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
In this special series, we highlight a member of the SGS Nutrasource team so you can get better acquainted with the experts behind your project.
Tags: Team Talk
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
Sports Nutrition as a business category within foods and dietary supplements have had a relatively short history. From a mass market perspective, it was not until 1965 and into the 1970’s that the nephrologist (kidney specialist) Robert Cade, MD started tinkering with a “homemade” beverage, later named Gatorade (Dr. Cade was the Director of the Renal Division at the University of Florida Medical School) for the sole purpose of helping football players stay hydrated during the hot and humid game conditions in Florida.
Tags: Clinical Trials, Claims, Regulatory, Sport Nutrition
As we are all adjusting to modifying our work practices to stay safe and “flatten the curve” during the time of COVID-19, work must go on. R&D, product development, and regulatory compliance are as important as ever as the FDA has been handing out warning letters for unsubstantiated coronavirus claims.
Tags: Clinical Trials, Claims, Regulatory
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
