Nutrasource Blog

GRAS or NDIN: Which is the Right Regulatory Strategy for My Ingredient?

Posted by Amy Mozingo, MS - VP, US Nutra Regulatory Sciences on Mon, Feb 07, 2022

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?

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Tags: Regulatory, Foods & Beverages, Dietary Supplements/Natural Health Products

The Latest in Food Allergen Labelling: Sesame

Posted by Ruth Conroy, Marketing Manager on Mon, Apr 26, 2021

Sesame has recently been added to the list of major food allergens, here's what you need to know for product labelling.

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Tags: Product Marketing, Regulatory, Foods & Beverages, Dietary Supplements/Natural Health Products

How to Develop Cutting-Edge (and Compliant) Dietary Supplements

Posted by Nutrasource on Thu, Aug 20, 2020

Developing dietary supplements with strong claims not only allows brands to stand out from the pack but also provides a competitive advantage.

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Tags: Claims, Regulatory, Concept to Claim, Dietary Supplements/Natural Health Products

The State of Sport Nutrition: a peek into the multi-billion dollar industry

Posted by Douglas Kalman, Ph.D., R.D., CCRC, FACN, Vice President of Scientific Affairs on Wed, May 06, 2020

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.

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Tags: Clinical Trials, Claims, Regulatory, Sport Nutrition

NDIN’s and Structure Function Claims in the Time of COVID-19

Posted by Amy Mozingo, MS, Director of Operations - GRAS Associates on Wed, Apr 22, 2020

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.

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Tags: Clinical Trials, Claims, Regulatory

Navigating Medical Foods in the U.S. and EU

Posted by Derek Tobin, Ph.D. on Thu, Mar 26, 2020

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”.

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Tags: Regulatory, Concept to Claim, Foods & Beverages, Dietary Supplements/Natural Health Products

The Continued Rise of Probiotics: A Q&A With George Paraskevakos

Posted by Nutrasource on Wed, Oct 09, 2019

 

How has the probiotics market evolved over the last 12 months?

We have seen some interesting market shifts over the past 12 months. A small pull back on market growth in the US, probably fueled by a combination of education gaps at the HCP and consumer level and too many copycat products in the market. Then in APAC, that market is starting to experience exponential growth. Where in Europe we are starting to see a small comeback in the supplement market. So varying situations which are region specific, just like the regulatory environments around the globe.

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Tags: Regulatory, Events, Probiotics

The 3 Requirements for Selling a Natural Health Product in Canada

Posted by Nutrasource on Mon, Jul 29, 2019

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.

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Tags: Regulatory, Concept to Claim, Dietary Supplements/Natural Health Products

A Regulatory Recipe for Adding Prebiotics and Novel Strains to Your Probiotic Line

Posted by Nutrasource on Wed, Jun 26, 2019

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.

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Tags: Regulatory, Concept to Claim, Probiotics, Dietary Supplements/Natural Health Products

Your (Canadian) CBD Questions Answered

Posted by Jennifer Andrews, M.Sc., MBA, Marketing Director on Thu, May 02, 2019

As the cannabidiol (CBD) market continues to gain steam, global regulators are working to carve out or update legal pathways to market. This makes keeping up—and staying compliant—an ongoing challenge for brands.

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Tags: Product Marketing, Regulatory, Cannabis