Nutrasource Blog

Thinking about placing a toxicological test on your novel ingredient? Go no further until you read this article.

Tags: Claims, Regulatory, Concept to Claim, market access

You may have a blockbuster food or dietary supplement ingredient, but if the manufacturing process introduces contaminants, it may not be safe to consume. Contaminants may be introduced into a botanical ingredient during growth, such as heavy metals or herbicides from soil or pesticides or antifungal agents applied to plants. Toxins can be produced by plants or be introduced into plants during storage by fungal contamination. Ingredients that are produced by chemical synthesis may be contaminated with solvents or unintended metabolites, and ingredients that are manufactured by microbial fermentation can be contaminated with the microbes or toxins produced by them. Other sources of contaminants include water, processing aids, filters/columns, fermentation media ingredients and packaging materials. Use of Good Manufacturing Practice (GMP), potable water and food grade materials (by U.S. standards) can help reduce levels of contaminants in an ingredient. However, even if these procedures are in place, contaminants may be present in your ingredient.

Tags: Claims, Regulatory, Concept to Claim, market access, Animal Supplements

Tags: Claims, Regulatory, Concept to Claim, market access, Animal Supplements

Summary: FDA announces draft guidance for industry on their policy to exercise enforcement discretion on delinquent notifications to encourage firms to submit NDIN to correct past failures. Read on to learn more.

Tags: Product Testing & Certifications, Regulatory, Concept to Claim, ingredients, market access

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

Starting with the end in mind

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

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

Cannabis has taken Canada by storm since legalizing recreational use in October 2018, and the highly anticipated second wave of regulations has finally arrived. Cannabis edibles, extracts, and topical products will hit the shelves mid-December 2019, and consumers and companies alike are buzzing with anticipation.

Tags: Concept to Claim, Cannabis