Commonly Cited AER Statistic for Supplements Has Been Misinterpreted, CRN Says

February 21, 2012

The association says that this misused statistic is being used to support calls for “overreaching” regulations or laws that would create “pharmaceutical-like” regulations for supplements.

The Council for Responsible Nutrition (CRN; Washington, DC) is clearing up confusion related to an often-cited statistic regarding dietary supplements and adverse-event reporting (AER). According to CRN, the statistic, which is often cited by the media and in conferences and scientific journals, says that FDA receives “less than 1% of all adverse events associated with dietary supplements.” However, CRN, says, this statistic is based on outdated, irrelevant data.

CRN says that the statistic is not related to dietary supplements at all; rather, it addresses AERs involving prescription drugs and vaccines. The statistic is also outdated, as it is from an FDA-commissioned study that the agency released in 2000-well before the law was created in 2006 requiring dietary supplement manufacturers to report AERs to FDA.

Nevertheless, says CRN, this misused statistic is being used to support calls for “overreaching” regulations or laws that would create “pharmaceutical-like” regulations for supplements.

The association also points out that between 2007 and 2010, FDA received a total of 4,194 serious AERs associated with dietary supplements. By contrast, in 2010 alone, FDA received more than 471,000 reports of serious AERs related to drugs or biologic products. “These numbers demonstrate the wide margins of safety that dietary supplements enjoy as billions of dosage units were sold during that same timeframe,” it says.

Read CRN’s full background explanation here.

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