Keep supplement AERs out of CPSC database, says CHPA

By Lorraine Heller

- Last updated on GMT

Related tags Dietary supplement Food and drug administration

A dietary supplement trade group has urged the Consumer Product Safety Commission (CPSC) not to require adverse event reports from nutritional supplements in its incident reporting system as it will confuse consumers and interfere with existing processes.

CSPC’s safety incident database, required under section 212 of the Consumer Product Safety Improvement Act of 2008, sets out an adverse event reporting system for products under its jurisdiction, which include a range of consumer products (primarily for children) used in the home, in sports, in recreation and in schools.

Although CPSC does not have jurisdiction over food and drugs, the Consumer Healthcare Products Association (CHPA) raises concerns that some of these products may fall within the scope of CPSC’s authority if these have specific packaging requirements set out in the Poison Prevention Packaging Act (PPPA).

As such, the trade group – which represents both supplement and over-the-counter drug manufacturers – has submitted comments to a proposed rule on the product safety information database published in the Federal Register on May 24, 2010.

Differences in interpretation

CHPA urges the commission not to exclude dietary supplements and OTC drugs from the database when interpreting the “meaning and intent”​ CPSIA database provisions.

“If the CPSC were to incorporate PPPA regulated drug and dietary supplement product packaging into its safety incident database, it is likely to cause significant consumer confusion,” ​states CHPA in its comments.

“Consumers using drug and dietary supplement products may not distinguish between packaging-related consumer safety incidents and incidents related to the underlying drug or dietary supplement. Therefore, it is likely that consumers would inadvertently submit important drug or supplement safety information to the CPSC instead of to the manufacturer or FDA, thereby delaying the appropriate review of this important information.”

The Food and Drug Administration’s (FDA) Adverse Event Reporting (AER) regulations for supplements came into effect in December 2007, requiring all manufacturers, packers, distributors or marketers of dietary supplements to notify FDA of any serious adverse event reports received in connection with their products.

According to CPSC, any delays to reports received via this system could have “significant health and safety consequences for consumers”.

To view the full comments submitted by CHPA, click here​.

Related topics Regulation GMPs, QA & QC

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