Bipartisan 31-State AG Coalition Urges FDA to Deny Marketing Clearance of Tobacco-Free Nicotine Products

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. Mr. Califf, asking the agency to reject pre-marketed tobacco. Product Applications (PMTA) for all products that contain non-tobacco-derived nicotine, also known as non-tobacco nicotine (NTN) or synthetic nicotine.

The letter expressed concern that some manufacturers of electronic nicotine delivery systems (ENDS) were marketing NTN products with minimal oversight, that the health implications of these products had not been sufficiently assessed, and that the he use of non-tobacco flavorings in these products attracted and endangered youth. State AGs have warned that the “[l]The lack of effective national regulation of these products would virtually guarantee that a new generation of young people would become unnecessarily addicted to nicotine and subject the public to the potential harm of a product whose effect on the human body is not well understood. . They urged the FDA to deny marketing authorization for, at a minimum, flavored NTN products (if not all NTN products).

The timing and the message of the letter are curious. Based on recent legislative developments we reported on, the FDA is already in a position to address the concerns highlighted in the June 10 letter.

Until recently, the FDA only regulated tobacco products made or derived from tobaccobecause the Federal Food, Drug, and Cosmetic Act (FDCA) defines “tobacco product” as “any product manufactured or derived tobacco which is intended for human consumption, including any component, part or accessory of a tobacco product”. Although the FDA could potentially regulate NTN products as a “component” of a tobacco product or under the separate authority of the FDA to regulate “drugs”, the agency chose neither route. .

Everything changed earlier this year. In March 2022, Congress amended the FDCA’s definition of the term “tobacco product” to include “any product manufactured or derived from tobacco, or containing nicotine from any source, which is intended for human consumption,” placing NTN products under the jurisdiction of the FDA. 21 USC § 321(rr)(1) (emphasis added). As a result, as of April 14, a multitude of requirements now apply to manufacturers of NTN products, including the requirement to register with the FDA, submit product lists and ingredient submissions, refrain from making unauthorized modified risk claims (such as claims that NTN products are less harmful than cigarettes) and obtain premarket clearance from the FDA to sell the products. As for the last requirement, all manufacturers of NTN products had to submit PMTAs by May 14. If the FDA has not cleared the product by July 13, the product must be removed from the market.

With this process in place, the FDA is close to resolving many of the issues identified in the June 10 letter. First, NTN products are now subject to extensive agency oversight, including all FDA regulations applicable to tobacco products. Secondly, the PMTA process should allay concerns that any health impact of NTN products will be understood, as this application requires, among other things, disclosure of the chemical properties of NTN products and investigation reports regarding the effects of the products on health. Specifically, a manufacturer must demonstrate that the marketing of the tobacco product is “appropriate for the protection of public health”, taking into account the likelihood that current users of tobacco products will stop using those products and the likelihood that non-smokers, especially young people, start using tobacco products. 21 USC § 387j(c)(4). The FDA’s decision 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 to the FDA. Third, since the FDA has not authorized an ENDS product without a tobacco flavor to date, it is unlikely that the agency will backtrack and authorize a flavored NTN ENDS product.

Finally, from a practical standpoint, we believe it is highly unlikely that the FDA will clear an NTN ENDS product by July 13. Many PMTAs for tobacco-derived nicotine ENDS have been pending for more than two years. Here, the FDA only has 60 days to review the PMTAs of NTN ENDS products. As a result, the tight deadline is already expected to result in a de facto ban on all NTN products from July 13.

The key question, and one not expressly posed in the June 10 letter, is to what extent will FDA enforcement be after July 13? Although the FDA has the authority to seize adulterated and mislabeled products and seek criminal and civil penalties for FDCA violations, the agency has so far relied largely on warning letters to make comply with FDCA requirements for tobacco products. With additional pressure from state AGs, the agency could adopt a more aggressive enforcement stance.

If not, we expect state AGs to look to their own consumer protection laws to take action. North Carolina Attorney General Josh Stein has already launched an investigation into Puff Bar after the company reformulated its productions to replace tobacco-derived nicotine with synthetic nicotine. In the Attorney General’s press release announcing the June 10 letter, Attorney General Stein said, “I appreciate that the FDA has begun to take some action, but more needs to be done to curb this industry and ensure the safety of our children. Based on experience, if state AGs ask the federal government to do more, and regulation does not meet state AGs’ expectations, we expect state AGs to take matters into their own hands. .