For immediate release
Thursday, April 1, 2004
Joan Eve Quinn, 914-378-2436
YONKERS, NY, April 1, 2004–Consumers Union, the independent, non-profit publisher of Consumer Reports, urges the Food and Drug Administration (FDA) and Congress to adopt the Institute of Medicine’s science-based guidelines for evaluating the safety of dietary supplements released today.
We strongly agree with the Institute’s recommendation that the Dietary Supplement Health and Education Act (DSHEA) should be revised to require manufacturers and distributors to report serious adverse events associated with use of their dietary supplements to the FDA in a timely manner. We also strongly agree that DSHEA must provide adequate resources to collect and analyze information to protect consumers from unreasonable risks than can be associated with dietary supplements.
Consumers Union also supports the recommendation that supplement makers and manufacturers should be required to provide the FDA with all available safety data, both favorable and unfavorable, on their new products well in advance of marketing them.
The Institute of Medicine addresses the two most important public health issues at stake here: Dietary supplement safety, which Consumers Union has been writing about for nine years, and that reporting of adverse events by the manufacturer to the FDA must be made mandatory.
Dr. Marvin M. Lipman, Consumers Union’s Chief Medical Adviser, stated, “If the FDA and Congress see the wisdom of adopting the Institute of Medicine’s guidelines, it will bring legitimacy and science into what is now a totally chaotic marketplace. In the long run lives will be saved.”
The law must be revised to require supplement manufacturers to report adverse events because voluntary reporting just does not work. For example, in the Consumer Reports January 2004 article on the dangers of ephedra, we reported that since 1993 the FDA had received 16,961 reports of adverse events, including heart attack, strokes, seizures, and more than 100 deaths associated with use of ephedra supplements. More than 14,500 of these adverse events were withheld from the FDA by one manufacturer for over five years.
Consumers Union continues its commitment to informing the public about the dangers of dietary supplements with an audio news conference for working journalists only on Monday, April 5th at 1:00 PM Eastern Time. For more information contact Joan Eve Quinn, Communications Counsel, Consumer Reports, at 914-378-2436.