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”.
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.
The global health product industry is constantly innovating—leveraging current science and consumer trends to launch products that pique the interest of health-conscious consumers. Probiotics are among the most popular health supplements worldwide, with global sales surpassing $44 billion USD in 2019 (Euromonitor, 2019).
As a contract research organization (CRO), we field many inquiries about stability storage testing here at Nutrasource. Despite being extremely important, analytical product testing for stability and shelf-life is often overlooked. Keep reading to find our analytical team’s answers to the most commonly asked questions about stability storage testing for different dosage forms.
The Western world is hungry for health products, and industry is meeting that demand with increased product innovation and global expansion like never before. In Canada, consumer health products are categorized as foods, drugs, cosmetics, and natural health products (NHPs). NHPs (referred to as dietary supplements in the U.S.) are health products sold in traditional medicinal formats. Vitamins and minerals, protein powders, herbal medicines, probiotics, and many others, are all examples of products that are sold as NHPs. A 2010 survey showed that 73% of Canadians consume NHPs regularly, proving Canadian consumers are more interested in alternative health products than ever before.
It’s no secret that probiotics are dominating the supplement market, and the consumer demand for foods and supplements that contain beneficial bacteria is increasing exponentially. In fact, the probiotics market is predicted to be worth $69.3 billion by the year 2023.
What if you could develop one dietary supplement, with a single product specification, and sell it in multiple countries simultaneously – with no reformulation or regulatory headaches involved?
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?