A recent report on the results of a series of unannounced “vape shop” visits by federal inspectors raises questions about quality-assurance in the preparation of some e-cigarette products.
Vape shops typically sell products, including electronic nicotine delivery devices and “e-liquids” solutions that are atomized by heating elements within the devices. When inhaled, the resulting vapor delivers nicotine, flavorings and other additives to the user.
The purpose of the U.S. Food and Drug Administration inspectors’ visits to 59 vaping businesses was to “learn about business and manufacturing practices” in the industry, according to the authors of a “Notes from the Field” piece in the Aug. 31 issue of Morbidity and Mortality Weekly Report.
Among the 59 vape shops visited, 31 sold only finished, pre-manufactured e-liquids, with 28 offering house brands manufactured on-site using measuring devices and recipes to create blends of nicotine, flavoring and other ingredients, the authors reported.
Among the shops making products on-site “only one manufacturer reported testing the finished products to ensure the product contained the concentration of nicotine listed on the label,” the inspectors found.
The inspectors also concluded that “none of the establishments had quality assurance programs or practices, standard operating procedures or standardized job training for manufacturing house brands of tobacco products. Workers received on-the-job training and used recipes, the authors wrote.
“Although all vape shops inspected were found to be in compliance with the regulatory requirements of FDA that were in effect at the time of the inspection, the lack of quality-assurance programs, standard operating procedures and full labeling of ingredients by the inspected manufacturers suggests that consumers might not receive complete information regarding product contents or purchase products of consistent quality,” the authors noted. “These concerns might be addressed by future FDA regulatory activities.”
The inspections took place during the Obama administration in October and November of 2016, just months after the FDA finalized a rule to regulating all tobacco products, including electronic cigarettes, starting this year.
But after President Donald Trump took office, the agency in 2017 extended a regulatory deadline to comply “as part of a sweeping plan to overhaul tobacco regulation. Under the revised timeline, manufacturers won’t need to file until 2021 for combustible products like cigars, and until 2022 for noncombustible products like e-cigarettes,” Angelica LaVito explained in a story for CNBC. Anti-tobacco groups and public health organizations have sued the FDA over the delay.