Center to collect data on supplement ingredients and adverse effects
MINNEAPOLIS / ST. PAUL (Feb. 14, 2005) — Researchers from the University of Minnesota’s College of Pharmacy have developed a center that will shed light on the safety of dietary supplements, which are increasingly popular with the public. The Center for Dietary Supplement Safety, based in the College of Pharmacy, will collect, analyze, and disseminate scientific information about dietary supplements, which have become a $20 billion industry in the United States.
“The public is starved for information about dietary supplements and their safety,” said Richard Kingston, Pharm.D., professor of pharmacy and director of the center. “We want to provide data to answer questions in a more systematic and ongoing basis and provide day-to-day monitoring of safety issues associated with the use of dietary supplements.”
Dietary supplements are regulated by the Food and Drug Administration (FDA) under the framework of the Dietary Supplement Health and Education Act of 1994 (DSHEA). Under DSHEA, ingredients in dietary supplements are presumed to be safe, and evaluation of whether a dietary supplement product presents a significant or unreasonable safety risk takes place after the product is on the market. While the FDA encourages manufacturers, marketers, and distributors of dietary supplements to report adverse events associated with use of their products, no mandatory requirements for reporting exist.
“I believe that this center will serve important needs of the public and of health professionals for reliable information about the safety of dietary supplements, so that individuals can use them, and health professionals can recommend them, with confidence,” said Marilyn K. Speedie, Ph.D., dean of the College of Pharmacy.
Highlighting the interdisciplinary strength of the University, center faculty include researchers from the College of Pharmacy, the College of Agriculture, Food and Environmental Science, School of Public Health, and Medical School.
Goals for the center include: serving as a clearing house for data on safety related issues associated with supplement use; publishing reports on product safety; developing a national supplement product database of ingredients; and promoting dialog about supplements between manufacturers, health care providers, the public and regulators including the FDA.
The center will seek funding through government grants as well as donations and service contracts from the dietary supplement industry or other non-governmental organizations. As an academic unit of the University, the Center will maintain a policy of full disclosure regarding safety findings that impact public health.
Kingston, who will serve as director of the center, is a nationally recognized expert in the areas of post-market surveillance and product safety regarding consumer products. A scientific advisory panel will oversee the reporting of information to industry, the FDA, and the public.
Kingston also is a partner and clinician with SafetyCall International, a poison control focused private medical practice and University affiliated teaching site that provides clinical services on behalf of companies, government, and other organizations. SafetyCall clinicians manage product exposures by responding to questions and
providing medical advice to consumers or health care providers reporting adverse effects during or after product use. In an effort to centralize safety related information on supplements, manufacturers will be encouraged to share adverse event information collected on their behalf by SafetyCall and other poison centers with the new center.
The College of Pharmacy, the only school of pharmacy in Minnesota, offers its program on the Twin Cities and Duluth campuses. Founded in 1892, the College of Pharmacy educates pharmacists and scientists and engages in research and practice to improve the health of the people of Minnesota and society. The college is part of the Academic Health Center, which is home to the University of Minnesota’s six health professional schools and colleges as well as several health-related centers and institutes.
Rebecca Lentz, College of Pharmacy, 612-624-7654
Sara E. Buss, Academic Health Center, 612-624-2449