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CHPA says keep drug, supplement AERs out ot CPSC database

This article was originally published in The Tan Sheet

Executive Summary

The Consumer Healthcare Products Association argues OTC drug and dietary supplement adverse event reports should not be part of a safety incident database required by the Consumer Product Safety Improvement Act of 2008. In a July 20 letter to the Consumer Product Safety Commission, CHPA Associate General Counsel Alison Manhoff says the act exempts the type of food and drug products manufactured by CHPA members because they already are regulated by FDA. CPSC has regulatory authority over only food and drug products with packaging requirements covered in the Poison Prevention Packaging Act, Manhoff writes. Additionally, CHPA worries that consumers will be confused about where to report adverse events if PPPA products are included in CPSC's database. She explains that consumers may report incidents related to a drug or supplement to CPSC instead of FDA, thus delaying the possibility of a safety review. Manhoff writes "it is imperative that the commission provide sufficient instructions making it clear to the consumer that reports regarding the drug or dietary supplement itself should not be submitted to CPSC and must be reported directly to FDA and/or the manufacturer, as appropriate.

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