Key points:
·Legal Conflict: Iowa state law requires e-cigarettes to obtain FDA authorization, but the FDA is using a case-by-case approach, allowing some products to be sold without authorization.
·Federal Preemption: A lower court has ruled that the state law is preempted by federal law, leading the state government to appeal to the Eighth Circuit Court of Appeals.
·Industry Impact: E-cigarette groups argue that enforcement of the law would result in businesses closing and consumers being unable to access smoking cessation tools.
·Standing: The state government questions the standing of e-cigarette groups to sue, arguing that their request violates federal law, while the groups counter that the FDA's enforcement discretion should not be determined by the state.
·Legal Outlook: The outcome of the case will impact the regulation of the e-cigarette industry and consumer rights, with much attention on the ruling from the Eighth Circuit Court of Appeals.
According to a report from Law360 on August 27, a group of e-cigarette sellers and buyers are urging the Eighth Circuit Court not to overturn an injunction blocking the enforcement of a law in Iowa that requires e-cigarettes sold in the state to be authorized by the US Food and Drug Administration (FDA). They argue that the district court found that the law was preempted by federal law.
In the submitted complaint, the group led by "Iowans for Alternatives to Smoking & Tobacco" countered the state government's appeal, arguing 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 chosen to review e-cigarette products on a case-by-case basis within its discretion and has allowed some products to continue being sold on the market without premarket authorization. Iowa laws impose civil penalties on the FDA for choosing not to enforce its regulations in certain areas.
The complaint also points out that while the state government can implement other restrictions that are not preempted by federal law, such as banning certain flavors or limiting nicotine concentrations, the incorporation and reference of the Food, Drug, and Cosmetic Act in this law means it is preempted by federal law.
Furthermore, according to the complaint, the provisions of this law would be rendered ineffective without the support of the Family Smoking Prevention and Tobacco Control Act, placing it entirely within the scope of federal preemption.
The lawsuit challenges HF 2677, a law that grants the Iowa Department of Revenue the power to fine retailers, wholesalers, and manufacturers of e-cigarettes who have not obtained FDA authorization for their electronic nicotine delivery system products.
United States District Judge Stephanie M. Rose blocked the enforcement of the law in May, finding it to be preempted because it infringed upon the FDA's authority to regulate e-cigarettes under the Food, Drug, and Cosmetic Act.
The state government has appealed to the Eighth Circuit Court and argued in a July filing that e-cigarette stakeholders and other plaintiffs do not have standing to sue because their lawsuit is essentially requesting continued violation of federal law. Additionally, the state government also pointed out that historically states have been allowed to regulate tobacco sales in instances where federal law does not preempt.
In the complaint filed on August 26, e-cigarette stakeholders also defended their standing to sue, arguing that the state government incorrectly likened the nature of their actual harm to drug traffickers and users. Because the FDA is exercising its enforcement discretion, whether the sale or use of e-cigarettes is "illegal" should not be determined by the state of Iowa.
The complaint also points out that the e-cigarette company claims that if the HF 2677 bill is enforced, they will be forced to shut down and consumers will be unable to access the devices they use to quit smoking, which has already demonstrated their harm and irreparable losses.
These companies further argue that under HF 2677 legislation, they will not only lose sales due to the banned e-cigarette products, but will also be forced to shut down all operations, including those products that are explicitly approved by the FDA.
If this law is not prohibited, these companies argue that they can present necessity as a defense in any enforcement action against them, therefore they have reason to challenge the law in anticipation of enforcement.
The case is filed under docket number 25-2087 at the United States Eighth Circuit Court of Appeals.
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