FDA Won’t Enforce Pre-Market Review Requirement for E-Liquid Packaging Modified to Incorporate “Flow Restrictors”
In March of this year, the Consumer Product Safety Commission (CPSC) announced that it would interpret the Child Nicotine Poisoning Prevention Act of 2015 (CNPPA) as mandating specific flow-restrictor requirements for liquid nicotine containers that are sold, offered for sale, manufactured for sale, or distributed in commerce. CPSC soon began aggressive enforcement of its new interpretation, sending out dozens of Notices of Violations to manufacturers of e-liquids, demanding immediate stop sale, withdrawal, destruction of products from distributors and retailers, and transition to new packaging incorporating flow restrictors. However, CPSC’s demands that manufacturers change their packaging put them at risk of enforcement actions by the Food and Drug Administration (FDA) for introducing “new products” without premarket approval.
The E-Vapor Coalition, a group of national and state vapor trade associations, came together to advocate for the industry and sent a detailed letter to CPSC detailing the flaws in the Commission’s new interpretation of the CNPPA. The letter, which was also sent to FDA, outlined how CPSC’s actions, which apparently did not involve coordination with FDA, potentially conflict with FDA’s rules prohibiting changes to e-liquid packaging without FDA premarket approval. Thereafter, the E-Vapor Coalition, and many individual companies, repeatedly requested that FDA clarify whether it would enforce premarket review requirements for products that were modified to include flow restrictors. Until now, FDA refused to provide such clarification.
Finally, on November 25, 2019, the FDA published a notice in the Federal Register announcing a new “Compliance Policy for Limited Modifications to Certain Marketed Tobacco Products.” The guidance states that FDA will not enforce violations of the premarket review requirements where modifications to packaging have been made to protect children from ingesting liquid nicotine by adding flow restrictors. The new guidance removes significant regulatory uncertainty faced by companies that acceded to CPSC’s demands.
The guidance also states that FDA will not enforce premarket review requirements for companies modifying their battery-operated delivery systems to meet the safety standards of UL 8139 (Standard for Safety for Electrical Systems of Electronic Cigarettes and Vaping Devices). This means that companies can finally adopt product features that will make their devices safer without risking enforcement actions that would take them off the market.
While FDA has taken steps to help manufacturers improve safety by removing regulatory uncertainty, CPSC has continued its aggressive enforcement of its new interpretation of the CNPPA. Last week, CPSC published an open letter to e-liquid retailers, warning them that, in its interpretation, sale of nicotine-containing e-liquids in packages without flow restrictors is a violation of federal law that can subject the seller to civil monetary penalties. The letter instructs retailers to remove the products from sale and quarantine them. The letter specifically warns retailers against selling these products at a discount, an action that CPSC views as an implicit acknowledgment that the retailers are “engaged in selling illegal products.” The letter is the first time that CPSC openly directed its enforcement actions to retailers. It was published as CPSC continues to face increasing pressure from advocates, legislators, and the media over its perceived lack of enforcement of the CPSC’s interpretation of the CNPPA. Since CPSC issued this new interpretation, members of the e-liquid industry have sought to work cooperatively with both FDA and CPSC in the interest of protecting consumers and clarifying the legal rules of the road. The industry, however, remains confident that CPSC’s novel interpretation of the CNPPA is not supported by the statutory language or legislative history.