OTC Medicines

The DEA invited comments on the proposed rule to revise existing regulations that manage quotas for controlled substances and List I chemicals held by DEA-registered manufacturers. We have comments on three areas within the proposed rule.

FDA has determined that the currently available evidence does not support the conclusion that acetaminophen causes cancer. Accordingly, a Proposition 65 cancer warning on the labeling of products containing acetaminophen would not be scientifically accurate, and such labeling would be false or misleading.

We strongly urge the CIC not to “list” acetaminophen as a carcinogen due to the lack of evidence that it has been “clearly shown” to cause cancer, and due to the unnecessary confusion and fear it could cause among consumers and patients.

This information is submitted on behalf of CHPA in response to the September 20, 2019 OEHHA notice: Announcement of the Carcinogen Identification Committee Meeting Scheduled for December 5, 2019, Notice of Availability of Hazard Identification Materials for Acetaminophen and Notice of Public Comment Period.