NSF International “Ensuring Product and Athlete Integrity Through the Supplement Certification Process” 15 th FINA World Sports Medicine Congress Chris Steele General Manager, Toxicology Group, LLC October 12, 2004

Overview 1.A brief overview of NSF International 2.Role of NSF/ANSI Standard 173: Dietary Supplements in conveying product integrity and quality 3.Components of NSF Certification Process 4.The key elements of NFL/NFLPA/NSF Banned Substance Certification Program

NSF’s Mission: NSF International, an independent, not-for-profit, non-governmental organization, is dedicated to being the leading global provider of public health and safety risk management solutions while serving the interests of all stakeholders.

History and Overview Established in 1944 as a standards developer and product certifier Accredited by the American National Standards Council (ANSI) and the Standards Council of Canada (SCC) Offer a wide range of public health based risk management solutions to our 4,800 clients worldwide 370+ staff, scientists and engineers (200+ independent field auditors, worldwide) World Health Organization Collaborating Centers for Food Safety, Indoor Air Quality, and Drinking Water Safety and Treatment The Public Health and Safety Company™

Business Scope Public Health and Safety Business Scope: Public Health and Safety

Sports Supplements in the Media “… Tonight I call on team owners, union representatives, coaches, and players to take the lead, to send the right signal, to get tough, and to get rid of steroids now. ” – President Bush, 2004 State of the Union Address A recent study tested 600 supplement products around the world for substances that were not listed on the label and are banned by the NCAA, and United States Olympic Committee. – 28% of the supplements tested in the United States had banned substances in them with no disclosure on the label. –14% of the supplements tested out side the United States had banned substances in them with no disclosure on the label.

Public health regulators act for athletes protection -DIETARY SUPPLEMENT & FUNCTIONAL FOODS CERTIFICATION PROGRAM -GMP Audit of manufacturing facility -Chemical and Microbiological analytical testing of label claims -Heavy Metal, Contaminant, and dissentigration testing -NFL/NFLPA SUPPLEMENT CERTIFICATION PROGRAM WAS ANNOUNCED AT SUPER BOWL -Program designed to provide NFL athletes with a safer choice for selecting supplements. - Components of program are designed to be rigorous and strict to ensure no presence of banned substances.

NSF’s Dietary Supplements Certification Program Only third-party dietary supplement certification program accredited by the American National Standards Institute (ANSI) and the Standards Council of Canada (SCC) 60 years experience in independent third-party certification Meets requirements of ISO Guide 65 Criteria developed through input of stakeholders Voluntary participation

NSF/ANSI Standard : Dietary Supplements “ANSI” Standards are developed based on the principles of due-process, participation, and consensus Developed with participation from the dietary supplements industry (trade associations), public health regulators, suppliers, manufacturers of dietary supplements, and user groups Continued Stakeholder involvement in the evaluation of the Standard and Certification Program

NSF/ANSI Standard : Dietary Supplements, elements of: The purpose of NSF/ ANSI Standard 173 is to serve as an evaluation tool for analyzing dietary supplements (DS) and dietary ingredients Provides test methods and evaluation criteria to allow for the determination that DS contain the ingredients claimed on the label or product specifications, either qualitatively or quantitatively and that they do not contain specific undeclared contaminants The standard includes provisions for single ingredient products, multiple ingredient products, raw materials and/or finished products

Components of NSF Dietary Supplement Certification Process Application to NSF Plant Audit (GMP’s) Formulation Review Product Testing Documentation, Report, Registration and Certification Ongoing Monitoring

Components of the NFL/NFLPA Banned Substance Certification Program

NSF Certification Process: Framework for NFL/NFLPA Banned Substance Program Requirements –Compliance with NSF/ANSI Standard 173 Testing for identity and quantity of ingredients Testing for contaminants Full GMP audit for initial qualification and every three years –On-going surveillance testing –Annual monitoring audits every year

Official NFL/NFLPA Supplement Certification Program Details Interested companies apply to NFLPA –NFLPA applies selection criteria before referring to NSF for certification Certification Criteria include: –Semi-annual testing for content claims, microbiological growth, disintegration, heavy metals, and other contaminants and adulterants –Lot-by-lot NFL banned substances testing –Label and formulation change control –Random “off-the-shelf” testing –Annual Good Manufacturing Practices audits of all facilities –Potential for metabolic clinical studies and review

Identifying Certified Products Certified Products are identified several ways: –Companies are awarded use of the “Mark” to differentiate products –NFL/NFLPA Mark can be used on products, sales literature and other marketing collateral if approved –Certified Product Listings appear at Accessed 1.49 million times in 2003

Certification Mark Examples: Mark Required on Certified Products Contents Tested

NFL/NFLPA Product Certification Mark

NSF’s Online Product Listings

NSF Certification Program Strengths –Analytical methods development and validation –Clinical study capabilities –Cost effective laboratory services –Strategic partnership with the University of Utah- Center for Human Toxicology –Toxicology Group, LLC –Distinctive approach to consumer outreach Toll-free consumer hotline & consumer-focused website National marketing campaign

NSF Certification Program Strengths Cont. –Program Office Registered Dietitian and Nutritionist on staff –NSF investment in Information Technology Dynamically generated certification listings Streamlined audit capabilities –Highly trained auditors worldwide –75,000 sq ft of laboratory space 150 chemists, microbiologists, food scientists and engineers on staff

NSF Contact Kathy Pompliano, MS, RD General Manager, Dietary Supplements Certification EXT 6856 Chris Steele General Manager, Toxicology Group, LLC EXT 5159 Lori Bestervelt, Ph.D. Chief Technical Officer, NSF International

IN CONCLUSION NSF has been an industry leader for over 60 years, committing to public health and safety. Importance of control over banned substances is being addressed by a public health organization Development of Banned Substance Certification Program, taken on by NSF. Trust in NSF Third-Party Certification Program.

The NSF Mark Delivers: A sign of quality and trust. The NSF Dietary Supplement Programs are the most rigorous and inclusive available, and deliver real value to you, your members, the general public, and the industry.