March 2005

University center to study supplement safety

Researchers from the University of Minnesota’s College of Pharmacy are establishing a center to study the safety of dietary supplements.

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.

“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,” said Richard Kingston, PharmD, professor of pharmacy and director of the center.

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 the act, 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.

Goals for the center include: serving as a clearinghouse 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 dialogue about supplements between manufacturers, healthcare 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.

Source: University of Minnesota, www.umn.edu

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