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?"
Tags: Clinical Research
Fish oil supplements remain popular sources of EPA and DHA omega-3 fatty acids. Some studies have suggested that commercially available fish oil supplements are excessively oxidized, impacting oil quality and safety.
To investigate this issue, Nutrasource's scientific team paired with the Global Organization for EPA and DHA Omega-3s (GOED) and DSM to commission the largest study ever to evaluate oxidation parameters in a large database of fish oil omega-3 dietary supplements, and to compare the data with other common commercially available dietary oils.
It's official: 2018 is going to be big. Our calendar is jam-packed with the year's hottest events in dietary supplements, foods, omega-3s, and probiotics.
We're always ready to help companies overcome barriers on the pathway to market. It doesn't matter if your product is new or existing, food or pharma, early or late in the product lifecycle, or at any stage of the supply chain - our team is here to help!
Schedule a meeting with us at one of the following events to learn how we can help you launch your product with confidence.
Making the decision to conduct a clinical trial can be daunting. Many complex steps are involved in getting a study off the ground, including designing the study, assessing risk, and determining whether a trial will achieve return on investment.
The International Probiotics Association (IPA) works with industry, government and academia to advance probiotic technology, research and product development.
Nutrasource is back again this year partnering with IPA to bring you the Probiotics Resource Center at SupplySide West 2017. Stop by the pavilion and meet up with our team and other people and companies who have an interest in the prebiotic and probiotic industry.
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.
Consumers have become increasingly concerned about the use of genetically modified organisms (GMOs) in food production — an occurrence that has contributed to the popularity of products that have not been genetically engineered (GE) through modern biotechnology.
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. Due to inherent properties of probiotics, exposure to unfavorable conditions can have serious impacts on the study product, among other advice. Baisley suggests sponsors should consider sending research sites additional product that will be used to test, and demonstrate, the survivability of the probiotic through shipment to the CRO/site, and during storage.
When Congress passed the Dietary Supplement Health and Education Act in 1994, dietary supplements were placed in a unique marketing position. Unlike prescription drugs, which must be rigorously tested to prove both safety and efficacy before they are approved by the Food and Drug Administration (FDA) for commercial release, dietary supplements can go to market immediately. The FDA monitors the “claim” to ensure there is no implied cure wording and the Federal Trade Commission (FTC) assesses the truthfulness of the label claim only if there is a complaint.
The FDA's New Dietary Ingredient (NDI) draft guidance, released this past August, continues to shake up the supplement industry. Companies are struggling to understand what the new guidelines mean and exactly how the changes will impact their product lines once implemented.