Technical Label Review

Importing and selling health products requires compliance with regulations in the country/region in which it will be sold.  Each jurisdiction has unique nuances that must be clearly understood in order to reduce risk of regulatory action and ensure compliance.

For example, in Canada, labelling of natural health products is tightly regulated. Labels forming part of the Product Licence Application must include correct ingredient nomenclature, dosing and risk information, substantiated health claims and bilingual labelling.

In the United States, labels must be compliant with applicable regulations outlined in the Federal Food, Drug and Cosmetic Act.  Labels are more similar to foods and include a supplements fact panel which must be prepared in a standardized manner.  As pre-market approval is not applicable in the United States, it is important that claims are appropriate and compliant with regulations.

How to review natural health product (NHP) labels for compliance | www.nutrasource.ca

In the EU, this can become even more confusing as member states of the EU often have specific requirements over and above those of EU guidelines including specific font sizes, languages and nomenclature.  Additional complexities arise due to varying product classification rules of by jurisdiction.  Where bilingual labelling is required, we are able to provide this service to our clients.

Because a label review goes beyond the product package itself, it often requires review of marketing material, advertisements, websites and social media pages to ensure that advertising material (which is considered part of the label) is truthful and not misleading to the consumer to ensure regulatory compliance.  This can be easily overlooked, but it is a critical aspect to manage risk of enforcement action.

At Nutrasource, we simplify the labelling process for you.  Our regulatory team is experienced in label reviews for many global jurisdictions and will identify and correct any errors or language that is at risk of regulatory enforcement action in a cost competitive manner.

Looking for more information on product label compliance? Contact a member of our team today or email us directly at info@nutrasource.ca. You may also request a customized quote and we will contact you with details within two business days.