Kava Research FDA Compliance

[Groggy]

With the introduction of the analytics tab, inside a vendor's product profile, there is a great emphasis on the nobility of said kava but no mention in reference to more important testing done such as the presence of heavy metals, bacteria, pesticides and so on. These are all factors that a FDA compliant business or in this case kava vendor would be testing for as well. Kava is not considered a food therefore it does not need FDA approval, however it is considered to be a nutritional supplement and in that category it should be FDA compliant.

There have been other threads in here in reference to the same subject, yet it seems it got nowhere. I am not a kava vendor but as a kava consumer I would expect that vendors in the United States are following these guidelines. So as @Henry suggested I do on a different thread, I would like to know which kava vendors are following these guidelines and more importantly what their FDA compliance registration number is? This is information that should be added to a vendors profile and in my opinion further validates the legitimacy of the kava market and hopefully future scrutiny from the DEA.

 

[TheKavaSociety]

In NZ kava (when sold as a traditional beverage) is considered a food and it even has its own food standard (https://www.legislation.gov.au/Details/F2015L00466/Explanatory Statement/Text). It is illegal to sell any of the aerial parts or organic extracts of kava for human consumption. Additionally, kava needs to be packaged in a council-approved facility and handled by people holding a valid food safety certificate. We only sell tiny amounts of kava as part of our society's overall activities, but in order to comply with the regulations I have done a food safety course and obtained that certificate and have registered with our local council ($450 per year ). Furthermore, in addition to sending samples to True Kava, I've sent samples of our Mighty Tongan to a food safety testing lab in Christchurch to check water activity, mould, bacteria etc levels.
Here's our grade:

NZ Kava food standard:

 

[Alia]

With the introduction of the analytics tab, inside a vendor's product profile, there is a great emphasis on the nobility of said kava but no mention in reference to more important testing done such as the presence of heavy metals, bacteria, pesticides and so on. These are all factors that a FDA compliant business or in this case kava vendor would be testing for as well. Kava is not considered a food therefore it does not need FDA approval, however it is considered to be a nutritional supplement and in that category it should be FDA compliant.

There have been other threads in here in reference to the same subject, yet it seems it got nowhere. I am not a kava vendor but as a kava consumer I would expect that vendors in the United States are following these guidelines. So as @Henry suggested I do on a different thread, I would like to know which kava vendors are following these guidelines and more importantly what their FDA compliance registration number is? This is information that should be added to a vendors profile and in my opinion further validates the legitimacy of the kava market and hopefully future scrutiny from the DEA.

That, also, is my understanding however for U.S. -FDA requirements. Glad to read @Henry's Post regarding NZ. We are trying to get an International Codex Alimentarius listing for kava as a safe Food. That effort has begun but really gets underway July 2017. No guarantee it is going to happen. Meanwhile here in Hawai'i, at least, we have written a draft for a Bill to make 'awa beverage a Food by State Law. The federal guidelines define food to include beverage. It is all frustrating because the indigenous cultures that have consumed kava/'awa/sakau have done so as a daily practice, an evening beverage not a dietary supplement. Meanwhile I remain glad I grow my own and am not commercial! If you wish more details on the justification of food vrs. dietary supplement that's available.

 

[verticity]

Agreed. All vendors should be doing this testing in addition to nobility testing. My understanding is that basically all kava is grown organically (it is the law in Vanuatu) anyway, so I wouldn't expect pesticides would be a problem, but bacteria and heavy metals should be tested for. We don't need the bad publicity that would happen if people got sick from kava tainted with virulent bacteria.

 

[HeadHodge]

Chipolte Kava

 

[Groggy]

That, also, is my understanding however for U.S. -FDA requirements. Glad to read @Henry's Post regarding NZ. We are trying to get an International Codex Alimentarius listing for kava as a safe Food. That effort has begun but really gets underway July 2017. No guarantee it is going to happen. Meanwhile here in Hawai'i, at least, we have written a draft for a Bill to make 'awa beverage a Food by State Law. The federal guidelines define food to include beverage. It is all frustrating because the indigenous cultures that have consumed kava/'awa/sakau have done so as a daily practice, an evening beverage not a dietary supplement. Meanwhile I remain glad I grow my own and am not commercial! If you wish more details on the justification of food vrs. dietary supplement that's available.

The Codex Alimentarius seems more appropriate on an international level as my understanding it is the case. I understand your argument for kava being a beverage but not really sure why use that instead of the already established and respected FDA (For the US), furthermore if kava becomes classified as a food it will require even more strict regulations, which is not necessarily bad but may not be cost effective for the average vendor.

 

[TheKavaSociety]

The USP thresholds for bacteria, mould, etc in kava: https://hmc.usp.org/monographs/piper-methysticum-root-and-rhizome-powder-1-0

 

[Groggy]

Ok, just to be fully transparent:

In NZ kava (when sold as a traditional beverage) is considered a food and it even has its own food standard (https://www.legislation.gov.au/Details/F2015L00466/Explanatory Statement/Text). It is illegal to sell any of the aerial parts or organic extracts of kava for human consumption. Additionally, kava needs to be packaged in a council-approved facility and handled by people holding a valid food safety certificate. We only sell tiny amounts of kava as part of our society's overall activities, but in order to comply with the regulations I have done a food safety course and obtained that certificate and have registered with our local council ($450 per year ). Furthermore, in addition to sending samples to True Kava, I've sent the samples of our Mighty Tongan to a food safety testing lab in Christchurch to check water activity, mould, bacteria etc levels.
Here's our grade:

View attachment 7076

NZ Kava food standard:

View attachment 7077

Thank you Henry, I will add this information to the analytics section of your folder once additional fields are created.

 

[Alia]

The Codex Alimentarius seems more appropriate on an international level as my understanding it is the case. I understand your argument for kava being a beverage but not really sure why use that instead of the already established and respected FDA (For the US), furthermore if kava becomes classified as a food it will require even more strict regulations, which is not necessarily bad but may not be cost effective for the average vendor.

My understanding of the matter is that if "Food"/ (beverage) then the required certified kitchen (possibly even less regulation) is all that would be necessary. Under FDA a "Guidance for Industry: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Small Entity Compliance Guide". ...has to be adhered to if "Dietary Supplement". The State Health Dept. has only required doing the processing in a certified kitchen. Space in a CK can even be rented out. I am not claimng to be an expert but this is just what I have found from looking in to this tangle. Please let me know if I am missing something here. I believe anyone who is getting an income from selling kava (at least within the US) should have an interest in this.

 

[Alia]

In the USA kava is classed as a dietary supplement, and under this classification it is not specifically regulated or approved by the FDA. The dietary supplement industry is expected to "self regulate", which consists mainly of proper labeling, ensuring that the product is what it says it is (i.e. kava must actually be kava and nothing else), and self-reporting any serious adverse events. Here's some key points, emphasis mine:

• Federal law requires that every dietary supplement be labeled as such, either with the term "dietary supplement" or with a term that substitutes a description of the product's dietary ingredient(s) for the word "dietary" (e.g., "herbal supplement" or "calcium supplement").
• Federal law does not require dietary supplements to be proven safe to FDA's satisfaction before they are marketed.
• For most claims made in the labeling of dietary supplements, the law does not require the manufacturer or seller to prove to FDA's satisfaction that the claim is accurate or truthful before it appears on the product.
• In general, FDA's role with a dietary supplement product begins after the product enters the marketplace. That is usually the agency's first opportunity to take action against a product that presents a significant or unreasonable risk of illness or injury, or that is otherwise adulterated or misbranded.
• Dietary supplement firms must report to FDA any serious adverse events that are reported to them by consumers or health care professionals.
• Dietary supplement manufacturers do not have to get the agency's approval before producing or selling these products.

(Source: How Are Supplements Regulated?)

The guidelines given in the USP monograph are just that, guidelines. If there is no reasonable expectation of certain contaminants or problems, no test is required. This is part of the self-regulating aspect of dietary supplements. For instance, since virtually no pesticides are used in kava producing nations and no heavy metals are known to be present, these tests are not considered necessary by the experts I have spoken with. Microbial/yeast/mold problems are potentially present, therefore these tests should be performed, but again, they are not required.

I routinely run microbial tests using the 3m Petrifilm system on all samples I receive, but I've only seen two failures - and both of those were glaringly obvious even before the test. Kava is interesting in this respect, it has inherent antiseptic qualities that apparently keep it much safer than other botanicals. More research is needed, but experts have noted that if kava were capable of breeding hidden microbial issues, half the South Pacific would be dead. The sanitary conditions of these nations are fairly hideous, yet kava causes no problems.

Your best assurance here is confidence in your vendor. Mold and other issues can develop in transit, but in my experience and that of the vendors I deal with, these issues are very obvious. In the few cases they have experienced such issues, they don't bag the kava and send it to you!

Yes, trust in the Vendor is really the key here, but what do you think of the idea of kava having a "Food" (beverage) classification? What is your mana'o based on your experience?

 

[Groggy]

The guidelines given in the USP monograph are just that, guidelines. If there is no reasonable expectation of certain contaminants or problems, no test is required. This is part of the self-regulating aspect of dietary supplements. For instance, since virtually no pesticides are used in kava producing nations and no heavy metals are known to be present, these tests are not considered necessary by the experts I have spoken with. Microbial/yeast/mold problems are potentially present, therefore these tests should be performed, but again, they are not required.

Those are some valid points, but because it is not required, it does not mean it should not be done and presented along side with your nobility results (since you are using the kavas you test as the example).

Federal law requires that every dietary supplement be labeled as such, either with the term "dietary supplement" or with a term that substitutes a description of the product's dietary ingredient(s) for the word "dietary" (e.g., "herbal supplement" or "calcium supplement").

I don't recall seeing this on any of the kavas you test or others for that matter.

 

[kasa_balavu]

what do you think of the idea of kava having a "Food" (beverage) classification?

This isn't an answer to your question, but...

I'm curious if this would do anything for the nomenclature... I'd love to see the names kava, kava kava, ava, awa reserved for the dried powder and unadulterated aqueous beverage.
Extracts could perhaps be called kavalactone extracts rather than kava extracts just like coffee extracts are marketed as caffeine.

Kava is a food/beverage. Kavalactone extracts are a dietary supplement.

 

[Kojo Douglas]

@Deleted User and I both like the flavor of Kava! Excellent.

Also, excellent post. I completely agree that we can and should talk about Kava the way we talk about coffee and other beverages.

 

[Bob Chill]

Excellent post, Deleted User. I agree with everything. A minefield is a great description.

Personally, I think FDA involvement would cause far more harm than good to consumers like us. Many people think (not saying anyone here does) that the FDA studies new products for safety and efficacy and then issues guidance based on true science and unbiased results. The magical "FDA Approved" label is often misunderstood.

The beverage classification seems plausible but the tricky part is Kava has psychoactive properties a few steps beyond simple caffeine and nicotine and is used recreationally for those effects. Recreational use of anything "mind altering" is high on the list of the FDA's reasons to interfere in a bad way. One of the worst things that can happen is someone linking Kava to impaired driving. Our Government does not want its citizens using anything for fun that isn't heavily taxed, regulated, and tied directly to large corporate profits. Right now kava use is too small to garner much attention. Bigger fish to fry probably keeps things safe for now.

When dealing with grey area products, typically one of 2 things has to happen first before the FDA gets involved. A class of people is harmed from use (emergency room visits or multiple documented adverse reactions etc) or a big corporation sees a threat to their profits and prompts the FDA to look into "the problem". The FDA represents crony capitalism and corruption much more than protection of public health. In the event of multiple adverse reactions the FDA could issue knee jerk guidance of an outright ban. It's happened plenty in the recent past with recreational use of things like spice and bath salts.

Thankfully noble kava is 100% natural and has a very long history of safe use. Most of the dodgy supplements aren't really effective from everything I've read so far. As long as single use harm doesn't show up it seems unlikely that long term use of something ineffective would happen on a large scale. Of course if China puts out something that works hard core that catches on then all bets are off. Even worse...a kava powder cocktail spiked with "research chemicals".

IMHO the biggest threat to Kava would come from a threat to alcohol company profits or even potentially pharmaceutical companies. We're a long way from that but so were e-cigarettes from threatening the tobacco companies back in 2009. It's not apples to apples because kava doesn't = alcohol like e cigs = nicotine inhalation but the possibility can't be overlooked. Just seeing how many people share my own experience with kava as a viable recreational alternative to drinking alcohol makes me wonder how popular kava could be in 10 years...and at the expense of alcohol consumption. That will not happen without serious push back. The playbook is well written to spread agenda driven misinformation, half truths, and flat out lies to eliminate threats to profits or to allow large corporations to corner emerging markets. Habitually consumed products are heavily sought after by big companies. And those big companies try their hardest to make little ones go away. Often with the help of the Government.

 

[Alia]

@Bob Chill : You offer that "kava has psychoactive properties a few steps beyond simple caffeine", but pondering this I'm not sure I agree... I'm sure we all know some "coffee addicts", and personally I know people that drink enormous amounts. Certainly their mental processes are changed by this, which I believe would qualify as "psychoactive". But since coffee is not viewed - or tested - in the same light as alcohol or drugs, the effects of their consumption are never really noted. Who's to say that when one of these individuals is involved in a traffic accident that caffeine is not involved? Would they have pulled out in front of that school bus if they weren't jazzed on coffee? Does coffee consumption have a positive correlation with speeding? I'm not aware of any research on this topic, and I'm not advocating it either. The government already has their nose in too many areas. But to me, kava - as a water extracted beverage - is very much the same as coffee.

The parallel is even more evident in the fact that while both coffee and caffeine are on the GRAS (Generally Recognized as Safe food additives) list, the entry for coffee makes no mention of caffeine level, where the entry for caffeine specifies "0.02% - Cola-type beverages". Further, a Select Committee Opinion on caffeine states the following:

A. While no evidence in the available information on caffeine demonstrates a hazard to the public when it is used in cola type beverages at levels that are now current and in the manner now practiced, uncertainties exist requiring that additional studies be conducted.
B. It is inappropriate to include caffeine among the substances generally recognized as safe (GRAS). At current levels of consumption of cola-type beverages, the dose of caffeine can approximate that known to induce such pharmacological effects as central nervous system stimulation.

This coffee/caffeine situation is basically identical to the one we face with kava, but I'm not really sure that the FDA is aware of this. This is yet another reason that I am firmly against the promotion and use of kava extracts in any form. They are NOT kava as we know and love it, and I don't want to see traditional water extracted kava beverage painted with the same brush.

BTW, I'm also in complete agreement that we can expect resistance from the alcohol and pharmaceutical industries at some point, but I'm also hopeful that this can be overcome at a "grassroots" level, where by the time they see the threat it's just too late. But for that to happen, I think our experts need to organize and address these issues now with the FDA.

That @Deleted User is a great Post! And I totally agree. To add a bit more regarding the difference between the beverage and the kavalactone supplements- the aqueous beverage is a rich, complex mixture of nutritional compounds albeit minor but as an entourage, maybe not so minor. Kava beverage has 15 amino acids, sugars and starch, minerals—Potassium, Calcium, Magnesium, Sodium, and Iron. Kava also contains cinnamic acid. Research has clearly shown that kava beverage has complex calcium mobilizing abilities not found in the OTC kavalactone pills and extracts. I add this Chaminade University research which showed that traditional beverage can do things for us the extracts cannot. Many readers of this Forum already know this but, getting this message out to more folks sure cannot hurt the issue.

 

[Bob Chill]

@Deleted User: I totally agree with everything you write.

One of the issues I see going forward is the rising popularity of Kava and how it is marketed. There are a lot of "alternative to alcohol" and even "liquid zanax" references floating around in news articles. Many references to "getting buzzed" as well. This is where my reference to psychoactive effects a few steps above caffeine and nicotine comes from. Kava is marketed that way and people drawn by the media attention are looking for a "new buzz". This is the type of ammo that regulators need to justify control even if kava is pretty much benign. As much as I hope kava ends up in the same bucket as coffee and coffee bars, I'm pretty jaded and skeptical based on previous experiences in life.