In a move instructive on how government agencies execute their enforcement powers, the Food and Drug Administration (FDA) recently made an unannounced on-site inspection at the headquarters of e-cigarette maker Juul Lab. Agency inspectors toted away more than 1,000 documents. The raid was related to the FDA’s growing concerns about teenagers’ use of e-cigarettes. Juul was the perfect target. It controls 71% of the e-cigarette market in the US. The company’s sales for that product soared from 2.2 million devices in 2016 to 16.2 million in 2017. The agency is concerned that Juul is intentionally marketing to teen agers.
Juul’s e-cigarettes are particularly popular with high school students because they are small (about the size of a flash drive) and so are easily concealable. Additionally, they come in a variety of popular fruit flavors.
The authority of the FDA to enter and inspect premises without any advance notice comes from the federal Food, Drug and Cosmetic Act (FDCA), a set of laws passed by Congress in 1938 and updated numerous times, that gives the FDA authority to oversee the safety of food, drugs and cosmetics. Neither consent nor permission of the business being inspected is required. Instead, the FDA’s authority to conduct the search is based on statute. If the business refuses to permit a lawful examination of its premises, the FDCA sanctions criminal penalties for the refusal. The courts have affirmed the legality of FDA inspections provided they are conducted at a reasonable time, within reasonable limits, and in a reasonable manner.
E-cigarettes contain a higher dose of nicotine than cigarettes and so are more addictive. A recent study found that teens who use e-cigarettes are more likely to start smoking regular cigarettes than teens who do not use e-cigs. Said an FDA spokesperson, “The new and highly disturbing data we have on youth use demonstrates plainly that e-cigarettes are creating an epidemic of regular nicotine use among teens.” Said the CEO of Juul, “We want to be part of the solution in preventing underage use. . . “.
The FDA has begun a multimillion dollar anti-e-cigarette advertising campaign posting public service announcements warning young folks of the dangers of smoking and vaping nicotine. Vaping is the act of inhaling and exhaling the aerosol, often referred to as vapor, that is produced by an e-cigarette. The promotional campaign is focused on websites popular with teens and on high schools.
The FDA will review the documents it seized from Juul to help determine whether any enforcement action will be taken against the company.
Over the summer the FDA conducted undercover operations at stores that sell e-cigarettes. This effort revealed that many national retailers such as Walgreens and 7-Eleven are illegally selling e-cigarettes to minors. In response, the FDA has mandated that companies that sell the product submit a plan within 60 days on how to stop access by underage customers.
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