In the wake of California's updated Prop 65 requirements—which came into force August 30, 2018—many of our clients have approached us with questions regarding compliance.
Our regulatory affairs team has regular contact with the U.S. Food and Drug Administration (FDA) for a number of projects. Occasionally we learn about subtle policy shifts regarding Generally Recognized as Safe (GRAS) Notifications and New Dietary Ingredient Notifications (NDIN).
Below is an overview of FDA’s latest updates to GRAS and NDINs which will have important implications for the dietary supplement and medical foods industry in the U.S.
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.
It’s surprisingly easy not to notice that you are living in a time of revolution. The technological revolution we are living through has been rumbling along for so long now, sometimes it’s hard to appreciate it or get excited. But the revolution in DNA sequencing and its effects on society are worth our attention – especially when it comes to how we characterize and identify natural products.
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.
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.
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.
As the probiotic segment continues to trend upward, more companies are investing in well-designed clinical trials to support efficacy.
One area that has presented substantial learning opportunities, and has helped shape the future of probiotic clinical trials, is the study of antibiotic associated diarrhea (AAD) and probiotic intake.