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Kava U.S. FDA Petition May 2023

kavahana

Los Angeles, CA
Kava Vendor
Hi All! The FDA is revamping the Dietary Supplement Ingredient list – Kava is on it. The FDA is seeking comments and feedback until the end of this month (may 2023). I feel like this is our chance to be heard! Is there a petition we could all fill out to share with the FDA to get kava generally recognized as safe (GRAS) ?
 

kavahana

Los Angeles, CA
Kava Vendor
Thanks Kap'n! Btw, I'd love to get in touch with you - my business partner and I just met Ed Johnston on the big island. We're starting a kava bar in los angeles pretty soon. It would be great to chat - my email is [email protected]
 

Alia

'Awa Grower/Collector
We've drafted up a letter. Have a look.

Mahalo nui loa for posting these details.
This is an opportunity that kava drinkers should embrace with testimony to FDA.
Right now! Today! One can go to FDA listing of dietary supplements and see this:
"March 25, 2002 The Food and Drug Administration (FDA) is advising consumers of the potential risk of severe liver injury associated with the use of kava-containing dietary supplements. Kava (Piper methysticum) is a plant indigenous to ...".
This is not only wrong, outdated, culturally inapproriate, it keeps kava reputation in peril. It is a deeply driven systemic blunder! Even here in Hawai'i a Native Hawaiian Health Practioner wrote about the cancer prevention action of 'awa. She cautions- "may cause liver failure" .
 
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Groggy

Kava aficionado
Admin
Mahalo nui loa for posting these details.
This is an opportunity that kava drinkers should embrace with testimony to FDA.
Right now! Today! One can go to FDA listing of dietary supplements and see this:
"March 25, 2002 The Food and Drug Administration (FDA) is advising consumers of the potential risk of severe liver injury associated with the use of kava-containing dietary supplements. Kava (Piper methysticum) is a plant indigenous to ...".
This is not only wrong, outdated, culturally inapproriate, it keeps kava reputation in peril. It is a deeply driven systemic blunder! Even here in Hawai'i a Native Hawaiian Health Practioner wrote about the cancer prevention action of 'awa. She cautions- "may cause liver failure" .
&
 

kavahana

Los Angeles, CA
Kava Vendor
Mahalo nui loa for posting these details.
This is an opportunity that kava drinkers should embrace with testimony to FDA.
Right now! Today! One can go to FDA listing of dietary supplements and see this:
"March 25, 2002 The Food and Drug Administration (FDA) is advising consumers of the potential risk of severe liver injury associated with the use of kava-containing dietary supplements. Kava (Piper methysticum) is a plant indigenous to ...".
This is not only wrong, outdated, culturally inapproriate, it keeps kava reputation in peril. It is a deeply driven systemic blunder! Even here in Hawai'i a Native Hawaiian Health Practioner wrote about the cancer prevention action of 'awa. She cautions- "may cause liver failure" .
We're with you! We just submitted a letter to [email protected]
 

The Kap'n

The Groggy Kaptain (40g)
KavaForums Founder
Someone asked on reddit what the difference in classifications would mean. This was my response:

Regulation: If kava powder is classified as a food, it would be subject to FDA regulations pertaining to food safety, manufacturing practices, and labeling. If it's classified as a dietary supplement, the regulations are somewhat different. Dietary supplements are not required to be proven safe or effective before they're sold, as long as they don't make disease treatment or prevention claims. This means the level of scrutiny applied to the product in terms of its production, handling, and sales could vary depending on its classification.

Good Manufacturing Process (GMP): Both classifications require GMP. The GMPs for food focus on ensuring that food is safe and has been prepared, packed, and stored under hygienic conditions. They cover areas like the cleanliness of the facilities, the control of potential sources of food contamination, the training and personal hygiene of employees, the maintenance of processing equipment, and the proper storage and transportation of the finished product. Dietary supplement GMPs, on the other hand, are more extensive and specific, reflecting the unique risks associated with dietary supplements. These GMPs cover similar areas as food GMPs, but they also require manufacturers to substantiate that their products meet quality specifications like identity, purity, strength, and composition. This means that supplement manufacturers must test their products or verify the testing done by their suppliers. They must also keep extensive records and have written procedures for many aspects of manufacturing. Considering there is no standard set for powdered kava products, we have to ask ourselves if powdered kava was ever fit for this "dietary supplement" category to begin with. Kava extract products would certainly fall into this, as the consumer will be looking specifically at ingredients.

Labeling: As a food, kava would need a "Nutrition Facts" label, listing items such as serving size and nutritional content. As a dietary supplement, it would need a "Supplement Facts" label, which focuses more on the active ingredients and their amounts. Since powdered kava is a singular specific product, "Supplement facts" don't logically make sense here. A "Kava Extract Dietary Supplement" might contain many ingredients including the kava extract itself, excipients, and emulsifiers, and therefore is more fitted for supplement, instead of food.

Health Claims: As a dietary supplement, kava extracts could make more specific health-related claims, such as "promotes relaxation" or "supports mood," as long as it doesn't claim to treat, cure, or prevent diseases. As a food, it could only make general health claims, like "can aid in relaxation," and only if that claim can be substantiated. You could no longer say "aids in reduction of anxiety" on the bag. Honestly we should be getting away from these phrases in regards to powdered kava, anyway. While 250mg per day of kavalactones has been shown to be efficacious in extracts against situational stress and anxieties, we have no idea, quantitatively, the level of kavalactones consumed in traditional kava, so we can't make specific health claims about it anyway. While kavalactones have been proven to be helpful in relaxation, we can't necessarily say this about kava in its powdered form due to its fundamental non-standardization. One bag of powdered kava will likely be slightly different from another, even if it's marked as the same product. It's known among drinkers that consuming a strong kava too quickly could actually cause anxiety-like symptoms instead of relieving them.

If this leaves you thinking "Hmmm, not many people follow the federal rules as they are written, even today", you're correct. The understanding of what is necessary for selling kava in the United States is convoluted and different in each state. We want the rules to be ubiquitous in regards to powdered kava and extracts. This means we must focus our efforts at the FDA level.
 

Alia

'Awa Grower/Collector
Someone asked on reddit what the difference in classifications would mean. This was my response:

Regulation: If kava powder is classified as a food, it would be subject to FDA regulations pertaining to food safety, manufacturing practices, and labeling. If it's classified as a dietary supplement, the regulations are somewhat different. Dietary supplements are not required to be proven safe or effective before they're sold, as long as they don't make disease treatment or prevention claims. This means the level of scrutiny applied to the product in terms of its production, handling, and sales could vary depending on its classification.

Good Manufacturing Process (GMP): Both classifications require GMP. The GMPs for food focus on ensuring that food is safe and has been prepared, packed, and stored under hygienic conditions. They cover areas like the cleanliness of the facilities, the control of potential sources of food contamination, the training and personal hygiene of employees, the maintenance of processing equipment, and the proper storage and transportation of the finished product. Dietary supplement GMPs, on the other hand, are more extensive and specific, reflecting the unique risks associated with dietary supplements. These GMPs cover similar areas as food GMPs, but they also require manufacturers to substantiate that their products meet quality specifications like identity, purity, strength, and composition. This means that supplement manufacturers must test their products or verify the testing done by their suppliers. They must also keep extensive records and have written procedures for many aspects of manufacturing. Considering there is no standard set for powdered kava products, we have to ask ourselves if powdered kava was ever fit for this "dietary supplement" category to begin with. Kava extract products would certainly fall into this, as the consumer will be looking specifically at ingredients.

Labeling: As a food, kava would need a "Nutrition Facts" label, listing items such as serving size and nutritional content. As a dietary supplement, it would need a "Supplement Facts" label, which focuses more on the active ingredients and their amounts. Since powdered kava is a singular specific product, "Supplement facts" don't logically make sense here. A "Kava Extract Dietary Supplement" might contain many ingredients including the kava extract itself, excipients, and emulsifiers, and therefore is more fitted for supplement, instead of food.

Health Claims: As a dietary supplement, kava extracts could make more specific health-related claims, such as "promotes relaxation" or "supports mood," as long as it doesn't claim to treat, cure, or prevent diseases. As a food, it could only make general health claims, like "can aid in relaxation," and only if that claim can be substantiated. You could no longer say "aids in reduction of anxiety" on the bag. Honestly we should be getting away from these phrases in regards to powdered kava, anyway. While 250mg per day of kavalactones has been shown to be efficacious in extracts against situational stress and anxieties, we have no idea, quantitatively, the level of kavalactones consumed in traditional kava, so we can't make specific health claims about it anyway. While kavalactones have been proven to be helpful in relaxation, we can't necessarily say this about kava in its powdered form due to its fundamental non-standardization. One bag of powdered kava will likely be slightly different from another, even if it's marked as the same product. It's known among drinkers that consuming a strong kava too quickly could actually cause anxiety-like symptoms instead of relieving them.

If this leaves you thinking "Hmmm, not many people follow the federal rules as they are written, even today", you're correct. The understanding of what is necessary for selling kava in the United States is convoluted and different in each state. We want the rules to be ubiquitous in regards to powdered kava and extracts. This means we must focus our efforts at the FDA level.
First, I agree that a food label should not make specific health claims and "...we should be getting away from these phrases in regards to powdered kava, anyway."
partly because "we have no idea, quantitatively, the level of kavalactones consumed in traditional kava, so we can't make specific health claims about it anyway."
However, I still believe it is appropiate for Forums, Websites, drinking establishments with Kava as a focus, to write about and/or Post "Studies" that specifically credit traditional kava beverage for benefits such as:
1. National Cancer Institute Fall 2021 Newsletter reports-
“Kava, a commonly consumed South Pacific Island beverage used to promote calmness, may reduce lung cancer risk by decreasing NNK-derived DNA damage and enhancing NNK detoxification.”
2. Dr. Einbond, et. al. “Traditional preparations of kava inhibit the growth of breast and colon cancer cells.”
3. Kava as a Clinical Nutrient (September 2020)
“Whereas the neurological benefits of proper kava use appear to be undeniable, particularly in reducing stress and anxiety, there is growing evidence that its consumption could be associated with low incidence of cancer. Furthermore, anti-inflammatory activities have been reported for kava and its compounds, suggesting their potential for the treatment of inflammatory disease."
What do others think?
 

The Kap'n

The Groggy Kaptain (40g)
KavaForums Founder
First, I agree that a food label should not make specific health claims and "...we should be getting away from these phrases in regards to powdered kava, anyway."
partly because "we have no idea, quantitatively, the level of kavalactones consumed in traditional kava, so we can't make specific health claims about it anyway."
However, I still believe it is appropiate for Forums, Websites, drinking establishments with Kava as a focus, to write about and/or Post "Studies" that specifically credit traditional kava beverage for benefits such as:
1. National Cancer Institute Fall 2021 Newsletter reports-
“Kava, a commonly consumed South Pacific Island beverage used to promote calmness, may reduce lung cancer risk by decreasing NNK-derived DNA damage and enhancing NNK detoxification.”
2. Dr. Einbond, et. al. “Traditional preparations of kava inhibit the growth of breast and colon cancer cells.”
3. Kava as a Clinical Nutrient (September 2020)
“Whereas the neurological benefits of proper kava use appear to be undeniable, particularly in reducing stress and anxiety, there is growing evidence that its consumption could be associated with low incidence of cancer. Furthermore, anti-inflammatory activities have been reported for kava and its compounds, suggesting their potential for the treatment of inflammatory disease."
What do others think?
@Alia They'll have to physically stop me from writing about those. As long as I have something to do with it, those topics will be freely discussable here until the sun burns out ;)
 

Groggy

Kava aficionado
Admin
Whereas the neurological benefits of proper kava use appear to be undeniable, particularly in reducing stress and anxiety, there is growing evidence that its consumption could be associated with low incidence of cancer. Furthermore, anti-inflammatory activities have been reported for kava and its compounds, suggesting their potential for the treatment of inflammatory disease."
What do others think?
I think the above is the most promising path, with the biggest return in investment, so to speak.

I also think some sort of foundation/organization, perhaps created by those of us with an interest in kava's future, and/or kava vendors could and should be created to propel new studies by researchers, Universities, whomever we can get to listen, learn and share. Perhaps such entity could move the ball forward, faster with the FDA and other agencies.

The amount of research that is outdated and outright proved to be incorrect that is still being cited out there on the interwebs is astounding! It's about time the information gets updated, kava warrants better and larger studies to be carried out.

Then sorting kava from that other krap, is a whole other headache, but more research is always better, specially as you mentioned, in relation to cancer, these types of studies should be sought out, so much more could be done.
 

kavahana

Los Angeles, CA
Kava Vendor
I think the above is the most promising path, with the biggest return in investment, so to speak.

I also think some sort of foundation/organization, perhaps created by those of us with an interest in kava's future, and/or kava vendors could and should be created to propel new studies by researchers, Universities, whomever we can get to listen, learn and share. Perhaps such entity could move the ball forward, faster with the FDA and other agencies.

The amount of research that is outdated and outright proved to be incorrect that is still being cited out there on the interwebs is astounding! It's about time the information gets updated, kava warrants better and larger studies to be carried out.

Then sorting kava from that other krap, is a whole other headache, but more research is always better, specially as you mentioned, in relation to cancer, these types of studies should be sought out, so much more could be done.
I'm ready to move on this and know what might just work. If anyone is interested in helping out please get in touch.
 

kavahana

Los Angeles, CA
Kava Vendor
Evidently, after 90+ amazing responses from our kavahana AI, the FDA has chosen to disregard our comments. Kava is still a supplement as of now.
 
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