017.

27. Serenoae repentis fructus (Sabal fructus). Saw palmetto fruit. ESCOP monographs. The Scientific Foundation for Herbal Medicinal Products. 2nd ed. Stuttgart, Germany: Thieme-Verlag; 2003:477-486.

28. Suter A. New perspectives on saw palmetto (Serenoa repens): a medico historical/ analytical comparison of preparations derived from it and a clinical pilot trial in patients with benign prostatic hyperplasia and sexual dysfunctions [PhD]. London, United Kingdom, University College London; 2012.

29. Booker A, Suter A, Krnjic A, et al. A phytochemical comparison of saw palmetto products using gas chromatography and (1)H nuclear magnetic resonance spectroscopy metabolomic profiling. J Pharm Pharmacol. 2014;66(6):811-822.

30. Mikaelian G, Sojka M, Minatelli J. The ultimate way to win the fight against saw palmetto extract adulteration. Nutra Bus Technol. 2009;1:46-49.

31. Mikaelian G, Sojka M. Authenticating saw palmetto extract : a new approach. Nutra Bus Technol. 2009;5:24-27.

32. Perini M, Paolini M, Camin F, et al. Combined use of isotopic fingerprint and metabolomics analysis for the authentication of saw palmetto (Serenoa repens) extracts. Fitoterapia. 2018;127:15-19.

33. Gafner S, Blumenthal M, Foster S, Cardellina II JH, Khan IA, Upton R. Botanical ingredient adulteration – How some suppliers attempt to fool commonly used analytical techniques. Acta Hort. 2018:in press.

34. de Combarieu E, Martinelli EM, Pace R, Sardone N. Metabolomics study of saw palmetto extracts based on 1H NMR spectroscopy. Fito-terapia. 2015;102:56-60.

35. Liva R, He X, Xiong L. Economically motivated adulteration. Integr Med. 2011;10(2):38-42.

36. Gafner S. Evidence for adulteration of saw palmetto extracts. Botani-cal Adulterants Monitor. Vol 11. Austin, TX: ABC-AHP-NCNPR Botanical Adulterants Prevention Program; 2017.

37. Saw palmetto adulteration found in six samples [press release]. Natu-ral Products Insider: Informa USA2017.

38. Little DP, Jeanson ML. DNA barcode authentication of saw palmetto herbal dietary supplements. Sci Rep. 2013;3:3518.

39. Pais P. Botanical extract adulteration in the US market. Supply Side West; 2012; Las Vegas, NV.

40. Wang M, Avula B, Wang Y-H, Zhao J, Parcher JF, Khan IA. Fatty acid analysis of saw palmetto (Serenoa repens) and pygeum (Prunus africana) in dietary supplements by gas chromatography/mass spectrometry in the selected ion monitoring mode. J AOAC Int. 2013;96(3):560-566.

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REVISION SUMMARY

Version # , Author, Date Revised Section Revised List of Changes

Version 1, S. Gafner, S. Baggett

n/a n/a none

Version 2, S. Gafner, S. Baggett

03/14/2017 3.7 All these monographs describe a TLC method for authentication and quantification of the fatty acids by GC using a flame ionization detector (FID),

replaced with

Two of them (Saw Palmetto and Powdered Saw Palmetto) include a TLC method for authentication, and all four monographs describe quantification of the fatty acids by GC using a flame ionization detector (FID)

Version 3, S. Gafner 10/23/2018 All Addition of common name in ChineseUpdate of sales and market data Addition of new regulations to harvest saw palmetto berries issued by the Florida Department of Agriculture and Consumer Services in sections 2.3 and 4Inclusion of additional evidence for adulteration (i.e., references 28, 29, and 33)Inclusion of documentation requirements related to the presence of animal products in section 3.6Addition of color characteristics and stable isotope analysis to section 3.7

Official Newsletter of the ABC-AHP-NCNPR Botanical Adulterants Program

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41. Habib FK, Wyllie MG. Not all brands are created equal: a compari-son of selected components of different brands of Serenoa repens extract. Prostate Cancer Prostatic Dis. 2004;7:195.

42. Gafner S. Alleged saw palmetto adulteration. Botanical Adulterants Monitor. Vol 8. Austin, TX: ABC-AHP-NCNPR Botanical Adulter-ants Prevention Program; 2016.

43. Consumers advised to read labels carefully when selecting herbal supplements for prostate. ConsumerLab.com; 2003. https://www.consumerlab.com/news/prostate_supplement_saw_palmetto_beta-sitosterol_tests/05-20-2003/. Accessed August 30, 2017.

44. Austin DF. Acoelorrhaphe wrightii. Florida Ethnobotany. Boca raton, FL: CRC Press; 2004:63-64.

45. Powdered saw palmetto. USP 41-NF 36. Rockville, MD: United States Pharmacopeial Convention; 2018:4858-4860.

46. Saw palmetto capsules. USP 41-NF36. Rockville, MD: United States Pharmacopeial Convention; 2018:4862-4865.

47. Saw palmetto. USP 41-NF 36. Rockville, MD: United States Pharmacopeial Convention; 2018:4856-4858.

adulteration of saw palmettocms.herbalgram.org/bap/pdf/bap-babs-sawpalmetto-cc...4 serenoa reens •...

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