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Kava History The continued persistence of kava product liver warnings in the United States.

The Kap'n

The Groggy Kaptain (40g)
KavaForums Founder
Hello Kava lovers, over the last few months I’ve been on a quest to understand why we continue to label our products with frightening warnings related to liver toxicity when we haven’t seen an adverse event involving liver damage in the last 20 years with kava products per the FDA’s own adverse event database, FAERS.

You read that correctly, in the last 20 years of reported adverse cases involving kava, no hepatic (liver) damage has been noted [1].

Be this as it may, we continue to see liver warnings plastered all over the side of most (not all, thankfully) kava product packaging.

Why is this?

We should define a specific organization here, and that’s The Council for Responsible Nutrition known as the CRN. This organization was founded in 1973, based in Washington D.C, and is the leading trade association representing dietary supplement and functional food manufacturers and ingredient suppliers. The CRN is a body consisting of due-paying members. CRN states their mission as “to protect and advance a climate for our members to responsibly develop, source, manufacture, and market science-backed dietary supplements, functional food, and their ingredients, for better health and nutrition”. This organization heavily relies on the idea of “self regulation” in the supplement industry, and makes various suggestions to their members based on current scientific data [2].

On November 11 2014 the CRN released a document to their members related to the supplements DHEA, Ephedra, and Kava [3]. Contained in this document were “Suggested elements for a Voluntary Label for Kava Products”. In this document they suggest to present the following wordage on kava product labels:

  • The US FDA advises that a potential risk of rare, but severe, liver injury may be associated with kava-containing dietary supplements.
  • Ask a healthcare professional before use if you have or have had liver problems, frequently use alcoholic beverages, or are taking any medication.
  • Stop use and see a doctor if you develop symptoms that may signal liver problems, including jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other nonspecific symptoms can include nausea, vomiting, light-colored stools, unusual tiredness, weakness, stomach or abdominal pain, and loss of appetite.
  • Not for use by persons under 18 years of age, or by pregnant or breastfeeding women.
  • Not for use with alcoholic beverages.
  • Excessive use, or use with products that cause drowsiness, may impair your ability to operate a vehicle or heavy equipment.
While suggesting this, the document also gives a rather interesting and familiar disclaimer:

  • “CRN’s “Suggested Elements for a Voluntary Label for Kava Products” are based on a CRN process of scientific assessment, consultation and coordination with FDA, other trade associations, and outside scientific advisors. CRN members should understand that neither FDA, CRN, nor any other assessment has suggested that scientific evidence has established a causal relationship between kava consumption and liver problems. Thus, CRN’s recommendation is seen solely as a matter of ample prudence.”
Again here we see speculation and fear instead of suggestions based on scientific facts and safe history under the guise of “ample prudence”. Suggesting caution for something they disclaim as possibly toxic, but in the same breath saying there is no evidence to assert this is the hallmark of warnings related to kava. This is the same mentality which toppled the entire industry and caused massive losses to those leaning on exports for monetary subsistence in the South Pacific [4].

Essentially these voluntary and suggested warnings stem from an unfounded fear, based on faulty adverse reports from over 20 years ago [5], and are solely a throwback to the 1998-2004 era. These warnings are not required on any kava product packaging per any federal or state rule, and to be quite honest they likely wouldn't absolve a seller of liability anyway. The liver warnings on kava products do nothing but continue to perpetuate a myth that died a long time ago.

[1] “FAERS Kava Adverse Reports.” September, 2022. Google Docs. Accessed November 17, 2022. Link

[2] “About CRN.” n.d. Accessed November 17, 2022. https://www.crnusa.org/about-crn.

[3] CRN. 2014. “CRN Safety Considerations for Dosage Recommendations and Labeling.” Council for Responsible Nutrition. https://crnusa.org/sites/default/fi...derations-Vol_Dosage_Labeling-Revpost2014.pdf.

[4] Gruenwald, Joerg, Cordula Mueller, and Skrabal Juergen. 2003. “In-Depth Investigation Into EU Member States Market Restrictions On Kava Products.” Centre for the Development of Entreprise.https://www.taxtyranny.ca/images/HTML/Health-Regulatory-History/Canada/Articles/kavareport.pdf

[5] Schmidt, M., and Harsewinkel. 2002. “Is Kava Really Hepatotoxic? An Analysis of the Known Data on Adverse Effects of Kava Preparations on the Liver.” http://www.fijihosting.com/dload/is_kava_really_hepatotoxic.pdf
 

Alia

'Awa Grower/Collector
Hello Kava lovers, over the last few months I’ve been on a quest to understand why we continue to label our products with frightening warnings related to liver toxicity when we haven’t seen an adverse event involving liver damage in the last 20 years with kava products per the FDA’s own adverse event database, FAERS.

You read that correctly, in the last 20 years of reported adverse cases involving kava, no hepatic (liver) damage has been noted [1].

Be this as it may, we continue to see liver warnings plastered all over the side of most (not all, thankfully) kava product packaging.

Why is this?

We should define a specific organization here, and that’s The Council for Responsible Nutrition known as the CRN. This organization was founded in 1973, based in Washington D.C, and is the leading trade association representing dietary supplement and functional food manufacturers and ingredient suppliers. The CRN is a body consisting of due-paying members. CRN states their mission as “to protect and advance a climate for our members to responsibly develop, source, manufacture, and market science-backed dietary supplements, functional food, and their ingredients, for better health and nutrition”. This organization heavily relies on the idea of “self regulation” in the supplement industry, and makes various suggestions to their members based on current scientific data [2].

On November 11 2014 the CRN released a document to their members related to the supplements DHEA, Ephedra, and Kava [3]. Contained in this document were “Suggested elements for a Voluntary Label for Kava Products”. In this document they suggest to present the following wordage on kava product labels:

  • The US FDA advises that a potential risk of rare, but severe, liver injury may be associated with kava-containing dietary supplements.
  • Ask a healthcare professional before use if you have or have had liver problems, frequently use alcoholic beverages, or are taking any medication.
  • Stop use and see a doctor if you develop symptoms that may signal liver problems, including jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other nonspecific symptoms can include nausea, vomiting, light-colored stools, unusual tiredness, weakness, stomach or abdominal pain, and loss of appetite.
  • Not for use by persons under 18 years of age, or by pregnant or breastfeeding women.
  • Not for use with alcoholic beverages.
  • Excessive use, or use with products that cause drowsiness, may impair your ability to operate a vehicle or heavy equipment.
While suggesting this, the document also gives a rather interesting and familiar disclaimer:

  • “CRN’s “Suggested Elements for a Voluntary Label for Kava Products” are based on a CRN process of scientific assessment, consultation and coordination with FDA, other trade associations, and outside scientific advisors. CRN members should understand that neither FDA, CRN, nor any other assessment has suggested that scientific evidence has established a causal relationship between kava consumption and liver problems. Thus, CRN’s recommendation is seen solely as a matter of ample prudence.”
Again here we see speculation and fear instead of suggestions based on scientific facts and safe history under the guise of “ample prudence”. Suggesting caution for something they disclaim as possibly toxic, but in the same breath saying there is no evidence to assert this is the hallmark of warnings related to kava. This is the same mentality which toppled the entire industry and caused massive losses to those leaning on exports for monetary subsistence in the South Pacific [4].

Essentially these voluntary and suggested warnings stem from an unfounded fear, based on faulty adverse reports from over 20 years ago [5], and are solely a throwback to the 1998-2004 era. These warnings are not required on any kava product packaging per any federal or state rule, and to be quite honest they likely wouldn't absolve a seller of liability anyway. The liver warnings on kava products do nothing but continue to perpetuate a myth that died a long time ago.

[1] “FAERS Kava Adverse Reports.” September, 2022. Google Docs. Accessed November 17, 2022. Link

[2] “About CRN.” n.d. Accessed November 17, 2022. https://www.crnusa.org/about-crn.

[3] CRN. 2014. “CRN Safety Considerations for Dosage Recommendations and Labeling.” Council for Responsible Nutrition. https://crnusa.org/sites/default/fi...derations-Vol_Dosage_Labeling-Revpost2014.pdf.

[4] Gruenwald, Joerg, Cordula Mueller, and Skrabal Juergen. 2003. “In-Depth Investigation Into EU Member States Market Restrictions On Kava Products.” Centre for the Development of Entreprise.https://www.taxtyranny.ca/images/HTML/Health-Regulatory-History/Canada/Articles/kavareport.pdf

[5] Schmidt, M., and Harsewinkel. 2002. “Is Kava Really Hepatotoxic? An Analysis of the Known Data on Adverse Effects of Kava Preparations on the Liver.” http://www.fijihosting.com/dload/is_kava_really_hepatotoxic.pdf
It still all goes back to the doorstep of the FDA? Would you agree? The FDA holds ultimate "responsibility" with regards to perpetuation (sp) of the liver issue?
 

The Kap'n

The Groggy Kaptain (40g)
KavaForums Founder
It still all goes back to the doorstep of the FDA? Would you agree? The FDA holds ultimate "responsibility" with regards to perpetuation (sp) of the liver issue?
Absolutely. Their continued inaction perpetually keeps us in this weird state. It seems any agency with a name lacks the proper fortitude to stand up against the liver hysteria. They would simply say "oh....well more research is needed" and leave it at that forever. The research is in, the product is safe. Even the FDA warning page is in shambles.


 

Kalm with Kava

Kava Vendor
It still all goes back to the doorstep of the FDA? Would you agree? The FDA holds ultimate "responsibility" with regards to perpetuation (sp) of the liver issue?
Absolutely. We all know as well that the FDA is a nearly immovable organization that will always be reactive instead of proactive. Until someone tests the issue somehow they'll never change the status or warnings of kava.
 

PapaCthulu

Kava Lover
Absolutely. Their continued inaction perpetually keeps us in this weird state. It seems any agency with a name lacks the proper fortitude to stand up against the liver hysteria. They would simply say "oh....well more research is needed" and leave it at that forever. The research is in, the product is safe. Even the FDA warning page is in shambles.


I am not a big fan of the FDA. They cause just as many problems as they fix. Another example: Pasteurization and milk. Pasteurization was invented to solve a problem that no one understood at the time of the American civil war. Now it is generally no longer needed as we understand the problem so long as dairy farms follow good practices. People from other countries that allow you to drink unpasteurized milk come here after drinking it all there lives and then become lactose intolerant because the process affects the milk so adversely.
 
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