The FDA has recently announced that it has delayed a critical decision on the future of Juul electronic cigarettes.
WASHINGTON — The US Food and Drug Administration (FDA) has announced that it has ruled on millions of electronic cigarettes submitted to the agency’s Center for Tobacco Products (CTP) through the legally mandated premarket tobacco product application regulatory pathway. However, the agency reports that it has yet to finalize its ruling on the status of electronic cigarettes and e-liquid pods sold by vaping industry giant Juul Labs. Juul, as a company, is owned in portion by tobacco giant Altria Group.
“All new tobacco products on the market without the statutorily required premarket authorization are marketed unlawfully and subject to enforcement action at the FDA’s discretion,” said Mitch Zeller, an attorney and the director of FDA’s Center for Tobacco Products. “The FDA is committed to completing the review of the remaining products as quickly as possible to provide regulatory certainty and will continue to keep the public informed of our progress. In the meantime, products for which no application is pending, including, for example, those with a Marketing Denial Order and those for which no application was submitted, are among our highest enforcement priorities.”
“If such products are not removed from the market, the agency intends to follow its usual enforcement practices in these circumstances and will issue a warning letter before initiating enforcement action (such as civil money penalties, seizure, or injunction) and afford the recipient an opportunity to respond,” Zeller continued. A decision about Juul is expected soon.
However, the agency has already issued marketing denial orders for hundreds of thousands of applications to PMTA. The agency is also expected to make a further decision on major vaping brands owned by other tobacco companies including British American Tobacco and Imperial Brands. Per the federal law outlined by the Tobacco Control Act, the applications must show that their products provide a net benefit to public health. While vaping as a whole is considered potentially safer than smoking cigarettes, the small companies that have applied are unable to pay for the exorbitant costs for testing and further regulatory compliance. Larger companies, including the non-tobacco industry-affiliated vaping companies, are more likely to have the money to issue the necessary scientific research mandated in the tobacco law.