We Are Kratom

We are kratom. Botanical Education Alliance, American Kratom Association, American Herbal Products Association, Center for Regulatory Effectiveness, a letter to the Office of Management and Budget, 51 members of Congress, Nine Senators and Two additional Senators and 11 PhD’s have all joined together to urge the DEA to delay the Schedules of Controlled Substances: Temporary Placement of Mitragynine and 7-Hydroxymitragynine Into Schedule I. This is an unprecedented coallition who has come together in less than 30 days. The media has turned for being mostly negative untrue reports about kratom to mostly accurate reports of a safe harmless herb that has been put in the crosshairs of an enforcement agency who is attempting to protect the public health and safety. The letter from Sanders Hatch and nine other Senators reads as follows: “The use of this emergency authority for a natural substance is unprecedented, so it is important to determine whether the circumstances here necessitate a jump to Schedule I.” “Congress has established a specific set of review protocols for scheduling decisions that will create significant disruption in the marketplace that allows for the full engagement of consumers, researchers, health professionals, law enforcement officials, and other stakeholders. Given the long reported history of Kratom use, coupled with the public’s sentiment that it is a safe alternative to prescription opioids, we believe using the regular review process would provide for a much-needed discussion among all stakeholders. We understand the DEA’s desire to uphold public health and safety, and we share the goal of seeing unsafe products removed from the market. However, hearing multiple perspectives allows for more fulsome decision-making.” The letter from the 11 Senators continues: “Given the extremely short timeframe for the implementation of the proposed DEA scheduling order, we urge you to take appropriate steps to delay the order to allow both for a public comment period and sufficient time for the DEA to outline its evidentiary standards to Congress regarding the justification for this proposed action.”

The separate Wyden-Booker-Gillibrand Senate letter states: “We are concerned that the 30-day comment period for such a proposed regulatory action is not a sufficient amount of time for public comment on a drug that, according to recent scientific studies, may actually be an effective substance to help combat the opioid epidemic. While we understand there are times when public safety demands that your agency act quickly on scheduling decisions, we believe that in this instance additional time for the scientific community, public health officials, and other members of the public to comment is warranted and may prove to be in the interest of public health and safety.’

“As you know, Schedule I … is reserved for substances that have a high potential for abuse and that have no currently accepted medical use. An increasing body of research has shown kratom’ s potential value as a treatment for a number of conditions. On September 2, 2016, eleven scientists from well-respected research institutions in the U.S. wrote an open letter to Congress expressing “grave concern” about the agency’s proposed action and expressed their opposition to any efforts to designate kratom as a Schedule I controlled substance of the CSA …”

“Given that we are in the midst of a drug crisis and there is promising evidence from the research of kratom’s potential medical benefits, including the possibility of new, safer medications for the treatment of pain, we believe that placing kratom in Schedule I without adequate time for experts to weigh in via public comment may have unintended consequences.”

“Furthermore, since 1980, our federal prison population has exploded by nearly 800 percent. This increase is a result of draconian drug policies that continue to place nonviolent drug offenders behind bars. We should not, in haste and without adequate opportunity for comment and analysis, place substances in categories that may be inconsistent with their medical value and potential for abuse.”

Daniel Fabricant, the previous director of the FDA who now is with the Natural Products Association, is quoted in a nutra ingredients recent article stating “I get that kratom people are upset” “What you always hear from people who advocate for this or other botanicals is that they are passionate about it. Thats fine, but at the end of the day people are going to fall back on the scientific data, and in the case of kratom there is a lack of company-level data for its safety. If you are to use it as supplement you should go through the NDI gate.” What he is referring to is New Dietary Ingredient process with the FDA. The term “new dietary ingredient” means a dietary ingredient that was not marketed in the United States in a dietary supplement before October 15, 1994. This path was set forth by the FDA Import Alert for Kratom originally published February 2014. This document gives the FDA and US Customs the ability allow districts to detain, without physical examination, the specified products from the firms identified in the RED LIST of this alert. Effectively blocking import of kratom as a dietary supplement for sale for human consumption.

“Congressman Mark Pocan had a productive conversation with the acting (DEA) administrator today and learned that the DEA will be not announcing a final decision on kratom today,” Pocan’s office said in a statement released on Twitter.

The Pain News Network’s Pat Anson reports “It appears the DEA will instead open up a modified comment process before a final decision will be made. While we do not know the exacting timing or details of the new comment period for kratom, Acting Administrator Rosenberg assured Congressman Pocan that we will find out more in the near future.” No further details were released by Pocan or the DEA, although kratom activists were encouraged by the development. “The DEA will be releasing a statement in the next few days about opening a public comment period and exactly what that will look like. Obviously we are going to need to flood them with comments!” said Susan Ash, founder of the American Kratom Association in a Facebook post. We have yet to hear any official word from the DEA in regards to the modified comment period. The Botanical Education Alliance reports ” Such unprecedented progress in Congress within the short time frame we were given is a testament to the organizational skills and will-power of the Kratom community. This is a combined effort from Kratom consumers, vendors, and organizations working together.

There is a Petition to the White House with 141,877 signors. The BEA Botanical Education Alliance Report Shows Unjustified Gov’t Action Could Inflict Up to $5 Billion in Financial Losses; American Kratom Association Estimates 3-5 Million Kratom Users in US Alone. We will not be swept under the rug. We demand to be heard. In the midst of a catastrophic opioid epidemic of colossal proportions if there is hope that this herb can aid in the battle of addiction that we are loosing we need to look at this. We need to be careful in our rhetoric to avoid making claims that would push kratom towards IND Investigative New Drug which would only allow for kratom to be used after extensive company funded research is done. Drugs are required to be prescribed by a medical doctor. During this modified comment period that we believe will be announced shortly we need to avoid these sort of claims.

We should all be very proud of our accomplishments as a community and we need to keep the pressure on. Donations to the BEA and the AKA are funding the joint effort on a national PR campaign that has been extremely successful. The organizations have also hired to of the nations top law firms Hogan and Lovells led by David Fox, whom the director of the FDA Rosenberg and the Attorney General Loretta Lynch, have both spent many years employed at this firm along with Venable another top DC law firm. Now that we have passed the September 30th date with no final notice being published we need to keep the donations to these organizations flowing. I can not tell you how key this is to keeping kratom available to all responsible adults.

We need to look at Florida and its two failed attempts to schedule 1 kratom at the state level along with two failed attempts to ban kratom on the county level.The State of Florida choose to do a study headed by The Florida Drug and Law Enforcement Agency FDLE which concluded, “…Kratom does not constitute a significant risk to the safety or welfare of Florida residents. The Florida Department of Health (DOH) reports no pervasive health issues attributed to the ingestion of Kratom products in Florida.” The DEA and the federal government should take a close look at what Florida has done and also do a similar study. Companies who market kratom need to also do their own company level data during this time and go through the NDI process which the FDA has set forth. We can keep kratom available its up to us. In the words of the late Bob Marley “The hotter the battle the sweeter the victory.”

Sincerely, Lucky

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