Lawmakers should support the centralized progress made on ingredient evaluation, labeling, and packaging protections by specialized national children’s health agencies instead of allowing jurisdiction confusion that ultimately hinders healthcare advancement for all ages.
Dextromethorphan serves as a safe, effective antitussive ingredient in many critical OTC cough and cold formulations. While reasonable age restrictions may curb adolescent misuse without limiting adult access, lawmakers should refrain from unnecessary additional barriers. Targeted age controls strike the right balance between safety and availability.
Manufacturers have developed an anti-smurfing educational program for the retail setting that is voluntary and offered to retailers at no cost. The intent is to educate potential illegal purchasers about related criminal penalties and how the real-time, stop-sale system works.
While VOCs can have environmental impacts in aggregate, existing alternatives don’t always provide the consistent therapeutic results needed for OTC products relied upon by millions for. As such, any legislation aimed at further restricting pharmaceutical VOCs must carefully weigh potential unintended consequences on public health.
This proposed safety administrative order addresses the GRASE status of OTC oral health care drug products containing benzocaine alone or with phenol preparations labeled for anesthetic/analgesic indications (21 CFR 356).
