The Federal Trade Commission is hosting a workshop on September 21, 2015 to evaluate advertising for over-the-counter homeopathic products. The workshop will bring together a variety of stakeholders, including medical professionals, industry representatives, consumer advocates, and government regulators.
During the last few decades, the homeopathic drug industry in the United States has grown from a multimillion- to a multibillion-dollar market. In that same time, the homeopathic drug market has shifted: from one based primarily on formulations prescribed for an individual user, to mass-market formulations widely advertised and sold in major retail stores throughout the United States.
The workshop is free and open to the public. This is an all day workshop.
Questions? Email email@example.com.
Gregory W. Fortsch
Attorney, Division of Advertising Practices, FTC
Maureen K. Ohlhausen
Commissioner, Federal Trade Commission
Panel 1: Homeopathic Industry & Advertising
This panel will look into the evolution and growth of the homeopathic industry, including the increase in mass marketing, labeling, and advertising of OTC homeopathic products or products labeled as homeopathic as well as consumers’ understanding of homeopathy.
Mary K. Engle, Associate Director
Division of Advertising Practices, FTC
John P. Borneman
Chairman and Chief Executive Officer
Standard Homeopathic Company and Hyland’s, Inc.
WSL Strategic Retail
Operations & Regulatory Affairs, Boiron, Inc.
Independent Retail Consultant
Senior Vice President
Scientific & Regulatory Affairs
Council for Responsible Nutrition
Panel 2: Scientific Support for Homepathic Advertising Claims
This panel will discuss the principles of homeopathy and how homeopathic drugs are defined. The panel will also discuss the substantiation of advertising claims for OTC homeopathic drugs.
Richard L. Cleland, Assistant Director
Division of Advertising Practices, FTC
Department of Pharmacology and Physiology
Georgetown University Medical Center
New England School of Homeopathy
Freddie Ann Hoffman
Wayne B. Jonas
President & CEO
Richard (Rik) Lostritto
Division Director and Acting Associate Office Director for Science in the Office of Policy for Pharmaceutical Quality (OPPQ)
Food and Drug Administration
Academy of Integrative Health and Medicine
Integrative Medicine Institute
- John Williamson
Basic and Mechanistic Research in Complementary and Integrative Health
National Center for Complementary and Integrative Health
National Institutes of Health
LUNCH 1:30 pm
Panel 3: Legal/Regulatory Issues Presented by Homeopathic Advertising
This panel will consider a variety of legal issues presented by OTC
homeopathic drug advertising, including the application of Section 5 of the FTC Act and the effect of recent class actions against homeopathic product companies, as well as possible remedies to address these legal issues.
Gregory W. Fortsch, Attorney
Division of Advertising Practices, FTC
Senior Staff Attorney
National Advertising Division
Council of Better Business Bureaus
Food and Drug Administration
Law Office of Alvin J. Lorman
Paul D. Rubin, Esq.
Ropes & Gray, LLP
Senior Staff Attorney
Division of Advertising Practices
Federal Trade Commission
Christina Guerola Sarchio
Orrick, Herrington & Sutcliffe, LLP
David C. Spangler
Senior Vice President, Policy, and General Counsel and Secretary
Consumer Healthcare Products Association
Faruqi and Faruqi, LLP
PANEL 1: Homeopathic Industry & Advertising
John P. Borneman earned a bachelor of science degree in Chemistry from St. Joseph's University (Philadelphia) in 1980, followed by a Master of Science in Chemistry, and a Master of Business Administration with a concentration in Finance. He subsequently earned his doctorate from the Department of Health Policy and Public Health at the University of the Sciences in Philadelphia. Dr. Borneman has been associated with homeopathic firms throughout his life, joining Standard Homeopathic Company and Hyland's, Inc. in 1987, where he now serves as Chairman and CEO. In addition to chairing Standard's Board, Dr. Borneman serves on the Boards of: the Homoeopathic Pharmacopoeia of the United States, where he serves as its President; the Consumer Healthcare Products Association (CHPA), where he served as Chairman of the CHPA Political Action Committee; and the Southwest College of Naturopathic Medicine and Health Sciences. He serves on the Advisory Board of the Health Policy and Physician’s Assistant Programs of the University of the Sciences in Philadelphia and as a Section Councilor for the Integrative, Traditional and Complementary Health Practices Section of the American Public Health Association.
Candace Corlett currently serves as the president for WSL Strategic Retail. Prior to starting her career at WSL Strategic Retail in 1996, Ms. Corlett worked in consumer product marketing in the alcoholic beverage, pharmaceutical, and beauty industries for nearly thirty years. In the consumer products marketing industry, she has held management positions in marketing and market research at Bristol Myers-Squibb, Del Labs and Revlon. Since joining WSL Strategic Retail, she has served as a retail strategist, principal and president of the company. She holds a bachelor of science degree from Saint John’s University (NY) as well as a Master of Arts degree from New School University (NY).
Mark Land has 35 years of industry experience in the manufacturing, marketing, and distribution of homeopathic drug products. He has served 10 years as the president of the American Association of Homeopathic Pharmacists (AAHP). During his tenure he has focused his efforts encouraging regulatory compliance among AAHP members. Mark also serves on several committees for the Homeopathic Pharmacopoeia Convention of the United States, in which he has been a member for 13 years. He holds a master’s degree in regulatory science from Temple University’s School of Pharmacy. His research interests are the regulation of homeopathic and OTC drug products.
Yale Martin is an independent retail consultant residing in Bentonville, Arkansas. He retired in November 2014 from Walmart Stores, Inc. after 18 years in Walmart’s buying office. Mr. Martin spent much of his career as a buyer and for the last five years supervised Walmart's over-the-counter (OTC) buying office, responsible for more than 4,000 OTC items retailed in Walmart's 5,000 US stores. Previously, Mr. Martin held buying positions in Baby, Pet, Health and Beauty Aids/Cosmetics, and OTC. Mr. Martin holds a bachelor's degree from the University of California and serves on the Board of Directors of Angie’s Artisan Treats, an organic snack food company owned by a private equity firm.
Duffy MacKay is senior vice president, scientific and regulatory affairs for the Council for Responsible Nutrition (CRN). Dr. MacKay oversees CRN’s science and regulatory affairs department, ensuring that the association’s scientific, policy, and legislative positions are based on a credible scientific rationale. His expertise combines practical knowledge of industry regulation and scientific product development with hands-on experience as a medical practitioner. He is a licensed Naturopathic Doctor who still sees patients on a part-time basis in an integrative medical practice, and previously was co-owner and practitioner in a family-owned New Hampshire complementary and alternative medicine private practice. Dr. MacKay serves on the Advisory Board for the American Botanical Council and on the NSF International Joint Committee on Dietary Supplements. He is also Chair of the Steering Committee for the Standard Information on Dietary Supplements (SIDI) Work Group. Dr. MacKay earned his degree in Marine Biology from the University of California, Santa Cruz and his N.D. from the National College of Naturopathic Medicine in Portland, Oregon.
PANEL 2: Scientific Support for Homeopathic Advertising Claims
Adriane Fugh-Berman, MD is currently an Associate Professor in the Department of Pharmacology and Physiology, and in the Department of Family Medicine at Georgetown University Medical Center. A general practitioner, Dr. Fugh-Berman teaches courses that cover medicinal plants, dietary supplements, and evidence-based medicine. She also directs PharmedOut, a research and education project that advances evidence-based prescribing and educates healthcare professionals about marketing practices that affect prescriber choices. Dr. Fugh-Berman is the author of a clinicians' reference text, The 5-Minute Herb and Dietary Supplement Consult, and a consumer book, Alternative Medicine: What Works. Previously, Dr. Fugh-Berman was a medical officer in the Contraception and Reproductive Health Branch, National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH). She also was medical director of two alternative medicine clinics in Washington DC.
Paul Herscu is a graduate of the National College of Naturopathic Medicine and has been in private practice since 1986, specializing in the treatment of neurological, psychological, and immune dysfunction diagnoses. He has authored a number of books on homeopathy including The Homeopathic Treatment of Children, Pediatric Constitutional Types and Provings, Volume I & II. He founded The New England Journal of Homeopathy, which was published from 1992-2002. Dr. Herscu is an internationally sought-after speaker, and is the founder and director of The New England School of Homeopathy, the oldest and largest homeopathic postgraduate training program in the US, articulating a scientific and accessible approach to constitutional homeopathy.
Freddie Ann Hoffman is CEO of HeteroGeneity, LLC. She trained as a pediatric hematologist-oncologist at the National Cancer Institute, where she was later responsible for Nutrition and Supportive Care and Clinical Trials with Biological Response Modifiers in the Division of Cancer Treatment. She then joined FDA where she spent more than 13 years, becoming deputy director of the Medicine Staff within the Office of the Commissioner. Among her many duties, she served as Agency spokesperson and liaison for Complementary and Alternative Medicine and initiated several internal working groups which addressed the regulation of acupuncture needles, botanicals, and homeopathy, and was a member of the working group for Dietary Supplement Structure and Function Claims. Retiring from the U.S. Public Health Service, she became Senior Director for Medical & Clinical Development at Pfizer-Warner Lambert Consumer Healthcare (NJ), where she was responsible for the development and review of OTC products and advertising. Dr. Hoffman returned to Washington, DC in 2003 to found HeteroGeneity, LLC, a consulting firm focused on the science, regulation, and policy of complex, heterogeneous product development in the United States and Canada.
Wayne B. Jonas is the President and Chief Executive Officer of Samueli Institute, a non-profit medical research organization supporting the scientific investigation of healing processes and their application in health and disease. He is a widely-published scientific investigator, a practicing family physician, Professor of Family Medicine at Georgetown University and the Uniformed Services University of the Health Sciences, and a Fellow of the American Academy of Family Physicians. Dr. Jonas is a retired Lieutenant Colonel in the Medical Corps of the United States Army.
Richard (Rik) Lostritto currently serves as Division Director and Acting Associate Office Director for Science in the Office of Policy for Pharmaceutical Quality at the Food and Drug Administration (FDA). Prior to assuming the current position at the FDA, he served in a number of different roles at the Agency including Acting Deputy Office Director for Science & Policy and Biopharmaceutics Lead in the Office of New Drug Quality Assessment, CMC Division Director (oncology, pulmonary, allergy, hematology, cardio-renal, neurology, and psychiatric drug products), CMC Team Leader (pulmonary, allergy, and oncology drug products), and Review Chemist in several therapeutic areas. Dr. Lostritto began his career as an Assistant and Associate Professor of Pharmaceutics at The University of Connecticut School of Pharmacy. Following his time at The University of Connecticut, Dr. Lostritto worked as the leader of a group that focused on developing medical aerosol drug products at Boehringer Ingelheim Pharmaceuticals before embarking on his career at the FDA.
John Williamson is the Branch Chief, Basic and Mechanistic Research in Complementary and Integrative Health at the National Institutes of Health’s National Center for Complementary and Integrative Health (NCCIH). He oversees the basic and mechanistic research programmatic operations at the NCCIH and maintains a portfolio of grants relating to the biological mechanisms associated with natural products. He received his bachelor of science degree in pharmacy from The University of Mississippi, his doctorate in medicinal chemistry and natural products chemistry from The University of Iowa, and postdoctoral training in molecular, cellular, and developmental biology at Yale University. Prior to joining NCCIH, Dr. Williamson served as professor of medicinal chemistry and research professor of the National Center for Natural Products Research, and research professor of the Research Institute of Pharmaceutical Sciences in the Department of Medicinal Chemistry, School of Pharmacy, at The University of Mississippi where he holds Emeritus Professor status. His work has been published widely in a variety of peer-reviewed scientific research journals in medicinal chemistry, natural products chemistry, and microbiology, and he has served on numerous journal editorial boards. His academic research career interest focused on the design and development of new chemotherapies and the use of new biocatalytic technologies and methodologies to better understand the underlying biological mechanisms associated with natural products.
David Riley is board certified in Internal Medicine, a medical editor, and has conducted clinical research in conventional and integrative medicine including homeopathy in Europe and North American since 1992. He has participated in the development of health research reporting guidelines beginning with the CONSORT guidelines in 2000 followed by the reporting guidelines for case reports in 2011 the CARE Guidelines. Dr. Riley is trained in a variety of integrative medicine disciplines and is currently on the Board of Directors of the Academy of Integrative Health and Medicine (AIHM) and the Homeopathic Pharmacopoeia Convention of the United States (HPCUS). He is an associate editor with The Permanente Journal.
PANEL 3: Legal/Regulatory Issues Presented by Homeopathic Advertising
Kathleen Dunnigan works as Senior Staff Attorney in the National Advertising Division (NAD), which she joined in 2008. While she has written case decisions in every product category, in recent years, her focus at NAD has been health-related advertising claim substantiation. Prior to joining NAD, she was a staff attorney for the Legal Aid Society's Juvenile Rights Division, the Center for Appellate Litigation for many years. She also litigated employment discrimination and civil rights claims at a small plaintiff’s firm for many years. Ms. Dunnigan graduated from The State University of New York Maritime College with a bachelor’s degree in engineering and as an officer in the United States Merchant Marines in 1993, and she obtained a degree from New York University Law School in 1999.
Elaine Lippmann serves as Regulatory Counsel in the Office of Regulatory Policy in the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research. Ms. Lippmann provides oversight and leadership in the development of regulations, policies, procedures, and guidances that affect the drug approval process, and in the development of new legislation. Prior to joining the FDA in 2011, Ms. Lippmann was an attorney at Spiegel & McDiarmid, a law firm that represents municipalities in administrative law and regulatory matters. Ms. Lippmann received her bachelor’s degree from Oberlin College and her law degree from Northeastern University School of Law. She clerked for the Honorable Judge Norma Shapiro in the U.S. District Court for the Eastern District of Pennsylvania in Philadelphia.
Al Lorman has practiced food and drug law for 39 years and advises clients in all aspects of Food and Drug Administration (FDA) regulation, including claims substantiation, whether on labels or in advertising. He has represented several clients in FTC advertising substantiation matters. He represents major segments of the homeopathic drug industry, including the American Association of Homeopathic Pharmacists and represented the industry in the discussions that lead to the issuance of the FDA compliance policy guide on homeopathy in 1988.
Paul D. Rubin is a partner at Ropes & Gray LLP, specializing in Food and Drug Administration (FDA) and FTC law. Mr. Rubin co-chairs the firm’s Retail and Consumer Brands Practice and represents many FDA-regulated companies, including over-the-counter (OTC) drug companies, with a significant interest in FTC advertising requirements. Mr. Rubin’s practice includes the representation of companies subject to FTC investigation and in disputes before the National Advertising Division (NAD) of the Better Business Bureau. Mr. Rubin obtained his B.S. in Economics, magna cum laude, from the Wharton School of the University of Pennsylvania, and his J.D., cum laude, from the University of Pennsylvania Law School.
Michelle Rusk is a senior staff attorney in the Division of Advertising Practices, Bureau of Consumer Protection at the FTC. She has worked on various food and dietary supplement policy matters and enforcement actions over the years and helps the FTC coordinate with Food and Drug Administration, U.S. Department of Agriculture, and the National Institute of Health’s Office of Dietary Supplements. She was involved in writing the FTC’s 1994 Enforcement Policy Statement on Food Advertising and the 1998 Dietary Supplements: An Advertising Guide for Industry. Ms. Rusk joined the FTC from private practice in 1990. She received her bachelor of arts degree in psychology from Harvard University and her law degree from the Georgetown University Law Center.
Christina Guerola Sarchio a partner in the D.C. office of Orrick, Herrington & Sutcliffe, LLP, and focuses her legal practice on complex commercial disputes, class actions, and government investigations. Her representations span several industries, including homeopathic products, food and beverage, consumer goods, oil and gas, and sports. Ms. Sarchio’s class action successes include a precedent-setting summary judgment victory on behalf of an international homeopathic manufacturer cited in more than 50 subsequent decisions. This precludes the consumer class from seeking injunctive relief in the form of label changes, dismissal of a false advertising class action against a national organic grocer, and dismissal of a class action against former quarterback Joe Theismann for his celebrity endorsement of a dietary supplement. Recently named one of the Top 50 Women Lawyers in DC, Ms. Sarchio, a former prosecutor, has received a number of awards, been profiled by Law360, Powerful Latinas and the Minority Corporate Counsel Association, and has been recognized by numerous publications.
David C. Spangler directs the Consumer Healthcare Products Association’s (CHPA) legal affairs and international affairs, and oversees association policy initiatives. Mr. Spangler joined CHPA in 1984 as a legislative analyst and then subsequently served in a number of roles for the association in the president's office, project management, and international affairs. After completing law school in 1995 at George Washington University Law Center, Mr. Spangler joined CHPA's legal department. Mr. Spangler was named a vice president in 1997 and a senior vice president in 2006. Spangler serves on the board of directors of the World Self-Medication Industry as well as the District of Columbia Bar and the American Society of Association Executives. He authored the chapter on over-the-counter medicines in Modern Pharmaceutical Industry: A Primer (Jacobsen and Wertheimer, eds., 2009) and serves on the editorial board for the Food and Drug Law Institute's Policy Forum. Spangler earned his Certificate in Organizational Management in 1991 from the U.S. Chamber of Commerce's Institute for Organization Management.
Anthony Vozzolo serves as chair of the Faruqi & Faruqi’s consumer law practice. He focuses on complex commercial and class action litigation and in the areas of consumer protection and securities law. Mr. Vozzolo has served as class counsel in numerous high-profile consumer class actions across the country, alleging a variety of improper, unfair, and deceptive business practices. Mr. Vozzolo has recovered hundreds of millions of dollars and other significant remedial benefits on behalf of consumers. He has litigated several matters against manufacturers of homeopathic products, obtaining one of the largest certified classes of purchasers of homeopathic products in the country.
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