The U.S. Drug Enforcement Administration (DEA) recently announced its plans to classify kratom's alkaloids (mitragynine and 7-hydroxymitragynine) as a Schedule 1 controlled substance effective September 30, 2016. This move would make kratom illegal – in the same category as cocaine and heroin – for a minimum of two years, while the DEA investigates its safety. And at any time during that two-year timeframe, kratom's Schedule I status could be made permanent.
This news has been heartbreaking for many kratom users, who utilize this unique botanical for a wide range of ailments, from treating opiate withdrawal symptoms, to self-treating chronic pain, relieving the effects of anxiety and depression, and combatting lethargy, while providing a bit of euphoria. Kratom's effects are very diverse and there is no single botanical that can serve as an effective kratom substitute.
Many have become resigned, feeling helpless and hopeless when it comes to keeping kratom legal. But there is reason for hope! In fact, a recent letter issued by the Center for Regulatory Effectiveness (CRE) offers several rays of hope. There are also a few additional developments that offer further reason to believe in the possibility that kratom could remain legal beyond September 30, 2016. In fact, the CRE is calling upon the DEA to take several actions, including delaying the Schedule I classification of kratom until July 1, 2017.
Watchdog Group CRE Investigating Pending Kratom Ban; Urges Action
The CRE has sent a letter to acting DEA administrator Charles P. Rosenberg, informing him that “when 100,000 members of the public express outrage with a regulatory decision, it deserves a second look. Consequently, CRE, in its role as a nationally-recognized regulatory watchdog, is going to investigate this matter.”
The CRE has reportedly received hundreds of letters, written by kratom advocates just like you who took the time to share your experiences with kratom. And your voice has been heard!
The CRE is now calling for The Office of Information and Regulatory Affairs (OIRA) parent agency, the Office of Management and Budget (OMB), to take action. This agency has the ability to intervene with regulatory agencies such as the DEA. The CRE cited “a sharp disagreement among a number of federal agencies” as grounds for the proposed intervention. The CRE wrote, “If there were ever a time for an OMB intervention, this is it.”
The Center for Regulatory Effectiveness cites several compelling arguments in favor of kratom.
One point of contention surrounds the omission of relevant kratom research, published in the peer-reviewed neuroscience journal Brain Research Bulletin. Notably, the Principal Investigator of another federal agency (the National Institute of Child Health and Human Development).
The study revealed that, “While several cases of toxicity and death have emerged in the West, such reports have been non-existent in South East Asia where kratom has had a longer history of use. We highlight the possible reasons for this as discussed in the literature. More importantly, it should be borne in mind that the individual clinical case reports emerging from the West that link kratom use to adverse reactions or fatalities frequently pertained to kratom used together with other substances. Therefore, there is a danger of these reports being used to strengthen the case for legal sanction against kratom. This would be unfortunate since the experiences from South East Asia suggest considerable potential for therapeutic use among people who use drugs.”
What's more, the National Institute of Health (NIH), the National Institute for Drug Abuse and the National Center for Research Resources all issued grants to researchers at the University of Massachusetts Medical School and the University of Mississippi to study kratom's beneficial properties.
In fact, the studies were so compelling and well-received by the medical and scientific communities that the universities reportedly applied for patents!
The CRE points to these facts, arguing that the “DEA is obviating another agency's research that was conducted with appropriate funds. With its action, DEA is also obviating the progress and promise of kratom research to boosting the American bio-sciences industry.” On this basis, the CRE calls upon the OMB to “reassert itself with respect to the regulatory actions of the agency.”
But it doesn't end here.
CRE Calls Kratom Ban a Violation of the US-Canada Regulatory Cooperation Council (RCC) Agreement
The DEA's move to make kratom's alkaloids Schedule I substances stands in sharp conflict to Canada's position on kratom. Health Canada classifies kratom as a permitted National Health Product (NHP). This is quite problematic when you consider that in recent months, the U.S. Food and Drug Administration (FDA) ruled that Canada's food safety system is “comparable” to that which is in place in the United States.
The FDA has been working with Canadian officials to develop the US-Canada Regulatory Cooperation Council (RCC) “in which the countries intend to better align their food safety regulatory systems, reduce unnecessary duplication, enhance information sharing, and to the extent possible, leverage resources so that the agencies can better meet their public health objectives.”
The DEA’s action undermines the RCC in a very problematic way. The dilemma comes into sharper focus when you realize that the US-Canada Regulatory Cooperation Council established a new process for dealing with substances like kratom.
Under the new plan, kratom (and any other substance) would need to go through “a notice-and-comment process in both the US Federal Register and in Canada Gazette...The DEA’s efforts to place kratom into Schedule I without going through a notice-and-comment rulemaking [process] is a clear and flagrant abuse of discretion.”
The CRE added, “...Since kratom is a legal product in Canada, its scientists would have acted if in fact an imminent threat to public health of existed. Second, Canada choosing not to take prohibitory action concerning kratom is underscored by a similar posture at the US Department of Agriculture. In its own extensive studies of kratom, the USDA did not note any 'imminent hazards' posed by its homeopathic uses."
The CRE also pointed to “the likelihood that a ban on kratom in the United States would create an environment for transnational crime,” adding that, “It would behoove the DEA to spend as much time on the criminal implications of its position as it did on the claimed health consequences.”
And this isn't the end of the story. The CRE has found fault in other areas as well.
CRE Claims the DEA Violating the Information Quality Act by Failing to Designate its Schedule I Kratom Classification as a Highly Influential Scientific Assessment (HISA)
The Center for Regulatory Effectiveness is arguing that the DEA violated the Information Quality Act by failing to designate this move as a HISA – a highly influential scientific assessment.
A HISA is defined as follows: “A scientific assessment is considered ‘‘highly influential’’ if the agency or the OIRA Administrator determines that the dissemination could have a potential impact of more than $500 million in any one year on either the public or private sector or that the dissemination is novel, controversial, or precedent-setting, or has significant interagency interest.”
The CRE argues that kratom's Schedule I classification is both controversial and it holds significant interagency interest.
Notably, in addition to the DEA, the OMB (Office of Management and Budget) both have the ability to designate a scientific study as being a highly influential scientific assessment.
CRE: Kratom Schedule I Listing Should be Postponed Because There is No Imminent Hazard
The Center for Regulatory Effectiveness further argues that per guidelines set forth in The Controlled Substances Act, there is no imminent threat associated with kratom.
The CRE explained, “Kratom has been in use for decades, if not centuries. What compelling documentation does the DEA, a law enforcement agency, have in its possession that would support a finding of an imminent hazard? DEA did present arguments in the Federal Register in which they claim kratom poses a threat to public health, but none so convincing that it is an imminent threat to public health. The public, including a wide range of experts, should have been given the opportunity to comment on DEA’s findings. The DEA chose to bypass the preferred listing process in the Controlled Substances Act, which allows for public comment, by claiming that kratom is an 'imminent hazard.' By taking this action without providing sufficient detail of the factual predicate justifying its determination that kratom is somehow an imminent hazard, the DEA inappropriately revoked any rights of the public to comment on the agency's findings.”
Additionally, the DEA's noticed in the Federal Register failed to even categorize kratom properly, calling mitragynine and 7-hydroxymitragynine “opiates.”
CRE Calls Upon DEA to Delay Making Kratom a Schedule I Substance
The Center for Regulatory Effectiveness concluded its letter to the DEA administrator by calling for several actions, which included the following:
· Extend the effective date for placing kratom into schedule I until July, 1, 2017;
· Open a Federal Register notice-and-comment proceeding on placing kratom into Schedule I and inform the public that the DEA’s proposal is a “significant regulatory action”;
· Submit the proposed listing to OMB for review;
· Inform the US-Canada Regulatory Cooperation Council (RCC) via the OMB of the DEA’s intent to place kratom on Schedule I and seek its comments; and
· Conduct an interagency peer review of DEA’s science which lead to a Schedule I listing of kratom as required by the HISA requirements of the Data (Information) Quality Act.
The CRE has also requested a copy of a May 2016 letter in which the DEA stated it's plans to make kratom a Schedule I substance. To date, that letter has not been made public so the CRE has requested a copy.
In all, the CRE has made a very strong argument and the organization's calls for action should give hope to kratom enthusiasts and other proponents. To view the original letter visit http://www.thecre.com/forum11/wp-content/uploads/2016/09/CRE-DEA-Kratom-1.pdf.
There is also some additional encouraging news.
WhiteHouse.gov Kratom Petition Gathers 100K+ Signatures
As soon as the DEA's move hit the news, a petition surfaced on WhiteHouse.gov, asking the White House to intervene. As of Monday, September 12, the petition had received over 117,000 signatures – far beyond the 100,000 signatures required to elicit a response from the White House.
The petition highlights the fact that once Alabama banned kratom, opiate usage and opiate-related deaths increased significantly in this state. What's more, numerous studies and anecdotal evidence suggest that kratom does, in fact, have beneficial effects – it is not the dangerous, deadly drug that has been described by the DEA.
If you would like to sign the petition, visit https://petitions.whitehouse.gov/petition/please-do-not-make-kratom-schedule-i-substance
Pro-Kratom Activities Underway in Washington DC
The American Kratom Association has co-organized a peaceful march and protest in front of the White House. The march is slated for Tuesday, March 13, at 12:00 noon. So those who live near the nation's capital may wish to take part in this event. To learn more, visit KratomMarchDC.com.
Additionally, the American Kratom Association has retained the services of a powerful Washington D.C. Law firm that is now working to take measures that will block the inclusion of kratom's alkaloids as Schedule I substances.
You can also write to the lawmakers representing your region, telling them how kratom has impacted your life and why you believe that it should remain legal and accessible to Americans. Need help writing a letter? Click here.