The first steps when developing any health and wellness product is to know first, what it is and second, how its regulated and in each target market as categorization may differ between regions. Many factors are taken under consideration when determining product classification as summarized in the figure below.
Tags: Product Marketing, Regulatory, Concept to Claim, Dietary Supplements/Natural Health Products
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?
Tags: Regulatory, Foods & Beverages, Dietary Supplements/Natural Health Products
| Budget, timelines, and pressure to be innovative are just a few of the barriers that many companies face when looking to gain market access. The trick is knowing what you want to say about your product, what you can say, and having a clear understanding of the marketplace you’re looking to penetrate. From there, a strategic solution can be developed to assist in achieving your goals. |
Tags: Product Marketing, Claims, Concept to Claim, Dietary Supplements/Natural Health Products
Sesame has recently been added to the list of major food allergens, here's what you need to know for product labelling.
Tags: Product Marketing, Regulatory, Foods & Beverages, Dietary Supplements/Natural Health Products
Developing dietary supplements with strong claims not only allows brands to stand out from the pack but also provides a competitive advantage.
Tags: Claims, Regulatory, Concept to Claim, Dietary Supplements/Natural Health Products
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.
Tags: Clinical Trials, Concept to Claim, Foods & Beverages, Dietary Supplements/Natural Health Products
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”.
Tags: Regulatory, Concept to Claim, Foods & Beverages, Dietary Supplements/Natural Health Products
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.
Tags: Clinical Trials, Dietary Supplements/Natural Health Products
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).
Tags: Probiotics, Dietary Supplements/Natural Health Products
As a contract research organization (CRO), we field many inquiries about stability storage testing here at SGS 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.
Tags: Product Testing & Certifications, Dietary Supplements/Natural Health Products
