FDA Inspections Of E-liquid And Vapor Product Manufacturing Establishments Increasing Rapidly; Audit And Inspection Program Reaches Milestone
In a widely anticipated move, FDA has significantly increased the frequency of inspections of vapor manufacturing and retail facilities over the past few weeks, with some inspections spanning two days. We have received reports from vapor businesses across the country that they are receiving unannounced visits from FDA investigators conducting biannual inspections pursuant to Sections 704 and 905 of the Food, Drug, and Cosmetic Act as amended by the Tobacco Control Act. Under the Act, FDA is required to inspect every tobacco manufacturing facility at least once every two years. FDA uses a broad definition of manufacturing – repacking and relabeling are considered manufacturing acts and retailers that mix e-liquids for consumer sale are considered manufacturers.
During the course of their inspection, FDA investigators have requested product samples, labeling and invoices for raw materials, and labeling and invoices for finished goods. We understand that inspections have included both production (cleanroom) and non-production areas and have made use of photography and recordings. FDA appears also to be doing a lot of “fact finding” – learning as much as they can about the industry and how these products are manufactured and distributed, potentially for use in the development of future guidance documents and rulemakings.
We have also received reports of inspectors visiting vapor businesses from other agencies, including the Federal Aviation Administration (FAA), federal and state Environmental Protection Agencies (EPA), as well as state inspectors (e.g., California Department of Tax and Fee Administration).
As FDA continues to visit facilities across the country, it is critical that manufacturers, including retailer-manufacturers, understand the types of information that they are required to provide to the Agency upon request, as well as the type of that information that can or should be withheld. Similarly, Companies should understand the scope of authority that an FDA Investigator has in asking for specific product details. Vapor product manufacturers should fully prepare for their impending inspection now, so that they can demonstrate a high-degree of confidence when FDA arrives. Critically, and as third-party consultants begin to enter the Good Manufacturing Practice (GMP) space, manufacturers and retailer-manufacturers should ensure that the guidance they receive from outside counsel is accurate and based on experience in sound science and law and is protected from disclosure to FDA by attorney-client privilege.