The US Food and Drug Administration (FDA) had done an about-turn and reversed a ban on e-cigarette products made by Juul Labs, the company widely identified as making the product that ignited the youth vaping craze.
The decision has been welcomed by Juul but criticised by the Campaign for Tobacco-Free Kids, which has urged the agency to “finish its review and again deny marketing applications for all Juul products”, reports The Washington Post.
The decision will not immediately affect consumers as the products have remained on store shelves as the company appealed the FDA’s initial June 2022 decision to banish the products.
The FDA said last Thursday that the move to rescind the ban was made in light of court cases involving the vaping industry and because the agency has since “gained more experience” with scientific issues involving e-cigarette products. The agency stressed that the decision was not an approval of Juul’s requests to market products but instead, returns those applications to the status of pending review.
The decision comes as the Supreme Court is scheduled (on 20 June) to privately discuss, for the first time, whether to weigh in on conflicting lower-court decisions involving FDA regulation of e-cigarette products for other companies.
The vaping industry has long decried how the FDA’s Centre for Tobacco Products handles requests to legally market products. The agency, citing risks to public health, has denied approvals for thousands of e-cigarette products in recent years while approving just 23.
But courts have split on whether the FDA has acted fairly in denying applications to companies.
In January, a divided US Court of Appeals ordered the FDA to reconsider its decision prohibiting two companies from marketing their e-cigarette products. In a stinging decision, the majority said the agency sent manufacturers on a “wild goose chase” of application requirements.
The FDA is asking the Supreme Court to accept the case, saying the lower court’s decision “has far-reaching consequences for public health and threatens to undermine” the agency’s regulatory powers.
Vaping manufacturers, in turn, are asking judges to settle the legal issues.
Juul is not a part of those cases but remains the highest-profile manufacturer of e-cigarettes, which has emerged as a major public health concern during the past decade. Juul’s popularity skyrocketed after it introduced a sleek vaping device with fruity flavours in 2015.
Its marketing featured young models on websites and social media, and spurred the growth of the vaping industry while prompting backlash from parents and health officials who blamed Juul for a surge in teenage vaping.
In June 2022, the FDA ordered Juul products off the country’s shelves after saying it had worries about the e-cigarette device as well as pre-filled cartridges in menthol and tobacco flavours.
Regulators said they had concerns about “insufficient and conflicting data” about damage to DNA and potentially harmful chemicals leaching from the cartridges.
After Juul filed a lawsuit in federal court, the FDA paused its ban pending further review of the company’s application.
Juul remains confident that a “full review of the science and evidence” will show its products are safe for the public”.
The Campaign for Tobacco-Free Kids said that Juul’s history “shows its products are highly appealing to kids, and it cannot be trusted to act responsibly”, according to CEO Yolonda Richardson.
States and others have sued Juul over its marketing tactics, resulting in more than $1bn in settlements. The company is also seeking FDA approval of a vape device that requires age verification.
See more from MedicalBrief archives:
Juul to fork out millions of dollars after e-cigarette marketing probe
FDA delays Juul e-cigarettes’ decision but culls almost a million products
Judge approves multi-million dollar class action settlement against vaping giant