Iowa Vape Law Be Challenged Violating FDA Enforcement Discretion

According to Law360 on August 27th, a group of vape sellers and buyers are urging the 8th Circuit Court not to overturn an order blocking the enforcement of Iowa law in the United States. The law requires that vapes sold in Iowa must obtain authorization from the US Food and Drug Administration (FDA). They stated that the trial court found that the law had been replaced by federal law.

Core contents:
Legal conflict: Iowa vape law requires vapes to obtain FDA authorization, but the FDA adopts a case by case review approach, and some products can still be sold without authorization.
Federal Replacement: The initial court ruled that the state law had been replaced by federal law, and the state government appealed to the Eighth Circuit Court.
Industry impact: Vape groups say that if the bill is implemented, it will lead to business closures and consumers will not be able to access smoking cessation tools.
Litigation Qualification: The state government questions the eligibility of the vape group to sue, claiming that their request violates federal law. The group argues that the FDA’s enforcement discretion should not be determined by the state.
Legal prospects: The outcome of the case will affect the regulation of the vape industry and consumer rights, and the ruling of the Eighth Circuit Court has attracted much attention.

In the submitted lawsuit, the group led by Iowa for Alternatives to Smoking&Tobacco refuted the state government’s appeal, stating that the new law actually mandates compliance with the Food, Drug, and Cosmetic Act (FDCA), which Congress has authorized the FDA to enforce.
According to the complaint, the FDA has adopted a case by case review approach to pre-market authorization requirements for vape products within its discretion, allowing some vape products to continue to be sold in the market without authorization. Iowa law imposes civil penalties on areas where the FDA decides not to enforce its regulations.
The lawsuit also points out that although state governments can implement other restrictive measures that will not be replaced by federal law, such as banning certain flavors or limiting nicotine concentrations, the inclusion and citation of the Food, Drug, and Cosmetic Act by this law means it is replaced by federal law.
In addition, according to the lawsuit, the provisions of the law would be ineffective without the support of the Family Smoking Prevention and Tobacco Control Act, placing it entirely within the scope of federal law replacement.
The lawsuit challenges the HF 2677 Act, which grants the Iowa Department of Revenue the power to impose fines on vape retailers, wholesalers, and manufacturers who have not certified their electronic nicotine delivery system products to FDA authorization.
US District Judge Stephanie M. Rose blocked the enforcement of the law in May, ruling that it had been replaced because it violated the FDA’s power to regulate vapes under the Food, Drug, and Cosmetic Act.

The state government has appealed to the Eighth Circuit Court and argued in its July lawsuit that vape stakeholders and other plaintiffs do not have standing to sue because their lawsuit is actually seeking to continue violating federal law. In addition, the state government also pointed out that historically, states have been allowed to regulate tobacco sales without being replaced by federal laws.
In the lawsuit filed on August 26th, vape stakeholders also defended their litigation qualifications, claiming that the state government mistakenly compared their actual harm to drug smugglers and users. Because the FDA is exercising its enforcement discretion, whether the sale or use of vapes is “illegal” should not be decided by the state of Iowa.

The lawsuit also points out that vape companies claim that if the HF 2677 Act is enforced, they will be forced to shut down and consumers will not be able to access the devices they use to quit smoking, which fully demonstrates their harm and irreparable losses.
These companies further argue that under the HF 2677 Act, they will not only lose sales due to prohibited vape products, but will also be forced to shut down all businesses, including those explicitly authorized by the FDA.
If the law is not prohibited, these companies argue that they can raise alternative defenses in any enforcement action against them, and therefore have reason to challenge the law in the expected enforcement situation.
The case number 25-2087 is in the United States Court of Appeals for the Eighth Circuit.

References: Iowa Vape Group Asks 8th Circ. To Keep E-Cig Law On Ice – Law360