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Kava Bar / Local Health Authority / FDA

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The Kap'n

The Groggy Kaptain (40g)
KavaForums Founder
Summary: A kava bar in Eugene OR was asked by the local health authority to stop serving kava. After the kava bar challenges the request, the FDA responds supporting the kava bar's arguments, and the LHA reversed their decision. The kava bar is now back serving kava.

https://www.eugeneweekly.com/2018/08/23/kava-controversy/

Kava Controversy
Kava bar stops serving after conflicting communications

Eugene’s only kava bar stopped serving kava for about a week in July after a misunderstanding between local and state health authorities about what’s a food and what’s an additive.

The LovaKava Bar and Restaurant downtown serves a selection of teas from kava root, Piper methysticum, said by users to infuse a sense of calm.

“My staff at the kava bar got a phone call from Lane County Environmental Health (LCEH) telling us and warning us that we had to immediately stop serving kava,” says LovaKava owner John Sholar. “Quite frankly, that made no sense to me at all.”

Sholar says a county health inspector told him that LCEH was following guidelines from the Oregon Health Authority (OHA) on the legalities of serving kava. He closed the restaurant around July 10, he says, and sent all 12 part-time and full-time employees home.

LovaKava then opened again for a few days but refrained from serving kava.

“My whole restaurant was shut down for a week,” Sholar says. “It was pretty bad. We really took a hit. After that, we had to shut down all these other kava products that I carry in-house and prepare for people.”

He adds in an email, “This action would have affected every kava bar in the U.S.”

After receiving a letter from Sholar’s attorney, OHA contacted the federal Food and Drug Administration (FDA) in mid-July. FDA decided kava tea is a food and not an additive.

“My attorney proved to them it isn’t a food additive, but it’s actually been a food that’s been consumed for 4,000 years. Adding a food to water does not change the constitution of the food. The water is a delivery system,” Sholar says.

OHA reversed its decision within days of receiving the letter from Sholar’s attorney. “The FDA came back and said this is OK,” says Brett Sherry, OHA program manager with the Food, Pool and Lodging Program.

Lane County spokesperson Devon Ashbridge says LCEH told Sholar around July 10 that he couldn’t serve kava as an additive to food. In an email to EW, Ashbridge writes:

“In June, Lane County Environmental Health (LCEH) received an update from Oregon Health Authority (OHA) stating that kava was not on the Food & Drug Administration’s list of approved additives — meaning that it could not be added to food prepared and served at a restaurant, but could be sold as a dietary supplement. LCEH was aware of one restaurant using kava and, after receiving the above notification from OHA, as a courtesy called the restaurant.”

Sholar says the daily routine at LovaKava Bar downtown is back to normal. His team of employees quickly returned to serving kava tea, which comes in different strains like Vanuatu (billed as “relaxing, pain-relieving and heavy on the body”).

“We’re just a little kava bar, trying to do our little thing,” he says.
 

Alia

'Awa Grower/Collector
I wonder if therevwas some kind of a misunderstanding. Arent dietary supplements a special cat of foods? In NZ dietary supplements have to meet food safety requirements in addition to dietary supplement specific stuff. Maybe the local authorities assumed kava was neither, but the fda stated it was fit for human consumption as a supplement? Not sure. Obviously, ideally they now classify it as an ordinary food product, but this would be a sudden and fairly raducal change!
Yes, this is why seeing the letter would be nice because there is a bit of confusion in the article, although it clearly states- "FDA decided kava tea is a food and not an additive". Later there is reference to it being a dietary supplement.
 

SelfBiasResistor

Persist for Resistance!
Yes, this is why seeing the letter would be nice because there is a bit of confusion in the article, although it clearly states- "FDA decided kava tea is a food and not an additive". Later there is reference to it being a dietary supplement.
Definitely need to see the letter. The reporter may not be aware of the differences between foods, additives and dietary supplements and didn't take care to use the terms correctly. It seems apparent the county and states health departments don't understand the differences either which is kind of scary but they also may have been under pressure (or bribes) to eliminate competition for other industries and assumed this kava bar was a helpless target.
 

kasa_balavu

Yaqona Dina
@Alia sought more info from the Oregon Health Authority regarding this case and received this in response. (Highlighting by me):

As you are likely aware, the regulation of Kava in a food service setting is quite complicated. The FDA considers Kava to be a dietary supplement. Dietary supplements are regulated by the FDA as foods, not drugs. However, dietary supplements have their own set of regulations that are different than those covering conventional foods. In the case of the LoveKava Kava Bar in Eugene, OR, the restaurant was serving Kava as a tea. There were no health claims being made about the product. After consulting with the FDA, the Oregon Health Authority determined that the restaurant was allowed to sell Kava as a tea. The FDA did not provide my office with a letter stating that Kava is a food. As mentioned earlier, supplements are regulated as foods, so there can certainly be some confusion around this. Kava is still not “generally recognized as safe” by the FDA, which means it can not be added to other types of food in a restaurant setting.
OHA is continuing to work with state and federal partners on this topic, and we hope to have clearer guidance for restaurant inspectors as well as individulas looking to pursue a business serving kava in the near future.
That last highlighted bit sounds a bit like the New Zealand food standards regarding kava (acceptable as an unadulterated beverage)
 
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SelfBiasResistor

Persist for Resistance!
That last highlighted bit sounds a bit like the New Zealand food standards regarding kava (acceptable as an unadulterated beverage)
It's saying that kava combined with water is OK because water isn't an actual food being combined with a dietary supplement. Basically like any herbal tea. The NZ standard is directed at kava specifically.
 

Alia

'Awa Grower/Collector
Taking the time to actually read this letter is an inspiration!
The Oregon kava bar (LovaKava) should be congratulated to have taken a stand and followed through
with intelligence and authority .
The Lawyer is very thorough in the cases, arguments, logic he uses.
This may not change things completely (eg. not GRAS yet) but it is a very big step.
 
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Alia

'Awa Grower/Collector
The link for the letter isn't working for me. Could you possibly message it to me? This could prove very useful in my area.
Hopefully, you will be able to read this letter soon. Please confirm when you can with your thoughts on the contents.
I think it is not quite precedent setting but very close.
 

Intrepidus_dux

Kava O.G.
Hopefully, you will be able to read this letter soon. Please confirm when you can with your thoughts on the contents.
I think it is not quite precedent setting but very close.
I just finished reading it. It's very well written and clear. The example case with the oil being added to capsules was a good one and even proves further that kava is even more simple than that scenario.

There are some people in the kava community who want kava to be classified as a food, and this letter falls in line with the same thinking. I can't remember who all was pushing for classifying kava as a food. Chris at GHK and who else?
 

Zaphod

Kava Lover
One of our members was able to come up with this public record thanks to the Freedom of Information Act.
And that right there is why a lawyer can be worth every penny....well reasoned argument with supporting case law. Do we have a copy of the official response as well?
 

Alia

'Awa Grower/Collector
And that right there is why a lawyer can be worth every penny....well reasoned argument with supporting case law. Do we have a copy of the official response as well?
Yes, the response from the Oregon Health Authority (after they conferred with FDA) is posted somewhere in these Forum...actually in this thread.
It was obtained before the Attorney's letter was obtained due to FOIA time-line.
 

Alia

'Awa Grower/Collector
I just finished reading it. It's very well written and clear. The example case with the oil being added to capsules was a good one and even proves further that kava is even more simple than that scenario.

There are some people in the kava community who want kava to be classified as a food, and this letter falls in line with the same thinking. I can't remember who all was pushing for classifying kava as a food. Chris at GHK and who else?
Yes, the Association for Hawaiian 'Awa and numerous others throughout the Pacific kava growing regions are working on having kava beverage classified as a safe food, GRAS, etc.
 

Alia

'Awa Grower/Collector
I like the letter and find at least some of his arguments intelligent. However, I am not sure the government will buy them in light of their published statements on the use of non-GRAS substances in "conventional beverages". The lawyer suggests that many teas can be sold as dietary supplements and also served as hot beverages. This is true, but I wonder if: a) like kava, they lack GRAS status; b) this is due to the government's official position or simple lack of enforcement. I am no legal expert, but it does seem to me that your food laws are very poorly enforced. I mean, look at this whole K@ situation.

In general, the key argument I find in his letter is that adding kava to water does not constitute adding a dietary ingredient to a food product.
The lawyer admits that adding a non GRAS ingredient to a beverage would make it unlawful, but claims that water in itself is not a beverage, but a mere method of serving the product. This may or may not be true, but I somehow doubt that this could possibly be the case. Does it even make any logical sense?

The FDA are dead against adding non GRAS stuff being part of beverages ("Any substance added to a beverage or other conventional food that is an unapproved food additive (e.g., because it is not GRAS for its intended use) causes the food to be adulterated under section 402(a)(2)(C) of the FFDCA (21 U.S.C. 342(a)(2)(C)). Adulterated foods cannot be legally imported or marketed in the United States." and "In addition, if a manufacturer could create a dietary supplement simply by adding a dietary ingredient to any pre-existing conventional food and labeling the resulting product as a supplement, firms could easily evade the requirement that ingredients in conventional foods be generally recognized as safe (GRAS) or approved for their intended use (see section III.D.1, below)." (https://www.fda.gov/food/guidancere...yinformation/dietarysupplements/ucm381189.htm), so I guess it really does boil down to one's definition of water. Is water a beverage? :)
You bring up some great details and observations that are prompting me to look even closer at the letter.
I also looked up "water" in the dictionary and was surprized at the complex definition.
The fact is that-- a Kava Bar got shut down, told to stop serving kava beverage and the letter convinced the FDA and the Oregon Health Authority (OHA) to allow the Bar to re-open continue serving kava beverage.
It is a small milestone but I'd rather see kava beverage as GRAS and not a "dietary supplement".
Ultimately the Codex work, if sussessful, will be the best outcome.

Quote--After receiving a letter from Sholar’s attorney, OHA contacted the federal Food and Drug Administration (FDA) in mid-July. FDA decided kava tea is a food and not an additive. “My attorney proved to them it isn’t a food additive, but it’s actually been a food that’s been consumed for 4,000 years. Adding a food to water does not change the constitution of the food. The water is a delivery system,” Sholar says.
 
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