Kava Culture The Kava Flow - K@ Follow-Up & Recent Kava Controversies

[verticity]

Three groups of substances may be legally sold for human consumption in the USA:

1. Foods (includes "dietary ingredients")
2. Dietary Supplements
3. Drugs

Foods consist of those items that are currently on the Gras list, and obviously K@ is not. New Gras submissions can be made, this requires a 300-500 page document proving historical safe use as a food, including extensive scientific evidence. K@ cannot possibly qualify in this category.

Dietary supplements may be added through the FDA Notification program, where an entity announces their intent to sell a new one. If the FDA returns "no question", it is considered acceptable for that substance to be sold. K@ has been submitted and rejected in this process, thus ANY product containing K@ is considered adulterated.

Drug approval is a total maze of regulations I know little about, and this is the only possible classification where K@ could be added and be eligible for human consumption - and this is also where the vast majority of those who petitioned the DEA believe it belongs. K@ may be eligible for this category, but as of now it is not included. Let me also add that when you see K@ bar advocates claiming that the ABC and AHPA are their allies, they are not telling the truth. Every legitimate botanical organization knows it's a drug, and certainly none would approve of selling K@ in the manner it is being sold in "kava" bars.

Bottom line: It is explicitly illegal to sell K@ for human consumption in the USA.

Nitpick:
I'm not an expert on this, but as far as I can gather, the FDA seems to make a distinction between "food" and "food additives". The GRAS list is a subset of another list called the EAFUS (Everything Added to Food in the United States) list. That list includes the GRAS list, plus other things not on the GRAS list, each with specific regulations about how it can be used in food. For example: Acetone is on the EAFUS list, but not the GRAS list. On the EAFUS list, acetone is notated with several regulations. If you look up one of those it says:

"Sec. 173.210 Acetone. A tolerance of 30 parts per million is established for acetone in spice oleoresins when present therein as a residue from the extraction of spice"

So microscopic acetone residue is allowed in food, but it's not GRAS, so you can't dump in 500 mL of it or something.

The EAFUS list is very comprehensive. K@ is not on the list, neither the scientific nor common name, nor the names of the active chemicals in it. (Kava isn't on this list either, of course: it is on the list of "grandfathered dietary ingredients': dietary ingredients are a subset or component of dietary supplements, not a subset of 'foods' -- I think )

So that would suggest that K@ could not possibly be considered a "food" by the FDA. But wait. This is where things get really confusing. What else is not on the "Everything Added to Food" list? Lettuce, water, asparagus, apples, pork, fish, etc. Foods are not on the list of things added to foods! Things like "asparagus extract" and "apple essence" are on the list, but not basic food items. So this is not a list of foods, it is a list of things added to foods. Where can you find the official FDA list of things that are foods?? I have no idea.

So there are lots of things that we all know are foods that are not on any official list that I can find. Maybe I didn't look hard enough, I don't know. Can we leap from that to say "OK, well asparagus isn't on an FDA list, but we all know it's legal and sold as food for human consumption. Does that therefore imply that other things not on the list could be considered 'foods' that are just fine to sell for people to consume? Such as K@ maybe?" I am kind of baffled by this, but I just really really doubt that that could possibly be true. But honestly I don't know.

 

[Rick.Sanchez]

I mean "leaving no room for confusion". Yes, I am speaking of the Mitrasafe Notification attempt. While that rejection alone does not forbid future submissions under the same Notification process, it does make their likelihood of success nil, considering the combined obstacles of the prior Mitrasafe decision AND the still pending DEA classification. So, the current status is that K@ is explicitly illegal to sell for human consumption, since it meets none of the criteria necessary in my former post.

Also bear in mind that the DEA's pending final decision will be based on two things: comments from the community, and the recommendation of the FDA. I find it extremely unlikely that the FDA will reverse their prior position, and though comments from the community are strongly against a Schedule 1 classification, virtually all recognize that K@ is in fact a drug. I know some are proclaiming the halted DEA scheduling of K@ as a great victory, but I personally don't see it that way at all. I believe that it will be classified as a drug, but not so tightly scheduled as to prevent all research. There is absolutely no plausible scenario that will legalize what these "kava" bars are doing now.

You're missing a piece of the puzzle. The DEA was also being pressured by members of Congress and the Senate to abstain from scheduling K@ which is a bigger boon than either public opinion or scientific research. The DEA isn't actually supposed to schedule drugs, but congress ceded them the authority to schedule drugs that pose an immediate public danger. The reason behind passing that responsibility to the DEA was due to all the new drug analogs that the FDA and legislators couldn't possibly keep up with. There's broad consensus that the DEA would be overstepping their legal authority by scheduling K@. That's partly why the DEA's reversal was a huge success. Even if they did schedule K@, they would probably lose in a court battle based on the current laws. The only way K@ is scheduled is via the traditional way, because there is absolutely no factual basis that it is an immediate danger to the public.

Now, the future of K@ largely hinges on the FDA's assessment and our legislators. It's already possible that K@ could be killed with the SITSA act which would unambiguously give the justice department the authority to schedule almost anything they wanted, including things like kava, Valerian, coffee, cheese, etc.

 

[Rick.Sanchez]

Nitpick:
I'm not an expert on this, but as far as I can gather, the FDA seems to make a distinction between "food" and "food additives". The GRAS list is a subset of another list called the EAFUS (Everything Added to Food in the United States) list. That list includes the GRAS list, plus other things not on the GRAS list, each with specific regulations about how it can be used in food. For example: Acetone is on the EAFUS list, but not the GRAS list. On the EAFUS list, acetone is notated with several regulations. If you look up one of those it says:

"Sec. 173.210 Acetone. A tolerance of 30 parts per million is established for acetone in spice oleoresins when present therein as a residue from the extraction of spice"

So microscopic acetone residue is allowed in food, but it's not GRAS, so you can't dump in 500 mL of it or something.

The EAFUS list is very comprehensive. K@ is not on the list, neither the scientific nor common name, nor the names of the active chemicals in it. (Kava isn't on this list either, of course: it is on the list of "grandfathered dietary ingredients': dietary ingredients are a subset or component of dietary supplements, not a subset of 'foods' -- I think )

So that would suggest that K@ could not possibly be considered a "food" by the FDA. But wait. This is where things get really confusing. What else is not on the "Everything Added to Food" list? Lettuce, water, asparagus, apples, pork, fish, etc. Foods are not on the list of things added to foods! Things like "asparagus extract" and "apple essence" are on the list, but not basic food items. So this is not a list of foods, it is a list of things added to foods. Where can you find the official FDA list of things that are foods?? I have no idea.

So there are lots of things that we all know are foods that are not on any official list that I can find. Maybe I didn't look hard enough, I don't know. Can we leap from that to say "OK, well asparagus isn't on an FDA list, but we all know it's legal and sold as food for human consumption. Does that therefore imply that other things not on the list could be considered 'foods' that are just fine to sell for people to consume? Such as K@ maybe?" I am kind of baffled by this, but I just really really doubt that that could possibly be true. But honestly I don't know.

This nonsense is kind of why I clarified that it isn't explicitly illegal to sell K@ for human consumption until we have clarification from the FDA and/or the courts. I definitely don't know all of the laws and regulations about food products, but the FDA is extremely inconsistent in how they classify things and enforce their policies. It has more to do with how products are marketed than the actual products themselves.

 

[verticity]

This nonsense is kind of why I clarified that it isn't explicitly illegal to sell K@ for human consumption until we have clarification from the FDA and/or the courts. I definitely don't know all of the laws and regulations about food products, but the FDA is extremely inconsistent in how they classify things and enforce their policies. It has more to do with how products are marketed than the actual products themselves.

It makes my head hurt...

 

[Rick.Sanchez]

It makes my head hurt...

I'll definitely agree with you there

 

[sɥɐʞɐs]

@Rick.Sanchez Your point on implicit and explicit legality were clear to me. As in, you can't definitively say something is illegal until the law explicitly says so. No one should be getting fined, arrested or told they're committing a crime for things that might only be implied or gleaned without an actual explicitly stated law attached.
So, for example, when Henry says there is a law stating that it is illegal and 'not for human consumption' to adulterate any product with K@, I do not see that law to also encompass whole K@ by itself as being illegal in the same way, because in that case it is singular item and no longer an adulterant.

I've never researched K@ law to see what details are out there, so I don't really know what the truest legality is, but I see your point none-the-less.

 

[Rick.Sanchez]

@Rick.Sanchez Your point on implicit and explicit legality were clear to me. As in, you can't definitively say something is illegal until the law explicitly says so. No one should be getting fined, arrested or told they're committing a crime for things that might only be implied or gleaned without an actual explicitly stated law attached.
So for example, when Henry says there is a law stating that it is illegal and 'not for human consumption' to adulterate any product with K@, I do not see that law to also encompass whole K@ by itself, because in that case it is singular item and no longer an adulterant.

I've never researched K@ law to see what details are out there, so I don't really know what the truest legality is, but I see your point none-the-less.

Unfortunately, it's also clear in the import alert @Henry mentioned that K@ cannot be sold as a dietary supplement by itself either.

 

[sɥɐʞɐs]

Unfortunately, it's also clear in the import alert @Henry mentioned that K@ cannot be sold as a dietary supplement by itself either.

If not 'sold', then what about given or traded.

 

[Rick.Sanchez]

If not 'sold', then what about given or traded.

Haha that I couldn't tell you. But TBH, it's 100% legal to sell K@ not intended for human consumption which is why most distributors take that approach instead of toying with the FDA. If a vendor sells it for human consumption, I think it's highly unlikely that they would receive criminal charges, but they could easily have their inventory seized.

 

[ThePiper]

I

Sweden really looks up to the USA.

I'm so sorry



But seriously I thought this was a great video and I love the message of solidarity

 

[SelfBiasResistor]

Well, most vendors just add stickers saying "not for human consumption" while they continue describing it as a "tea", serving it in bar, praising it on krat forums, etc etc.
Apparently the FDA ignore such stickers and look at the actual evidence (marketing materials, public statements, forums, etc): https://d3gn0r3afghep.cloudfront.net/foia_files/2016/11/03/document53.pdf

People aren't hiding the fact that it is consumed. The stickers are just to try to avoid further issues with the FDA.

Really, I don't know what the point is of having all of these threads. Why not discuss things like what would make kava more appealing and how a kava bar could potentially operate selling only kava. If they sold chamomile tea at a kava bar, would that be acceptable? What about coffee? Or is the only point of these threads to attack K@ since it's being perceived by some to be a threat to kava?

 

[SelfBiasResistor]

Check out the link I posted to see how useless this tactic is..

Yeah, I'm not saying it's useful. I just don't see the point in dwelling on it.

I know what sparked the discussion but it really doesn't seem to go anywhere and always turns into an attack on K@ in general. Like I asked, are you opposed to anything else being served at kava bars? Do kava bars in NZ survive on selling kava alone?

 

[SelfBiasResistor]

I am only strongly opposed (not that my opinion matters to any bar owner..) to bars using kava as a "front" for illegal activities. And I am kind of not happy about kava businesses selling kava alongside legal highs, alcohol, K@ or anything else that can: a) interact with kava; b) attract negative attention.

Obviously, there are also many types of kava bars that I personally would not want to visit (e.g. those with loud techno music or "drink kava until you puke" events), but that's another story.

There are actually no kava bars in New Zealand. There are many kava clubs (kalapus) and one "kava house" (basically an indo-fijian snooker club with some kava and fast food). Why? It's a long story, but mainly because of cultural issues + our food legislation that prohibits mixing kava with any other foods/flavours, etc.

K@ is a prescription medicine in New Zealand so it can only be obtained through a medical practitioner.

I really doubt any of our opinions matter to any establishment that is not selling on the internet. Their customer base is going to be very localized...

Do we know how these K@ teas are even made? Are they really tea brewed from leafs or are they just making a tasty drink and adding some kind of extract to it? That could be one reason they sell more than kava if there is no undesirable taste.

For some reason I thought there was mention of kava bars in NZ. Their approach to regulating kava seems to be more common sense based. Except not being able to mix it with foods or flavorings.