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Because of FDA's safety concerns regarding the control and monitoring of levomethorphan, CHPA supports the control of levomethorphan as an impurity and respectfully submits the following comments regarding the proposed updates to the DXM monograph as proposed in the IRA published in PF 40(3).

These comments are submitted on behalf of CHPA in response to the National Institutes of Health notice entitled, “Nominations to the Report on Carcinogens and Office of Health Assessment and Translation; Request for Information”.

Letter to Drs. Femia and Santos regarding multiple active ingredient product monographs.

As FDA is recognized as an authoritative body by Proposition 65, we believe that OEHHA should await the outcome of FDA's review rather than bringing BP-3 to the DARTIC for review.

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.

Letter regarding modernization of the USP compendia for OTC medicines. CHPA supports improving the compendial test methods and establishing product standards for safety.

Supply chain resilience is essential to assure consumer healthcare products Americans depend on remain widely available, including in times of disease outbreaks or global crises.

While DXM is used safely by millions of Americans, some teenagers and young adults are intentionally abusing large quantities of medicines containing DXM in an effort to get high.

Herein, CHPA provides comments on Citizen Petition FDA-2017-P-27331 which requests the addition of a warning to labeling for all OTC drug products labeled to relieve or prevent heartburn associated with reflux disease, acid indigestion, and sour stomach noting that these products do not eliminate the risk of esophageal cancer.

CHPA appreciates that FDA has taken the time to review the data associated with certain isolated or synthetic carbohydrates not listed as a dietary fiber and looks forward to engaging with FDA in efforts to clarify and improve the regulation of all dietary supplements.