Ben A Firschein JD LLM Director US Government Affairs Panel on Nutritional Supplements Conference of Western Attorneys General CWAG Annual Meeting Sun Valley Idaho July 18 2016 ID: 781499
Download The PPT/PDF document "Role of Public Quality Standards" is the property of its rightful owner. Permission is granted to download and print the materials on this web site for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.
Slide1
Slide2Role 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
Slide3Key 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
Slide4Scientific 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
Slide5What 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
Slide6Role of USP Quality Standards in Law
Drugs
:
-
Must
comply with USP standards
Dietary Supplements
:- Misbranded if represented as “USP” but does not meet standard
Slide7How 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
Slide8USP 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 practicesThe USP verified mark has appeared on more than 670 million product labels, www.uspverified.org
8
Slide9Slide10