Held in conjunction with the SupplySide MarketPlace Global Expo and Conference, the AHPA Botanical Congress was designed to provide guidance to dietary supplement ingredient suppliers and manufacturers that bear the burden of regulatory compliance under 21 CFR 111 (dietary supplement cGMP), which includes finished-product testing and the verification of botanical identity via “scientifically valid” methods. This year's event provided participants with a full-day of interactive and hands-on activities focused on botanical identity and available testing methods and technologies, including an organoleptic tasting exercise, demonstrations from analytical labs and equipment providers, and live roundtable-style discussions with legal and regulatory experts.
“You have to be able to identify every ingredient,” noted Anthony Young of Kleinfeld, Kaplan and Becker and AHPA general counsel, who participated in a regulatory panel. “You have to be able to ID powders, extracts, the whole plant, and other plant parts. This goes beyond verifying the Certificates of Analysis and other self-affirming methods that your supplier has provided you. It's a fundamental requirement that manufacturers get tripped up on all of the time.”
In addition to interactive discussions with legal and regulatory experts, participants had an opportunity to gain an understanding for the various identity methods and analytical technologies, including workshop demonstrations on how the various technologies work for many popular botanical ingredients. Workshops included interactive presentations from Botanical Liaisons, Bruker BioSpin, Camag, Grace, and others.
“This precedent-setting event brought together and addressed manufacturer needs and technology-provider solutions to address critical botanical identification and other testing issues,” said Steven Dentali, Ph.D., AHPA's chief science officer. “The interaction and education offered to participants will assist the regulated botanical industry in its continued responsible development.”
Analytical technologies and methodologies covered during the congress included organoleptic analysis, high performance thin layer chromatography (HPTLC), nuclear magnetic resonance (NMR), flash chromatography, Fourier transform infrared and near infrared spectroscopy (FTIR/NIR) on a variety of botanical ingredients. In addition, representatives from several U.S. governmental offices (USDA, NIST, NIH-ODS) were on hand to provide content and discuss topics, such as method development, standard reference materials, and extract identification.
Discussing the use of organoleptic testing to determine botanical identification, Trish Flaster of Botanical Liaisons noted that the task for manufacturers is taking valid subjective tests to make them objective enough that they become a valid method.
“First, create a taste panel,” she said. “You can then develop specific standards for each herb by creating description words that can be applied to each. Additionally, the total analysis is not based on just gustatory taste. It also includes tactile and olfactory tests--how the herb smells and the odor it gives. The descriptions become part of your in-house sensory program that allows you to quantify your incoming in-house materials.”
“The discussions were really helpful in keeping businesses updated on what other companies and organizations are doing with regards to identity and testing,” said Jigar Gandhi, quality control chemist with Bactolac Pharmaceuticals, a contract manufacturer in New York who attended the event. “Demonstrations of the latest technologies, particularly NMR, HPTLC, and the tasting of herbs in order to verify identity, were of particular interest.”
Attendees were also provided with valuable resource documents, including two articles authored by Dr. Dentali, and originally published in Nutraceuticals World, “Botanicals: Not Your Simple Chemical Ingredients” and “Extracts: Not Single Chemical Ingredients.” AHPA's guidance document, Organoleptic Analysis of Herbal Ingredients, a 37-page guidance document intended to provide useful information for companies that want to use sensory analysis for identifying herbal ingredients was also distributed to attendees and is available free to AHPA members via the AHPA online bookstore.