AERs: supplements 604 – drugs 450,000

By Shane Starling

- Last updated on GMT

Related tags: Dietary supplements, Food and drug administration

There have been 604 adverse event reports (AERs) – including five deaths – in six months, according to the Food and Drug Administration (FDA), which implemented the system last year.

This compared to 450,000 AERs reported in pharma-related cases.

FDA’s Office of Nutritional Products, Labeling and Dietary Supplements in the Center for Food Safety and Applied Nutrition said it had received 368 mandatory reports from dietary supplements manufacturers and 236 reports from consumers or health care professionals.

AER reporting is designed to bring greater transparency to the dietary supplements industry while protecting consumer safety. AERs can range from question marks over a supplement’s efficaciousness to, in extreme cases, death or disability.

These events were reported in the six months until April 15 and are the most recent figures but no supplements or categories were named.

AERs A-OK

In addition to the five deaths, there were 85 hospitalizations. "Some of these deaths were likely due to underlying medical conditions,​" said an FDA spokesperson in press reports.

The vice president of scientific and regulatory affairs of the Natural Products Association, Daniel Fabricant, told NutraIngredients-USA.com the law was doing what it was intended to do and there was no great shock in a number as high as 600.

"As it stands now, the number of mandatory AERs is well within – and even a bit below – the normal range that the FDA expected to receive from dietary supplements based on last year’s guidance,”​ he said. “To put the number in perspective, the FDA received more than 450,000 mandatory AERs in 2007 from prescription pharmaceuticals.”

He added: “NPA was a big supporter of the law and played a pivotal role in its passage. We most certainly believe the law is doing what it was intended to do: protect the consumer. And we believe it is bearing out what we’ve said along, that dietary supplements are an overwhelming safe consumer product. This is especially true when judged against the same reporting standards used for prescription medications, medical devices and over-the-counter drugs."

Accountability

Along with the Dietary Supplements Education Act (DSHEA) of 1994, and the Good Manufacturing Processes (GMPs) regulations implemented last year, AERs are seen as part of a triumvirate of regulations that promote a more accountable industry in the face of what at times has been harsh criticism from some regulators, citizen groups and the pharma lobby.

One of the sponsors of the AER regulation, the Democrat, Senator Richard Durbin, praised the progress that had been made.

"Five years ago, the dietary supplement industry claimed they had no reports of health problems — zero — related to their products,"​ Durbin told USA Today. "Thanks in part to our legislation, we today know there are hundreds of serious problems each year, many involving hospitalization and death.”

"These numbers don't alarm us,"​ said Steve Mister, president and chief executive of the supplement trade group Council for Responsible Nutrition. "We thought they would be much less than the FDA estimate."

Related topics: Regulation, GMPs, QA & QC

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