On June 10, a bipartisan coalition of 31 state attorneys general, led by Idaho, Illinois, Nebraska, and Pennsylvania, sent a letter to Food and Drug Administration (FDA) Commissioner Dr. Robert M. Califf, asking the agency to reject premarket tobacco product applications (PMTAs) for all products that contain nicotine not derived from tobacco, also known as non-tobacco nicotine (NTN) or synthetic nicotine.
The letter expressed concerns that some manufacturers of electronic nicotine delivery systems (ENDS) have been marketing NTN products with minimal oversight, the health implications of those products have not been sufficiently evaluated, and the use of non-tobacco flavors in these products entice and endanger youth. The state AGs cautioned that the “[l]ack of effective national regulation of such products would all but guarantee that a new generation of young people will needlessly become addicted to nicotine and subject the public to potential harm from a product whose effect on the human body is not well understood.” They urged FDA to deny marketing authorization for, at a minimum, flavored NTN products (if not all NTN products).
The timing and messaging of the letter is curious. Based on recent legislative developments that we have reported on, FDA is already positioned to address the concerns highlighted in the June 10 letter.
Until recently, FDA only regulated tobacco products made or derived from tobacco, because the Federal Food, Drug, and Cosmetic Act (FDCA) defined “tobacco product” as “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product.” Although FDA could have potentially regulated NTN products as a “component” of a tobacco product or under FDA’s separate authority to regulate “drugs,” the agency had not chosen either path.
That all changed earlier this year. In March 2022, Congress amended the FDCA’s definition of the term “tobacco product” to include “any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption,” bringing NTN products squarely within FDA’s jurisdiction. 21 U.S.C. § 321(rr)(1) (emphasis added). Therefore, as of April 14, a host of requirements now apply to manufacturers of NTN products, including requirements to register with FDA, submit product listings and ingredient submissions, refrain from making unauthorized modified risk claims (such as claims that NTN products are less harmful than cigarettes), and to obtain FDA premarket authorization to sell the products. With respect to the last requirement, all manufacturers of NTN products were required to submit PMTAs by May 14. If FDA has not authorized the product by July 13, then the product must be removed from the market.
With this process in place, FDA is poised to address many of the issues identified in the June 10 letter. First, NTN products are now subject to extensive agency oversight, including the full complement of FDA regulations applicable to tobacco products. Second, the PMTA process should alleviate the concern that any health impacts concerning NTN products are not understood because that application requires, among other things, the disclosure of the chemical properties of NTN products and investigation reports concerning the products’ health impacts. Specifically, a manufacturer must demonstrate that the marketing of the tobacco product is “appropriate for the protection of the public health,” taking into account the likelihood that current tobacco product users will stop using such products and the likelihood that nonsmokers, particularly youth, will start using tobacco products. 21 U.S.C. § 387j(c)(4). FDA’s determination on this point is based on a review of “well-controlled investigations,” including clinical investigations, as well as other scientific evidence submitted by each applicant or otherwise known by FDA. Third, given that FDA has not authorized a non-tobacco flavored ENDS product to date, the likelihood that the agency will now reverse course and authorize a flavored NTN ENDS product is remote.
Lastly, as a practical matter, we think it highly unlikely FDA would authorize any NTN ENDS product by July 13. Many PMTAs for tobacco-derived nicotine ENDS have been pending for more than two years. Here, FDA only has 60 days to review PMTAs for NTN ENDS products. As a result, the tight deadline is already likely to result in a de facto ban of all NTN products as of July 13.
The key question, and one not expressly made in the June 10 letter, is how extensive will FDA enforcement be after July 13? Although FDA has authority to seize adulterated and misbranded products and seek criminal and civil punishments for FDCA violations, the agency to date has largely relied on warning letters in enforcing the FDCA’s tobacco products requirements. With added pressure from state AGs, the agency could adopt a more aggressive enforcement posture.
If not, we expect the state AGs to look to their own consumer protection laws to take action. North Carolina Attorney General Josh Stein has already launched a probe of Puff Bar after the company reformulated its productions to replace tobacco-derived nicotine to synthetic nicotine. In the attorney general’s press release announcing the June 10 letter, Attorney General Stein stated: “I appreciate that the FDA has started taking some steps, but it must do more to rein in this industry and keep our kids safe.” Based on experience, if the state AGs ask the federal government to do more, and regulation does not meet the state AGs’ expectations, we expect the state AGs to take matters into their own hands.