CRN adds voice to demand for dietary supplement AER system
swell of support for the dietary supplements industry to develop an
appropriate reporting system for serious adverse events.
The dietary supplement industry has recently been engaged in on-going discussions about ways to improve adverse event reporting systems. The debate came to a head at the beginning of June when various senators demanded in a hearing before a senate governmental affairs subcommittee that makers of vitamins and other dietary supplements should have to report potential safety risks to the FDA.
While the CRN is in favour of change, it believes that a new system would have to be simple and easy for the industry to use, as well as being beneficial for the consumer.
"It is important to develop the right system so that the reporting of serious adverse events will be helpful for the FDA in providing advice to consumers and be workable for industry," said Annette Dickinson, president of the industry body.
At the June hearing, American Herbal Products Assocation (AHPA) also showed itself in favour of updating the system. The organisation agreed that the 10-year-old Dietary Supplement Health and Education Act (DSHEA) that regulates supplements should be modified to help the government better police unsafe products and cited the mandatory reporting of serious health problems in patients as a necessary step.
The FDA however suggested it already had sufficient power to act against risky supplements and was not seeking any changes to the law.
The agency is trying to make the most of its current powers under the 1994 law "before we ask for any new authority," said Robert Brackett director of the agency's Center for Food Safety and Applied Nutrition at the hearing.
It is estimated that seven out of ten Americans use dietary supplements. The industry's annual sales are estimated at $18 billion.
Under the 1994 law, companies can sell supplements without putting them through the extensive safety and effectiveness testing required for pharmaceuticals.
Earlier this year the FDA banned a supplement for the first time, namely the herbal weight-loss pill ephedra, after it was linked to heart attacks, strokes and deaths.
CRN, other industry trade associations, and the College of Pharmacy at the University of Minnesota are co-sponsoring a one-day seminar on June 30, in Minneapolis, MN, to discuss this topic.
