Dietary supplements: Amazon’s game-changer for analytical laboratories
What does Amazon’s new Dietary Supplements Policy mean for testing laboratories? How can you ensure your lab is ready for the new opportunities and challenges in analysing health supplements? And how exactly can proficiency testing help?
Earlier this year, the world’s biggest online retailer announced a game-changer for testing in the multi-billion-dollar dietary supplements industry.
Amazon told retailers on its platform that – from May 2021 – they must comply with its strict new Dietary Supplements Policy or risk being removed from the site.
The new rules are in response to growing concerns about dietary supplements and their potential dangers, which have coalesced around four main areas:
potency, or whether there is too little of an active ingredient;
extraneous material, intended to bulk up products but often unlabelled;
substitution of a synthetic product for a claimed, naturally derived material; and
adulteration with drugs, or drug analogues.
Amazon’s move followed a spate of worrying headlines involving dietary supplements in recent years - beginning in 2015, when four major US retailers were ordered to stop selling certain herb supplements because many did not contain what they were supposed to. A large proportion contained plant materials not listed on the labels – such as rice, beans, asparagus, and wheat – while many others contained no identifiable plant DNA whatsoever.
Last year, scientists from the Informed quality assurance in sports supplements programme – part of LGC ASSURE - published their study of 20 Internet and shop-bought products that claimed to improve or enhance sexual performance with ‘all-natural’ ingredients. Using liquid chromatography and high-resolution accurate mass spectrometry, they detected substances including the banned alkaloid yohimbine, the WADA-prohibited steroid Dehydroepiandrosterone (DHEA) and the erectile dysfunction and hypertension drugs sildenafil and tadalafil.
In December 2020, the US FDA said it had found hidden drugs in almost 50 dietary supplements sold online - or 80 per cent of the products it tested. And it advised consumers to be extra-cautious about using products related to sexual enhancement, weight loss, bodybuilding, sleep aid or pain relief. At the time of writing, the FDA website also lists more than 1,000 potentially hazardous dietary supplement products, with the warning that this represents only “a small fraction” of the adulterated supplements available.
The European Food Safety Authority is meanwhile investigating safety concerns around six substances used as ingredients in food supplements, including ephedra species. Ephedra alkaloids - including ephedrine - are banned doping stimulants, while the use of ephedra herb in food supplements is prohibited in many European countries because of concerns about adverse health effects – including heightened blood pressure and increased heart rate.
Ensuring the safety of dietary supplements is a high-stakes business in more ways than one. In the absence of internationally agreed definitions and standards for dietary supplements, countries such as India and China are seeking separately to update and expand regulation of the industry in order to better protect consumers. But also front of mind is the sheer amount of money that can be made from dietary supplements. In 2020, the industry was worth an estimated $140 billion, and it is also expected to expand at a compound annual growth rate of 8.6 per cent between 2021 and 2028. Therefore, with increasing consumer awareness regarding personal health and wellbeing a key factor in driving the market, bolstering consumer confidence in product safety may also help to boost profit margins.
Amazon tightening up its rules also means exciting new opportunities for testing laboratories - as reputable, properly certified labs can now expect to find themselves in high demand. One of the online giant’s main stipulations is that Certificates of Analysis provided with every product must be from an ISO/IEC 17025 accredited laboratory; an in-house laboratory compliant with current good manufacturing processes; or evidence that the product is enrolled in a third-party quality certificate programme.
Proficiency testing (PT) can play a crucial role in helping testing laboratories to meet new quality and regulatory requirements. Participating in a PT scheme is essential to your lab achieving accreditation to ISO/IEC 17025, and ensures that you and your customers across the world can have confidence in the measurement of your results.
For 40 years, LGC AXIO Proficiency Testing has been a trusted partner for laboratories working to keep consumer products safe for everyone.
We move with the world’s changing demands, which is why we’ve launched five new samples to help you keep pace with new testing requirements for dietary supplements – including metals in pollen (PT-PH-17), potency of gingko biloba (PT-PH-18), phytochemical identity confirmation (PT-PH-19), and multivitamin potency (PT-PH-20).
We’re also introducing a multielement potency sample (PT-PH-21), where participants will not only be able to quantify the different elements and minerals present, but also use their measurement uncertainty to assess the compliance with the labelling of this sample.
Drawing on decades of proficiency testing expertise and our truly global reach, AXIO is your perfect partner in proficiency testing.
Head to lgcstandards.com/AXIO to find out more and place your order.
LGC. Science for a safer world.