Submissions

On behalf of the Consumer Healthcare Products Association, enclosed herein are comments on the 2019 revised draft guidance document as well as FDA’s decision to revoke CPG 400.400.

While the “essential workforce” list is solely advisory in nature, it provides much-needed guidance to state and local governments as they proceed with their own “stay at home” orders across the country. It is important to make this list as precise as possible with few vagueries that can be left to interpretation.

It is imperative that the federal, state, and local governments come together with uniform definitions of “critical infrastructure”, making clear what manufacturers must continue to operate, and take seriously the need to transport those products and keep operations running.

We strongly agree that healthcare product manufacturers have a central role to play in the fight against this pandemic. Provided employers comply with CDC guidelines to protect workers, healthcare product manufacturers have the special responsibility to maintain their current work schedules.

Enclosed are comments on “Transdermal and Topical Delivery Systems - Product Development and Quality Considerations”. CHPA and our member companies marketing external analgesic ingredients have an interest, experience, and expertise in this area and appreciate this opportunity to comment.

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.

CHPA submitted this citizen petition to address the definition of a dietary supplement under section 201(ff) of the Federal Food, Drug and Cosmetic Act and to request that FDA establishes a regulatory pathway to legally market dietary supplements containing CBD.

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.