ANTHONY L. YOUNG*, CYNTHIA L. MEYER

*Corresponding author

Kleinfeld, Kaplan and Becker, LLP, 1140 Nineteenth St. NW, Washington, DC 20036, USA

Abstract

This article discusses obligations of manufacturers and suppliers under the United States regulatory system for dietary supplements. Such obligations include compliance with current good manufacturing practices (cGMPs), facility registration, prior notice of imports, and reporting requirements for the Reportable Food Registry. Additionally, basic information regarding what to expect during FDA inspections is presented, including how to respond to an FDA 483 Notice of Observations or Warning Letter .

INTRODUCTION

The United States regulatory system for dietary supplements is unique. While dietary supplements are considered a subset of food (21 U.S.C. § 321(ff)), the manufacturing requirements for supplements (1) are much more detailed than those that apply to food (2). A wide variety of dietary ingredients are permitted in such products, many of which are lawful in food but which, like amino acids, are added to dietary supplements not only for their nutrient value but also to provide a structure-function effect. Moreover, the US regulatory regime permits more claims for dietary supplements than for foods, specifically claims that describe how dietary supplements affect the structure or function of the body.
The United States registration requirements both for manufacturers and distributors of most food, food and dietary ingredients, and dietary supplements are straightforward. Such manufacturers or distributors, regardless of where they are located in the world, must be registered with the US Food and Drug Administration (FDA) (3). Exporters of foods and dietary supplements to the United States must also provide prior notice of such imports ...