LAKEVILLE, Minn. — The U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) Director Mitch Zeller presented a live webinar with an update on the FDA’s tobacco regulations.
At the beginning of his presentation, Zeller noted the FDA’s appreciation for the continuing respectful dialog with NATO on behalf of retailers regarding tobacco regulatory issues. While an FDA policy does not allow the recording of FDA-presented webinars, here are some of the highlights of Zeller’s presentation:
Progress on PMTAs
The agency received premarket tobacco product applications (PMTAs) for nearly 6.7 million tobacco products by the Sept. 9, 2020, filing deadline; the vast majority of PMTAs were for electronic nicotine delivery systems (ENDS).
The FDA uses a three-step process to review PMTAs. First, a determination whether the applications meet the minimum standard for review (e.g., legibility, in English or electronic compatibility). If not, a refuse-to-accept letter (RTA) is issued to the manufacturer. If so, FDA determines whether the applicant provided information needed for a scientific review. If not, an RFT letter is issued. If so, a scientific review determines whether a marketing denial order (MDO) or marketing granted order (MGO) is issued. The applicant may file a lawsuit or ask for an internal review to reconsider an RTA, RTF or MDO.
As flavored ENDS products, other than tobacco flavor, have youth appeal, applicants must provide robust, reliable evidence that the product’s potential benefit for adult smokers outweighs the risk of underage use. Tobacco-flavored ENDS do not pose the same risk of youth uptake, so the burden a manufacturer must meet for tobacco-flavored products is different.
FDA must assess the scientific evidence an applicant submits to determine whether the product is “appropriate for the protection of the public health,” based on risks and benefits to users and nonusers, i.e., whether current tobacco users would stop or reduce their usage or current nonusers would start using the product. FDA knows of recent studies that local flavor bans led to more smoking, but applicants must demonstrate the benefits to adults outweighs the risk to underage youth.
FDA has reviewed PMTAs filed by the Sept. 9, 2020, deadline which cover about 99% of the tobacco products that are the subject of the applications. The agency continues working on the remaining PMTAs covering about 55,000 tobacco products that were filed by the deadline.
FDA has issued RTA and RTF letters for more than 5 million products that were the subject of PTMAs. Also, the agency has issued MDOs for more than 1 million flavored ENDS products (not including tobacco-flavored ENDS products). To date, manufacturers have filed legal challenges to 46 of the MDOs that were issued; 45 legal challenges remain pending. To date, the FDA has rescinded, in whole or part, MDOs to four companies and issued administrative stays to three companies; and courts have issued temporary injunction stays to three other companies.
Ten new tobacco products have received marketing granted orders, including R.J. Reynolds Vapor Co.’s Vuse Solo tobacco-flavored electronic nicotine products, after demonstrating the benefit to adult smokers switching entirely to ENDS or significantly reducing cigarette consumption outweighing the risk of youth using these products. Concurrently, FDA issued 10 MDOs for other flavors of the VUSE electronic cigarette product.
Although FDA makes MDOs public for existing products, it cannot disclose the actual brand names of products that were the subject of a PMTA to avoid disclosing commercially confidential information. Zeller suggested retailers check with suppliers to ensure products may be marketed.
Rules and Guidance
The FDA’s graphic health warnings rule that requires new health warnings on cigarette packages and cigarette advertisements created by manufacturer or retailers goes into effect Jan. 9, 2023. However, two lawsuits challenging the new graphic cigarette health warnings remain pending, which could impact the legality of the warnings. The FDA encourages retailers that create their own cigarette advertisements to submit warning rotational plans to the agency by March 12, 2022.
Two proposed product-standard rules are expected by April 2022. One product standard would prohibit the use of menthol in cigarettes and the second product standard would prohibit characterizing flavors in cigars. FDA believes the rules will reduce youth initiation, increase chances of smoking cessation, and address health disparities among certain population segments.
Under current law, nicotine made or derived from tobacco is considered a tobacco product. Synthetic nicotine may be a tobacco product if it is a component or part of a tobacco product. The FDA regulates nicotine as a drug when a company wants to market nicotine gums, lozenges, and inhalers. However, if a manufacturer does not intend its product to be regulated as a drug and the nicotine is not derived from tobacco, FDA’s regulatory authority over synthetic nicotine is less clear. Whether FDA can regulate disposable electronic nicotine products with synthetic nicotine is being determined on a case-by-case basis.
Previously, chemistry readily differentiated tobacco-based from synthetic nicotine; changes in synthetic nicotine make that differentiation more difficult.
The FDA is quite concerned, from the standpoint of public health and fairness to manufacturers who filed PMTAs for products with tobacco-derived nicotine, about manufacturers using synthetic nicotine to evade federal regulation; some manufacturers explicitly acknowledge doing so, he said. The FDA is exploring how to address the issue and has informed Congress of the situation.
The FDA has updated its regulations to reflect the required annual inflation-related increases to civil money penalties (CMPs), or fines, that can be assessed against retailers that violate federal tobacco regulations during compliance check inspections. The adjusted CMP fine amounts apply to retail penalties assessed on or after Nov. 15, 2021. Below is a list of the new fine amounts.
|Number of Violations||Penalty|
|1 violation||Warning letter|
|2 violations within 12 months||$301|
|3 violations within 24 months||$602|
|4 violations within 24 months||$2,409|
|5 violations within 36 months||$6,022|
|6 violations within 48 months||$12,045|
Thomas A. Briant is the executive director of NATO, a tobacco retailing association based in Lakeville, Minn. Reach him at firstname.lastname@example.org to receive a copy of Zeller’s presentation.