Surge in FDA inspections of vape shops & manufacturers reaches new high
A Washington, DC law firm specializing in government regulation now claims that the frequency and length of FDA inspections of vape shops and retailers are reaching epic proportions. Over the past few weeks, several vaping establishments are complaining of unannounced visits by FDA inspectors that last as long as 2-days. During the inspection process, FDA agents often ask for e-liquid samples, labeling criteria of individual ingredients, inventory invoices, and extensive documentation related to non-juice products. They also often photograph and record their visits.
E-liquid mixologists are particularly under scrutiny. Under the Tobacco Control Act as pursuant to Sections 704 and 905 of the Food, Drug, and Cosmetic Act, companies that mix their own specialty brands of vape juices are deemed “manufacturers,” and therefore liable to biannual FDA inspections. However, according to a report issued by the legal offices of Keller and Heckman (K&H), the FDA now seems to be broadening its scope in recent weeks. Retailers who simply repackage and relabel e-juice products are now falling victim to these surprise visits and intrusive audits by FDA agents in higher numbers.
“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.”
Representatives of K&H also report that the inspectors themselves are not always FDA employees. Perhaps because the vaping industry in the United States spans from coast to coast, officials from other federal agencies are now getting involved. Some vendors are being inspected by representatives of the Environmental Protection Agencies (EPA) and the Federal Aviation Administration (FAA). Why an “aviation” agency has the authority or the expertise to conduct vape shop inspections is somewhat unclear.
Vaping vendors beware: FDA authority during inspections is limited by law
State government agencies are also taking part, including inspectors from the California Department of Tax and Fee Administration, for example. As these various inspections by differing agencies continue to surge in both frequency and duration across the country, it is crucial that retailer-manufacturers fully understand the types of documentation and information that the investigators will be requesting.
Companies should also be well-aware of the types of materials that inspectors do not have the authority to review and to educate their employees accordingly. While unexpected visits from FDA agents can be very intimidating, the scope of the FDA’s authority is not all-encompassing. There are limits, and vendors should know their rights to be fully prepared in advance.
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