Hello,
I would like to get involved in a group that can Lobby FDA administrators. The stated goal would be to properly classify Kratom & make importation easier. Is anyone out there have any advise as to how positively deal with the FDA?

Here's a suggestion. Read the FDA regulations on the restrictions on marketing herbal supplements. Don't talk about health benefits unless they are backed by research, don't promote kratom as a legal high or drug alternative that doesn't show up on drug tests, and don't market it as a wonder drug that is a remedy to all sorts of ailments.

This is something you have failed to do miserably.
kratomxl.a-plushosting.info/

I am curious to know if any other vendors, or individuals that purchase their Kratom outside the US, have noticed Customs holding onto shipments. I have never had a problem with USPS, but my latest shipment from Indonesia seems to be spending a very long time there (10 days)

Does anyone who has gone through this before have any advice on how to proceed with Customs? Any input would be greatly appreciated.

tkc I have been apprised of FDA regulations regarding herbal supplements for the past decade. I can't stand seeing herbs I love being misrepresented by the uncaring Merchants & the Media. The website you referred to was a stalled build in progress. Our Web Designer proposed making active, I blocked that action ( see KratomXl.com.) Not quite sure how you found it. Any who, Do you offer advice with importation of Kratom or are marketing dos & don't your sole fancy?
Either way,
Thank you for your time.

Yes I received a Notice from customs that claimed Kratom was a chemical of concern by the FDA. I was not able to find a list of Chemicals of concern on the FDA Website. Have the import regulations officially changed?

I'm not aware that any regulations have changed. In fact, the FDA (or DHS) has periodically confiscated imports on the basis that Kratom is an "unapproved drug." They have essentially acknowledged that it has potential medical benefit, however, it is not approved for human usage. Because it is not approved for human usage it also can't be considered a dietary supplement, technically.

I hate to be the one to rain on your parade - per se - BUT - none of you have this quite right. I suggest we pool some funds and have a webinar or something like that presented by an import/FDA expert attorney to explain it to all those willing to help pay for it - both vendors and concerned kratomers. IF we understand the issues we can better help communicate to the lawmakers etc... to work towards keeping it legal.
I have learned a TON of legitimate info about all this by hiring a lawfirm that specializes in this stuff and I think it would seriously help our mutual cause if more of us actually understood the LAWS and REGULATIONS that REALLY govern and apply to Kratom importing, marketing and selling. Anyone interested in putting some money out to get this valuable info please let me know - (PM) and we can start working on it. I will gladly spearhead this effort.

FDA has referred to kratom as a "street drug alternative" in their internal memo's since years back already. They have recently started to act upon it by stopping some of the imports. Basically it seems that all that shows up on their "oasis" (FDA early warning system) as Kratom or Mitragyna speciosa etc, is bound to be seized, destroyed or returned.

There isn't such a thing as "valuable" info, there is only an FDA that obviously has the wrong idea about kratom and that should be changed immediately.

I strongly recommend that everyone who has had issues with CBP or FDA comes forward and take action. The seizure notifications include an option to petition, use this! Besides that we should take joined action and address this issue at the appropriate agencies.

I recommend we open a closed discussion to plan a joined action for those affected.

Kratom is listed on the DEA website as a Drug of Concern. Because the DEA list it as a drug, the FDA states it cannot be used in dietary supplements. I know this because I spoke with both FDA and DEA representatives on multiple occasions. Our product, known under a different name then, was marketed and sold as a dietary supplement. I never received information stating I needed to stop selling it as such, but made the proper decision to do so until the "man" changes the classification. Although I disagree, as a company we must comply if we intend on staying in business.

Hi OtherWorld;
I have to say this to you but please dont take it the wrong way because I am not trying to slam you or anything!! But - if you are getting your info FROM the FDA and DEA you are making a HUGE mistake because they will tell you what THEY want you to think - NOT what the TRUTH is. If you want to know the truth you need to be talking too people that specialize in the LAWS and Regulations and that work with the entities you named.
I am trying to get interested vendors and freedom fighters to join together to pay for a webinar that will do just that. If you are interested please PM me to discuss further.

I personally suggest that anyone and everyone interested in this information please PM Angel7. I've been hearing of the work she has been doing with lawyers for several weeks now and I would certainly like to learn everything that I can from them. If we get enough people to chip in we can minimize individual costs for the law firm to put on this webinar. This is a great opportunity to get the facts.

I'm aware of this. From a business stand point, where you're looking at the organizations who have more leverage when deciding what substances are deemed legal, illegal and fit for human consumption via legislation, whether right or wrong, it makes more sense to comply. I, personally, have read about 90% of the legislation regarding dietary supplements, and although kratom DOES fall into that category, DEA's listing it as a Drug is the sole reason it can't be sold as a Dietary Supplement. The FDA only has "say" over the labeling of a dietary supplement and what qualifies as dietary supplement. That being said, if it was classified as a herb in the eyes of the DEA, versus a drug, then all would be fine and dandy. The first step is changing the mind of the few and powerful, not fighting them by rebeling and selling a product the way YOU want too. The last thing a company wants to do is have its "bread and butter" taken away because they "paint the fence a different color". The stand needs to be taken by the people, not the vendors (hear me out). I, as a person, will do what I can to "right the media's wrong" and change the minds of many. Acting out as a vendor and rebeling by selling a product, that I CLEARLY was told can't be sold like this, will sew my own demise. I'm thoroughly aware of what you are saying, and you are correct. I don't want to ruin a good thing for anyone.

Please understand my point. No offense was taken. I will pm you soon btw.

Hi OW;
Thanks for your comments - I understand where you are coming from and appreciate your concerns. Please understand first that I am NOT in any way saying to REBEL or do it our own way AT ALL!! Quite the opposite in fact! What I am saying is that we need to understand the laws and regulations correctly so we CAN be legally correct and "NOT poke the bear" but work within the guidelines already there and work to change the guidelines that need changing. I agree with you, that the "people" need to be involved but I believe too that the vendors have responsibility in this even more so. For instance, selling Kratom as "not for human consumption" is a HUGE problem that gives the FDA an edge against us right off the get go. We (the vendors) need to be importing/marketing and selling this like it is legal (because it is!!) and not like we are trying to sneak around thru the back door or "underground" which simply gives greater impression that we are doing something wrong - when we arent. The idea of a webinar is to educate the people AND the vendors of what the laws and regulations REALLY are and how to work within them AND to help formulate the best path to accomplish changing the bad P R to good to those who make the major decisions - ie, lawmakers, legislators etc...
The way we have been doing things seems to be catching up to us since I personally know several vendors with shipments being rejected entrance/delivery to the US as FDA has gotten into it more - not less, by the way we are handling things. TOGETHER - we can make a positive change so the responsible handling of Kratom can continue.

OtherWorld wrote:


I fully agree with this , although a seller can of course also act as a normal user, hell most of us are.

So we have both sellers and users affected by the current "import restrictions", what is next? Advice to file the petitions (customs CBP will send a seizure letter normally that offers such option), collect all cases and somehow take joint action? Contact the FDA (since they obviously are the one brieving CBP to seize such shipments) and try to get some dialogue? Or take public action, as we have done before?

So far there has never been a normal dialogue between kratom users/sellers and the FDA , as far as I know. Wouldnt that be a suitable thing at this stage ?

ADMIN; "So far there has never been a normal dialogue between kratom users/sellers and the FDA , as far as I know. Wouldnt that be a suitable thing at this stage ?"

PRECISELY!! BUT - before that can happen we MUST understand the regulations governing kratom imports & sales - thus, the webinar idea. Also, I believe the dialogue should take place between FDA and kratom users/sellers via proper legal representation who is best qualified to correctly represent us. (in fact, I know that this has occured on a individual type level already)
If we can properly organize, fund our efforts, and make a plan of having this dialogue that would be a great thing. I trully believe our first step is to try to pull the webinar together so we are properly educated and armed with the facts and details to have the intelligence to fight the battle properly. Then - we organize further to make the "plan" of media and lawmaker contact/education also.
With regard to the webinar - I am meeting with the law firm tomorrow to try to get an estimated cost. Also - to get a good idea of what they suggest be presented. THEN - come back here to explain and see what members here think about the idea. I think that if anyone here has other topics of concern etc... they can be gathered and I can ask the webinar presenter to address that also. I would like to see us have X amount of time for questions & answers at the end of the presentation - OR - maybe a better idea would be for us each to process the info individually that is given at the webinar - then submit additional questions as a group and then have a 2nd webinar to have a specific questions/answers time. Just thinkin outloud again!

OK, these are useful moves.
Some questions;

Wouldnt we need to make a collection of folks (sellers/users) affected, so they can be represented?

As for the funds, sellers clearly want their shipments and might chip in , affected or not, we can do some online fundraising and ask sponsoring, but I recommend to keep costs low, this isn't a oil market so to speak:)

I think we should keep the concerns focused and clear;
a. We simply need a normal legal status for kratom, since it is not illegal, so sellers and buyers can transact freely in the future without fear or the need of giving wrong information ("not for human consumption")
b. If FDA does indeed label kratom as "an unauthorized medicine" (which somehow seems odd since they already said that it cannot be sold for consumption) they should create options to have kratom approved or to develop guidelines with seller to limit abuse or misuse.

Does anyone have a 3rd?

Great points! And, I agree. The webinar will present a general overview of where kratom stands in the eyes of FDA and DEA and the issues/problems of importing/selling it which will help us in formulating a strategic plan. I assure you your questions will be answered in detail so we all know whats what. FDA, by the way, has not determined that kratom can not be used for human consuption. Not sure why everyone thinks that - I also thought that until my attorney educated me some on it. That said, however, selling it for consumption is where the slope gets very slippery. These are EXactlY the kinds of things we will want addressed. ALSO - I think he can give good suggestions on best ways to proceed on our goals.
Yes - we will need folks to contribute to this. Not sure yet how we can do that. Maybe set up a thing online (there are websites where funds can be collected - looking into this currently)- ANOTHER question I will ask the presenter who I think will be able to give us direction on that too.
I would like to see us be able to get the webinar paid for by as many contributors as can and then advertise to everyone that may want to see it and charge a minimal fee to "attend" to help cover the cost.
I think that AFTER I get the basic info tomorrow and then post it here - then, perhaps people can email me additional thoughts or questions (which many will likely be along the same lines) and then I can spread them for everyone after grouping similar ones together. IF there are TONS more than what is initially offered we can then vote on top additional info asked for. I believe, though, that what the presenter is going to suggest as initial content will likely cover the bulk.

I will post on a few other forums I frequent once you return from seeing your lawyer. These forums are where more of the kratom population seems to thrive and I'm sure they would have some suggestions or questions. Thanks Angel.

OK Friends - I spoke to the attorney who is excited at the prospect of being able to do a webinar that will help folks interested in Kratom to have the truth and facts about it.
He estimates that a webinar would probably need to be somewhere around 2 hours long in order to get everything explained that he feels we need explained and to also have a 30-45 minute question/answer period would cost in the range of $3500. This is right close to the $$ I had thought it may be so I was glad to hear it.
His webinar would present the following;
A) What ARE the actual laws/regulations regarding Kratom?
What ACTUALLY OCCURS with regard to kratom (issues with Customs, FDA etc...)
c) Questions & Answers period (one of our 1st questions could be "What will be the best way to advance the cause of Kratom in the eyes of FDA/DEA etc...)

So - now I need to know;
1) IF you want to proceed in trying to accomplish this?
2) Who amoung you are willing to chip in on the cost?
3) those willing to chip in - HOW MUCH are you willing to COMMIT? **NOTE - you will just be making a committment now - not paying anything yet**
As far as cost and how much you can commit I suggest that you PM me and I will run a tally and report back in a few days of what the interest/committment amounts are for all of us (without names matched to amounts disclosure) to then decide how to proceed.
Spread the word so we can gather info as quickly as possible.

I would suggest that a "suggested donation" amount be set for both simple consumers, and one for vendors.
As a consumer, that's how I see it. After all, some of you are making money by selling to me.

If kratom goes away, I simply stop using an herb. On the other hand, if kratom goes away, vendors go out of business.