Reports about drug product packaging will be included in the CPSC safety information database.

CPSC Holds Firm on Public Database's Outlines

The agency will allow "any and all consumers" to submit reports of harm and rejected comments seeking a narrower definition of "harm." Reports about drug product packaging will be included.

How the soon-to-be-launched safety information public database from the Consumer Product Safety Commission will be used is now clear, with a CPSC rule published in the Federal Register explaining its decision on several comments. Principally, the commission said it will allow "any and all consumers" to submit reports of harm, and it will not narrow the definition of "harm" as requested.

Some commenters said leaving the database open in this way invites people with no firsthand knowledge of harm to submit inaccurate information. The commission's rule answered this by saying allowing all consumers to submit reports "serves the purpose and intent of the Database and of our primary statutory mission, which is to protect consumers from unsafe products. Furthermore, a manufacturer is free to post a comment indicating whether they know if the submitter had firsthand knowledge or not."

"We also note that reports of harm received from individuals in some of the other statutory categories, such as other government agencies, health care professionals, and public safety entities, will likely lack firsthand knowledge about an incident," the agency added. "For example, a physician who treats an individual who was injured by a consumer product is unlikely to have witnessed how or when the injury occurred, but the statute permits the physician to submit a report of harm. If we find that false and fraudulent reports are being submitted for inclusion in the Database, we will consider what legal actions to take to address the problem and proceed accordingly."

The proposed definition of "harm" is any injury, illness, or death, or any risk of injury, illness, or death, as determined by the commission. Some commenters said "any risk of injury" should be changed to "substantial risk of serious injury," and the definition should be narrowed to exclude reports of harm that have near zero risk of causing injury. The commission disagreed but did delete the word "any."

One commenter said incident reports involving over-the-counter drugs and dietary supplements should not be included in the database because food and drugs are regulated and monitored by FDA, and the commission has authority only over the product packaging. This is true, but the commission noted a harm report must contain at least one word or phrase sufficient to distinguish the product as a consumer product, a component part of a consumer product, or a product or substance regulated by the commission. "Every report of harm will be reviewed to ensure that the minimum requirements for publication are met before being published in the Database. Also, as with our current online incident report form, the Database will describe the products that are not within the Commission's jurisdiction, including food and drugs. This information will include links to the appropriate government agencies that do have jurisdiction. We have no intention of including reports of harm solely involving products or substances not within our jurisdiction, but will include all products and substances that do fall within our jurisdiction, including complaints about drug product packaging."

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