HARRISBURG — Attorney General Dave Sunday is providing an update on Act 57, a law passed last year that prohibits sales in Pennsylvania of electronic nicotine delivery systems (ENDS) that do not appear on Pennsylvania’s ENDS directory.
The Office of Attorney General, per Act 57, is empowered with building and publicizing a directory of approved ENDS products. The current directory — as well as other forms, information, and FAQs about Act 57 — are HERE.
Beginning October 19, the Office of Attorney General may commence enforcement of Act 57.
“This law is about keeping harmful products out of the hands of both children and adults who may not realize what they are consuming,” Attorney General Sunday said. “Since Act 57 was signed into law, my office has been working diligently to build resources for companies and consumers so they can be in compliance when the enforcement date arrives. I applaud the legislature for their bipartisan support of Act 57 to provide this important public health safety measure to the Commonwealth.”
Approval relies on information provided by companies that shows compliance with Act 57 and Pennsylvania law. Approval may only be given for products FDA has approved to be sold or which are the subject of timely filed applications with FDA that have been accepted for filing by FDA and are still under review by FDA or subject to a denial order which has been stayed by FDA or Court order.
The Office of Attorney General plans to do targeted enforcement across the Commonwealth. During inspections, the office will provide education regarding compliance with the new law. Penalties will be graduated in accordance with the law for repeat offenders.
Our office continues to work with companies regarding product submissions currently in pending status, including working with companies who have failed to provide complete documentation.
Per the law, the Office of Attorney General will maintain and make publicly available a directory that lists all manufacturers of electronic cigarettes that contain nicotine, brand names, categories (such as e-liquid, e-liquid cartridge, e-liquid pod, or disposable), product names, and flavors — for which certification forms have been submitted and approved by the Attorney General.
The law will ensure that only ENDS products that have FDA approval or are pending review as part of a “timely filed” premarket tobacco product application (PMTA) (on market by 8/8/16 and PMTA submitted by 9/9/20), or meet other specific requirements, are listed on the directory.
For non-nicotine containing electronic cigarettes that use the same brand name as an ENDS brand and which is not a part or component required by FDA to be submitted on a PMTA, you will be required to certify that the product does not contain nicotine and provide a test of the e-liquid or other substance from a certified domestic lab confirming the absence of nicotine in the product.
If you find that you cannot answer your question adequately from the materials on the ENDS directory webpage linked above, you may direct questions to PaVapeDirectory@attorneygeneral.gov.
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