Nutrasource Blog

Sports Nutrition as a business category within foods and dietary supplements have had a relatively short history. From a mass market perspective, it was not until 1965 and into the 1970’s that the nephrologist (kidney specialist) Robert Cade, MD started tinkering with a “homemade” beverage, later named Gatorade (Dr. Cade was the Director of the Renal Division at the University of Florida Medical School) for the sole purpose of helping football players stay hydrated during the hot and humid game conditions in Florida.

As we are all adjusting to modifying our work practices to stay safe and “flatten the curve” during the time of COVID-19, work must go on. R&D, product development, and regulatory compliance are as important as ever as the FDA has been handing out warning letters for unsubstantiated coronavirus claims.

The current pandemic situation highlights a weakness in our traditional approach to clinical trials.  You are probably experiencing some form of lock-down (“stay at home order” by your local or national government).  Our innate sense of optimism says this crisis will blow over fast, but there are also dark clouds suggesting weeks may turn to months and true return to normality will take longer than we dare to think.

Whether you are launching a new product or looking to substantiate a novel claim, strong science is crucial to the success of your health product. In Canada, many ingredients have been “pre-cleared” for specific claims at particular doses. Monographs give guidance and provide substantiation for these ingredients, so you don’t have to.

Clinical research is an important investment for the entire supply chain, from ingredient companies to brands selling finished health products. Primary research serves many purposes, and is most commonly used to validate efficacy, safety, and substantiate claims that increase the impact of a company’s marketing messages.

The term "partnership" has become a trendy word in the contract research organization (CRO) world. While it's meant to describe a close collaborative relationship between CRO and client, too many organizations claim to be partners when in reality they are only research sites or project-based consultants.

Regulatory strategy is the backbone of successful product development. Brands that lack a clear regulatory plan at the beginning of the process can face longer times to market and potentially higher costs associated with re-work or failure.

One of the most common questions we hear from clients early in the product lifecycle is: "How do I let my customers know our product is safe, and that it works?"

Investing in clinical research is necessary to establish a product’s safety and efficacy. Whether this is your first clinical study on your product or you’ve conducted a number of clinical trials to substantiate claims for your dietary supplement, begin with the understanding that there are risks of all shapes and sizes involved and that the project manager’s first order of business is to eliminate or mitigate as many as possible.

A comprehensive clinical testing program is essential to the success of virtually all health products. Writing in the International Probiotics Association blog, Josh Baisley, associate director of clinical trials for Nutrasource, notes that ensuring the stability of a probiotic for the duration of clinical studies is a vital aspect of analyzing the outcome.