I wouldn't put anything past the FDA. The courts have consistently struck down their attacks on cigars but they won't give up, and the pipe tobacco industry doesn't have nearly as strong a lobby as cigars do and I don't think there's a pipe lobby since we never had to worry about this until recentlyAh, the folks who make ‘em, the folks who want to buy them. Me, for that matter, ‘cause PAD still strikes me. But, since nothing’s imminent, I guess it just being philosophical.
And a waste of time to be "scared" which I'm pretty sure you really aren't, now "philosophical", so some healthy de-escalating if it is, but raising alarm bells over something that's been out there for almost a decade and hasn't really affected the ability to buy almost any pipe and no indication it will isn't productive.Ah, the folks who make ‘em, the folks who want to buy them. Me, for that matter, ‘cause PAD still strikes me. But, since nothing’s imminent, I guess it just being philosophical.
Great commentary on the FDA and pipes!Wow! I had no idea pipe makers were registering with the FDA. Makes me think the Agency may be closer to taking a harder look at pipes.
This whole concept of substantial equivalence comes from the medical device industry, which I actually have some experience with. If a new medical device is substantially equivalent to a device which already has FDA approval, the approval for the new device (called a 510k) is pretty streamlined. If your device has no substantial equivalent, you are subject to pre-market approval, a long and complicated process involving significant clinical trials. It looks like the FDA just copied this whole structure for tobacco products. As several of the posters have said, SE is an amorphous term and subject to very subjective interpretation. What struck me, looking at that FDA link, was that Sutliff filed a ton of applications for SE approval for things as petty as changing from a bag to a pouch or from changing from 1 ounce to 1.5 ounces (or vice versa, I forget which). But really petty stuff, as the tobacco itself was not changing. Easy things for the FDA to approve, but — thinking like a lawyer (always a dangerous thing) — if the FDA bureaucrats get it in their heads that SE is limited to such minor changes, perhaps they’d be more skeptical of changing from Cyprian to Turkish Latakia, for example, or changing the Virginia varietal to maintain a flavor profile. Or maybe I just worry too much. It’s a lawyer’s disease, which sticks with you even after you retire.
Years ago at the height of the fear of the deeming, several carvers retired to not have to deal with it.Sorry, flying fingers posted too soon. In reading those notorious Deeming rules, when the FDA asserted its jurisdiction over tobacco products, something hit my eye. In the Guidelines for substantially equivalent predecessors, I noticed that they have subcategories for pipe tobacco…..and one of those categories is pipes. In other words, pipes are categorized as a tobacco products. In FDA speak, it’s probably viewed as a nicotine delivery system. Now the FDA has not made any move that I know of to regulate pipes and as far as I know is not planning any. But what scares me — for the longer term future — is that they think they have the authority to do so. Can you imagine Savinelli having to get FDA approval because they now have a bent pipe with a red stem? Again, no need to panic now, but reason to be alert.
...you got that right. It's some people's life mission to dictate other people's lives. They will never stop.I wouldn't put anything past the FDA. The courts have consistently struck down their attacks on cigars but they won't give up
Most of those were using Sutliff tobacco.Small custom blenders
So right…We are losing a lot of global communityWell, half of the planet has lost access to three websites overnight, including tobaccoreviews.com. is it a big loss, you tell me