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If you are a tobacco product manufacturer or seller and have never received a Warning Letter from the U.S. Food and Drug Administration (FDA), you may be surprised to learn than many (if not most) Warning Letters now begin with the following opening paragraph:
The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed the website [seller web address] and determined that e-liquid products listed there are manufactured and offered for sale or distribution to customers in the United States.
Most such Warning Letters then go on to list specific tobacco products which FDA has identified as being adulterated and misbranded as a result of not having FDA-required marketing authorization (among other alleged violations of the Federal Food, Drug, and Cosmetic Act – or, FD&C Act).
Unfortunately, this first paragraph of many Warning Letters serves as most tobacco and vape companies’ introduction to what FDA terms “website surveillance”. Website surveillance is exactly what it sounds like – FDA randomly scanning the websites of tobacco and vape companies for products which FDA may ultimately deem to be in violation of the FD&C Act.
While FDA has at times utilized website surveillance in furtherance of general tobacco and vape use data collection and research, at all times in recent years, FDA is also engaged in all-out market surveillance, surfing the internet and social media for alleged FD&C Act violators.
For tobacco and vape companies who may be at risk, the Clark-Esposito Law Firm, P.C. thought this article may be a gentler way of learning about FDA website surveillance, rather than through a Warning Letter.
FDA website surveillance is not limited to marketing authorization – FDA assesses all manner of FD&C Act requirements and agency regulations, including required warning statements on digital advertising, health and modified risk claims, and digital age verification best practices. As of early 2023, FDA has issued more than 400 Warning Letters to tobacco and vape companies with online storefronts for a wide variety of alleged violations. Further, FDA uses website surveillance to identify tobacco and vape companies for more thorough – and potentially more serious – investigations.
Website surveillance is FDA’s modern-day equivalent of the old-fashioned brick and mortar compliance check inspection, and they require significantly less manpower to cover a larger number of operators. And just like old-fashioned compliance check inspections, FDA also investigates underage sales in cyberspace.
In setting up – or updating – your digital tobacco and vape storefront, it is important to keep in mind FDA’s prying eyes, its broad enforcement authority, and the simple steps you can take to protect your business.
Have questions? Give our office a call today at (917) 546-6997 and we would be happy to speak with you.
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