Though rising PFAS levels prompt important health questions that must be monitored, restrictions should remain grounded in conclusive toxicology to avoid reactionary bans on safe modern alternatives — as inconsistent standards across 50 individual states would only stifle healthcare advancement.
This Proposed Safety Administrative Order addresses the GRASE status of codeine, codeine phosphate, and codeine sulfate as antitussive active ingredients.
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.
Safe use of acetaminophen is a top priority for manufacturers of OTC medicines. Manufacturers work closely with FDA, healthcare provider groups, pharmacist groups, and consumer health advocates to drive safe and responsible use of acetaminophen.
This document serves as a voluntary guideline to assist manufacturers of dietary supplements with compliance with the dietary supplement current good manufacturing practice (cGMP) requirements of the US FDA 21 CFR §111.