Food Supplements: moving from the ‘Wild West’ towards quality and compliance
A growing body of scientific research suggests that supplementing our diets with vitamins, minerals, botanicals, or fatty acids can have positive effects on various aspects of health - from sports performance and recovery [1] to cardiovascular fitness [2], obesity [3], memory [4] and neurological disorders [5]. This trend is driving a boom in the supplements industry, [6] but recent scrutiny has also called into question the safety and effectiveness of many supplements. These include discrepancies between advertised and actual concentrations of active ingredients, as well as the presence of contaminants and toxic compounds in some products [7-12, 28]. Given the widespread availability of supplements in Europe and the USA through shops and online retailers, combined with the significant safety and quality concerns, this whitepaper explores shortcomings in US and EU regulations [33, 10]. It emphasises the crucial role of Proficiency Testing (PT) in supporting a rigorous and transparent testing programme that enables reputable brands to differentiate themselves from lower quality competitors. Drawing on insights from the LGC AXIO Proficiency Testing team, we examine the breadth and diversity of quality markers and chemical contaminants present in supplements, and consider the significant technical challenges faced by manufacturers. Sales of supplements are booming, but are they safe and effective? Under the 1994 Dietary Supplement Health and Education Act (DSHEA), dietary supplements in the US are not subject to pre-market approval regarding safety, efficacy, purity, or labelling. In the majority of cases, the Food and Drug Administration (FDA) reacts only in response to serious adverse events, in cases where drug-like claims are made on the label, or if new scientific findings are reported after the goods have gone on sale. Consequently, misleading labelling is common. For example, 30 dietary supplements sold with claims to ‘boost the immune system’ were purchased from a major US online retailer and tested as part of a 2022 study published in the journal JAMA Network Open [7]. It found that more than half had inaccurate labels when compared with the contents of the products, while 13 featured ingredients on the label that were not detected. An FDA news release published in December 2020 also confirmed the presence of undeclared drugs in 50 supplements sold by major online retailers, [8] demonstrating that consumers should be cautious about using certain products, especially those claiming to enhance sexual performance, weight loss, body-building, sleep or pain relief. Although the FDA is the ultimate authority to regulate the US market, the dietary supplements manufacturer Now Foods launched its own testing programme after becoming frustrated by such persistent reports of the widespread availability of low quality, potentially unsafe products online. In an interview with LGC [9], the company’s Senior Director of Quality, Katie Banaszewski, stated that, following six years and 15 rounds of testing of products from lesser known brands, purchased from major US websites, “All studies performed to date show 50-75% of evaluated brands are non- compliant with their label claims”, and that some of those brands “also use deceptive language on their labels, creating the perception that a product is more potent than it is.” She added that the Now Foods’ analysis had identified some serial offenders, with one unnamed company “failing all seven rounds of testing we have done”. Still too frequently, dietary supplements are in the spotlight for the wrong reasons
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