Why you need a safety study

You have a great product concept but you need to make sure you have the dosing right. How do you make sure your product is safe for consumption?

The process for bringing new drugs to market is lengthy (the FDA itself estimates it takes 8.5 years to study a drug before approving its use for the general public), complicated (have you tried to navigate the various phases of drug development?) and expensive (most recent research estimates it at about $1B). As part of the approval process, the FDA mandates safety and efficacy studies for all new drug applications.

Thankfully, for most non-drug products, there is no cumbersome regulatory approval process, but they must be registered and follow GMP (good manufacturing practices). This enables manufacturers to get their products in market quicker, offers consumers broader choice, and increases product quality with the heightened competition.

But the unfortunate reality is that there are a lot of products on the market today that have unsubstantiated claims, are ineffective, and worst of all – are potentially unsafe.

Just because a safety study isn’t mandated, doesn’t mean it’s not an important pre-market step in formulation development, especially for new dietary supplements and natural health products.

What is a safety study?

Safety studies assess the risk profile of a product in identifying, characterizing, and quantifying a safety hazard. There are a number of different protocols and methodologies that can be implemented when conducting a safety study, depending on the various stages of product development.

Here are 5 reasons why you should consider conducting a safety study on your plant-based product:

1. It helps predict whether products are safe for use / consumption

Stating the obvious, we validate the safety of the dosage and whether there are any side effects

 2. It helps consumers understand how to consume responsibly

Because dosage is measured and side effects are monitored, the parameters for safe and responsible usage can be more precisely determined and the products can be labelled appropriately

 3. It’s a critical stage-gate in formulation development

Provides scientists / developers with the data required to make a go/no-go decision on moving the prototype through to the next phase of product development. It can also assist in comparing prototypes

 4. It’s relatively inexpensive and fast to execute

Typically cost much less than clinical trials and with fast turnaround for protocol development, study execution, and reporting

 5. It provides the ability to enhance consumer uptake and increases brand reputation

Once products are validated, it provides manufacturers with the ability to accurately label and market the product to set consumer expectations. It also can be used to help increase the brand’s credibility because it provides confidence that products are scientifically tested and validated

ESEV R&D is a life sciences company dedicated to advancing research and development of emerging plant-based solutions that improve quality of life for people and pets.

Contact us today to learn more about our full suite of CRO services and how we can help accelerate your R&D success.