We often think of clinical evidence as something you generate to obtain FDA approval. But evidence has value even when a product isn’t pursuing the pharmaceutical pathway. It builds trust, influences adoption, and differentiates products.
What do you do when your product has therapeutic potential, but isn’t a drug?
Many food technology companies are starting to realize that their products can be more than just supplements. Some may provide meaningful health benefits beyond basic nutrition. That raises an interesting question: how much clinical evidence is enough?
Superbrewed Foods recently caught my attention because they chose to conduct a nutritional study on their postbiotic protein rather than pursue a pharmaceutical development pathway. The study found that their protein performed similarly to whey for supporting muscle protein synthesis. For their intended market, that may be exactly the level of evidence they need.
Clinical studies provide evidence of efficacy and safety – or lack thereof. That’s valuable. Most nutritional products, however, reach the market with far less clinical evidence than pharmaceuticals, making it difficult for consumers and healthcare providers to judge which products truly work.
But clinical evidence has value even when it doesn’t lead to FDA approval.
It can build consumer trust, differentiate a product, support partnerships, strengthen fundraising, and give healthcare providers greater confidence in recommending it. Not every clinical study has to end with a drug approval to create value.
The challenge, of course, is cost.
Pharmaceutical development requires an enormous investment, and companies need a clear path to recovering that investment. Nutritional studies occupy a different space. They are typically less expensive than pharmaceutical trials and can generate meaningful evidence, but they don’t allow companies to make therapeutic claims.
For Superbrewed Foods, that tradeoff may make perfect sense. Their goal isn’t to market a drug. It’s to demonstrate that their protein performs as intended in a nutritional setting. But what happens when a nutritional product shows promise beyond general wellness?
To read more about Superfoods and their clinical study click here.