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.

McClelland: Sadly, It’s Official

Updated Feb. 4 & 5

Note the sentence “Without the supportive infrastructure our government used to provide [see Update 2 below], a small company such as ours cannot continue.” This is an obvious reference to the pending FDA rules — “deeming regulations” — that would regulate — read: stifle — pipe tobacco manufacturers and retailers. When (if?) the rules take effect, “new” blends would be very costly to introduce. And “new” wouldn’t even mean actually new, but blends that went on the market after some arbitrary past date. The original date specified was Feb. 15, 2007, though this could be changed to Aug. 8, 2016. Think of the effect on smaller companies! Moreover, retail tobacconists would be treated as manufacturers whenever they mixed two or more tobaccos already on the market and would effectively be stopped because the cost would be prohibitive. Blending might even include scooping 2 ounces from a larger bag of bulk tobacco. Other draconian rules are in the offing — such as treating pipes like tobacco products rather than accessories — unless Congress, a court, or the FDA itself scraps these outrageous rules. The compliance date is now set for 2021. This change from August of this year has been interpreted as portending a softening of the FDA’s attitude. We can hope so, but nothing short of repeal could make me feel confident that pipe and cigar smokers are safe.

More on this madness in future posts. Many in the YouTube Pipe Community are keeping up with this. On last year’s hopeful developments, see Derek Tant’s video here.

UPDATE 1: For background, see this article at Pipes and Tobacco Magazine. Pipes Magazine radio has more.

UPDATE 2: According to a statement read by Bradley at StuffandThings, the McNeils are closing McClelland not only because of the lack of quality red Virginia and the FDA threat but also because the government ended subsidies to tobacco growers (some time ago). For the record, the government never should have supported tobacco growers or any other crop or industry. Why should anyone be forced to support business people?