Alleged Saw Palmetto Adulteration

Euromed S.A. (Barcelona, Spain), a 45 year old manufacturer of botanical extracts, alerted the Botanical Adulterants Program of a number of cases of saw palmetto adulteration. Four saw palmetto batches originating from China were analyzed – among other tests – for the acid value, fatty acids, fatty alcohols, and sterols using the gas chromatographic methods listed in the European Pharmacopoeia (EP), 8th edition.¹ The results – when compared to authentic saw palmetto extract – showed a different fatty acid profile, and the content of sterols was too high, while total fatty alcohols were unusually low. In addition, the acid values were below EP specifications, and the samples were of light color or colorless, unlike genuine saw palmetto extracts which are of a dark brown color in the case of hexane and ethanol extracts and yellowish-brown to orange-brown for supercritical CO₂ extracts.

Comment: The appearance of low-quality or adulterated saw palmetto extract in the supply chain may be linked to the poor saw palmetto berry harvest in Florida, where yields have been below average for the third year in a row. Inventories of major suppliers of berries and berry extracts are low, and some suppliers are even out of stock. Such saw palmetto extract shortages in the supply chain have led to admixture of or substitution with other vegetable oils in the past. The use of standard testing methods, such as those specified in the EP or the United States Pharmacopeia,² allows the detection of adulterated material.

References

1. The European Directorate for the Quality of Medicines & HealthCare. European Pharmacopoeia (EP 8.0). Sabalis serrulatae extractum. Strasbourg, France: Council of Europe; 2014:2046-2049.
2. United States Pharmacopeial Convention. Saw Palmetto. In: United States Pharmacopeia and National Formulary (USP 38–NF 33). Rockville, MD: United States Pharmacopeial Convention; 2015.

Note: The evidence for the above-reported case of adulteration is based on internal data gathered by the companies but has not been independently verified by a third-party analytical laboratory.