According to Faith Day, the center's creator and operator, FDA inspectors visited five times over the span of a week beginning in January based in part on positive comments she made about kratom in a video on view here. In addition, agents seized products — although a document she provides claims that the samples were "provided at no charge."
"When I was living in my car doing drugs, I never once thought I'd be dealing with the FDA," says Day, a former heroin addict who used kratom to help kick the habit — a story that echoes other accounts about the herb's addiction-fighting properties recently shared in this space. "But I'm not really nervous, and I'm not scared of jail."
Why not? "I was arrested when I was eighteen for multiple felony charges, and I was on probation for seven years," Day reveals. "Standing in front of a judge when you've committed a crime is one thing. But I'm not going to be nervous of them threatening to take my freedom because I want to help someone."
Day is very up front about her past experiences. On the website for Clean Kratom Wellness Center, located at 1520 Simms Street, she writes, "My name is Faith Day. For the past ten years I was a drug user. I had no formal education, was in and out of jail for drug related issues, and was never able to lead a productive life. With the power of Kratom, my life was changed. I am dedicated to securing a legal future for the industry. I love what I do, and I love my team. We stop at nothing to provide only the best, batch tested, quality Kratom in the State of Colorado and Surrounding areas. I am 25 and now am the proud owner of 4 business ventures. None of this was possible as a heroin addict, but that's all behind me now. Because I got #Clean."
A few months back, after penning this introduction, Day sold the center to an investment company. However, she still runs the day-to-day operation, which she says "mimics an early pot shop in California when they were first opening."
She adds that after launching last year, "we grew really successful and gained 6,000 followers on Facebook. But then the FDA came in and said I was under investigation for making medical claims."
In his "advisory about deadly risks associated with kratom," issued on November 17, 2017, three days before Denver prohibited the herb for human consumption, FDA Commissioner Scott Gottlieb describes the substance as "a plant that grows naturally in Thailand, Malaysia, Indonesia and Papua New Guinea. It has gained popularity in the U.S., with some marketers touting it as a 'safe' treatment with broad healing properties. Proponents argue that it’s a safe substance largely because it’s a plant-based product. The FDA knows people are using kratom to treat conditions like pain, anxiety and depression, which are serious medical conditions that require proper diagnosis and oversight from a licensed health care provider. We also know that this substance is being actively marketed and distributed for these purposes."
At Clean Kratom Wellness Center, Day insists that she doesn't cross this line. Instead, she says, she runs the facility on a membership model — "We don't sell to the public," she points out — and sticks closely to the standards established in Colorado by the Colorado Natural Health Consumer Protection Act, signed into law in 2013.
The original bill's summary says it "provides that a person engaging in traditional, cultural, complementary, or alternative healing arts and health care treatments who makes specified written disclosures to a client and who does not engage in specifically prohibited acts is not violating the practice acts regulating licensed, certified, or registered health care professionals."
The summary adds that the measure "exempts from the definition of 'practice of medicine' the rendering of complementary and alternative health care services if performed consistent with the requirements of the bill."
During one FDA visit, Day mentioned the Colorado Natural Health Consumer Protection Act to an inspector: "I said it gives us safe-harbor exemptions. We are legally allowed to open any type of herbal establishment as long as we're not practicing regulated medicine. And they didn't know anything about it."
However, the agents were very well acquainted with a video starring Day that won a contest staged by the American Kratom Association last year — and no wonder, since she specifically mentions the FDA in it. Here's the clip:
In the video, Day discusses her prior use of opioid pills and heroin, as well as an online search for ways to get off them that led her to kratom. "I mixed it with orange juice," she points out, and within ten minutes, "I stopped seizing, I stopped shaking, dry-heaving. I wasn't withdrawing anymore." She subsequently talks about "taking the FDA's safety concerns and kind of breaking them down into why are they saying this is illegal, why are they saying this is unsafe. I didn't really understand, so I just kept doing a lot more research."
What she learned allayed her fears, she allows: "The fact of the matter is, this plant literally helped me go from one end of the spectrum to the other."
Some of Day's statements in the video were quoted verbatim in an affidavit that she refused to sign — "and if you don't sign it, they don't give you a copy," she says. But she's got other paperwork from the visits, including the aforementioned assertion that seized products were actually given to the inspectors free of charge and another that outlines possible punishment for violations of the federal Food, Drug and Cosmetic Act consisting of "fines and/or imprisonment up to one year." Moreover, the document goes on, "felony convictions, which apply in the case of a second violation or intent to defraud or mislead, can result in fines and/or imprisonment up to three years."
The following fines are applicable for each offense:
• Up to $100,000 for a misdemeanor by an individual that does not result in death.
• Up to $200,000 for a misdemeanor by a corporation that does not result in death.
• Up to $250,000 for a misdemeanor by an individual that results in death, or a felony.
• Up to $500,000 for a misdemeanor by a corporation that results in death, or a felony.
The first time inspectors stopped by, Day recalls, "they said they were just getting information, and I could continue doing business as normal. But then they kept coming back. I asked, 'Am I in trouble? What's happening?' They said, 'We don't know.' I kept asking, 'How do you have regulation over this? Because I don't advertise it for any kind of intended use.' And they said, 'We know otherwise.'"
Nonetheless, Day refuses to be cowed by this implied threat.
Day points to a line in an FDA document saying that samples were "provided at no charge."
Courtesy of Faith Day
She also maintains strict quality control over her kratom supply and actually advocates for thorough consumer-protection rules in Colorado: "I don't think kratom should be sold in head shops and places of that nature because of how delicate it is, and because you don't know what you're getting there. We've found e. coli in kratom before, and parasites, bugs, all kinds of stuff like that. So I think state regulations should be put in place. If they could come up with the same type of testing and policies like they have for marijuana here that fit kratom use, I think it would be a great move in the right direction of keeping it legal."
These days, Day doesn't personally use kratom; now that she's off opiates, "I don't see the point of it for me." But her father does — "He broke his neck in a car accident," she says — and she believes strongly that it can benefit a wide range of other people, too.
Furthermore, she's among the many kratom advocates convinced that the FDA's antipathy for the herb comes down to Big Pharma dollars and cents: "It's a medicinal plant the government can't patent, and they don't want it being sold, because companies can't make any money off it."
A few weeks have passed since the FDA's last stop at Clean Kratom Wellness Center, but Day knows that could change at any moment. "We're in a weird gray area right now," she feels. But that doesn't mean she's going to stay silent.
"This is literally the same battle that marijuana had to fight," she says. "People had to go to jail so that people could go across the street and buy a joint. And I know I've got to start doing something — pushing state representatives or whatever we can do. We need to unite this industry."
