AG Healey Joins Bipartisan Coalition Calling on the FDA To Regulate Non-Tobacco Nicotine Products

BOSTON — Attorney General Maura Healey today joined a bipartisan coalition of 31 attorneys general calling on the U.S. Food and Drug Administration (FDA) to reject marketing authorization for all non-tobacco nicotine products, which are currently being sold without regulation of their contents, manufacturing, health effects, required warning labels or marketing claims.  

In today’s letter, the coalition argues that these products currently don’t meet the FDA’s public health standard, and that the health of our residents – especially our young people – should not be gambled on the unknown effects of these highly addictive products. The

letter specifically calls for the FDA to reject a request by product manufacturers to grant marketing authorization for non-tobacco nicotine products. The letter also insists that if the agency does grant marketing authorizations for these products, it imposes the same restrictions required of tobacco-derived nicotine products including a ban on all products with 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, including claims that a product is safer than tobacco. 

“I am joining my colleagues in calling on the FDA to step up and consider the health and well-being of the public – most notably, our young people – by rejecting the marketing authorization for all non-tobacco nicotine products, or at the very least, ensuring they meet the same regulations that we require of tobacco-derived nicotine products.” said AG Healey. “We know how dangerous, addictive, and highly appealing to teens these products are. The health and safety of our young people is a top priority for my office.”  

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, also referred to as “synthetic 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. A new law signed in March by President Joe Biden gives the FDA jurisdiction to regulate these products and requires that manufacturers now seek FDA approval to market and sell them.  

The lack of regulation on non-tobacco nicotine products has created an unlevel playing field, as manufacturers of one category of nicotine products have evaded regulatory burdens and restrictions, while manufacturers of tobacco-derived nicotine products must undertake the expense and effort required 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. 

In the letter, the coalition argues that there is no justification for regulating non-tobacco nicotine any differently than tobacco-derived nicotine. On the contrary, synthetic nicotine’s obscure origins, unexplored chemical characteristics and use in flavored products that appeal to youth call for heightened vigilance. 

AG Healey has been a leader in taking on the e-cigarette industry. Beginning in 2018, AG Healey announced an investigation into JUUL Labs, Inc. and other online e-cigarette retailers over concerns about the marketing and sale of electronic smoking devices and products to minors. In 2020, the AG’s Office filed a lawsuit against JUUL for creating a youth vaping epidemic by intentionally marketing and selling its e-cigarettes to young people. In 2021, AG Healey entered into a $51 million consent judgment with another e-cigarette company that permanently banned the company from selling, distributing, marketing, or advertising any tobacco products to consumers in Massachusetts, after suing them initially in 2020. 

This coalition is led by Illinois Attorney General Kwame Raoul, Idaho Attorney General Lawrence Wasden, Nebraska Attorney General Doug Peterson and Pennsylvania Attorney General Josh Shapiro. Joining AG Healey and the lead attorneys general in sending the letter are the attorneys general of Alaska, California, Colorado, Delaware, District of Columbia, Guam, Hawaii, Maine, Maryland, Michigan, Minnesota, 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.