The Open Door

img_20180528_124658On a visit to Fayetteville, Arkansas, my wife and I dropped in at Open Door Cigars and Pipes, where we were warmly welcomed to this fabulous tobacco establishment, bar, and lounge. It reminds me of those great wood-paneled clubs of old. I picked up some G. L. Pease Haddo’s Delight and Cornell & Diehl Star of the East, both of which I enjoyed on first smoke. I also acquired an HIS black straight apple sandblast, which is now breaking in quite nicely. I’ll definitely be back.

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Preliminary Court Win! But It’s Not Over Yet

This week a U.S. district judge ruled the FDA’s legal grounds insufficient for requiring local tobacco shops that blend pipe tobaccos to register as manufactures, a costly and onerous process that would destroy in-shop blending and other services traditionally rendered by tobacconists. However, the judge has given the FDA a chance to come up with stronger legal grounds, so this victory is not final.

This is from the website of the International Premium Cigar & Pipe Retailers (IPCPR):

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.

Brief Background:
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.

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 the IPCPR FDA Toolbox Compliance Hub.  The association recommends that retailers review this information.

The Next One

Orson Welles

While having a smoke, I often catch myself thinking about the next one. Why is that? I would hate to miss the full pleasure of the current smoke because I was absorbed in thinking about what I’ll be smoking next. You might think I’m looking forward to a different blend or another pipe in my collection.

Yes, that is all part of it. But I’m also anticipating the procedure I’ll get to execute once again: carefully packing the bowl, testing the draw, applying the char light, puffing the first puff, tamping lightly, relighting, settling in, etc.

It’s all part of the experience, the pleasure.