Dietary Supplement Regulatory Services

Supplements are concentrated sources of nutrients or other substances with a nutritional or physiological effect that are intended to supplement the normal diet and are often in dose form, such as tablets or capsules.  

The regulation of supplements varies widely between jurisdictions worldwide.  In some jurisdictions they are regulated similarly to foods, while in other jurisdictions they are regulated similarly to drugs. As such, many aspects of the regulations can vary including permitted types of health claims and accompanying standards of evidence, permitted dosage format, pre-market approval of supplement ingredients, requiring a license for the finished product, and good manufacturing practices. Navigating these regulations and preparing any required pre-market approval documents can be complex.

Intertek’s global experts have an unparalleled understanding of the intricacies and processes of regulatory agencies and requirements to develop a successful strategy, follow-through with the submission process, and act as a liaison with regulatory agencies for supplement products in the global marketplace.

Intertek’s services include: 

• Determining the regulatory strategy required to bring the supplement to market in different jurisdictions;
• Conducting feasibility assessments to determine whether sufficient data exist to pursue successful applications in different jurisdictions;
• Providing recommendations to meet regulatory requirements for safety, efficacy, and quality;
• Providing product development support; 
• Assisting in the design, placement, monitoring, and management of clinical trial protocols for health claim substantiation;
• Compiling technical and scientific submissions to regulatory authorities;
• Preparing expert opinion letters; 
• Acting as a liaison with regulatory authorities during the submission review process; and 
• Administering programs to meet post-market requirements, including adverse event reporting, regulatory monitoring, and surveillance programs. 

Intertek has extensive experience in the following jurisdictions: