FDA Stays Juul Ban, Announces Plan To Implement New Policies

On June 23, 2022, the FDA banned the sale of Juul’s tobacco-and menthol-flavored products. The agency’s reasoning was that Juul’s applications did not have sufficient toxicological evidence to support the marketing of the products as appropriate for protecting public health.  Juul has long since been on the FDA’s radar for past marketing practices including the marketing of their now-discontinued fruit or candy-like flavors, which were viewed as appealing to minors.  The company secured an emergency stay on June 24, asserting that the FDA did not fully consider its 125,000 page application which purportedly contained studies showing how the products expose users to lower levels of harmful toxins as compared to conventional cigarettes.  Juul also cited political pressure as the FDA’s motivation due to an “inappropriate” level of interference from Congress.

On July 5, 2022, the FDA announced that it would allow Juul products to stay on the shelves pending additional review of evidence related to the company’s application to market the e-cigarettes but noted that their denial order was not rescinded.  The FDA has also announced that it intends to issue a proposed rule in May 2023 and seek  public comment on limiting nicotine in cigarettes to non-addictive levels with the goals of preventing future generations from becoming addicted, as well as helping current smokers quit.

The FDA’s moves have sparked some concern that the strategies may backfire.  One such concern is whether, in response to lower nicotine levels in the products, consumers will just smoke more cigarettes to intake the same amount of nicotine.  Another concern is whether the policies will create a demand for contraband products and an underground market.  Others see the movements as a public health victory and a long overdue measure to prevent minors from picking up the e-cigarette habit.

Legal experts are questioning whether the FDA is prepared to handle the legal challenges that the tobacco industry is likely to bring regarding new nicotine limits.  Pursuant to the Tobacco Control Act, the FDA cannot ban tobacco or mandate no nicotine in cigarettes, but tobacco companies may try to argue the proposed standards are not scientifically achievable.  While it is hard to predict exactly what claims companies could make given that the FDA has not yet issued the proposed rule, disputes over issues like this typically focus on the justification for the rule — whether issues like the creation of a black market have been adequately considered, whether the rule is appropriate for furthering the goal of protecting human health and whether the costs outweigh the benefits.  In this case, one such cost would be the cost for companies to comply with the new standards by reengineering their products and submitting applications for the reformulated products.

In the meantime, we will continue to monitor developments in this area and provide updates on our website.