Submissions

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.

On behalf of the Health Choices Coalition, we write to applaud efforts to restore OTC medications to full tax-preferred status, eliminating the need to first obtain a prescription.

Scilex Citizen Petition requesting that FDA remove from the market and prevent further marketing of lidocaine-containing drug products that have not been approved pursuant to a new drug application or an abbreviated new drug application submitted under 21 U.S.C. § 355.

As many dietary supplement products are being marketed as containing cannabidiol (CBD), CHPA has an interest in this subject and we presented oral comments at FDA’s May 31, 2019, public hearing. These written comments supplement our oral remarks.