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.
Medical Foods is a unique regulatory category wedged between supplements and drugs, a category where nutrients can be marketed with a claim for the management of a disease. A claim that has led some to call this category “supplements on steroids”.
Note: The regulatory information provided in this article pertains to the United States.
If you have been following recent CBD (cannabidiol) discussions happening around the world, you'll know that the evolving regulatory landscape is leaving many brands confused about their market access options.
As regulatory consultants, we field questions daily about CBD compliance and marketing, both from food and supplement brands and CBD suppliers looking to get to market quickly.
To help you find an efficient pathway to market, we've put together a list of frequently asked questions about CBD marketing, sales, and compliance—including GRAS—for the U.S. market. Read on for answers, then get in touch with us to discuss options specific to your company's needs and objectives.
Note: This article pertains to the United States. Products sold elsewhere are subject to different country/region-specific regulations.
Mandatory label compliance deadlines are drawing near. If you sell, or are planning on selling, a dietary supplement or food in the U.S., here is what you need to know about the updates required and how you can comply.
In addition to the changes to nutrition labeling, due for most companies January 1, 2020, FDA has set an official “uniform compliance date” of January 1, 2022 for final food and dietary supplement label regulations issued in 2019 and 2020. This compliance date also applies to the National Bioengineered Food Disclosure Standard.
With so many label updates coming in the near future, will your brand ready?
You've developed a new product and are keen to market it as a dietary supplement in the U.S. You're confident it fulfills the FDA's definition, but its "star" ingredient is newer to the market and, to your knowledge, hasn't been used in foods to date. This means that if you marketed it as is, the product would be considered adulterated.
What options do you have to go to market, and what is the most effective way to do so without raising regulatory red flags and risking your brand reputation?
The past year was a whirlwind of regulatory change that brought exciting opportunities and new challenges in equal measure.
As we look to another game-changing year ahead, our regulatory and scientific team reviews the top regulatory trends expected to shape health product innovation and marketing in 2019 and beyond.
Here's what to expect...
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.
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.
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.