When it comes to food and supplement labeling, there are significant differences between the US and Canada – even spelling the word “labelling (labeling)” is different. Both markets have their own set of regulations which detail the mandatory content required on a product label. The regulations also give guidance on voluntary content such as claims. It’s important to know which governing bodies have oversight, which regulations apply and how to properly classify your product to make sure you use the right set of regulations from the beginning.
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Regulatory,
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Dietary Supplements/Natural Health Products
Thinking about getting your toxicological results published? Go no further until you read this article.
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Claims,
Regulatory,
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market access
Thinking about placing a toxicological test on your novel ingredient? Go no further until you read this article.
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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.
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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Summary: FDA announces draft guidance for industry on their policy to exercise enforcement discretion on delinquent notifications to encourage firms to submit NDIN to correct past failures.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.
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Product Testing & Certifications,
Regulatory,
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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.
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Product Marketing,
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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. |
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Product Marketing,
Claims,
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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.
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Claims,
Regulatory,
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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.
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Clinical Trials,
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Foods & Beverages,
Dietary Supplements/Natural Health Products
