Slovenian private label contractor PharmaLinea surveyed supplement manufacturers at the Vitafoods Europe trade show this year, finding only six of 55 companies conducted end-product testing.
“Shockingly, few industry professionals are even aware of the likeliness of bioactives’ cross-interactions within finished products, how severely they affect the quantities of ingredients throughout the shelf-life and ultimately the product’s value for end-users,” said Denis Dalapa, PharmaLinea’s technical director.
Few companies, he said, conduct stability testing “because of the financial investment required and because it is rarely a regulated requirement.”
Dalapa said increasingly savvy consumers were demanding greater transparency from products.
‘The single evaluation of the raw materials and the formula are not enough…’
The Italian branch of Merieux NutriSciences, which conducts third party testing for hundreds of European supplements annually, told us European supplements were generally of a “high standard” but issues remained around stability, ingredient counterfeit, bad formulations and unmet label and shelf life declarations.
The firm’s Alessia Fornarolo said products could be trusted if “they are based on stability studies and in compliance with official guidelines.”
“The single evaluation of the raw materials and the formula are not enough because we need to consider the possible interactions among the ingredients in the final packaging during the real shelf-life.”
She said overall European supplement quality was “constantly increasing” with the growing number of drug firms demanding pharma-grade QC standards a major influencer along with tighter regulations and “competent authorities strengthening official controls.”
‘We need rules’
Expert view: Luca Bucchini, PhD, at Rome-based consultancy Hylobates Consulting, thinks regulators need to do more, and called out retailers like Amazon to step up.
Does Europe have a supplement quality problem?
“In short, yes. We have some of the best companies in the world, but also too many companies that do not understand quality. I think parts of the industry have not policed themselves as aggressively as they should have. There are problems with raw materials, and with finished products.”
Are regulators doing enough?
“We need GMPs at EU level; we need the coordinated control plans that other food sectors have. We need rules on the quality of botanicals and address adulteration which is the greatest threat to that segment of the industry.”
“And we need proportionate harmonisation on some substances. The playing field is too uneven. In general, companies that cut corners on quality are not exposed, or investigated.”
Are trade groups doing enough?
“Some have programmes available for quality, conduct and compliance but too few trade organisations take any disciplinary action. Trade organisations should do more.”
Are retailers doing enough?
“Though many will disagree, I am of the view that we need more responsibility placed on retailers, especially online, and more active enforcement. The food sector improved significantly when retailers got serious about certification.
E-retailers such as Amazon, which are great for the industry in many ways, should be driving similar improvements rather than helping lower standards. I disagree with authorities all the time but some behaviours can only be corrected by enforcing food law with determination.”
Strict legal framework
Trade groups and experts contacted by NutraIngredients differed in their view of the extent of the QC problem and the effectiveness of existing regulations.
Patrick Coppens, regulatory and scientific director at Food Supplements Europe (FSE), defended the market noting the “EU legal framework for food supplements is among the strictest in the world.”
Coppens reflected that low numbers of product seizures at Customs facilities indicated a relatively clean market, and said fresh legislation due to kick in in 2020 “will enable enforcement authorities to set up equally efficient controls for imported products, provided mainly via the internet.”
The good the bad and the unstable
Robert Verkerk PhD, executive and scientific director at the Alliance for Natural Health International (ANH-I), pointed to a mixed market quality-wise with web-only players the most likely to offend.
“There’s good and bad quality products out there, and it’s the people who are chasing the cheapest products, usually available only on the Internet, that are most at risk,” he said.
“There are still too many, especially less established brands selling only online, that have been desk-formulated and have never gone through full stability and quality assurance tests to determine and ensure quality at the end of the shelf life.”
Dr Verkerk said many reputable brands formulated with overages to compensate for less stable ingredients but noted challenges of formulating with nutrients with often vastly disparate degradation rates.
He agreed with Coppens that the EU had a “comprehensive system of quality, hygiene and contaminants laws” and didn’t require pharma-style legislation that could increase product costs and de-incentivise self care-style nutritional interventions that could save billions of euros in healthcare costs.
Global surveys conducted by US-based market surveyor Consumerlabs.com have found 40-50% of products fail to meet label claims in categories like botanicals and gummies, with a supplements industry-wide fail rate of about 25% worldwide.
But the cost of testing remains a barrier for many companies, especially smaller players, said Fornarolo.