1 U.S. Regulation and Legislation of Traditional Chinese MedicineRyan Abbott, M.D., J.D., M.T.O.M. Professor of Law and Health Sciences University of Surrey, School of Law Adjunct Assistant Professor of Medicine University of California Los Angeles (UCLA), David Geffen School of Medicine, Center for East-West Medicine

2 A quick word on my personal background and research in TCM.I’m a physician specialist in integrative medicine and an acupuncturist as well as an attorney. My TCM research has taken two forms, I have been principle investigator of clinical trials of TCM, for instance on the left is a randomized controlled trial my group did of self-acupressure to treat constipation that was published in the Journal of General Internal Medicine. We found it had a positive and clinically significant effect on constipation and improved quality of life. I also work in drug and device regulation, and in regulation of TCM. On the right is a text I prepared for the World Intellectual Property Organization on intellectual property issues associated with traditional medical knowledge.

3 UCLA CCIM Webpage: www.ccim.med.ucla.edu ExploreIM Web Portal: Center for East-West Medicine Mindful Awareness Research Center (MARC) Ka-Kit Hui, MD, FACP (Chair) Susan Smalley, MD Center for Excellence in Pancreatic Diseases Pediatric Pain Program Lonnie K. Zeltzer, MD Vay Liang W. (Bill) Go, MD School of Public Health Center for Human Nutrition Michael Goldstein, PhD David Heber, MD, PhD RAND/Samueli Institute Center for Neurobiology of Stress Ian Coulter, PhD Emeran Mayer, MD Simms/Mann Center for Integrative Oncology Bruce D. Naliboff, PhD Cousins Center for Psychoneuroimmunology Anne Coscarelli, PhD Mary Hardy, MD Michael Irwin, MD Stiles Program in Integrative Oncology e-CAM Edwin L. Cooper, PhD, ScD Richard Pietras, MD, PhD Doctoring Program, UCLA School of Medicine UCLArts and Healing Ping Ho, MA, MPH Margaret L. Stuber, MD I’m primarily based at the University of Surrey, but I also have an appointment at UCLA School of Medicine in the Center for East West Medicine. You might be interested in the extent to which TCM and IM are being integrated into UCLA, which reflects a broader interest in TCM by the UC system, and academic health centers generally. UCLA, for example, has a number of clinical and research programs and centers focused on TCM and IM. At the UCLA CEWM where I’m based, we have over 20k patient visits a year, and university leadership is interested in incorporating our East-West approach into conventional primary care. UCLA, UCSF, UCI, and UCSD all have centers for integrative medicine now, and about half of medical schools have centers that belong to a Consortium of Academic Health Centers for Integrative Medicine.

4 TCM in the U.S. National Health Interview Surveys (NHIS)2007 About 40% of adults use some form of Complementary and Alternative Medicine (CAM) 2012 $30.2 billion spent out-of-pocket on CAM products and services $14.7 billon visits to CAM practitioners In 2015, $36.7 billion on dietary supplements (NBJ) National Center for Complementary and Integrative Health (NCCIH)—$132 million budget UCLA’s adoption of TCM reflects a national shift in attitudes among the public The most recent strong data we have suggests that about 40% of Americans are using some form of complementary and alternative medicine.

5 Licensed CAM PractitionersProfession Number Licensed Accredited Schools States Regulated (Licensed) Accrediting Agency U.S. Dept of Education Recognition Standard National Exam Acupuncture 28,000 61 44 1982 1990 1985 Chiropractic 72,000 15 50 1971 1974 1963 Massage 280,000 88 2002 1994 Direct-entry Midwife 2,000 10 26 1991 2001 Naturopathic 5,500 7 18 1978 1987 1986 The practice of TCM is generally regulated at the state level, as is the practice of conventional western medicine. Nearly all states now regulate acupuncture, although there are a few states where there is not licensure of acupuncturists. Physicians may be able to practice acupuncture without any additional training, or may be required to complete a course on acupuncture. We also have about 3k medical doctors board certified in integrative medicine by the new board of integrative medicine, and for comparison there’s about a 900k medical doctors in the U.S. 2,800 MD/DOs certified by ABIHM; 1,100 MD/DOs completed UoA Fellowship in IM; 1,349 nurses certified by AHNCC (894,000 total MD/DOs and 3.3 million nurses) Source: Academic Consortium for Complementary and Alternative Health Care (2013)

6 Dietary Supplement Health and Education Act of 1994 (DSHEA)Focused on ensuring widespread consumer access Creates a new category of food for dietary supplements distinct from conventional foods and drugs; excludes dietary supplements from regulation as food additives Under DSHEA, it is the FDA’s responsibility to prove a dietary supplement is unsafe before it can be removed from the market. To withdraw a product, the FDA must prove that the product places consumers at “significant or unreasonable risk” Products consumed by mouth, other than tobacco and conventional foods, intended to provide nutritional or health benefit – amino acids, vitamins, herbs, etc. In passing the Act, Congress cited “overwhelming” public opinion in favor of widespread access to dietary supplements. Unlike pharmaceuticals, dietary supplements can be generally produced, sold and marketed without evidence of safety or efficacy Exempted manufacturers from conducting premarket safety and efficacy research and eliminated FDA’s premarket regulatory authority

7 Product Liability There have not been too many safety problems with marketing dietary supplements since DSHEA, although a number of consumers died in the 1980s and 1990s from adverse effects from the sale of Ephedra Sinica, in products like Metabolife. Ephedra is a traditional Chinese medicine that was marketed in the US as a weight loss supplement and athletic performance enhancer. That’s a longer story. More recently, there have been class actions lawsuits against homeopathic manufacturers, and the FDA has put out warnings about certain products. Product liability can have a very significant impact on the market in the U.S. Heel announced that it would stop marketing within the United States and Canada after August 31, Its press release attributed the decision to two class-action suits that has caused a "substantial financial burden."

8 Botanical Drugs In October, 2006, the FDA approved the first botanical pharmaceutical drug, Veregen, a purified green tea extract for the topical treatment of human papilloma virus Fulyzaq (crofelemer), the first anti-diarrheal drug for HIV/AIDS patients, is the second FDA approved botanical drug. Made from the sap of the Croton lechleri plant, which is used in traditional medicine to treat diarrhea. Compounds that qualify as dietary supplements may also be regulated as medical foods and drugs under certain circumstances. Botanical drugs were predicted in 2012 to have a value of $10 million in 2012 and of $599 million in 2017. The industry is growing slower than expected due to regulatory challenges. FDA Guidance in 2004. Ethnomedical uses of sangre de drago including the treatment of diarrhea, wounds, tumors, stomach ulcers, herpes infection, the itching, and pain and swelling of insect bites. About 500 applications have been submitted. The FDA gets about 4-5 botanical drugs submissions each month. Some undergoing OTC reviews.

9 CONTACT: [email protected]Me with Bruce Lee