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News Article Kava Bar / Local Health Authority / FDA

Discussion in 'Kava News' started by Kapmcrunk, Aug 24, 2018.

  1. Henry

    Henry Kava Enthusiast Moderator The Kava Society of New Zealand

    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 kratom 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? :)
  2. Alia

    Alia Kava Enthusiast

    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.
  3. Henry

    Henry Kava Enthusiast Moderator The Kava Society of New Zealand

    I think this quote (from the article, isn't it?) is a bit misleading. I dont think the FDA made any ruling regarding serving kava as a conventional beverage. Instead, they may have confirmed it is seen as a dietary supplement (a special kind of food) and can be sold for human consumption. this has been known for a long time. The question is: can it be served as conventional food or does it need to be sold as a supplement?
  4. Henry

    Henry Kava Enthusiast Moderator The Kava Society of New Zealand

    Another issue is tge lawyer's claim that supplements can be sold as hot teas. Is it really true? If yes then I wonder why that kava bar in montana was forced to sell kava in sealed, labelled bottles..
  5. SelfBiasResistor

    SelfBiasResistor Persist for Resistance!

    The winning argument isn't about the FDA view on kava being food or supplement but the fact that it is a supplement and the addition of plain water isn't modifying the supplement. That argument probably won't work with kava cocktails or edible products.
    Alia likes this.
  6. Henry

    Henry Kava Enthusiast Moderator The Kava Society of New Zealand

    It is a potentially strong argument but I dont think the FDA has actually officially accepted. Thoigh I might (and would love to be) mistaken
    Alia likes this.
  7. Henry

    Henry Kava Enthusiast Moderator The Kava Society of New Zealand

    If kava mixed with nothing but water can be sold as food in the states then it is a huge victory
  8. SelfBiasResistor

    SelfBiasResistor Persist for Resistance!

    I agree. It worked here but may not work in every situation. This wasn't a court battle won and the FDA regulations in this area aren't completely clear.
    Alia and Henry like this.
  9. SelfBiasResistor

    SelfBiasResistor Persist for Resistance!

    If kava cannot be added to food, a product made with kava cannot be sold as food. It's merely a dietary supplement consumed via water extraction.

    The FDA is poorly designed to regulate herbal/botanical products. Most of these food additive regulations are targeted at chemicals being created. With the rising public interest in various botanicals there will likely be inconsistent enforcement and confusion at all levels.

    Edit : Additionally we now have states legalizing cannabis products for sale that the FDA has deemed illegal. These are raw herb botanicals as well as food products. Beverages, food products, etc containing components/extracts of the plant. Those products aside, historically the FDA usually doesn't step in and remove natural botanicals from the market if they are not marketed in a way that makes health or medical claims (whether the claims are accurate or not).
    Last edited: Nov 8, 2018
    Alia likes this.
  10. Alia

    Alia Kava Enthusiast

    All of our discussion points on this important topic are relevant. Yes, for sure the newspaper article was miss-leading somewhat...but (according the email from Oregon Health Authority), the basis for allowing the Kava bar to re-open was made after recieving the albiet confusing letter "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". Clearly these cups of kava beverage are very likely to still be served with some bits of food at least so the wisdom and observations from you and @ SelfBiasResistor are right on as stated, "It worked here but may not work in every situation".
    Henry likes this.
  11. Alia

    Alia Kava Enthusiast

    My only knowledge of that Montana issue is annecdotal hear-say. If true it leads me to conclude that having an open, back and forth, respectful dialogue with the Overseeing authority could have altered that situation.