Paul Bolar is vice president of regulatory affairs of Pharmavite LLC, a major manufacturer of dietary supplements in Los Angeles. Bolar graduated from the University of California, Los Angeles with a bachelor’s degree in biochemistry in 1974. Shortly after, he joined Pharmavite where he has held various positions in quality control, quality assurance, legal affairs and regulatory affairs. In his current position, he is responsible for assuring corporate compliance with all food, drug and environmental laws, and oversees Pharmavite’s government affairs, consumer affairs and professional education departments. He also served as chairman of the Regulatory Affairs Committee for the Council for Responsible Nutrition (CRN) from 1994 to 2006. He also participated on FDA’s Food Advisory Committee on Dietary Supplement Good Manufacturing Practices (GMPs) Working Group and was a member of the Expert Working Group on GMPs for the Dietary Supplements Sector of the Trans Atlantic Business Dialogue.
Kevin Boot, Embria's regulatory counsel, leads all activities relating to government compliance and spearheads efforts to develop and execute global regulatory and product registration strategies. He is also responsible for liaison activities with government authorities as well as reviewing and approving advertising and labeling. Before joining Embria, Boot practiced food and drug law with a distinguished law firm in Washington, DC, as well as coordinating the international regulatory activities for a prominent ingredient manufacturer. He is a member of the state bars of New York, District of Columbia and Iowa.
Michael Bradley is an expert in FDA regulations that govern pharmaceuticals, foods (including nutritional supplements) and cosmetics. His regulatory expertise includes GMP regulations for foods and drugs, labeling regulations for food, drugs and cosmetics as well as a working knowledge of FDA administrative and regulatory practices. Bradley developed this expertise while working for Shuster Laboratories Inc., a consulting firm based in Quincy, Mass. From December 1996 to April 1999 he was director of regulatory affairs at Leiner Health Products Inc. From April 1999 to October 2000 he was director of quality assurance at Leiner Health Products Inc. Currently he is the director nutritional scientific affairs for the Perrigo Company of South Carolina. In this position, he serves as a member of the nutrition planning team, which is responsible for all the strategic and administrative business planning for the dietary supplement division. His responsibilities include the design and implementation for new product development, quality control testing, and quality assurance/compliance requirements for the Perrigo dietary supplement division. In his current assignment, he is responsible for implementing lean manufacturing and six sigma principles in the laboratory operations to align testing and compliance activities to customer expectations (Voice of Customer).
Annette Dickinson is a consultant on dietary supplement regulation and food and nutrition policy. She worked in Washington, D.C., for over 30 years for the Council for Responsible Nutrition (CRN), the leading trade association of the dietary supplement industry. During that time, she was responsible for regulatory and scientific affairs for CRN and served as the association’s president prior to her retirement and move to Minnesota in 2005. Dickinson is the author of CRN’s publication The Benefits of Nutritional Supplements, a comprehensive review of the evidence demonstrating the health benefits of core nutritional supplements including multivitamins. She was appointed in 2002 to serve a three-year term on the U.S. Food and Drug Administration’s Food Advisory Committee. She was appointed by President Clinton to the Commission on Dietary Supplement Labels (1995-1997) and has been a frequent witness before the U.S. Congress and at other public forums. Her expertise includes the legal and technical aspects of marketing dietary supplements, including provisions relating to labeling, advertising, and good manufacturing practices. She is a recognized leader in the development of industry and government policies based upon current science. She earned her doctorate in nutritional sciences and her master’s in food sciences from the University of Maryland.
Bill H. Frankos, Ph.D., serves as the director, Division of Dietary Supplement Programs (DDSP) for the FDA. Dr. Frankos directs and coordinates policy, budget, personnel and administrative activities within the division. He advises on policy and management issues and decision, and provides expert advice and assistance to the director of the Office of Nutrition, Labeling, and Dietary Supplements, and other key FDA officials on dietary supplement programs, new dietary ingredient safety assessments, good manufacturing practices, adverse reaction monitoring, and related activities pertaining to dietary supplements. Dr. Frankos is responsible for the full implementation of DSHEA through the interpretation and enforcement of dietary supplement requirements that ensure the safety and truthful labeling of dietary supplements, and support legislative compliance, enforcement and public affairs initiatives. Dr. Frankos received his master’s of science degree in molecular biology from the University of Maryland, and his Ph.D. in pharmacology and toxicology from the University of Maryland Pharmacy School. He has over 30 years of experience in the toxicological and pharmacological evaluation of data used to assess the safety of nutritional supplements, foods and food additives, drugs, medical devices, cosmetics and environmental chemicals.
Joy Joseph, is currently the president and founder of JOYS QM SYSTEMs , where she has been working in the industry to assist companies in the implementation of the new dietary supplement, good manufacturing practices and in the development of science based products. Joseph is theformer vice president of quality, technical operations, scientific affairs and research and development for Pharmavite LLC, a division of Otsuka Pharmaceutical, Osaka, Japan. She is serving her second term as Chairman of the USP Committee of Revision for Nutritional Supplements Non-Botanical. She also is a member of the Counsel for Responsible Nutrition, regulatory affairs committee. She has served as scientific advisor to Virgo Publishing and for Tablet and Capsule. In January 2005, she authored a chapter on “Regulation and Quality Issues Worldwide” for Regulation of Functional Foods and Nutraceuticals: A Global Perspective. She recently completed a text book chapter entitled “Manufacturing Challenges for the Dietary Supplement Industry” in collaboration with Larry Ausburger and Stephen Hoag of the University of Maryland. This text will be published in November 2007 by the Taylor and Francis Group, LLC, New York, New York.Working with the Council for Responsible Nutrition and other trade associations, Joseph played a key role in drafting the original GMP guidelines submitted to the FDA for consideration in formulating the final rule.
Eugene I. Lambert is a partner in the Washington, D.C., law firm of Covington & Burling LLP. He jointed the law firm in 1961, and shortly thereafter became enmeshed in two important pieces of FDA history -- passage of the Drug Amendments of 1962, and the adoption of the peanut butter standard. He was also a participant in various parts of the marathon FDA proceeding to revise the Special Dietary Food Regulations that began in 1964, in the passage of the Rogers-Proxmire Amendment over a decade later, and in the adoption of the Dietary Supplement Health and Education Act of 1994 (DSHEA). Since his participation in the passage of DSHEA, he has widely represented companies marketing dietary supplements in compliance with both the restrictions and benefits of that legislation. He has also regularly been involved in food labeling and food standards issues, and has represented not only individual companies, but also national trade associations. He was involved in the legislative development, not only of DSHEA, but also of the Nutritional Labeling and Education Act of 1990 (NLEA), and participated on behalf of numerous clients in the rulemaking processes for the adoption of the final NLEA and DSHEA labeling rules. He received his J.D. from Yale Law School and clerked in the D.C. circuit court.
David R. Schoneker is the director of global regulatory affairs at Colorcon. His responsibilities include global coordination of Colorcon’s worldwide regulatory activities and raw material assessments. He received his bachelor’s degree from Ursinus College and master’s degree in chemistry from Villanova University. His previous position at Colorcon was director of quality assurance and quality control. He has been at Colorcon since 1977. Schoneker has been active in many professional organizations such as AAPS, RAPS, ASQC, ACS, AOAC and the Delaware Valley Chromatography Forum. He also is involved with a number of trade organizations such as the International Pharmaceutical Excipients Council (IPEC), the International Association of Color Manufacturers (IACM), the Council for Responsible Nutrition (CRN) and the Institute of Food Technologists (IFT). Schoneker is currently the chairman of IPEC Americas.
