On Aug. 4, 2025, CDA President & CEO Kimberly Bolin, CDA Chair Jodi Buckner, and CDA Policy Advisors Tom Briant and Kathee Facchiano met with U.S. Food and Drug Administration (FDA) Commissioner Martin Makary, Center for Tobacco Products (CTP) Acting Director Bret Koplow, Deputy Commissioner for Human Foods Kyle Diamantas, FDA Chief of Staff Jim Traficant, and Policy Analyst Stephanie Socgfack. The meeting took place at FDA headquarters in Silver Spring, MD.
During the meeting, Bolin and Buckner discussed distributor concerns regarding tobacco product regulations and the Food Safety Modernization Act (FSMA) food traceability rule. These concerns included the illicit vapor product market, the status of Pre-Market Tobacco Application reviews, the need to focus on enforcement of current laws, the impact of the FSMA Section 204(d) food traceability rule, the consequences of the proposed bans of menthol cigarettes and flavored cigars, and the proposed very low nicotine standard which would ban virtually all cigarettes and cigars currently sold by distributors.
In response to the concern about the impact of the FSMA Section 204(d) food traceability rule, Deputy Commissioner Kyle Diamantas stated that the agency would be publishing a proposed rule regarding a 30-month extension of the rule’s implementation date. On Aug. 6, 2025, the FDA published in the Federal Register a proposed rule that would extend the FSMA Section 204(d) implementation date from Jan. 20, 2026 to July 20, 2028. A copy of the proposed rule can be accessed
here.
The public can submit comments to the FDA on the proposed extension of the FSMA Section 204(d) implementation date until Sept. 8, 2025.
In conjunction with the proposed rule, the FDA also released a constituent update to announce the federal register notice, the issuance of new FAQs about the food traceability rule and other updated resources. You can access the constituent update
here.
Another topic discussed during the meeting was CDA’s recent interactions with the FDA Technical Assistance Network (TAN), which is a group of FDA information specialists and subject matter experts that answer questions about the food traceability rule. At CDA’s request, the TAN group compiled a
Traceability Plan
specifically for distributors which was also released to the public. On Aug. 27, 2025, Angela Fields with the FDA will lead a CDA member webinar,
Understanding FSMA Section 204(d) – CTEs, KDEs and FDA’s Tools,
to provide insights into the FDA’s Food Traceability Rule for distributors. CDA appreciates the guidance and collaboration with the TAN of FDA.
In addition, Commissioner Makary and Acting Director Koplow expressed the shared concern about the need to prioritize enforcement against unauthorized vapor products. According to the FDA:
• Approximately 50% of electronic cigarettes sold today have been authorized by the agency and the other 50% that are on the market have not been authorized.
• The latest survey data shows that approximately 20% of high school students are using vapor products.
According to Commissioner Makary, the FDA will be conducting significant enforcement actions against unauthorized vapor products. The enforcement actions will focus on unauthorized vapor products at U.S. ports, in the distribution channel, and at retail stores.
CDA is optimistic and has confidence in the leadership of Commissioner Makary, Acting Director Koplow, and Deputy Commissioner Diamantas on tobacco and food traceability regulations. These FDA leaders were very receptive to CDA’s concerns and the association is pleased to see immediate results on the proposed extension of the FSMA Section 204(d) implementation date and the issuance of the distributor
Traceability Plan.
On a separate but related matter, on July 28, 2025, a group of eight Democrat Senators sent a
letter
to Commissioner Makary questioning the FDA's recent marketing granted orders for JUUL's e-cigarettes, including menthol-flavored vaping pods. The FDA authorization is a reversal of the agency’s issuance of marketing denial orders in 2022 prohibiting the sale of the company's products.
Read more about the letter from the senators to Commissioner Makary
here.