One of the main problems in PharmaLinea’s view is the stability of ingredients in finished products ... or lack thereof. There is a lot of discourse about a handful of movements, such as traceability or transparency, but almost nobody is talking about what happens to the product after it reaches the shelf.
Are all the ingredients claimed on the label still there and ready to deliver their promised effect? We know from years of experience that this is far from a given and we know from first-hand research that awareness of this issue is alarmingly low among industry professionals.
Today’s demand is driving the development of increasingly complex supplements that include many active ingredients. Often, these are already unstable compounds to begin with; but, when formulated together in a product, the probability for degradation increases.
PharmaLinea has found many of today’s most popular ingredients — folate, lutein, certain minerals and vitamins, complex natural extracts, etc. — to be very prone to cross-interactions, especially in today’s increasingly popular user-friendly product forms. Unless rigorously researched and adapted during development, supplements are likely to deliver less and less of the stated ingredients and provide their claimed effects as shelf-life progresses.
At Vitafoods Europe 2019, we surveyed 55 supplement manufacturers and found only six to be conducting ingredient stability studies. What was even more alarming was the lack of awareness among many professionals; the issue matter wasn’t always fully understood or perceived as a concern.
Regarding the reason for not performing such tests, companies most often stated high costs and the lack of regulatory requirements. Unlike in pharmaceuticals, very few regulatory environments require proof of claimed amounts of ingredients at the end of the shelf-life of food supplements.
So why bother with the extra investment if there is no immediate business reason? In recent years, several factors have emerged that are changing the playing field. First, increasing numbers of pharmaceutical companies are moving into the food supplement space, starting their own supplement product lines or subbrands.
We see first-hand with many of PharmaLinea’s partners that come from the pharma industry that ingredient stability is an absolute must for their internal quality standards. The phenomenon is, slowly but surely, raising standards throughout the entire industry and will eventually push non-effective products into price competition.
Not only is pharma raising the bar, but the evolving profile of today’s consumer is playing a role too. End users are becoming increasingly educated, seeking insight into product characteristics and demanding value from the items they purchase.
It's no surprise that rising amounts of failed independent test results from various markets are being seen in industry media. Alarmingly, even the largest brands in the business have recently been the subjects of such news. Contributing to this is the improvement and widespread accessibility of analytical methods.
It not only takes substantial expertise to develop complex products that remain stable in user-friendly delivery forms, it also takes funds and time. Often, brand owners cannot leverage the costs of such testing or are in a hurry to launch and capitalise on current trends.
This is when specialisation within the industry is most evident, with companies covering only a certain part of the product lifecycle and using their expertise to expedite time-to-market. We see the model of outsourcing development and production to be particularly successful and increasing with our partner pharmaceutical companies or other businesses with trusted brands.
Launching products involves risk; but, few organisations can afford the financial and reputational damage of a product recall. Companies based on scientifically proven efficacy that are looking to build consumer trust and succeed in the long-term require products that demonstrate the proven stability of their ingredients.
Although this may be only a subset of industry players at the moment, the previously mentioned factors are bound to improve the ratio and establish ingredient stability as one of the most discussed industry topics, alongside the likes of traceability, transparency or sustainability.
