Kava: Food, Supplement or Drug?

[verticity]

Current definitions of "dietary supplement" vs "food" are somewhat vague, and context is all-important. Here's how the FDA explains the difference:

"Conventional foods are foods that are not dietary supplements. A dietary supplement is a product taken by mouth that is intended to supplement the diet and that contains one or more "dietary ingredients." The "dietary ingredients" in these products may include vitamins, minerals, herbs or other botanicals, amino acids or other substances found in the human diet, such as enzymes. Dietary supplements must be labeled as such and must not be represented for use as a conventional food or as the sole item of a meal or the diet." (Source)

If sold in a pill/capsule/extract form, kava is clearly a dietary supplement and must be labeled as such. If sold in a kava bar as a prepared beverage, and not intended as a dietary supplement, kava - even now - meets the definition of "food". Kava has an extensive history as a beverage, thus inclusion in the Codex or GRAS will primarily reinforce what is already its current status.

K@ has no such precedence, either as a food or a dietary supplement. It has certainly never been sold as a food, and when marketed as a dietary supplement it was rejected by the FDA. In addition, two specific components in K@ - mitragynine and 7-hydroxymitragynine - are under scrutiny for classification as Schedule 1 drugs by the DEA. In contrast, kava has been the subject of a single (and now obsolete/archived) FDA Consumer Alert, and no specific components of kava have ever been questioned.

So what is K@? Some hold out hope that it will be cleared as at least a dietary supplement, but even should that happen there will never be "K@ bars". The logic behind my opinion lies here, in the FDA's answer to the question "Is a dietary supplement a food or a drug?":

"The Dietary Supplement Health and Education Act defines dietary supplements as a category of food. However, there is one exception: if a dietary supplement meets the definition of a drug, it is regulated as a drug." (Source)

That makes me wonder what the FDA's definition of a "drug" is. It is this:

"Drug
A drug is defined as:

• A substance recognized by an official pharmacopoeia or formulary.
• A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
• A substance (other than food) intended to affect the structure or any function of the body.
• A substance intended for use as a component of a medicine but not a device or a component, part or accessory of a device.
• Biological products are included within this definition and are generally covered by the same laws and regulations, but differences exist regarding their manufacturing processes (chemical process versus biological process.)"

https://www.fda.gov/drugs/informationondrugs/ucm079436.htm
​

But I am still confused about what a drug is. That definition is ambiguous because they fail to specify if the items in the bullet points are in and "AND" or an "OR" relationship. In other words, do all of those bullet points have to be met for a thing to be called a drug? If that is the case, then that is a pretty stringent definition. Something could be used to treat a disease, but not be listed in an official formulary and not be a "drug". Also the way the items are phrased is not clear. Something could be potentially useful and effective in treating a disease, but marketed without the intention of treating any disease and thus not be technically a "drug".

There are in fact a lot of supplements that would seem to meet this definition if the bullet points are ORed, or even ANDed. Vitiman C can treat scurvey, and is probably listed in an official pharmacopoeia for that purpose, but it is not a "drug" according to the FDA.

I mean I know what a drug is in a medical and scientific sense, but still not clear on what the FDA thinks a drug is in the legal sense.

 

[Rick.Sanchez]

I'm fairly certain it only needs to meet one of those terms. How the FDA defines a product is largely dependent on how it's being marketed. Very little science, mostly legal BS. That's why supplements often need legal disclaimers to specificy their product is not meant to treat any illnesses, etc even though they often mention treating illnesses etc. on the packaging.

 

[Zaphod]

For those interested there is also a section on beverages:
https://www.fda.gov/food/guidancere...yinformation/dietarysupplements/ucm381189.htm
After reading the FDA definitions I would interpret those descriptions that Kava is a Dietary Supplement and not a full fledged Food or Beverage. It is not intended to be a source of liquid, quenching of thirst etc. Its intention is to be an addition to the a normal diet. I am not sure how you can argue it being Food by the FDA definition. Of course that calls into question why Coffee would be considered a beverage, since most people I know drink it for the caffeine in which case it is really a dietary supplement and anybody who drinks decaffeinated coffee deserves to be punished like Tantalus.

 

[Señor Chuggs]

For those interested there is also a section on beverages:
https://www.fda.gov/food/guidancere...yinformation/dietarysupplements/ucm381189.htm
After reading the FDA definitions I would interpret those descriptions that Kava is a Dietary Supplement and not a full fledged Food or Beverage. It is not intended to be a source of liquid, quenching of thirst etc. Its intention is to be an addition to the a normal diet. I am not sure how you can argue it being Food by the FDA definition. Of course that calls into question why Coffee would be considered a beverage, since most people I know drink it for the caffeine in which case it is really a dietary supplement and anybody who drinks decaffeinated coffee deserves to be punished like Tantalus.

"Dietary supplements are defined as products that, among other requirements, are intended to supplement the diet. (See section 201(ff)(1) of the FD&C Act [21 U.S.C. 321(ff)(1)].) In contrast, beverages generally are intended, for example, to quench thirst or otherwise provide a source of fluids (e.g., water, soda), provide nutritive value (e.g., milk, orange juice), or provide taste and aroma (e.g., hot cocoa).


That's copied from the link above. I'd say traditionally prepped kava is intended to be a source of fluid, taste, and aroma. Like soda, it doesn't necessarily need to be hydrating. I drink Kava to cool off, much like an iced tea.

Intention to supplement a diet leaves some room for interpretation.... I mean, one must consume other foods in order to subsist, but at the same time, one could argue that the kava beverage is intended not to be consumed with food.

I vote it's more food than supplement, not that it's status is under contest anyway.

 

[Zaphod]

"Dietary supplements are defined as products that, among other requirements, are intended to supplement the diet. (See section 201(ff)(1) of the FD&C Act [21 U.S.C. 321(ff)(1)].) In contrast, beverages generally are intended, for example, to quench thirst or otherwise provide a source of fluids (e.g., water, soda), provide nutritive value (e.g., milk, orange juice), or provide taste and aroma (e.g., hot cocoa).


That's copied from the link above. I'd say traditionally prepped kava is intended to be a source of fluid, taste, and aroma. Like soda, it doesn't necessarily need to be hydrating. I drink Kava to cool off, much like an iced tea.

Intention to supplement a diet leaves some room for interpretation.... I mean, one must consume other foods in order to subsist, but at the same time, one could argue that the kava beverage is intended not to be consumed with food.

I vote it's more food than supplement, not that it's status is under contest anyway.

Fair points, but I still disagree. There is no reason I would drink kava if it didn't have kavalactones in it. While I have come to not mind the taste it certainly isn't something I would grab to just drink if it didn't have the desired effect. Lots of people still drink decaffeinated sugar free soda, so it clearly has an appeal beyond just getting caffeine (same with coffee) - but Kava just for the taste and aromoa, no thanks!

 

[Kojo Douglas]

I would agree that Kava is not something I would drink if not for the effects. It is a medicine that can be used recreationally, for personal care, or for important cultural reasons. It is not a food.

In that sense, Kava is more like Krat than it is like a cheeseburger or a bag of carrots. I think that, among other reasons mentioned earlier in the thread, that is why the two plants are so closely associated. It is part of a legal market of substances that have medicinal and recreational affects on the mood.

This whole conversation is interesting.

 

[kasa_balavu]

I'm seeing a lot of opinions on what people consider to be food. The law doesn't work that way though. The law is weird, and beyond the comprehension of we mere mortals.

Didn't one of your states manage to classify pizza as a vegetable based on it's tomato content?
EDIT: It was Congress.

3. What does FDA consider to be a “food” for the purposes of FDA food labeling?
The definition is sweeping and includes most articles used as food or drink (for humans or animals). The definition includes chewing gum, food additives, a wide variety of beverages, cookies, bottled water, dietary supplements, candy, cereal, rice and so on.

- From http://www.bevlaw.com/services-fda-labels-faq.php

 

[Zaphod]

In NZ kava is regulated as food when it is served/sold as a traditional beverage or pure roots (fresh or dry). It is regulated as a dietary supplement when it is sold in the form of pills etc.

But the legislators have recognised that (just like tea or coffee) kava is mainly used for its relaxing effects and not because of any nutritional value hence it's one of the few food items that is exempt from the food-specific labelling requirements (nutritional content, etc).

View attachment 8031

I like the NZ approach - it seems pretty reasonable. Which mean it probably will never be adopted in the States. I really do wish Kava had a stronger association that could continue to push for sensible regulation, general education, and promotion of Kava here.

 

[Krunkie McKrunkface]

For me kava is a safe, effective, natural anti-inflammatory. Everything else is just gravy. It's a herbal supplement, like St John's Wort or Valerian. It's just the best herbal supplement in the world, is all.

 

[verticity]

I started a thread in my sleep. I must be losing it...

 

[verticity]

I like the NZ approach - it seems pretty reasonable. Which mean it probably will never be adopted in the States. I really do wish Kava had a stronger association that could continue to push for sensible regulation, general education, and promotion of Kava here.

I think the reason we don't have a common sense legal approach to kava like New Zealand is because of commerce. There is big money to be made in "Nutraceuticals", and moneyed interests have a disproportionate say in how the laws are made here. If companies weren't allowed to process, extract, and mix and match it with other stuff into "proprietary" formulations and generally "add value", but were instead simply required to sell traditional kava powder with no additives or chemical processing, there would be much less profit to be made. It's like how people I know who have worked in grocery stores have told me that the stores make most of their money off of highly processed packaged "convenience foods", whereas basic produce like vegetables, fruit, milk, etc. are much less profitable, almost to the point of being loss leaders.

 

[verticity]

I'm seeing a lot of opinions on what people consider to be food. The law doesn't work that way though. The law is weird, and beyond the comprehension of we mere mortals.

Didn't one of your states manage to classify pizza as a vegetable based on it's tomato content?
EDIT: It was Congress.

The pizza as vegetable thing is not quite true:
https://www.washingtonpost.com/blog...e-not-exactly/2011/11/20/gIQABXgmhN_blog.html

Also, the proposal from the early 80's to classify ketchup as a vegetable in school lunches was never implemented, although it has become part of our mythology:
https://en.wikipedia.org/wiki/Ketchup_as_a_vegetable

In fact it seems that school lunches in the US have actually become generally more nutritious, compared to when I was in school many years ago. There is a lot a variability in that, though. The lunches tend to be better in richer areas than in poor areas.

 

[Zaphod]

I think the reason we don't have a common sense legal approach to kava like New Zealand is because of commerce. There is big money to be made in "Nutraceuticals", and moneyed interests have a disproportionate say in how the laws are made here. If companies weren't allowed to process, extract, and mix and match it with other stuff into "proprietary" formulations and generally "add value", but were instead simply required to sell traditional kava powder with no additives or chemical processing, there would be much less profit to be made. It's like how people I know who have worked in grocery stores have told me that the stores make most of their money off of highly processed packaged "convenience foods", whereas basic produce like vegetables, fruit, milk, etc. are much less profitable, almost to the point of being loss leaders.

Agreed! It is sad that only those with "big money" get a say in our rules and regulations. I am curious, however, if kava on its own could be a large enough industry and with the right promotion (from a knowledge and scientific based association) become large enough to force some change?
I know what you are talking about with the grocery stores. I am pretty sure the way our local award winning Wegmans does so well is to place itself in higher end areas where people are willing to pay extra for the convenience of prepared foods. People rave about the store, and Wegmans rolls in the profits.

 

[Alia]

Is this deja vu all over again? As for Hawai'i- in 1948 Journal of the Polynesian Society Margaret Titcomb wrote, regarding 'awa- " Outside of water and drinking coconut, no other drink was known". Many of our Legislators and Senators, today, wish to pass a Law defining 'awa beverage as just that-a beverage. Hasn't passed yet but it may eventually. Internationally there is the Codex alimentarius Commission which looks at this issue later this month. I wrote a one page summary some time ago which, if anyone is interested, I'll post.
Maybe you'd have to live in an 'awa/kava/sakau/ava growing region to fully understand. I go out to my yard and harvest the roots of a plant and after washing these roots I place in a Ninja 1500 W. then strain and drink it! That's no supplement.

 

[The Kap'n]

Is this deja vu all over again? As for Hawai'i- in 1948 Journal of the Polynesian Society Margaret Titcomb wrote, regarding 'awa- " Outside of water and drinking coconut, no other drink was known". Many of our Legislators and Senators, today, wish to pass a Law defining 'awa beverage as just that-a beverage. Hasn't passed yet but it may eventually. Internationally there is the Codex alimentarius Commission which looks at this issue later this month. I wrote a one page summary some time ago which, if anyone is interested, I'll post.
Maybe you'd have to live in an 'awa/kava/sakau/ava growing region to fully understand. I go out to my yard and harvest the roots of a plant and after washing these roots I place in a Ninja 1500 W. then strain and drink it! That's no supplement.

I think you're probably running up against the wall of main stream american zeitgeist. Personally, I think the more we can educate about kava's beginnings and cultural importance, the better off we'll be when it comes to positioning kava for the long haul. In this instance I often again refer to the fact that there is a U.S. quarter with a depiction of a kava ceremony on it.

 

[Deleted User01]

I wished I had a quarter like that, that's seriously cool. But all this Bruhaha about food vs supplement etc. is confusing to me because I just want Kava to be in visible to the FDA and other governing bodies. If Kava ever becomes mainstream, the Kava Shortage will make it a nitemare for us to get any kind of kava at a reasonable price. Be careful what you ask for. Also, there will be a ton of bad extracts hitting the market just like in the 90s. Talk about Deja Vu all over again.