As I clicked on the Zoom video in anticipation for an interview with American Kratom Association (AKA) Senior Fellow on Public Policy, Mac Haddow, it was immediately apparent how involved and dedicated he is about the United States. Sitting tall in front of his American and Virginia State flags, along with family photos, it was obvious that he had a story to tell. We’re here to share Haddow’s story with you, and think you’ll be equally impressed on how he became so heavily involved in the battle to keep kratom legal.
In order to fully understand the throes of the kratom battle, it’s detrimental to look at the history of the industry of supplements and vitamins as a whole, who have quite literally faced mirrored challenges.
Where It All Began
Haddow was first introduced to the world of dietary supplements and vitamins in 1976, when he formally began working in politics.
“I ran Orrin Hatch’s campaign for the United States senate the first time he ran,” Haddow told Top Extracts. “And he was a personal fitness and health food nut.”
It was at this time that Haddow began learning why Hatch was so interested in supplementation and health in general. “It was one of the areas he was very interested in,” he explained, “and became a leader in the United States Senate on these kinds of issues.”
After leaving Hatch’s staff as a consultant, Haddow was hired to work on Ronald Reagan’s campaign. He was then offered a position at the Department of Health and Human Services (HHS) with the Reagan administration, and “ended up as the Chief of Staff there.”
“I got my first real exposure to the FDA’s insatiable desire for regulatory control over every aspect of product sales of Americans,” Haddow stated. “They have no boundaries.”
One of Haddow’s primary responsibilities was to “clear all congressional testimony that was made before a congressional committee by any agency official that was under the supervision of HHS, and the FDA was one of those.” He continued, outlining the following example:
I got a testimony that was proposed for a hearing that was being held for then-Senator Bill Roth from Delaware, and he was on a tear about Herbalife products. Herbalife was a weight management product base. But the real controversy at the time was that they sold through multi-level marketing, which was a relatively new marketing scheme. It was just being introduced at that time, and the FDA hated it.
The reason they hated it is because these independent representatives who weren’t employees of the company would go out and make impermissible health claims. And the FDA was right about that, they really shouldn’t have been able to do that. But because it was a new marketing program, they hadn’t contemplated how to regulate it or appropriately. The Federal Trade Commission (FTC) was really the entity who had the control over that kind of thing, and the FDA had some jurisdiction because of the health claims. So it was brand new to them, and their reaction was, ‘Well, let’s just regulate it out of existence.
Senator Roth, according to Haddow, was “anti-Herbalife” due to the lack of jurisdiction surrounding the products, and justifiably so. The ensuing testimony talked about “seven deaths” that were associated with the company’s products.
Being thorough was not only Haddow’s job, but clearly also his passion. His due diligence led to him requesting autopsy reports for each of the seven cadavers.
“I said, ‘I need to see the data,’” Haddow stated. And so they provided the autopsy reports for each. When he met with the scientists who were set to testify in regards to the death claims attributed to Herbalife, he sensed right away that something was amiss. “I could tell they [the scientists] were uncomfortable,” Haddow said. “And that was sort of a red flag to me as to why they would not be in a position to defend whatever they were going to say in front of a congressional hearing.”
Haddow specifically asked the scientists to first explain “the best (autopsy report to support the claims) right up front.” The example he was given is unfathomable, to put it mildly. He explained:
It was a 430 pound morbidly obese woman who was under a physician’s care in Florida. And her cardiologist specialist said, ‘You’ve got to lose 40 pounds, and if you lose 40 pounds then I can take you off of this cardiac medication that you’re on’ that had some unwanted, adverse effects.
The woman agreed with her friend, and decided that she would begin taking Herbalife products, only she decided to lose the weight at a much faster rate. Her thinking was that if she took quadruple the amount of the Herbalife products, that she could subsequently lose 40 pounds in a month, rather than taking four months. At the same time, she also decided to take herself off of her prescribed cardiac medication. As one can imagine, this didn’t end well, and she passed away due to a heart attack.
Haddow immediately questioned how on earth the woman’s death could be attributed to Herbalife. To him it was clear that she didn’t go about losing the weight or taking herself off of the heart medication in an intelligent manner. In response to his argument, Haddow said he was told “…She would never have gotten down that path had she not been induced to buy and to follow the protocols of Herbalife.” The company never recommended that she quadruple the recommended dose, or take herself off of her prescription, so why should they be blamed?
The same could be said for anyone who has lost their life after taking more of any medication, prescription or not, than directed. Yet we don’t hear about threats of Tylenol being taken off of the market, even though there are nearly, on average, 500 deaths per year due to overdoses associated with the drug.
“They said she was misled by these people and therefore we should get rid of Herbalife products,” Haddow continued. “I said, ‘well that one doesn’t sell to me and that’s your best one…tell me the next one [autopsy report].’”
The report that followed was even more puzzling than the first, in terms of Herbalife being blamed for a death. This autopsy involved a 19-year-old male who “stepped off a curb and was hit by a bus and killed.” Did you just ask yourself how on earth Herbalife could be blamed for this one? Haddow said he was told the company was blamed because the products “evidently” made the man “impaired.”
In addition, the man’s autopsy showed that there was an illicit drug in his system at the time of death.
“So you don’t think the impairment came from the illiegal drug?,” Haddow asked the scientists. “And you think it’s really because he was on Herbalife and was woozy because he was losing weight and not eating properly?”
The illicit drug found in the subject’s system, as one might guess, was known to cause cognitive impairments. Yet they single handedly blamed Herbalife. Seems nearly unbelievable being an outsider looking in. But in fact it was the true reality that Haddow was up against.
‘Hell Bent on Getting Rid of All Dietary Supplements’
A crusade against the world of supplements didn’t stop with Herbalife, according to Haddow. In fact, he described the issues as “churning into the early 90’s.”
“I said, ‘Senator Hatch (and this is a Replubican administration and he’s a Republican senator), you don’t want this testimony in front of your committee,” Haddow stated, steadfast and direct with his approach. ‘Because I’ve looked behind each one of these things and I had our investigators come out, and none of it stands out, and it’s all bogus.’ So I laid it out to him, and he agreed with me.”
However, the challenge was far from over. Haddow knew he had to stand up for what was right and just, and he did just that as the supplements industry as a whole was facing a complete ban.
“The FDA, at that point, were hell bent to get rid of all dietary supplements and vitamins,” Haddow stated. It was then proposed that it be “required for all of those products in that category to to be classified as unapproved drugs, and to be required to go through the new drug approval process.” Haddow continued:
The FDA knew that was the end of them, because no one was going to make the investment of $3-5 BILLION for each product, and go through the five to ten year review period. So they knew that was the end of the industry. So we had this big battle going on at Congress, and it was interesting because for the first time in the history of the Congress where a switchboard got shut down because of phone calls by outraged consumers.
Senator Hatch then proposed a bill, “The Dietary Supplement Health and Education Act (DSHEA)” that was being “resisted by the FDA,” explained Haddow.
“So there was this battle going on, with Congress getting caught in the middle with all of these consumers.” The result? A unanimous vote to pass the DSHEA Act. The people spoke, and their voices indeed made a difference in the government’s “anti supplements narrative.” It’s the reason why you and I are still able to go to any drug store and purchase supplements and vitamins.
It’s important to note that in some instances, according to Haddow, there were “dietary supplements that were poorly formulated or adulterated that did kill people…but it wasn’t the dietary supplement” itself.
This brings us to the next point, how the herb kratom was initially made illegal in some states using similar outlandish claims and allegations, and what Haddow and the AKA are doing to fight it.
Kratom Enters the Picture
As many who are reading this already know, there’s still a huge battle going on in the world of supplements, and one of the largest of them all involves the legality of kratom. And for good reason, considering the millions that it appears to help. When you look at each detail, or should I say autopsy, it’s in essence the same story of Herbalife. The only difference being the product itself.
In 2016, the U.S. Food and Drug Administration (FDA) recommended scheduling kratom as a Schedule 1 drug to the Drug Enforcement Administration (DEA). As the FDA doesn’t have the authority to schedule, they handed the proposed order to the DEA, who would be able to do just that.
This was all triggered by a 2009 report of deaths supposedly that were apparently linked to kratom. Specifically, the FDA focused on the deaths of nine people in Sweden who lost their lives after consuming Krypton, which was used to adulterate kratom from its natural form. Krypton contained a highly dangerous substance known as O-desmethyltramadol, a synthetic opioid.
If this sounds eerily similar to the Herbalife case already, you’re right on track. It was not in fact kratom in its pure form that was to blame for these deaths, but an adulterated product.
The deaths, according to Haddow, “got the attention of every public health official in the world.”
“As a result, there were some countries in Europe who banned kratom,” said Haddow. “We had the FDA running with a misinformation campaign, and they convinced six states to ban kratom between 2009 and 2016.” He continued:
And they [the six states] took the bait and banned kratom. What the FDA didn’t tell, and which most public officials around the world didn’t take recognition of, was a 2012 peer reviewed published article about those nine deaths from a group of Swedish researchers who looked at each death. And they said, ‘what’s the commonality in all of them?’ Well, kratom was it. Except that the kratom that was ingested by those nine people who died was adulterated with a toxic dose of O-desmethyltramadol, which is a chemical that’s used in the powerful opioid ‘Tramadol.’ So it wasn’t kratom that killed these people. If you took that same dose of O-desmethyltramadol and put it into your morning coffee, you’d be dead within minutes. It’s ridiculous for this to have happened, but the FDA didn’t care about that.
When looking at scientific reviews, the FDA has a duty to look at all of the scientific literature, Haddow explained. With anything that’s peer-reviewed and published, they must look at each and every publication, but failed to reference the study that outlined the true cause of the nine deaths. Even though they’re legally obligated to do so, they failed to do so. Just to reiterate this point, this isn’t a small town governmental agency we’re talking about, it’s the FDA. However, somehow they “just ignore it,” according to Haddow.
Having a great reputation in the lobbying community in regards to dietary supplements, Haddow was called on by the AKA leadership when kratom was set to be scheduled.
“You have zero chance, none, of getting the DEA to withdraw the scheduling of this,” Haddow said he told the AKA. As can be expected, he had his reasons.
“One, when the DEA puts the notice to schedule, they just don’t withdraw,” Haddow recalled. “Secondly, the FDA and the DEA collaborated to use a very narrow section of the Controlled Substances Act, ‘The Emergency Power Section,’ that allowed them to enact without any public comment period on the ban.
How could the DEA declare an emergency ban on kratom without a comment period? It was due to “part of a law that was enacted to take street drugs off of the street,” Haddow explained. Kratom, a street drug? That’s precisely what the DEA was describing kratom as, despite all of the literature that proved otherwise. That part of the law was designed to take dangerous emerging substances “that are killing people” off of the streets immediately.
In March 2018 the FDA announced “44 reported deaths associated with the use of kratom,” which included the misappropriated nine deaths that occurred in Sweden.
In the report, the FDA also included the deaths of 23 people who had a variety of substantial illicit drugs in their systems. Included were such substances as heroin, cocaine, methamphetamine, and pharmaceutical medications, including opiates. You guessed it, kratom was blamed.
The FDA cited 36 official deaths as being attributed to kratom use, which left eight unknown cases. To date, there has been no other evidence to support the eight deaths, despite the FDA stating in 2018 that they were “continuing to review the newly received reports and will release those soon.”
Kratom Enthusiasts Unite for the Good of All Who Benefit From the Herb
The scientific evidence is mounting that kratom's alkaloids present in the natural plant DO NOT HAVE ABUSE POTENTIAL.
The latest research from the NIDA-funding research team conclusively proves FDA is wrong on the science. https://t.co/fJywdMAqW0
— Mac Haddow (@HaddowMac) November 1, 2020
Not realizing at the time just how powerful kratom supporters in numbers can be, Haddow didn’t believe that kratom stood a chance against the DEA’s intent to schedule.”
“Little did I know, the day after the scheduling notice was published, that it started a grassroots movement,” he said. “You had 140,000 plus signatures that were submitted on a petition to The White House on the whitehouse.gov website. That got the attention of a lot of people on the policy side, and caused a lot of problems for the FDA.
While there was no official comment period open to debate the proposed ban of kratom, “the DEA received more than 6,000 phone calls and emails objecting to it.” It was then that the people had the DEA’s attention, according to Haddow:
They didn’t even know what kratom was. These people at the DEA were just reacting to what the FDA told them. And they work with with them all of the time, they trust them, and said ‘ok we’ll do it.’ And they had no idea from a policy perspective what they were dealing with. Suddenly they see all of these people who are outraged.
On October 13th, 2016, the DEA did the unthinkable. They withdrew the notice of the intent to schedule kratom, all due to the dedication of those who stood up for the plant they so strongly believed in. In simple terms, the DEA then asked the FDA to put their money where their mouth is.
The DEA requested the FDA to produce an expedited, full eight factor analysis for scheduling under the Controlled Substances Act (CSA) by December 1st. The analysis, according to Haddow, “is a listing of all of the public documents that are available that would prove the case that the FDA was trying to make about the addiction liability and the public safety risks of kratom.”
The AKA got straight to work, accumulating 23,232 letters and comments that were sent during the formal comment period to the DEA. “Of those who commented, 99.1 of those were overwhelmingly opposed to it,” Haddow told Top Extracts. “You had kratom consumers, medical professionals, First Responders, veterans, law enforcement people…all saying, ‘don’t do this, this is a mistake.’ That was powerful.”
It was at this time that Jack Henningfield, who previously worked at the National Insitute of Drug Abuse, and who had done numerous eight factor analysis’ on drug substances, volunteered on a pro bono basis to do an eight factor analysis. He completed it prior to the deadline set by the DEA, and submitted his findings.
“His conclusions were, like many substances that are schedulable, you might be able to make the case for scheduling of kratom’s alkaloids,” Haddow stated. “But they really weren’t great candidates for scheduling, and then he listed all of the reasons for that.” Haddow elaborated:
People are saying that they are effectively using kratom to manage the withdrawal from opioid addiction, and many of them are using kratom as a way to manage acute or chronic pain as a replacemetn for opioids. He said, ‘in just that fact alone,we ought to leave this on the market because if you ban it, you will create a black market.’ And the black market is rife with adulterated products that continues to be a problem today.
The FDA’s eight factor analysis, despite having a deadline of December 1, 2016, wasn’t submitted until November 17, 2017.
In February 2018, after the DEA “wasn’t reacting” to their eight factor analysis, the FDA held a press conference. At the conference, then Commissioner Scott Gotlieb falsely claimed kratom to be an opioid that was dangerous and killing people. While the plant acts on mu-opioid receptors in the brain (as does St. John’s Wort and chocolate, among many commonly consumed products), it does not produce a high, nor has any death been attributed to kratom alone.
“The question became, what is kratom’s activity?,” Haddow posed. Dr. Andrew Kruegel from Columbia University in New York explained it as “a light switch,” he said.
“When you take kratom and it starts to have that agonist effect, it’s like turning off the light switch because kratom doesn’t travel to the respiratory system, which accounts for the majority of the opioid overdose deaths in America. People die from an opioid overdose because you’re literally suffocating because of how it impacts your respiratory system.”
The Do’s & Dont’s of Marketing Kratom, & Why It’s Vital to Never Make Medical Claims
In order to preserve kratom’s legality, and to aid with legal measures being taken in banned states, it’s absolutely vital that it is never marketed as making medical or therapeutic claims.
Kratom, as defined by the FDA, is properly classified as a food under the provisions of the U.S. Food Drug & Cosmetic Act.
“It’s one thing to put something in the product and then by word of mouth people start talking about it,” according to Haddow. However, if the therapeutic or medical claims are made by a kratom or other supplement vendor, they “are aggressively monitored and prosecuted by the FDA, and they should be.” He continued:
There are bad actors out there. They’re saying such things as ‘buy our kratom and it will cure your pain, it will solve your arthritis, it will solve your gout’…whatever they want to say. Those are therapeutic claims that should not be allowed on the market and we (the AKA) support the FDA taking them off of the market. If you’re using a [labeling] claim that is impermissible or illegal to sell your product, you should be stopped. We agree with that.
When asked if the AKA’s efforts, such as Truth in Labeling, Good Manufacturing Practices (GMP) and the Kratom Consumer Protection Act, are proving to help get vendors aligned in operating the right way when marketing kratom, or if they are seeing a reduction in “bad actors,” Haddow said “there’s a substantial reduction” in those who are adulterating products. He further explained that “in addition to the FDA being aggressive and our turning them in,” that they’re also seeing a signficant reduction in those making therapeutic claims.
Haddow emphasized the GMP program, which was created for consumers to be able to make educated, informed decisions regarding who they purchase their kratom from.
The FDA complains that kratom vendors are making impermissible therapeutic claims to consumers. Some are, but the FDA is letting it happen when they have the duty to stop this illegal activity. Congress gave them the authority to stop bad actors, not just complain about them.
— Mac Haddow (@HaddowMac) October 1, 2020
“Every manufacturer has to be compliant with the GMP standards for food production. And if you cannot, if you cannot maintain those standards, you can’t be in the business…it’s about compliance and protecting public safety under the Food, Drug and Cosmetic Act, which we fully support. If you’re compliant, then yes, you’re in this community. If you’re not compliant, not because you’re a bad person, but you’re refusing to invest in or to build your business in a way that allows you to be compliant, then yes we have a problem with that.”
Moral of the story? If you’re looking to become a kratom vendor, do your research first and foremost, and make the necessary plans to become compliant before opening. If you’re not willing to do this, it could ruin the kratom industry for everyone, those who have fought and continue to fight with everything in them to ensure it is and will continue to be available. Take the high road by conducting your business in the most ethical way possible. Not only will you inevitably prosper by taking the time to do so, but you will be helping to preserve the plant that countless people benefit from!
Next time you head to your local convenience store to pick up your regular stock of vitamins and/or supplements, or because you feel a cold coming on, think of all of the legislative efforts that have occurred to make it possible! Without the dedication of lobbyists such as Haddow, the entire industry would be non-existent.
We cannot thank you enough for your previous and continued passionate efforts to protect the world of kratom and other supplementation, Mr. Haddow. We look forward to following your journey. You can follow Haddow on Twitter @HaddowMac.
Get Involved With Kratom Efforts in Your Community!
As you can see from the above snapshot of Haddow’s courageous story, power really does come in numbers. The people refused to back down, even when it looked as though there was no hope left for kratom…and it worked to save the plant, for now. However, that doesn’t mean the fight is even close to over, and you can make a difference by using your voice! Looking to get involved with kratom efforts in your own community and/or state? Help is always needed and appreciated, and you can begin the process here.