August 20, 2019

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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.

Audit and Inspection Program Completes Coast-to-Coast Site Visits in First Half of 2018

Keller and Heckman’s Audit and Inspection Program (AIP) provides companies that are involved in any aspect of the tobacco or vapor product supply chain with assurance that their facilities are operating in accordance with FDA requirements. AIP Program attorneys have completed audits from Florida to California since the Program first began in early 2018, and feedback has been overwhelmingly positive:

Having your team run a thorough inspection was extremely helpful in preparing us for a “real” FDA inspection. The knowledge and insight you guys were able to provide my “Team Awesome” will certainly help us navigate through the regulations and future inspections. During this interesting time for the industry, and as a responsible manufacturer, we must do everything possible to ensure we are going above and beyond what potential GMP’s may be down the road to keep consumers and the industry’s reputation safe.

As “cool” as some people think it is to be a manufacturer in the vape industry, it’s not to be taken lightly. We try to do everything possible to provide our consumers and retailers with top quality products that are manufactured in a clean and safe environment. Having your team come in to review our facility and manufacturing practices gives us confidence that we are doing exactly what we have set out to accomplish!

The AIP Program includes both audit and training components from attorneys experienced in tobacco and vapor law, inspections, and good manufacturing practices, and addresses a broad range of inspection activities, including: recordkeeping, product labeling, product samples, requests for video/audio/photographic recordings, standard operating procedures, cleanliness and sanitation, inventory control, and personnel interviews.

Audits by the AIP Program staff are covered by attorney-client privilege and attorney work-product privilege.

© 2019 Keller and Heckman LLP

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About this Author

Azim Chowdhury, Keller Heckman, ECigarette Research lawyer, FDA Regulatory Compliance Attorney
Partner

Azim Chowdhury joined Keller and Heckman in 2010 and practices in the area of food, drug, and tobacco law. 

Mr. Chowdhury advises domestic and foreign corporations in matters of FDA and international regulatory compliance. In particular, he assists corporations in establishing clearances for food and drug additives in the U.S., Canada, and the European Union, with an emphasis on indirect additives used in food-contact materials.  Mr. Chowdhury has also developed expertise in tobacco and e-vapor product regulation relating to the implementation...

202.434.4230
Daniel Rubenstein, Keller Heckman Law Firm, Washington DC, Food and Drug Law Attorney
Associate

Danny Rubenstein is a member of Keller and Heckman’s Food and Drug and Tobacco and E-Vapor Practice Groups. Leveraging his background and experience as an Industrial Engineer, Mr. Rubenstein appreciates both the technical and legal aspects of the challenges faced by industry in navigating the complex regulatory systems in place across the world. 

Mr. Rubenstein assists companies, organizations and trade associations in establishing compliance with regulatory requirements for food packaging materials and food ingredients throughout the United States, European Union (EU), Asia and South America (MERCOSUR). In this regard, Mr. Rubenstein assists clients in establishing a suitable U.S. Food and Drug Administration (FDA) status, and exemption from premarket review, for a variety of food-contact materials, and has successfully filed numerous Food Contact Notifications (FCNs) with FDA for new and innovative polymers, additives, and processing aids used in the manufacture of food-contact articles. In addition, Mr. Rubenstein advises clients regarding the suitable status of food-contact materials under the EU Framework Regulation, and the Plastics Regulation (EU) No. 10/2011.

As a former supply chain analyst for a Pittsburgh, Pennsylvania-based medical device manufacturer, Mr. Rubenstein has experience in process optimization, inventory control, facility layout and good manufacturing practice (GMP) in FDA-regulated facilities. Mr. Rubenstein uses this experience to assist clients in developing strategies to prevent and, when necessary, respond to contamination and “accidental additive” situations that arise during the manufacturing and transportation of food-contact materials. Mr. Rubenstein also proactively advises clients regarding quality control and internal auditing strategies and conducts in-depth analyses of manufacturing processes and Standard Operating Procedures (SOPs) for FDA-compliance purposes.

Mr. Rubenstein is a principal member of Keller and Heckman’s Tobacco and E-Vapor Audit and Inspection Program (AIP), which is designed to provide companies that are involved in any aspect of the tobacco or vapor product supply chain with confidence that their facilities are operating in accordance with FDA requirements. In this regard, Mr. Rubenstein conducts on-site training and auditing to evaluate and recommend improvements to e-liquid manufacturers and retailers under the Tobacco Control Act.

202-434-4293
Benjamin Wolf. Keller Heckmann Law Firm, Food and Drug Law Attorney
Associate

Benjamin Wolf practices in the area of food and drug law. Mr. Wolf advises food, dietary supplement, medical device, consumer product, and pharmaceutical clients regarding compliance with domestic and foreign regulations. His practice also includes providing state and federal legislative counsel to tobacco and e-vapor suppliers and manufacturers.

Prior to joining Keller and Heckman, Mr. Wolf worked for the Food and Drug Administration (FDA) as a regulatory counsel in the Center for Tobacco Products (CTP) and Office of...

202-434-4103