2. Role of Public Quality Standards Ben A. Firschein, J.D., LL.M. Director, U.S. Government Affairs Panel on Nutritional Supplements Conference of Western Attorneys General (CWAG) Annual Meeting, Sun Valley, Idaho July 18, 2016

3. Key Points Industry, regulators, and consumers have a stake in supplement quality and reputation Science-based public quality standards and independent 3 rd party verification programs based on such standards can help

4.  Scientific nonprofit organization founded in 1820  Sets public quality standards for medicines, dietary supplements and food ingredients  Process based solely on science  Works with scientists, practitioners, regulators  USP standards officially recognized and used in more than 140 countries What is USP

5. What is a “Public Quality Standard?”  Written recipe and “yardstick” (physical reference)  Available to anyone to test quality at any point in the supply chain  Determines a product’s identity, purity, quality, potency

6. Role of USP Quality Standards in Law  Drugs:  - Must comply with USP standards Dietary Supplements: - Misbranded if represented as “USP” but does not meet standard

7. How Do Public Quality Standards Help ? The requirement to do testing is part of Good Manufacturing Practices (GMPs) for dietary supplements - USP (and other) standards and Reference Materials can be used to perform the identity testing required under 21 CFR 111.75(h)(1) - Standards and reference materials can also be used for the testing on the finished batch of dietary supplements to ensure that they meet product specifications To address challenges of intentional illegality and suspected adulteration, USP is also developing special standards

8. USP Verification Services (Voluntary Program) The USP Verified Mark on the label indicates: What’s on the label is in the bottle Ingredients are present in the declared potency and amounts Product does not contain harmful levels of specified contaminants and/or adulterants Product will break down in the body within a specified amount of time The product is made using safe, sanitary and well-controlled manufacturing practices The USP verified mark has appeared on more than 670 million product labels, www.uspverified.org www.uspverified.org 8