Earlier this week, a Federal Judge seemingly rejected the FDA’s assertion that retailers who blend pipe tobacco in store must register as manufacturers and adhere to certain other compliance obligations. But what does this mean? What requirements and responsibilities must retailers now be aware of following this ruling? IPCPR attempts to provide some clarity below.
In the Deeming Rule’s preamble, the FDA claimed that those retailer establishments that blend pipe tobacco are subject to and must comply with “all applicable statutory and regulatory requirements for ‘tobacco product manufacturers.” This would mean that retailers who blend pipe tobacco in store would have to annually register as manufacturers with the FDA, submit initial listings for their blended “products,” submit bi-annual updates for those product listings, and otherwise comply with a host of requirements applicable to tobacco product manufacturers, including the premarket review requirements and compliance policies applicable to “new tobacco products.”
Did the Court settle this issue definitively?
No. In his ruling, Judge Mehta essentially told the FDA that the technical legal basis FDA cited to defend its decision that in-store blending triggered the section 905 registration and product listing requirements was lacking and struck down that decision. However, the Judge acknowledged that the FDA still may designate what retailer activities will trigger these requirements but must do so by applying the appropriate legal standard. So, in his ruling he sent the issue back to the FDA for reconsideration. If the FDA believes it can find a strong legal justification beyond what the Judge opposed, the Agency can double down on its previous approach to the section 905 requirements.
I blend pipe tobacco in my store…What should I do for now?
- If you are a retailer that blends pipe tobacco in your store and have notregistered with the FDA as a manufacturer, it is IPCPR’s opinion at this moment that you do not need to do so for now.
- If you are a retailer that blends pipe tobacco in your store and have registered with the FDA as a manufacturer, it is IPCPR’s opinion that, for now, you are not bound to the current requirements to re-register by the end of the year or update your product listings in June or December. However, you can continue to do so if you so choose.
What about how FDA broadly defines manufacturing?
Judge Mehta’s decision expressly applied only to FDA’s position on application of the registration and product listing requirements. It does not prohibit the FDA from enforcing other requirements applicable to “tobacco product manufacturers.” This includes required health warnings, ingredient listings, labeling and in some cases pre market approval.
However, IPCPR has previously released guidance on these issues and what retailers can do to try to avoid triggering these requirements. These guidance documents can be found by visiting our FDA Toolbox.