Jun 1, 2018
While states imposing supplemental labeling rules beyond minimum FDA requirements or USP standards often cite the public’s right-to-know as rationale, additional disclosure mandates present significant compliance difficulties for healthcare product manufacturers.
Adding new labeling directives city by city and state by state drives up operational complexity and costs without clinical proof of benefit. Tracking varied municipal public health regulations across multiple geographies, validating new data for complex ingredient tables on vast product portfolios, securing approval from overseeing health authorities, fully redesigning packaging systems and printing configured labels, exhausting and replacing existing inventories, implementing additional data warehouse and analytics demands, and more all cascade to expend limited resources better allocated to controlled research and development. These expenses threaten to reduce product availability as OTC healthcare goods derive from sophisticated global supply networks with tight profit margins.
Since existing federal laws already mandate comprehensive disclosure of all clinically relevant ingredients plus extensive post-market oversight, further state and local requirements layered on may afford minimal practical advantages despite straining critical quality assurance programs protecting consumer safety through reliable consistency.