Center for Regulatory Effectiveness Kratom DEAKratom’s Quiet Beginnings

I will start this article out by stating that everything you are about to read is only my humble, but expert opinion. I have been in the Kratom business since its inception; I was one of the first vendors to offer Kratom for sale online way back in the early 2000’s. I have seen more than my share, have dealt with everything from trustworthy people, to criminals, to bouts of fake and adulterated Kratom appearing in the marketplace once its popularity started to grow. It’s because of Kratom that we built Wonderland Labs, to test hundreds of Kratom products in the marketplace, to separate the garbage from the genuine article.

With that, the curious path Kratom has taken recently seems clear enough to me, although there is no way to verify it.

Kratom is a product that took such a hold in the marketplace, that over the past few years, it has attracted millions of users. It has always been illegal to sell Kratom for consumption as it is not currently considered to be a GRAS product. A GRAS product is any product that the FDA classifies as “Generally Regarded As Safe”. Also, if a product has been part of interstate commerce before September 6, 1958, it’s considered to be “grandfathered” into the marketplace, as was defined in the Dietary Supplement Health and Education Act of 1994. The Act states;

Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded. That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of DSHEA and FDA regulations. FDA is responsible for taking action against any adulterated or misbranded dietary supplement product after it reaches the market.

This is where the disclaimer on any legally manufactured dietary supplement comes from. (The disclaimer that reads; “These statements have not been approved by the Food and Drug Administration. This product is not intended to diagnose, prevent, or treat any disease.” Since there has been no public evidence of Kratom being sold commercially previous to 1958, the FDA considers it an NDI or New Dietary Ingredient.

NDI’s have to go through a rigorous process of testing that can cost millions of dollars, and mountains of research. By the time Kratom vendors realized this, and before the American Kratom Association was organized enough, Kratom was already placed on the DEA’s “Watch List”.  That means that anyone who wanted to begin the battle of presenting Kratom as a New Dietary Ingredient, would have little chance of success. Furthermore, since Kratom is a natural plant product, no one can apply for that NDI and retain exclusive rights to it. If one company or organization goes through the intensive process of getting Kratom approved as an NDI, then any company on the planet could benefit from Kratom becoming legal for use as a new dietary ingredient.

The Beginning of the End of Kratom

As awareness and popularity grew for Kratom, more and more vendors began to come out of the woodwork. And, as more Kratom vendors appeared, more started to put Kratom into capsule and sell it for consumption. There’s a fine line between offering a product for consumption, and offering a product as a non-consumable. Vendors have to walk this line continuously. And, if the FDA thinks that you’re selling a product for consumption (by putting it into capsules), but claiming it’s not for consumption, they can simply say that you are “misbranding” that product.

This leads to costly product recalls, and an inability to sell that product in the marketplace anymore. This happened with a product called “Viva Zen”, because it was a liquid dietary supplement being sold in convenience and liquor stores across the country. Other seizures have occurred across the country, with a clear focus by the FDA on Kratom products that have been encapsulated or used as an ingredient in dietary supplement drinks.

As popularity of Kratom grew, it started to become too large a problem for the FDA. Their seizures were making little difference in the Kratom marketplace. So, they took a more serious step, and issued a “RED ALERT” (Import Alert 54-15) on the import of any Kratom products intended for consumption. Specifically, the alert stated this:


Notice that the language of the RED ALERT focuses only on “dietary supplements and bulk dietary ingredients that are or contain” Kratom. This is because the FDA only regulates products that are intended for consumption. Kratom has a multitude of uses that have nothing to do with ingestion, such as ingredients in various incense and smoking blends, balms, ingredients in the manufacture of other products that do not involve consumption, as well as legitimate research uses, biological specimens and so on. And, after the RED ALERT came out, we saw several seizures that invoked Import Alert 54-15.

Still, this had virtually no impact on the Kratom industry. More and more companies popped up daily, many of which sold encapsulated Kratom, and for consumption, as well as any other consumable product you could imagine, such as Kratom Tea. I’ve seen many companies set up shop, apply for credit card processing, sell Kratom for a few months, get shut down, and then start the whole process over again with a new name, new website, and new merchant account.

The FDA was trying as best it could, but the Kratom industry had grown out of the FDA’s control and somewhat limited reach. In 2014, two of the largest Kratom manufacturers were raided by the FDA, and their facilities soon shut down. I personally witnessed both, as one occurred in Illinois, and the other in California, north of San Diego.

States Fail to Ban Kratom

By 2014, awareness had grown so large for Kratom, that individual states began to author and enact legislation that banned the sale of Kratom. As one of the original Board Members of the Botanical Legal Defense, we quickly coordinated, set up a website, hired a lobbyist, and dug our heels in to fight legislation state by state. Much to our own surprise, we saw a series of victories, and one of the early victories was in Illinois, where House Bill 5526 threatened to make Kratom a Schedule I substance in the state of Illinois. After an early fight, after mobilizing and heading to the capital of Illinois in Springfield to shake hands and educate our representatives, we got HB5526 amended to make Kratom legal for sale for those 18 and older. That victory wouldn’t have been possible without the BLD.

Similar successes were seen across the country, as each new state tried to ban Kratom.

If the FDA was hoping that individual states would ban Kratom, by mid-2015 they must have realized that it was a losing battle. By early 2016, Kratom was now over a $100,000,000.00 industry, with over 3,000,000 Kratom advocates or users. Clearly this was way out of the capabilities of the FDA to handle on their own, especially with historic shortages of FDA agents. With a marketplace that is estimated to be around $37,000,000,000.00 annually, and upwards of 25,000,000 dietary supplements flooding the market as herbal wholesalers go online, anyone can print package labels from their home computer, get a merchant processing account with a few clicks of a mouse, and put out a finished product in their garage; this is a battle that is getting far too big for the FDA to currently reign in.

In fact, in a recent FDA inspection at my GMP manufacturing facility in Chicago, IL, our agent was from the military! She said that there is such a shortage of agents in the FDA at the moment, that they’re recruiting the military to help out with everything from paperwork to inspections.

With Kratom failing to be regulated at a State level, if I were the FDA, I would be looking at other alternatives to try to reign in this industry.

The FDA Recruits the DEA

In a shocking announcement by the DEA on August 30, 2016, they stated their intention to place Kratom on Schedule I, a place reserved for plants and products with “no medical value.” Clearly, Kratom shows great possibility for medical value, as millions of people had been using it to help manage pain and to help heal their addictions to prescription opiates. In numerous published studies, few herbs have shown such incredible promise as Kratom has, so to arbitrarily place it into Schedule I would be beyond egregious. Heroin and LSD are Schedule I drugs. Kratom has absolutely no place there, especially since 3,000 years of use throughout the world and Asia has failed to produce direct connection to a single death from an overdose of Kratom.

Based on the flimsiest of evidence, and in what is one of the most hasty decisions I’ve ever seen, the DEA stated that Kratom was an imminent threat to public safety and had to be Emergency Scheduled. These are the exact words they used:

The Drug Enforcement Administration (DEA) today announced its intention to place the active materials in the kratom plant into Schedule I of the Controlled Substances Act in order to avoid an imminent hazard to public safety.

But upon closer examination of the notice they placed in the US Federal Register, the only evidence the DEA had for a decision that would have serious and life-changing ramifications for years to come, was Correspondences on file with DEA (dated April 19, 2016), and statistics from the Center for Disease Control. In Factor 4 of the notice, the DEA stated this:

In a 2016 publication, the Centers for Disease Control (CDC) characterized kratom exposures reported to poison centers and uploaded to the National Poison Data System (NPDS) [5] from January 2010 through December 2015. During the stated timeframe, U.S. poison centers received 660 calls related to kratom exposure. Of the calls reported, 487 (73.8%) reported intentional exposure to kratom, and 595 (90.2%) reported ingestion of the drug.

That seems like it could be an imminent threat to public safety, until one puts it into context. here is the context:

  • Poison Control Centers receive 3,000,000 calls per year.
  • The 110 calls about Kratom is only about 0.004% of the total calls.
  • On average, Posion Control Centers receive about 300,000 calls per year for reactions to analgesics
  • Household cleaning products recieve about 100,000 calls per year.
  • Two-thirds of that 0.004% of calls for Kratom were deemed to be “minor” incidents.

What Really Happened?

What I think really happened, is that the DEA had no idea how large the Kratom industry was. They vastly underestimated the pro-Kratom movement, the number of Kratom users, as well as the size of the Kratom industry. After reading through the extraordinarily cherry-picked, and very biased notice they entered into the Federal Register, the truth becomes difficult to deny. In fact, in a discussion with an industry insider who had an attorney in daily contact with the DEA, an agent was quoted as saying; “If we had any idea what the public reaction was going to be, we never would have move to schedule Kratom in the first place.”

And massive was the movement. Not only did the KRatom petition get 137,000 signatures as of this writing, nearly 50 congresspeople signed a letter to the DEA urging them to halt their actions. The Center for Regulatory Effectiveness authored a scathing letter to the DEA, citing several violations that the DEA had committed by making the arbitrary decision to place Kratom into Schedule I on an emergency scheduling basis. This movement to admonish the DEA was a true bipartisan movement, with countless citizens speaking out bravely to make a difference in the regulatory affairs of the government.

In fact, Senator Orrin Hatch (R-Utah), the chair of the Senate Finance Committee, authored a second letter to the DEA, urging them to postpone their plan to Emergency Schedule Kratom. He urged that the DEA “allow both for a public comment period and sufficient time for the DEA to outline its evidentiary standards to the Congress regarding the justification for this proposed action.”

Wow. Maybe the system isn’t as broken as many of us think it is!

In the letter, Hatch intimates that the DEA has overstepped their authority and, although he didn’t come out and say it, acting a rogue agency rather than a responsible government department partially responsible for the safety of the American people. Once the DEA realized how deep they were in, once they realized that they had a massive fight on their hands, and once they realized that perhaps they had made a hasty decision regarding the safety of Kratom, it became all about saving face.

The True Imminent Threat

ALSO, something people aren’t really talking about is what the true threat to public safety truly is in relation to this issue. Is a few hundred calls to the CDC an imminent public threat, or are millions of people who rely on Kratom, some of them addicts in recovery, some of them who have weaned themselves off of prescription medication at a far greater threat if Kratom is removed as an option for them?

This isn’t even considering the countless businesses who sell Kratom, all of their employees, and over $100,000,000.00 getting put back into the American Economy, helping, in no small part to reduce unemployment, and help directly help our economic recovery in these still trying times.

And, as has been witnessed by prohibition movements in the past, prohibition typically does far more harm than good. I had hoped that the DEA had learned its lesson from failed prohibition in the past. Implementing prohibition

With all research effectively halted for Kratom, a potentially critically important aid to help beat the current opiate epidemic would be a tragedy of massive proportions. If there is a natural plant product that has built in properties preventing it from being abused on the level that prescription opiates are being abused, then isn’t that something of infinite value? Doesn’t the hope of a natural, non-patentable product from Mother Nature with the ability to save literally countless lives seem to vastly outweigh any negatives that have currently been witnessed?

The imminent threat to public health and safety is forcing Kratom onto the Black Market and halting all research into its use as a medicine.

Kratom is not going to go away. If Kratom is forced underground markets, what will happen in the past will happen again: Prices will rise, quality will go down, and violence will break out. Millions of people will be turned into felons overnight, and will be left with the difficult choice of seeking out a safe and effective alternative to often dangerous and expensive prescription medication, or breaking the law to find Kratom on the streets. This may sound alarmist and dire, but I don’t think so.

Millions of Kratom users aren’t suddenly going to wash their hands of Kratom and seamlessly move on with their lives.  There will be far-reaching repercussions that will last for years. The DEA is already struggling (and losing) the Drug War. Do they really want to add yet another plant to that long and growing list of illegal plants? The fact that Cannabis is still a Schedule I substance, despite over 50% of Americans of all walks and parties want to legalize it, is mind-boggling. The fact that credit card companies have so much power that they closed every merchant account that was selling a completely legal product (Kratom), but allowing the sale of munitions, gambling, cigarettes, alcohol is beyond scary.

I’m still elated at the news that the DEA decided NOT to make Kratom into a Schedule I substance today. It makes me realize that we, the people can and did make a difference. It’s amazing to know that organizations like the Botanical Education Alliance, the American Kratom Association, the Center for Regulatory Effectiveness, actually were able to organize and produce a positive result in an organization as large as the Federal government.

The battle is won, but the war is far from over, as Kratom still remains illegal to consume. All of the previous regulations are still in effect, the IMPORT ALERT is still in place, and any company who sells Kratom for consumption (especially in capsules or in a drink) are still open to the same raids and regulation that was in place before this victory. We still have a lot of work to do, but for me, the fact that the door is still open for Kratom, that research may be able to continue unhindered is beyond gratifying. I personally think that Kratom could be one of the most effective weapons we have against the opiate epidemic, and am looking forward to what the future brings in relation to it.

One thing I know for sure if if the mainstream public didn’t know about Kratom before, they’re certainly going to know about it now. I don’t yet know what that might mean for the Kratom marketplace, but I am certain it will be quite an incredible ride over the next month or so.

If you’re interested in purchasing lab-tested Kratom, I fully endorse ShamansGarden; one of the original providers of genuine Kratom. As of this writing, they have a celebratory sale and are still selling their Kratom products at near-wholesale prices. With a 3rd party lab that focuses on Kratom testing, ShamansGarden has profiles over over 300 vendors and their KRatom products, 25% of which are offering bunk Kratom. Choose wisely, and don’t forget that the fight is far from over.