Whether you are a family business selling a single product, or a multi-national corporation with thousands of SKUs, the regulatory requirements are the same: it is industry’s responsibility to ensure products comply with regulations for safety, quality, efficacy, and label claims.
The dietary supplement/natural health product market is a broad category including everything from herbal products, vitamins, and minerals to omega-3s and probiotics. These products are regulated as dietary supplements in the U.S., natural health products (NHPs) in Canada, and food supplements in the EU.
Each jurisdiction has different compliance requirements. In Canada, NHPs require pre-market approval from Health Canada before they can be legally sold. This requires a Site Licence and Product Licence. In the U.S., products must meet the criteria set by the Food and Drug Administration (FDA) but do not require approval before going to market. Instead, post-market monitoring ensures the product does not violate the regulations. In specific cases, a Generally Recognized as Safe (GRAS) submission or New Dietary Ingredient Notification (NDIN) is needed.
Nutrasource provides full regulatory, clinical trials, and analytical and bioanalytical testing solutions to help our clients launch dietary supplements and NHPs globally. Through our expert regulatory leadership and full suite of clinical services, we will help you launch your supplement quickly, successfully, and with regulatory confidence. Our team can also help you navigate the regulatory framework so you can gain access to one or more regions simultaneously – without additional work or excess costs.
Explore our regulatory and clinical services for dietary supplements and NHPs:
- Product Development Strategy
- Clinical Trials
- Compliance Consulting
- Health Claims Substantiation
- Product Classification
- Technical Label Review
- Natural Health Product (NHP) Licensing
- Dietary Supplement Facts Panel Review
- Scientific Literature Reviews
- Temporary Market Authorization (TMA) Applications
- Master File Submissions
- Natural Health Product (NHP) Site Licensing
- Generally Recognized as Safe (GRAS)
- New Dietary Ingredient Notifications (NDIN)
Our product testing services for dietary supplements and NHPs include:
Learn how we can help you successfully commercialize your dietary supplement or NHP.
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