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.
While many U.S. states (and, of course, Canada) are approving medical and recreational use of cannabis products, confusion about how these products are regulated continues to grow.
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.
Choosing a contract research organization (CRO) is one of the most important steps in a dietary supplement research and development plan.
Product claims are a key component of dietary supplement positioning and marketing. Companies use claims to showcase their product's health effects, nutritional benefits or performance to reinforce brand values and help boost sales.
Substantiating product claims is an important aspect of any product launch or
repositioning strategy. Not having the right type or level of data required to support a
claim can put a brand at risk for regulatory consequences, negative publicity and,
ultimately, a loss of market share and competitive advantage.
Below are five essential tips and best practices from our Dietary Supplement Claims Substantiation E-Book which you can use to develop an effective claims strategy for your dietary supplement:
Prebiotics and probiotics aren't going anywhere. In fact, this emerging market has become so popular in recent years that there are now two major events dedicated solely to prebiotics/probiotics. Here we take a look at one of the most challenging aspects of the research and development (R&D) process for companies looking to bring prebiotics/probiotics to market.
You have an exciting new product idea and are ready to take the leap and go to market. Before you start selling, however, it is important to make sure your product is the best it can be from a regulatory standpoint.
GRAS is an acronym for Generally Recognized as Safe. GRAS status is a regulatory designation first introduced by the U.S. Food and Drug Administration (FDA) as part of the 1985 Food Additives Amendment to the Federal Food, Drug and Cosmetic Act (FD&C Act). Its purpose was to exempt certain food ingredients from the definition of food additive.