Detecting adulteration: American Botanical Council fights saw palmetto fraud with new guidance

17 Sep 2019 --- Due to a number of saw palmetto extract adulterations being detected in botanical supplements in the US, there has been a rising need to detect fraudulent components and guarantee the ingredient’s authenticity. The American Botanical Council’s (ABC) Botanical Adulterants Prevention Program (BAPP) has now published a new Laboratory Guidance Document (LGD) on saw palmetto (Serenoa repens) extract. The guidance document is touted as being instrumental in safeguarding product safety and eliminating adulterated supplements from the nutraceutical market.

“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. This is not only unfair to consumers but also to reputable companies that produce authentic, reliable saw palmetto ingredients and products made from them,” says Mark Blumenthal, ABC Executive Director and BAPP Founder.

Written by Stefan Gafner, Ph.D., Chief Science Officer of the ABC, the LGD evaluates the usefulness of 34 published analytical methods to detect saw palmetto berry and berry extract adulteration. The document 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 guidance details the chemical composition of saw palmetto and many of the known adulterants.

Saw palmetto extract is often used to support prostate health.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. 

Despite some clinical studies questioning its efficacy, saw palmetto is commonly known to treat benign prostatic hyperplasia (BHP), a nonmalignant enlargement of the prostate. Due to market demand in recent years, the price of saw palmetto berries has risen, and consequently there have been increased amounts of substitution and dilution of the saw palmetto extract in supplements. Some vegetable oils and designer fatty acid blends from plant or animal sources attempt to mimic saw palmetto’s fatty acid composition. 

“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,” Dr. Gafner explains. 

Adulteration: A market concern?
Despite market adulteration concerns, according to US Food and Drug Administration (FDA) data, the American Herbal Products Association (AHPA) recently reported that only 2 percent of recalled supplements in 2019 were dietary supplements. Merle Zimmermann, Ph.D., and AHPA Chief Information Analyst explains to NutritionInsight that the dietary supplement product class is relatively safe compared to other FDA regulated products such as foods and drugs.

Nevertheless, awareness of the importance of clinical evidence for new products is rising as pharmaceutical companies move toward nutraceuticals and consumer demand for quality products becomes more pronounced. The future market landscape could mean clinical substantiation of finished products will become a necessity for companies from all backgrounds, not only pharmaceutical.

Adulteration of dietary supplements and other medicinal products is not unique to saw palmetto extract. Schreiner MediPharm, a Germany-based provider of specialty pharmaceutical labeling solutions, has introduced BitSecure Mobile this month, a digital counterfeiting detection solution to help fight illegal trade in counterfeit medicines. 

The ABC has long been aware of the increasing fraud in botanical products. This month, it organized a symposium in cooperation with Euromed to develop strategies to tackle such botanical adulterations. Entitled “Economic Adulteration of Botanical Ingredients”, the symposium touted a diversified program with expert lectures on the different aspects of botanical adulteration and fraud, case studies exploring the health risks associated with counterfeit ingredients, the role of sourcing, as well as prevention tools for the industry and propositions for risk reduction and better quality control.

By Anni Schleicher