“There are certainly some natural products, and their ingredients that have pharmacological and pharmaceutical effects. And the pharma industry is starting, but needs to open up further, to that end,” comments William Rowe, president and CEO of Nutrasource Diagnostics – a contract research organization (CRO) specialising in regulatory consulting, clinical trials and product testing for the natural health and pharmaceutical industries.
While the regulatory landscapes are clearly very different, and the costs and regulatory frameworks much more complex in the pharmaceutical space, Ivan Wasserman, partner at Amin Talati Upadhye noted that many parts of the nutrition industry are looking at the options to explore pharmaceutical routes to market for products and ingredients.
“I definitely see, and I had meetings today with, people who are very interested in the pharmaceutical space. And, there’s a lot of excitement going on there,” he told NutraIngredients at the recent SupplySide West show in Las Vegas.
“Of course it’s a much more expensive process to go through. Intellectual property is very important, and if you’re going to go through the very very rigorous and expensive time to get FDA approval as a drug you want to make sure your IP is buttoned down – which is crucial,” said Wasserman.
Convergence in ‘consumer health’?
Also speaking to NutraIngredients at SupplySide West, Rowe noted that there has been a recent convergence between the two industries, as many pharmaceutical companies look to purchase nutraceutical companies and brands, and work together with them to explore the ways ingredients and bioactives can be taken down multiple routes to market.
Wasserman added that this trend may also help with manufacturing and quality standards, where pharmaceutical companies have a much longer history of complying with strong regulations in comparison to the nutrition industries, which have traditionally been as a sub-set of food regulations.
“I think the more supplement companies can, not necessarily follow the specific regulations that pharmaceutical companies do, [but] the more they can look to how they implement their quality systems, I think the better overall for consumer confidence,” he said.
Rowe added when it comes to clinical trials and building evidence, that while ‘the paradigm is shifting slowly’ in nutraceuticals, “they need to really take on more budget to do proper trials to substantiate their claims, which would help the integrity of the industry.”