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Determining the Regulatory Status of Your "Food": Hot Topics in FDA Regulation of Foods, Dietary Supplements, and Medical Food

1h 1m

Created on May 19, 2016

Intermediate

Overview

Is it a conventional food? Is it a dietary supplement? Is it a medical food? Or is it a drug? The answer to this question can have significant consequences for a consumer products company marketing an edible product in the United States.

This course, presented by Raqiyyah Pippins, Counsel at Arnold & Porter and trusted advisor of consumer health product companies and organizations, reviews the legal issues that should be considered by any company contemplating the development of a product intended for consumption by humans, that will be marketed with health-benefit claims. Decisions regarding the ingredients, target audience, and product claims for the product can have a significant impact on how the product is regulated by the Food & Drug Administration and non-compliance with the applicable regulations can be very costly to a company.  

Learning Objectives:

I.      Identify the different regulatory classifications that can be given to edible products promoted with health-benefit claims

II.     Grasp relevant federal and state laws and regulatory activity related to the different regulatory categories (conventional food, dietary supplement, medical food and drug)

III.    Obtain practical guidance to assist you with reducing the legal risk of your product obtaining an undesirable regulatory classification from the Food & Drug Administration 

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