Originally published February, 2011

Introduction

Bringing a new functional food product to market is a potentially complex process with many decision points driven by the US Food and Drug Administration’s (FDA) regulatory mandate. There is no single definition for functional foods, also known as nutraceuticals. They may encompass a range of products and uses, including dietary supplements, medical foods food additives or drugs. Careful consideration of the potential market for a product must be weighed against the time and expense necessary to determine the exact status of a product under the laws and regulations administered by the FDA. The regulatory status of a product is quite often the basis for the marketing of that product, so every possible consideration should be given to assure scientifically sound and legally defensible claims made for the functionality of the product.

This report outlines the requirements for each potential option and the relevant advantages and drawbacks of each pathway. It is intended to provide valuable background information on regulatory compliance, specific types of claims and key product categories.

Read The Full White Paper Here!

Related Posts