Attorney General Ellison urges FDA regulate non-tobacco nicotine products

Joins bipartisan coalition of AGs in highlighting dangers of unregulated nicotine products and appeal to youth; letter comes as JUUL lawsuit scheduled for trial in 2023

June 15, 2022 (SAINT PAUL) — Minnesota Attorney General Keith Ellison has joined a bipartisan coalition of 31 attorneys general in urging the U.S. Food and Drug Administration (FDA) not to authorize the marketing of any non-tobacco nicotine (NTN) products, which are currently being sold without regulatory constraints on their contents, manufacturing, health effects, or marketing claims. Attorney General Ellison’s letter to the FDA follows a new law that President Joe Biden signed in March, which gives the FDA jurisdiction to regulate these products and requires that manufacturers now seek FDA approval to sell and market them. Under the law, manufacturers who wish to market NTN products must obtain FDA’s authorization by July 13; otherwise, the products are subject to FDA regulation and enforcement. 

Attorney General Ellison’s letter also comes in the context of his lawsuit against JUUL Labs and Altria Group for engaging in unlawful marketing that propelled JUUL products to dominate the e-cigarette market and fueled the rise of youth tobacco use in Minnesota. Discovery in that litigation is ending this month. The case is set for trial in March 2023. 

“There’s no higher priority than keeping children and young people safe from harm — and profiteering off harming young people is reprehensible,” Attorney General Ellison said. “I’ve been using the power of my office to hold corporations accountable for deceptively marketing harmful products to youth — whether those products are e-cigarettes and nicotine-delivery systems or social media platforms. I thank President Biden for enacting this new law and in the strongest possible terms urge the FDA to use their power to ensure that non-tobacco nicotine products that have so harmed our youth can no longer be marketed to them.” 

To create nicotine products derived from substances other than tobacco, manufacturers have turned to chemicals with potential health impacts that are less understood than their tobacco-derived nicotine counterparts. Yet, these non-tobacco nicotine products have not faced the restrictions on sales and marketing that the FDA requires for tobacco products. As a result, these products are being sold in a variety of fruit and other flavors and have become increasingly popular with youth.  

In the letter to the FDA, Attorney General Ellison and the bipartisan coalition argue that NTN products currently fail to satisfy the FDA’s public-health standard, and that public health should not be gambled on the unknown effects of them. They argue there is no justification for regulating non-tobacco nicotine any differently than tobacco-derived nicotine. If anything, synthetic nicotine’s obscure origins, unexplored chemical characteristics, and use in flavored products that appeal to youth call for heightened vigilance. 

The lack of regulation on non-tobacco nicotine has created an unlevel playing field, as this one category of products has evaded regulatory burdens and restrictions, while its competitors undertake expense and effort to conform to FDA requirements. Non-tobacco nicotine products have also skirted the tobacco bans of some major online retailers and are available for purchase online from sellers that do not sell tobacco. These regulatory disparities create incentives for more manufacturers to switch to non-tobacco nicotine products, expanding the problem. 

If the FDA chooses to grant marketing authorization to non-tobacco nicotine products, despite the health risks to consumers and especially to youth, Attorney General Ellison and the coalition maintain that the FDA must impose the same restrictions required of tobacco-derived nicotine products. This would include a ban on all products that include a flavor other than tobacco and strict regulatory requirements regarding their contents, manufacturing, and effect on users’ health. Products should carry warnings concerning their addictiveness, and manufacturers should be required to validate health claims made about their products, such as claiming that a product is safer than tobacco. 

Joining Attorney General Ellison in the bipartisan letter are the lead attorneys general — Illinois Attorney General Kwame Raoul, Idaho Attorney General Lawrence Wasden, Nebraska Attorney General Doug Peterson, and Pennsylvania Attorney General Josh Shapiro — and the attorneys general of Alaska, California, Colorado, Delaware, District of Columbia, Guam, Hawaii, Maine, Maryland, Massachusetts, Michigan, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Northern Mariana Islands, Oregon, Puerto Rico, Rhode Island, South Dakota, Vermont, Washington, Wisconsin, and Wyoming.