An imposter in the house? Best practices for prevention of adulteration in the U.S. botanicals and dietary supplements industry

Substantial differences exist in regulatory frameworks governing manufacture of dietary supplements in the US and Europe, but critical economic and safety concerns about adulteration of medicinal plant ingredients and products are shared. A basic, global quality requirement is establishment of ingredients identity. How do supplement manufacturers assure accurate identification of botanicals, especially if dependent on global supply networks, and numerous geographic sources and vendors? Can adulteration be anticipated and avoided? How to recognize and avoid potential adulterants? Strategic tools for adulterant prevention in natural plant products are authenticated plant reference collections with selective emphasis: ingredients, their confounding species, and known or potential adulterants.

In 2013, Traditional Medicinals, Inc., a leading U.S. manufacturer of medicinal herbal teas, initiated an botanical identity program with several goals: 1) to build a collection with at least one representative whole plant voucher for each individual ingredient used in our products (>100 species), and confounding species; 2) to research, obtain known and potential adulterants; and 3) assemble strong comparative reference collections consisting of sample materials from suppliers and representative finished products. We proved the presence and identity of an intrusive high-pyrrolizidine contaminant in a passionflower shipment, demonstrating the utility risk-lowering value of standard reference collections.

Authenticated reference collections are used by both in-house chemistry and botany experts for baseline identity testing and comparison of results. The herbarium, reference collections and their applications have proven to be critical for proving compliance with CFR requirements, audits, and for influencing best practices in the industry.