In September, the Reagan-Udall Foundation for the FDA released a report on three industry roundtables regarding the ruling. The participants in the invite-only roundtables called out three major areas of concern: awareness of the rules, labeling, and warehouse management capacity.

The FDA’s Food Traceability Rule hits in January 2026. And a recent report from the Reagan-Udall Foundation found that retailers, suppliers, and distributors have no idea how it works.

The FDA’s Center for Tobacco Products, or CTP, is responsible for reviewing these new products, but its process needs reform. According to a report from the Reagan-Udall Foundation, the CTP’s lack of transparency and communication has created significant challenges for companies attempting to navigate the regulatory landscape.

Officials said Friday during a panel discussion — hosted by the FDA and the independent nonprofit Reagan-Udall Foundation for the FDA — that, while new treatments and drug approvals are needed, existing treatments aren’t being used to their full capacity.