FDA Warning Letters Mainly Sent to Small Online E-Cigarette Retailers
FRIDAY, Oct. 14, 2022 (HealthDay News) — The U.S. Food and Drug Administration has begun issuing warning letters to electronic cigarette (e-cigarette) companies, with almost all letters sent to small online retailers, according to a study published online Oct. 13 in Tobacco Control.
Barbara A. Schillo, Ph.D., from the Truth Initiative Schroeder Institute in Washington, D.C., and colleagues analyzed warning letters sent by the FDA to e-cigarette companies from Jan. 1, 2020, to Sept. 9, 2021. The letters were retrieved from the FDA website and were coded for company type, location, infractions listed, product type, and consequence. Three hundred three coded letters were included: 126 and 177 from 2020 and 2021, respectively.
The researchers found that 97.4 percent of the letters were sent to small online retailers. Of the companies cited, 94.1 percent were located within the United States. Most (75.2 percent) of the infractions were identified by reviewing a company’s website; 70.5 percent were premarket tobacco product application (PMTA) violations. In 2020 and 2021, 55.6 percent and nearly all infractions were PMTA violations, respectively. A total of 880 products were cited in the letters; 92.2 percent of these were e-liquid products, including 32.4 and 31.1 percent fruit and concept flavors, respectively.
“Strong, impactful and transparent consequences need to be in place to prevent the sale of products that violate regulations necessary in protecting the health of adult users of e-cigarettes and preventing youth use alike,” the authors write.