Dear Reader,

The consequences of the investigations into the authenticity of dietary supplements by the New York State Attorney General (NY AG) Eric Schneiderman continue to impact the dietary supplement industry and have increased the emphasis on the need for appropriate test methods to detect botanical ingredient adulteration. Following the NY AG’s investigation into devil’s claw supplements, the United Natural Products Alliance (UNPA) organized an analytical summit in Salt Lake City, Utah, which was held in November 2015. The goals of the summit were to update participants on the latest developments with regard to the NY AG’s actions, to discuss analytical technologies to authenticate dietary supplement ingredients, and to detect adulteration, with emphasis on DNA-based methods.

DNA-based identification of botanical ingredients was also one of the topics of the Adulteration and Fraud in Food Ingredients and Dietary Supplements workshop held in early December of 2015, co-sponsored by United States Pharmacopeia (USP), the American Botanical Council, and the Food Protection and Defense Institute. Based on the numerous talks on the topic of DNA-based identification methods during the two events, it is clear that genetic technologies represent a valuable tool for authentication of crude botanical ingredients, especially if combined with appropriate chemical or other (e.g., taxonomy, microscopy) identification methods. However, there is some disagreement among experts in DNA-based authentication methods with regard to the capabilities and limitations of the various methods, in particular the ability of genetic methods to identify processed ingredients (e.g., herbal extracts) and provide quantitative results, as well as the extent of validation requirements. In addition, DNA-based analytical techniques cannot differentiate among plant parts (e.g., root, leaf, flower, etc.) – an important requirement in Good Manufacturing Practices (GMPs) for herbal dietary supplements, thereby requiring the use of other methods, e.g., scientifically valid compendial analytical methods – nor is DNA methodology capable of differentiating between acceptable levels or trace amounts of foreign organic matter (for example, USP normally allows up to 2%). The two seminars have shown that dietary supplement adulteration is an increasingly important matter and that efforts to educate on the issues and provide solutions to the problems are much needed. A review of the highlights of these two conferences is provided in this Botanical Adulterants Monitor in the section on recent conferences focusing on botanical ingredient adulteration.

Regarding news from the Botanical Adulterants Program (BAP), the Laboratory Guidance Document (LGD) on black cohosh (Actaea racemosa, Ranunculaceae) was released in December. This document, which is available free of charge through the Program homepage on the ABC website, sums up the conclusions of a review of 36 methods for the analysis of black cohosh, which were evaluated with respect to their suitability to authenticate black cohosh and to detect adulteration. I am grateful to the 20 expert reviewers who spent the time to read the document and provided their expert feedback to help ensure the accuracy and authority of the document.

Looking ahead to upcoming BAP publications, the next in the LGD series will be on the adulteration of so-called grapefruit (Citrus × paradisi, Rutaceae) seed extract with synthetic antimicrobial compounds. Also, we will soon be introducing a new series consisting of short summaries on specific topics of adulteration, the Botanical Adulterants Bulletins, which are at various stages of production. Initial Bulletins drafts have been written covering the adulteration of bilberry (Vaccinium myrtillus, Ericaceae) fruit extract, goldenseal (Hydrastis canadensis, Ranunculaceae) root, grape (Vitis vinifera, Vitaceae) seed extract, and skullcap (Scutellaria lateriflora, Lamiaceae) herb, among others.

The Regulatory Alerts section of this issue of the Botanical Adulterants Monitor has a short report about the change in language used by the US Food and Drug Administration (USFDA) to talk about illegal active pharmaceutical ingredients (APIs) marketed as dietary supplements.

The review on newly published science pertaining to topics of adulteration focuses on chemical methods for the authentication of commercial products labeled to contain Rhodiola rosea (Crassulaceae) root and rhizome; the ability of hyperspectral imaging to differentiate Stephania tetrandra (Menispermaceae) from the carcinogenic, mutagenic, and nephrotoxic substitute Aristolochia fangchi (Aristolochiaceae); and a review of a DNA-based method to identify mushrooms and mycelia of the genus Ganoderma (Ganodermataceae).

Stefan Gafner, PhD
Chief Science Officer
American Botanical Council

Technical Director, ABC-AHP-NCNPR Botanical Adulterants Program