Label compliance for ingredient verification: regulations, approaches, and trends for testing botanical products marketed for “immune health” in the United States

Abstract

During the COVID-19 pandemic, the botanical product market saw a consumer interest increase in immune health supplements. While data are currently insufficient to support public health guidance for using foods and dietary supplements to prevent or treat COVID-19 and other immune disorders, consumer surveys indicate that immune support is the second-most cited reason for supplement use in the United States. Meanwhile, consumers showed increased attention to dietary supplement ingredient labels, especially concerning authenticity and ingredient claims. Top-selling botanical ingredients such as elderberry, turmeric, and functional mushrooms have been increasingly marketed toward consumers to promote immune health, but these popular products succumb to adulteration with inaccurate labeling due to the intentional or unintentional addition of lower grade ingredients, non-target plants, and synthetic compounds, partially due to pandemic-related supply chain issues. This review highlights the regulatory requirements and recommendations for analytical approaches, including chromatography, spectroscopy, and DNA approaches for ingredient claim verification. Demonstrating elderberry, turmeric, and functional mushrooms as examples, this review aims to provide industrial professionals and scientists an overview of current United States regulations, testing approaches, and trends for label compliance verification to ensure the safety of botanical products marketed for “immune health.”.