AUSTIN, Texas (December 16, 2021) — The ABC-AHP-NCNPR Botanical Adulterants Prevention Program (BAPP) announces the publication of a new Laboratory Guidance Document (LGD) on St. John’s wort (Hypericum perforatum) raw material and products. The document provides guidance for industry, academic, and regulatory analytical laboratories to be able to accurately and adequately test for identity and authenticity and detect potential adulteration of St John’s wort raw materials and extracts.
Traditionally, oil made from St. John’s wort flowers was used to treat burns and other wounds. Today, St. John’s wort herb extract preparations are commonly used to treat mild-to-moderate forms of depression. Human clinical trials on standardized extracts of St. John’s wort, and meta-analyses of these trials, support the safety and efficacy of the preparations for this purpose. In 2020, St. John’s wort dietary supplements were the 21st top-selling supplement in mainstream US retail stores, with annual mainstream sales totaling roughly $23.9 million.
Reports of St. John’s wort adulteration most often describe the undeclared addition of synthetic food dyes (e.g., the often-banned Red Dye No. 2, also known as “amaranth dye”) to the herb extract as a means to increase the appearance of the concentration value of total hypericins (the red pigments that are present in St. John’s wort) when measured by spectrophotometric laboratory analytical methods. This creates the false impression of an extract with a higher content of total hypericins and thus of a higher-quality ingredient. Also described in the literature are cases of substitution with other Hypericum species; however, these cases are infrequent and may be due to accidental co-harvesting of Hypericum species collected in the wild. Many companies in the herbal dietary supplement industry now use commercially cultivated St. John’s wort since wild-collected material is well known for its high variability in naturally occurring chemical constituents.
This latest in the series of BAPP LGDs was written by Nilüfer Orhan, PhD, an expert in natural products chemistry and analysis and a former professor of pharmacognosy at Gazi University in Ankara, Turkey. The LGD evaluates the usefulness of 67 published analytical laboratory methods to identify authentic St. John’s wort herb raw material and extracts, and finished St. John’s wort products, and to detect the adulteration of such St. John’s wort ingredients and products.
The LGD also summarizes the main advantages and disadvantages of each analytical method regarding its suitability for use in quality control laboratories. Additionally, the document provides short summaries and a table with the chemical compositions St. John’s wort and 10 potentially confounding Hypericum species. The LGD was peer-reviewed by 21 international experts from academia and the herbal dietary supplement industry.
Stefan Gafner, PhD, chief science officer of ABC and technical director of BAPP, explained: “I vividly remember the issue with the food dye adulteration of St. John’s wort extracts since this was one of the first alerts based on industry data published in BAPP’s ‘Botanical Adulterants Monitor’ newsletter back in 2015. While such food dye adulteration is readily detected by routine chemical analysis methods, the distinction of Hypericum species based on chemical markers is really difficult. Therefore, knowing the value chain (i.e., where, how, and by whom the St. John’s wort herb is cultivated, collected/harvested, and dried) is crucial to produce a dietary supplement with a reproducible composition.”
Mark Blumenthal, ABC founder and executive director and BAPP founder and director, said: “The addition of a banned red food dye to materials that are sold as ‘St. John’s Wort Extract’ in order to try to fool some of the analytical methods used in testing laboratories is an egregious practice, and is evidence of actual intent by the producer of the fraudulent material to try to make a profit by victimizing its customer(s). This is why it is so important for BAPP to continue its vital research and educational mission to help ethical, responsible manufacturers of botanical dietary supplements protect themselves from such fraud, and, in the process, help ensure that consumers are able to purchase authentic botanical preparations that are safe and beneficial for their intended use. BAPP LGDs help industry quality control laboratories by showing them which analytical methods do or don’t work to detect various types of documented adulteration.”
The St. John’s wort LGD is the 12th publication in the series of LGDs and the 68th peer-reviewed publication published by BAPP. As with all BAPP publications, LGDs are freely accessible on the program’s website (registration required).
The ABC-AHP (American Herbal Pharmacopoeia)-NCNPR (National Center for Natural Products Research at the University of Mississippi) 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 challenges 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.
To date BAPP has released 68 extensively peer-reviewed publications, including Botanical Adulterants Prevention Bulletins, Laboratory Guidance Documents, and “Botanical Adulterants Monitor” e-newsletters.