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Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s scientific evidence on the presence of opioid compounds in kratom, underscoring its potential for abuse

Kratom-Opioid

For Immediate Release

February 6, 2018

Summary

FDA releases adverse events and scientific analysis providing even stronger evidence of kratom compounds’ opioid properties.

Statement

Over the past several months, there have been many questions raised about the botanical substance known as kratom. Our concerns related to this product, and the actions we’ve taken, are rooted in sound science and are in the interest of protecting public health. However, we recognize that there is still much that is unknown about kratom, which is why we’ve taken some significant steps to advance the scientific understanding of this product and how it works in the body. Today, we’re providing details of some of the important scientific tools, data and research that have contributed to the FDA’s concerns about kratom’s potential for abuse, addiction, and serious health consequences; including death.

Notably, we recently conducted a novel scientific analysis using a computational model developed by agency scientists, which provided even stronger evidence of kratom compounds’ opioid properties. These kinds of models have become an advanced, common and reliable tool for understanding the behavior of drugs in the body. We also have learned more about deaths that involved kratom use, and have identified additional adverse events related to this product. This new data adds to our body of substantial scientific evidence supporting our concerns about the safety and abuse potential of kratom.

We have been especially concerned about the use of kratom to treat opioid withdrawal symptoms, as there is no reliable evidence to support the use of kratom as a treatment for opioid use disorder and significant safety issues exist. We recognize the need and desire for alternative treatments for both the treatment of opioid addiction, as well as the treatment of chronic pain. The FDA stands ready to evaluate evidence that could demonstrate a medicinal purpose for kratom. However, to date, we have received no such submissions and are not aware of any evidence that would meet the agency’s standard for approval.

The FDA’s PHASE model used to assess kratom

Federal agencies need to act quickly to evaluate the abuse potential of newly identified designer street drugs for which limited or no pharmacological data are yet available. This is why the FDA developed the Public Health Assessment via Structural Evaluation (PHASE) methodology – a tool to help us simulate, using 3-D computer technology, how the chemical constituents of a substance (such as the compounds/alkaloids found in kratom) are structured at a molecular level, how they may behave inside the body, and how they can potentially affect the brain. In effect, PHASE uses the molecular structure of a substance to predict its biological function in the body. For example, the modelling platform can simulate how a substance will affect various receptors in the brain based on a product’s chemical structure and its similarity to controlled substances for which data are already available.

Using this computational model, scientists at the FDA first analyzed the chemical structures of the 25 most prevalent compounds in kratom. From this analysis, the agency concluded that all of the compounds share the most structural similarities with controlled opioid analgesics, such as morphine derivatives.

Next, our scientists analyzed the chemical structure of these kratom compounds against the software to determine its likely biologic targets. The model predicted that 22 (including mitragynine) of the 25 compounds in kratom bind to mu-opioid receptors. This model, together with previously available experimental data, confirmed that two of the top five most prevalent compounds (including mitragynine) are known to activate opioid receptors (“opioid agonists”).

The new data provides even stronger evidence of kratom compounds’ opioid properties.

The computational model also predicted that some of the kratom compounds may bind to the receptors in the brain that may contribute to stress responses that impact neurologic and cardiovascular function. The agency has previously warned of the serious side effects associated with kratom including seizures and respiratory depression.

The third aspect of the model is the 3-D image we generate to look at not just where these compounds bind, but how strongly they bind to their biological targets. We found that kratom has a strong bind to mu-opioid receptors, comparable to scheduled opioid drugs.

So what does this body of scientific evidence mean? The FDA relies on this kind of sophisticated model and simulation to supplement its data on how patients react to drugs; often as a way to fully elucidate the biological activity of a new substance. The data from the PHASE model shows us that kratom compounds are predicted to affect the body just like opioids. Based on the scientific information in the literature and further supported by our computational modeling and the reports of its adverse effects in humans, we feel confident in calling compounds found in kratom, opioids.

Furthermore, this highlights the power of our computational model-based approach to rapidly assess any newly identified natural or synthetic opioids to respond to a public health emergency.

Learnings from reports of death associated with kratom

We’ve been carefully monitoring the use of kratom for several years, and have placed kratom products on import alert to prevent them from entering the country illegally. We have also conducted several product seizures. These actions were based, in part, on a body of academic research, as well as reports we have received, suggesting harm associated with its use. And we are not alone in our evaluation and our public health concerns. Numerous countries, states and cities have banned kratom from entering their jurisdictions. We described some of this information in a public health advisory in November 2017, in which we urged consumers not to use kratom or any compounds found in the plant.

Now, I’d like to share more information about the tragic reports we have received of additional deaths involving the use of kratom. Looking at the information we have received – including academic research, poison control data, medical examiner reports, social science research and adverse event reports – we now have 44 reported deaths associated with the use of kratom. This is an increase since our November advisory, which noted 36 deaths associated with these products. We’re continuing to review the newly received reports and will release those soon. But it’s important to note that these new reports include information consistent with the previous reports.

Today, we’re releasing the reports of the 36 deaths we referenced in November. These reports underscore the serious and sometimes deadly risks of using kratom and the potential interactions associated with this drug. Overall, many of the cases received could not be fully assessed because of limited information provided; however, one new report of death was of particular concern. This individual had no known historical or toxicologic evidence of opioid use, except for kratom. We’re continuing to investigate this report, but the information we have so far reinforces our concerns about the use of kratom. In addition, a few assessable cases with fatal outcomes raise concern that kratom is being used in combination with other drugs that affect the brain, including illicit drugs, prescription opioids, benzodiazepines and over-the-counter medications, like the anti-diarrheal medicine, loperamide. Cases of mixing kratom, other opioids, and other types of medication is extremely troubling because the activity of kratom at opioid receptors indicates there may be similar risks of combining kratom with certain drugs, just as there are with FDA-approved opioids.

However, unlike kratom, FDA-approved drugs have undergone extensive review for safety and efficacy, and the agency continuously tracks safety data for emerging safety risks that were previously unknown. So we have better information about the risks associated with these products; and can better inform the public of new safety concerns. For example, in August 2016, the FDA required a class-wide change to drug labeling to help inform health care providers and patients of the serious risks (including respiratory depression, coma and death) associated with the combined use of certain opioid medications and benzodiazepines. In June 2016, the agency also issued a warning that taking significantly high doses of loperamide, including through abuse or misuse of the product to achieve euphoria or self-treat opioid withdrawal, can cause serious heart problems that can lead to death. We also recently took steps to help reduce abuse of loperamide by requesting packaging restrictions for these products sold “over-the-counter.”

Taken in total, the scientific evidence we’ve evaluated about kratom provides a clear picture of the biologic effect of this substance. Kratom should not be used to treat medical conditions, nor should it be used as an alternative to prescription opioids. There is no evidence to indicate that kratom is safe or effective for any medical use. And claiming that kratom is benign because it’s “just a plant” is shortsighted and dangerous. After all, heroin is an illegal, dangerous, and highly-addictive substance containing the opioid morphine, derived from the seed pod of the various opium poppy plants.

Further, as the scientific data and adverse event reports have clearly revealed, compounds in kratom make it so it isn’t just a plant – it’s an opioid. And it’s an opioid that’s associated with novel risks because of the variability in how it’s being formulated, sold and used recreationally and by those who are seeking to self-medicate for pain or who use kratom to treat opioid withdrawal symptoms. We recognize that many people have unmet needs when it comes to treating pain or addiction disorders. For individuals seeking treatment for opioid addiction who are being told that kratom can be an effective treatment, I urge you to seek help from a health care provider. There are safe and effective, FDA-approved medical therapies available for the treatment of opioid addiction. Combined with psychosocial support, these treatments are effective. Importantly, there are three drugs (buprenorphine, methadone, and naltrexone) approved by the FDA for the treatment of opioid addiction, and the agency is committed to promoting more widespread innovation and access to these treatments to help those suffering from an opioid use disorder transition to lives of sobriety. There are also safer, non-opioid options to treat pain. We recognize that some patients have tried available therapies, and still have unmet medical needs. We’re deeply committed to these patients, and to advancing new, safe and effective options for those suffering from these conditions.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Wisconsin’s Governor wants to disqualify weed smokers from welfare

  • Steve Elliott
  • Comments302
  • 15 December, 2017
  • Wisconsins Gov. Scott Walker Wants To Drug Test People On Welfare 2 of 3 800x400 Wisconsins Governor wants to disqualify weed smokers from welfare

    ABOVE:  NEW YORK, NY – DECEMBER 11: A Harlem resident chooses free groceries at the Food Bank For New York City on December 11, 2013 in New York City. The food bank distributes dry, canned and fresh food to needy residents and works with community based member programs to provide some 400,000 free meals per day throughout the city. Need increased in November when 47 million low-income people nationwide saw their food stamps cut as the federal SNAP program expired. (Photo by John Moore/Getty Images)

    Wisconsin Governor Scott Walker believes that poor people who receive public assistance should have to undergo drug testing, and he’s taking steps to make sure that happens.

    Walker last week charged ahead with a plan to require drug testing for some recipients of Wisconsin’s food stamps program, formally referred to as the Supplemental Nutrition Assistance Program (SNAP), reports The Atlantic. The plan would make Wisconsin the first state in the union to drug test for food stamps, other states that have tried the move have been blocked by the feds.

    That comes on top of another plan to test Medicaid enrollees in Wisconsin. Oh, and don’t forget a law already on the books: That one requires drug testing for non-custodial parents getting funds Temporary Assistance for Needy Families.

    If Gov. Walker’s proposals pass federal scrutiny, all three of the major welfare programs in Wisconsin will involve drug-testing the recipients. Walker’s move to “overhaul welfare” over the past three years has already included some such “reforms.”

    The proposed change to SNAP would affect those who take part in its Employment and Training Program (ETP). Healthy, childless adults already have to meet work requirements to qualify for food stamps through ETP.

    Under Gov. Scott’s proposed new rules, those who test positive would be required to undergo drug treatment, or lose their benefits. The state would pay for “drug rehab” for pot smokers who couldn’t afford to pay for it themselves.

    While alcohol, amphetamines, cocaine, and barbiturates all clear out of a person’s urine after four days or so, marijuana can linger for 30 days or more. That means any drug testing, by definition, tends to catch more cannabis smokers than any other category of substance user.

    Arizona has published figures showing a net savings of just $3,500 for 26 individuals who either tested positive or failed to show up for their drug test appointment. That’s an overall saving of just $135 per person.

    According to state data, the seven states with existing programs— Arizona, Kansas, Mississippi, Missouri, Oklahoma, Tennessee, and Utah— are spending hundreds of thousands of dollars to detect very few drug users. The statistics show that welfare applicants actually test positive at a lower rate for drug use than does the general population.

    Meanwhile, the states have collectively spent almost $1 million on the effort, with millions more slated to be spent in years to come.

    Under the Obama Administration, Gov. Walker’s requests to add drug testing in the SNAP program were denied or delayed by the Agriculture Department because they were seen as an additional barrier to eligibility— one that Wisconsin wasn’t entitled to impose.

    While the state denied that, the argument had already been used successfully. The Centers for Medicare and Medicaid Services has also denied requests for waivers from states which wanted to impose drug testing for Medicaid.

    Early on, Centers for Medicare and Medicaid Services Administrator Seems Verma signaled the agency would now accept work requirements in Medicaid waivers, like the one being considered in Wisconsin. Verma also announced in November that CMS “will approve proposals that promote community-engagement activities,” typically including work, community service, and job training.

    According to Kaiser Health News, healthcare experts expect this move heralds the agency’s support for further conservative reforms impacting aid eligibility such as drug testing. Advocates are concerned the changes are just a way for states to kick millions of poor people off welfare programs, and undermine their mission of providing food assistance and health coverage to the poor.

    PLEASE CONTINUE READING…

    "It’s the height of hypocrisy,"…

    FDA Is Open To Medical Marijuana For Vets, But Other Agencies Stand In The Way

    Mona Zhang , Contributor

    Dr. Sue Sisley, a medical marijuana researcher, speaks at the Arizona Secretary of State’s Office Wednesday, April 14, 2010 at the Capitol in Phoenix. (AP Photo/Matt York)

    When the U.S. Food and Drug Administration (FDA) warned cannabidiol producers against making medical claims about cannabis products, it seemed par for the course for any federal agency. Cannabis is simply not considered medicine in the eyes of the government.

    But the FDA actually appears pretty open to considering the potential of marijuana as medicine. “We’ve had good experiences working with the FDA,” said Brad Burge, communications director at the Multidisciplinary Association for Psychedelic Studies (MAPS). The non-profit is currently conducting the first FDA- and DEA-approved clinical trial on whole-plant marijuana and enrolled its 30th participant on October 26.

    “We have a long relationship with the FDA — a lot through our MDMA research. They’ve been open to approving research protocols into Schedule I drugs,” said Burge. “It’s other regulatory agencies that have been standing in the way.”

    It’s certainly unhelpful that the National Institutes of Drug Abuse have a monopoly on growing research cannabis. The Drug Enforcement Administration and the Justice Department aren’t helpful on this front either. But the lack of support for the study from Veterans Affairs (VA) is even more egregious.

    Dr. Sue Sisley, the trial’s lead researcher, says she’s determined to focus on veterans for this study. She plans to examine the effects of cannabis on 76 subjects with treatment-resistant PTSD. Her main motivation in focusing on veterans is the epidemic of veteran suicides in the U.S. The VA estimates that about 22 veterans commit suicide every day – Sisley thinks that number is probably higher.

    “As a scientist, I’m skeptical of subjective claims,” said Sisley. “[But] we have a mountain of anecdotal reports from veterans claiming that cannabis is lifesaving.”

    The implications go beyond saving their lives – Sisley has heard plenty of military spouses and children sing the praises of the drug. “The kids will say, ‘I got my dad back’ after years of [him] being disengaged, irritable and mean,” she said.

    Now, her main challenge is recruiting enough veterans who fit the study criteria and are able to participate on-site in Phoenix, Arizona. Sisley estimates that the Phoenix VA hospital has 20,000 veterans in their system who meet the study’s eligibility requirements. But the hospital is refusing to provide information about the study to its patients.

    “[In] some of the states that have put in appropriate controls [for medical marijuana], there may be some evidence that this is beginning to be helpful,” said VA Secretary David Shulkin at a White House press briefing in May. “We’re interested in looking at that and learning from that.”

    But Sisley says that Shulkin has so far refused to express support for her study: “It’s the height of hypocrisy,” she said.

    “The VA Secretary could make a call to the Phoenix VA, and we could start sharing information with these patients,” said Sisley. “Why does it take political courage to defend a federally legal study? Not even defend it, just fast-track it. We’ve been stonewalled at every turn.”

    The researchers have paid for various types of advertising and hired a veteran to oversee recruitment efforts. Still, “the issue for us is [getting] cooperation from the Phoenix VA hospital,” said Sisley. Recruitment has dwindled to a “pretty slow trickle.”

    If the study fails to recruit 46 more veterans in the next couple of months, “we’ll have to reevaluate,” she said. “We fought for so many years and the veteran community has stood shoulder to shoulder with us, helping us kick down the doors… Many of them have adopted this trial as their own.”

    The American Legion, a veterans organization that has more than 2 million members, called on the VA to support the clinical trial in September. “We ask for your direct involvement to ensure this critical research is fully enabled,” wrote the organization’s National Commander Denis Rohan in a letter to Shulkin. “[The study] could potentially produce scientific evidence that will enhance, improve, and save the lives of veterans suffering from post-traumatic stress disorder.”

    But Shulkin has remained mum on the issue.

    “I’m assuming that [Attorney General] Sessions has created an atmosphere of fear around the word ‘cannabis’ and so nobody’s willing to step out,” said Sisley. “The FDA deserves major commendation because they at least are responsive.”

    CONTINUE READING…

    FDA News Release FDA warns companies marketing unproven products, derived from marijuana, that claim to treat or cure cancer

    For Immediate Release

    November 1, 2017

    Release

    As part of the U.S. Food and Drug Administration’s ongoing efforts to protect consumers from health fraud, the agency today issued warning letters to four companies illegally selling products online that claim to prevent, diagnose, treat, or cure cancer without evidence to support these outcomes. Selling these unapproved products with unsubstantiated therapeutic claims is not only a violation of the Federal Food, Drug and Cosmetic Act, but also can put patients at risk as these products have not been proven to be safe or effective. The deceptive marketing of unproven treatments may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.

    The FDA has grown increasingly concerned at the proliferation of products claiming to treat or cure serious diseases like cancer. In this case, the illegally sold products allegedly contain cannabidiol (CBD), a component of the marijuana plant that is not FDA approved in any drug product for any indication. CBD is marketed in a variety of product types, such as oil drops, capsules, syrups, teas, and topical lotions and creams. The companies receiving warning letters distributed the products with unsubstantiated claims regarding preventing, reversing or curing cancer; killing/inhibiting cancer cells or tumors; or other similar anti-cancer claims. Some of the products were also marketed as an alternative or additional treatment for Alzheimer’s and other serious diseases.

    “Substances that contain components of marijuana will be treated like any other products that make unproven claims to shrink cancer tumors. We don’t let companies market products that deliberately prey on sick people with baseless claims that their substance can shrink or cure cancer and we’re not going to look the other way on enforcing these principles when it comes to marijuana-containing products,” said FDA Commissioner Scott Gottlieb, M.D. “There are a growing number of effective therapies for many cancers. When people are allowed to illegally market agents that deliver no established benefit they may steer patients away from products that have proven, anti-tumor effects that could extend lives.”

    The FDA issued warning letters to four companies – Greenroads Health, Natural Alchemist, That’s Natural! Marketing and Consulting, and Stanley Brothers Social Enterprises LLC – citing unsubstantiated claims related to more than 25 different products spanning multiple product webpages, online stores and social media websites. The companies used these online platforms to make unfounded claims about their products’ ability to limit, treat or cure cancer and other serious diseases. Examples of claims made by these companies include:

    • “Combats tumor and cancer cells;”
    • “CBD makes cancer cells commit ‘suicide’ without killing other cells;”
    • “CBD … [has] anti-proliferative properties that inhibit cell division and growth in certain types of cancer, not allowing the tumor to grow;” and
    • “Non-psychoactive cannabinoids like CBD (cannabidiol) may be effective in treating tumors from cancer – including breast cancer.”

    Unlike drugs approved by the FDA, the manufacture of these products has not been subject to FDA review as part of the drug approval process and there has been no FDA evaluation of whether they work, what the proper dosage is, how they could interact with other drugs, or whether they have dangerous side effects or other safety concerns. The FDA has requested responses from the companies stating how the violations will be corrected. Failure to correct the violations promptly may result in legal action, including product seizure and injunction.

    “We have an obligation to provide caregivers and patients with the confidence that drugs making cancer treatment claims have been carefully evaluated for safety, efficacy, and quality, and are monitored by the FDA once they’re on the market,” Commissioner Gottlieb added. “We recognize that there’s interest in developing therapies from marijuana and its components, but the safest way for this to occur is through the drug approval process – not through unsubstantiated claims made on a website. We support sound, scientifically-based research using components derived from marijuana, and we’ll continue to work with product developers who are interested in bringing safe, effective, and quality products to market.”

    This latest action builds on the more than 90 warning letters issued in the past 10 years, including more than a dozen this year, to companies marketing hundreds of fraudulent products making cancer claims on websites, social media and in stores. Additionally, the FDA recently took decisive action to prevent the use of a potentially dangerous and unproven treatment used in ‘stem cell’ centers targeting vulnerable cancer patients. The FDA encourages health care professionals and consumers to report adverse reactions associated with these or similar products to the agency’s MedWatch program.

    The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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    SOURCE LINK / CONTINUE READING…

    SITSA creates a new “Schedule A” that gives the Attorney General of the United States the power to ban any “analogue” of an opioid that controls pain or provides an increase of energy.

    Image may contain: 1 person, plant, nature and outdoor

    Kratom Advocates:

    If you’ve had one of those days that starts with friends calling you with bad news, and the news just gets worse and worse as the day goes on – then that describes my day perfectly.

    On Friday of last week, Sen. Chuck Grassley of Iowa, and Sen. Dianne Feinstein of California, dropped a bill in the U.S. Senate that our lobbyists believe will give the FDA and DEA a backdoor way of banning kratom completely in the United States.

    S. 1327 is euphemistically called the SITSA Act.  And a companion bill in the US House of Representatives has already been filed, H.R. 2851, by Representative John Katco of New York.

    The SITSA Act stands for the “Stop Importation and Trafficking of Synthetic Analogues Act of 2017.”
    SITSA creates a new “Schedule A” that gives the Attorney General of the United States the power to ban any “analogue” of an opioid that controls pain or provides an increase of energy.

    That is kratom. Because kratom’s 2 primary alkaloids, mitragynine and 7-hydroxymitragynine, though not opioids, act similarly in some ways.
    They could of just called this bill the “Schedule Kratom” Act.

    This legislation will allow the Attorney General, and his supporters at the DEA, to add kratom to Schedule A on a “temporary basis” that will last for 5 years.
    And once added to Schedule A, the Attorney General can convert it to a permanent schedule.
    After everything that we’ve fought successfully against and endured together as a movement, our lobbyists are concerned that this is now the perfect storm for banning kratom.

    Under the current Controlled Substances Act, the FDA and DEA have to prove conclusively that kratom is dangerously addictive and unsafe for consumer use. That’s why we were able to stop them in their tracks when they tried to ram through an “emergency scheduling” ban on kratom.

    And it is why the FDA is having such a tough time in finding some justification to schedule kratom under regular rulemaking.

    So now the anti-kratom bureaucrats in Washington want to ban kratom simply by claiming it has the same effects as an opioid – calling it an “analogue” of the opioid.

    And the SITSA Act can enforce a ban on kratom by criminalizing any manufacturer or distributor of kratom. Ten years imprisonment just for manufacturing or selling a kratom product, and a fine of $500,000 if you are an individual, $2,500,000 if the defendant is a company.

    If you import or export kratom, it is a 20-year sentence.

    And then there are harsh penalties for what they call “false labeling” of a Schedule A substance.
    That’s why am writing – because I need your help again.

    We have to convince Sen. Grassley, Sen. Feinstein, and Representative Katko that they have to exempt natural botanical plants from the SITSA Act.
    We have to act quickly, because I learned today that the House Judiciary Committee is looking to schedule a Hearing before they leave for recess next month.

    So I hope you will help by doing three specific things:

    1.    Click on the link below and sign our petition that the AKA will have delivered to every member of the Senate and House Judiciary Committees. 

    PLEASE SIGN THIS PETITION URGING LAWMAKERS TO REMOVE KRATOM FROM THE SITSA ACT.

    2.    I need you to pick up the phone and call Sen. Grassley’s office, Sen. Feinstein’s office, and Representative Katco’s office. When the staff member answers the phone, tell them that their boss should exclude natural botanicals like kratom products from the SITSA Act.

    Here are the phone numbers you should call:

    Senator Grassley:    (202) 224-3744
    Senator Feinstein:    (202) 224-3841
    Congressman Katco:    (202) 225-3701

    When you call, be polite, but firm.  Kratom should be exempted from SITSA.

    3.    Please click on the donation link below and help us once again to take on this fight with a team of lawyers, lobbyists, and public relations professionals.  Please consider making a monthly contribution to the AKA.

    DONATION LINK TO HELP THE AKA FIGHT THIS LEGISLATION.

    I know I am asking a lot.

    But we need to fight back hard, or they will steal our freedoms from us to make our own decisions about our health and well-being.

    So please, sign the petition, call the the sponsors of SITSA, and please, please, give as generous a contribution as you can to help us put our team on the ground in Washington, D.C.

    With your help, we have established ourselves as a real force in Washington.

    With your continued help – help that I am so grateful for – we can win this battle against the enemies of kratom.

    Your contribution will help us hire the lawyers we need for a brief on why this legislation violates due process and current law; our lobbyists to knock on doors on Capitol Hill; and our public relations team to rally the press to tell our story.

    We will stand up for freedom.

    Thank you for your continued support.

    Sincerely,

    Susan Ash
    Founder and Spokesperson
    American Kratom Association
    www.americankratom.org

    http://mailchi.mp/americankratom/new-legislative-attack-on-kratom?e=2709219685

    https://www.facebook.com/kratom.us/photos/rpp.260289027341069/873568049346494/?type=3&theater

    The Stakes Are High As DEA Reconsiders Waging War On The Herb Kratom

    11/30/2016 04:03 am ET

    Those who use and study the plant say an outright ban could do serious harm.

    Seven weeks after the U.S. Drug Enforcement Administration officially withdrew its plan to ban kratom, the federal government is once again set to decide the fate of the herb and the people who rely on it for pain relief and other treatment.

    The DEA had initially planned to use its emergency scheduling power to push through the ban without input from the public, despite concerns from lawmakers and scientists ― as well as kratom users ― that the move would do more harm than good. In October, however, the DEA opened a public comment period allowing individuals to weigh in on the agency’s decision to place mitragynine and 7-hydroxymitragynine, two active compounds in kratom, in Schedule I. Substances in this category include heroin and LSD and are considered to have no known medical benefit and a high potential for abuse.

    With the comment period set to close on Thursday, the DEA will now have to take into account the nearly 9,000 submissions from people who wanted to voice their opinions about this proposed expansion of the war on drugs.

    But kratom isn’t in the clear yet. The DEA is currently awaiting the results of a U.S. Food and Drug Administration analysis on the potential harms and health benefits of the herb, which will determine if kratom truly poses an “imminent hazard to the public safety,” as the agency initially claimed in August.

    The DEA doesn’t know when it will get the results of the FDA’s review, Russell Baer, a spokesperson for the agency, told The Huffington Post.

    “We’ve asked the FDA to expedite their analysis, but they’ve not given us any indication as to when that may be done, other than as soon as practical,” said Baer. “They’re involved in an exhaustive scientific review and evaluation, so these things do take time.”

    Although Baer said he expects the DEA to wait for the FDA’s analysis before deciding on an appropriate schedule for kratom ― or whether it should be scheduled at all ― he noted that the agency could still proceed with emergency scheduling even in the absence of more concrete scientific evidence.

    The DEA’s next steps will have huge implications for people like Joshua Levy. In the video above, Levy explains that he turned to kratom after struggling with dependence on the opioid painkillers he’d been prescribed following a hit-and-run accident. Like many kratom users, he says the herb gave him back the life that had been taken from him by addiction and other side-effects of narcotic painkillers.

    “Since I started taking kratom, since I had gotten off of the pain pills, my life has basically opened up dramatically,” Levy told HuffPost. “I got a new job. I’m building a friendship up with my sister that I haven’t had in a long time. I’m not lazy anymore. I don’t want to isolate myself. I want to go out, I want to be out of the house.”

    The kratom community is full of success stories like Levy’s. But together, they form only anecdotal evidence of the herb’s benefits, which is not enough to support a more official confirmation of its medicinal value.

    Experts like Andrew Kruegel, an associate research scientist at Columbia University, hope the DEA will allow kratom to remain legal so they can keep working to unlock the herb’s potential.

    Kruegel’s studies have shown that kratom can be used to alleviate mild pain, and that the plant’s negative side effects are relatively minor.

    “As a scientist, I try to be as objective as possible and not overstate the promise of kratom,” said Kruegel. “We just don’t know that much about the plant yet.”

    But Kruegel also has bigger hopes for kratom, which he believes can be used to aid in the development of safer alternatives to the prescription opioids that claimed more than 18,000 lives in the U.S. in 2014 due to overdose.

    “Of course, if it’s in Schedule I, historically that greatly limits the ability to do research on it,” he said.

    CONTINUE READING…

    The DEA is withdrawing a proposal to ban another plant after the Internet got really mad

    By Christopher Ingraham October 12 at 10:42 AM

    The Drug Enforcement Administration is reversing a widely criticized decision that would have banned the use of kratom, a plant that researchers say could help mitigate the effects of the opioid epidemic.

    Citing the public outcry and a need to obtain more research, the DEA is withdrawing its notice of intent to ban the drug, according to a preliminary document that will be posted to the Federal Register Thursday.

    The move is “shocking,” according to John Hudak, who studies drug policy at the Brookings Institution. “The DEA is not one to second-guess itself, no matter what the facts are.”

    The DEA had announced in August that it planned to place kratom in schedule 1 of the Controlled Substances Act, the most restrictive regulatory category, as soon as Sept. 30. But since announcing their intent to ban kratom, the “DEA has received numerous comments from members of the public challenging the scheduling action,” acting administrator Chuck Rosenberg wrote in the notice, “and requesting that the agency consider those comments and accompanying information before taking further action.”

    A spokesman for the Drug Enforcement Administration did not immediately respond to requests for comment.

    [What it’s like to be high on kratom, according to the people who use it]

    Kratom is a plant from southeast Asia that’s related to coffee. It contains a number of chemical compounds that produce effects similar to opiates when ingested.

    People who take it have have said kratom helped them overcome addiction to opiates or alcohol and treat otherwise intractable pain. Researchers say that their work with kratom could eventually lead to the development of nonaddictive alternatives to powerful opiate painkillers. Placing kratom in schedule 1 would cripple researchers ability to study the drug, they say.

    U.S. lawmakers were among the groups expressing their displeasure with the DEA’s intent to ban kratom. A group of 51 U.S. representatives wrote to the DEA saying that the DEA’s move “threatens the transparency of the scheduling process and its responsiveness to the input of both citizens and the scientific community.”

    Another group of nine senators said the DEA’s “use of this emergency authority for a natural substance is unprecedented,” and urged the administration to reconsider.

    The DEA will now open up a period for public comment until Dec. 1 of this year. It is also asking the FDA to expedite a “scientific and medical evaluation and scheduling recommendation” for the active chemical compounds in kratom.

    At the close of the comment period, a number of things could happen. The DEA could decide to permanently place the plant in a schedule of the Controlled Substances Act, which would require an additional period for lawmakers and the public to weigh in. It could also decide to temporarily schedule kratom, which would not require any additional comment.

    It could also decide to leave kratom unregulated.

    [Police arrest more people for marijuana use than for all violent crimes — combined]

    Advocates for kratom use, who say the plant has helped them treat pain and stop taking more powerful and deadly opiate painkillers said they are elated.

    “I am in tears,” Susan Ash of the American Kratom Association said in an email. “Our voices are being heard, but we still have a long road ahead of us.

    Lawmakers who criticized the initial announcement to ban kratom are also pleased. “Concerned citizens across the country have made it clear, they want the DEA to listen to the science when it comes to the potentially life-saving properties of kratom,” said Mark Pocan (D.-Wis.) in an email.

    Researchers are welcoming the move, but they point out that the future of their work with the plant is an uncertain one.

    “It’s certainly a positive development,” said Andrew Kruegel of Columbia University in an email. Kruegel is one of the researchers working to develop next-generation painkillers based on compounds contained in kratom.

    Kruegel says that the FDA’s evaluation of the drug will carry a lot of weight in the DEA’s decision. But the kind of rigorous, controlled trials that the FDA typically refers to in situations like this simply don’t exist for kratom.

    “Unfortunately, in the United States I don’t think we have a good regulatory framework for handling this situation or taking perhaps more reasonable middle paths” between banning the drug outright or keeping it unregulated, Kruegel says.

    Still, he says, “the FDA is a scientific agency rather than a law enforcement agency, so I am encouraged that they will now be having more serious input on this important policy decision.”

    Marc Swogger, a clinical psychologist at the University of Rochester Medical Center who has published research on kratom use and earlier called the decision to ban the plant “insane,” said in an email that “I’m happy to see this. It is a step in the right direction and a credit to people who have spoken out against scheduling this plant.”

    CONTINUE READING…

    Kratom Advocates Sip Tea and Seethe at White House Rally Against DEA Ban

    One user plans to move to Canada. Another plans to quit. Many more don’t know what to do.

    By Steven Nelson | Staff Writer Sept. 13, 2016, at 6:20 p.m.

    Several protest attendees brought their own bottle of kratom tea Tuesday to the White House. Those who did not were offered a Solo cup.

    Several protest attendees brought their own bottle of kratom tea Tuesday to the White House. Those who did not were offered a Solo cup. Steven Nelson for USN&WR

    Hundreds of passionate protesters gathered Tuesday near the White House to demand that the popular plant product kratom remain legal. It was jointly a business industry conference, a tea party and a desperate consumer lobbying effort — but the clear-eyed crowd appears to have little chance of near-term victory.

    A comprehensive U.S. ban likely will take effect on Sept. 30, just a month after the Drug Enforcement Administration surprised users by saying it would invoke emergency powers to make leaves from the tree grown in Southeast Asia illegal by labeling two main constituents Schedule I substances.

    In the face of long odds and silence from Capitol Hill, the event called by the American Kratom Association sought to pressure officials to reconsider while laying the groundwork for what may become a protracted re-legalization campaign.

    A large jug of brewed kratom sat in the middle of Pennsylvania Avenue, with red Solo cups offered to anyone who wanted some. At least one reporter sipped the brew, which tasted like astringent green tea. Another journalist took a pill offered as a free sample by a businessman.

    Kratom users who attended the rally said it’s wrong for them to lose legal access to what they say is an effective treatment for pain, addiction, depression and other conditions.

    Though many said they were angry, chant-leaders asked the crowd of a couple hundred to stay on message and favored reason over rage, which often is a leading emotion at White House protests staged by marijuana reform advocates who say decades in Schedule I has stalled medical cannabis research amid millions of arrests.

    “I’m usually very quiet but felt the need to come out and speak,” says Veronika Bamford-Conners, a kratom-selling store owner from Sullivan, Maine, where, she says, most of her customers are older than 55.

    “If they don’t have insurance and can’t afford medications, they find a cheaper alternative in kratom,” she says, though some seem to prefer relief from the leaf to painkillers, such as a 73-year-old man who she says called her weeping “because pharmaceuticals were killing him” before.

    Chants at the rally advertised the death toll from accidental overdoses of opioids – more than 28,000 in 2014 alone, including legal painkillers and illegal drugs like heroin – with the low or nonexistent U.S. toll from kratom.

    The DEA says it believes 15 deaths were caused by kratom, though American Kratom Association founder Susan Ash says the group hired a toxicologist who concluded each case could be attributed to other drugs.

    Many kratom users say the plant has helped them abstain from substances they formerly were addicted to, often heroin or prescription painkillers.

    “Kratom saved me, I was a bad heroin addict,” says David Allen, who traveled from Chapel Hill, North Carolina. “It keeps cravings away and helped me not drink. I came because I don’t want to lose my medicine.”

    Allen says that although the DEA – and even some former kratom users – say the drug can lead to dependence, it’s nothing like the grasp of opioids. He says he believe it’s about as abusable as coffee, which comes from a related plant, and that like coffee withdrawal, ending kratom can cause minor headaches.

    Brad Miller, a physics teacher at Spotsylvania High School in Virginia, says he drinks small amounts of kratom tea between three and five times a day to treat arthritis in his knees. He says the effects are “very mild” and “just enough to take the edge off so I can get through my day standing.”

    Miller says prescribed painkillers from his rheumatologist were too strong and that unlike opioids he hasn’t developed an addiction to kratom. He says he went on a weeklong camping trip and – unlike the experiences of some users – felt no withdrawal symptoms.

    “I didn’t have withdrawal symptoms, but I did have arthritis pain,” he says. “I’d be surprised if anyone has experienced strong withdrawal symptoms.”

    Though Miller and others at the event said they aren’t sure what they will do at the end of the month, Heather Hawkins says she’s made up her mind to move to Canada, where kratom remains legal.

    Hawkins, a journalist with northern Florida’s Pensacola News-Journal and owner of the Kratom Literacy Project, says she has an incurable bladder disease and is eyeing Vancouver after already moved to the Sunshine State from Alabama in reaction to a local kratom ban.

    Talk about moving abroad often is spouted unseriously by political partisans around election time, but Hawkins says she’s completely serious after living in a painkiller-induced haze that left her depressed and unable to get out of bed.

    “I’m not going to stay here [if the ban takes effect] because I’m not going back to that life,” she says.

    Hawkins says she’s in addiction recovery from cocaine, which she says she used as self-medication to give her the energy to power through her pain and despair, and that if she regarded kratom as a drug she would not take it.

    Though kratom is widely known for claims that it can help keep opioid addicts clean, it’s also credited with sapping desire for other substances.

    Jeremy Haley, owner of Colorado’s Rocky Mountain Kratom, says he began using kratom in 2012 after a drunk driving arrest, and that it has helped veer him away from his alcoholism, which runs in the family.

    Although the ban hasn’t yet taken effect, Haley says local officials have shut down his shop for what he views as dubious reasons, making him unable to sell the remaining inventory – the latest in what he says has been a constant regulatory headache that featured him asking Yelp reviewers to delete positive reviews to placate federal officials who wanted proof he was not marketing kratom for human consumption.

    Haley plans to open a totally legal apothecary shop if the ban takes effect.

    CONTINUE READING…


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    A futuristic drug-detecting fingerprint scanner may soon follow.

    The DEA is looking for candidates to grow marijuana for research – but will it find any takers?

    Wanted: Someone to grow marijuana for the federal government. Benefits: A contract likely worth millions and the chance to enable medical research. Requirements: Ability to deal with the costs and regulations that come with growing an illegal drug for the federal government.

    For more than four decades, the University of Mississippi has had an exclusive license with the government to grow marijuana for federally sanctioned research. But this month, the Drug Enforcement Administration announced it would grant permission to other growers — an effort, it said, to expand the supply and variety of marijuana available for research.

    So has the change set off a gold rush to grow the green? Not exactly.

    STAT contacted almost a dozen agricultural schools, including those with industrial hemp programs, to gauge their eagerness to grow marijuana for the government.

    Not interested, said Cornell University, the University of Kentucky, and Virginia Tech. Ditto, said Michigan State University, the University of Vermont, and Western Kentucky University.

    No plans, said University of California, Davis, and University of Nebraska, Lincoln. Same with Colorado State University, Oregon State University, and Purdue University.

    “We are very boring that way,” Janna Beckerman, a plant pathologist who researches hemp at Purdue, wrote in an email.

    Some interested groups could be keeping their plans under wraps. And other possible candidates may be trying to get a better sense of what the DEA wants. But any reluctance might stem from more than being boring.

    More on this…

    To register with the agency, applicants will need to show that they will have security measures in place to protect the marijuana and be willing to comply with a host of other requirements. And depending on the scale of the operation, prospective growers will likely have to make significant investments to get it up and running.

    Bob Morgan, an attorney at Much Shelist who formerly led the Illinois medical marijuana program, said that facilities in states that have strict regulations on medical marijuana growers are probably looking at multimillion-dollar expenditures for construction alone.

    “I think everybody is just thinking about how to approach this,” said Dr. Igor Grant, director of the Center for Medicinal Cannabis Research at the University of California, San Diego. “What will it really take to get one of these DEA licenses?”

    Grant said he would consider talking with other universities and agencies in California to see if it was worth the effort to get a cultivation operation in the state, but beyond that had not heard of groups intending to apply.

    One researcher in the running is Lyle Craker, who studies medicinal plants at the University of Massachusetts, Amherst, and has tried in the past to get approval to grow marijuana. He did not reply to an email requesting comment, but a spokesman for a group called the Multidisciplinary Association for Psychedelic Studies — which sponsors related research — said it is supporting Craker’s efforts to get a license, as it has in the past.

    Other possible applicants include independent growers who operate in states where medical and recreational marijuana is legal. Some cultivators have an expertise in running a large-scale marijuana facility — with state-of-the-art practices and security measures and experience dealing with state regulators — that in theory might appeal to federal authorities.

    But the fact is, their existence contravenes federal law.

    In a memo announcing the policy change, acting DEA Administrator Chuck Rosenberg said that it would consider whether applicants have “engaged in illegal activity involving controlled substances … regardless of whether such activity is permissible under state law.” While that doesn’t disqualify current cultivators, policy experts and people in the industry say the DEA won’t look highly upon them.

    “They made it very clear that if you have been in violation of the [Controlled Substances Act], that would be weighted heavily against you,” said Rachel Gillette, an attorney at Greenspoon Marder in Colorado who represents marijuana businesses.

    That might not stop people from trying, though.

    Charlie Bachtell is the CEO and founder of Cresco Labs, which grows medical marijuana at three sites in Illinois. Bachtell said he is considering applying to the DEA because he wants to support research that could show marijuana has medical benefits.

    “The future of this industry definitely starts with research,” Bachtell said. “The opportunity to help progress the acceptance, the elevation, and the professionalism of the medical cannabis industry really starts with research.”

    The DEA’s policy change also opened the door to a new group of candidates: drug makers. While the Mississippi marijuana is funneled to academic research, Rosenberg wrote that marijuana can now be grown “for strictly commercial endeavors … aimed at drug product development.”

    GW Pharmaceuticals, a company that is developing a drug for epilepsy from a component of marijuana called cannabidiol, said it has not made a decision about a growing facility in the United States, but remained vague enough to suggest possible interest. The company makes the drug, Epidiolex, in the United Kingdom, where it is based.

    “We are exploring additional growing facilities in places around the world,” the company said in a statement.

    The DEA’s application process is open, but the agency has set no deadline to select growers. The agency has indicated it wants just enough marijuana to be produced so research demands are met, but not more than that.

    “It could be that two years from now, we still only have one registrant,” said Alex Kreit, an expert on marijuana law at Thomas Jefferson School of Law.

    Even if cultivators gets licenses, they will confront a chicken-and-egg quandary: If they get special approval to grow marijuana, where do they get the supply they need to start it?

    They could obtain marijuana from the University of Mississippi, but that would defeat the purpose of trying to expand the genetic variety of plants available. Or they could get seeds and plants from another country, such as Canada or Israel, with the proper permits.

    An existing grower could also surrender some marijuana to law enforcement, which could then hand it over to a newly registered grower.

    For its part, a spokesman wrote in an email that that the DEA “would require manufacturers to obtain their seeds from a lawful source, and the DEA would assist the new manufacturers in this regard.”

    CONTINUE READING…

    Marijuana studies

    Craker is known for proposing that medical grade marijuana be available for scientific studies into its possible health benefits. Since the marijuana available for studies is too weak for any kind of medical study, he proposed that medical grade marijuanna be made available for research purposes. He has been named in many newspapers on this subject. The federal government refuses to give him a license to grow medical grade marijuana. On April 29, 2009, Senators Edward M. Kennedy and John F. Kerry wrote a letter to the Honorable David W. Ogden urging the Deputy Attorney General to delay a final decision on the application by Lyle E. Craker of the University of Massachusetts Amherst to produce research-grade marijuana for use in federally approved clinical trials[3][2][4][5]

    FDA News Release: Kratom seized in California by US Marshals Service

    Mitragyna_speciosa111

     

    For Immediate Release

    August 4, 2016

    Release

    The U.S. Food and Drug Administration announced today that the U.S. Marshals Service seized more than 100 cases of products labeled as containing kratom. The products are distributed by Nature Therapeutics LLC, which does business as Kratom Therapy and is located in Grover Beach, California. The seized products are marketed under the brand name Kratom Therapy, and are worth approximately $150,000.

    The U.S. Department of Justice filed the complaint, on behalf of the FDA, in the U.S. District Court for the Central District of California, alleging that the seized kratom products are unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act.

    “The FDA will continue to take aggressive enforcement action to safeguard the public from harmful drug products illegally marketed as treatments for which they have not been studied or approved,” said Melinda Plaisier, the FDA’s associate commissioner for regulatory affairs.

    The FDA is warning consumers not to use any products labeled as containing the botanical substance kratom. Mitragyna speciosa, commonly known as kratom, grows naturally in Thailand, Malaysia, Indonesia and Papua New Guinea. Serious concerns exist regarding the toxicity of kratom in multiple organ systems. Consumption of kratom can lead to a number of health impacts including, respiratory depression, vomiting, nervousness, weight loss and constipation. Kratom has been indicated to have both narcotic and stimulant-like effects and withdrawal symptoms may include hostility, aggression, excessive tearing, aching of muscles and bones and jerky limb movements.

    In January 2016, the FDA inspected the Grover Beach facility and also found that Nature Therapeutics’ website and social media sites included claims establishing that the company’s Kratom Therapy products are drugs because they are intended for use in the cure, mitigation, or treatment of various diseases. The FDA has not approved Nature Therapeutics’ products for any use. In addition, the complaint alleged that Nature Therapeutics’ products are also misbranded drugs because their labeling fails to provide adequate directions for use. The California Department of Public Health embargoed the products on behalf of the FDA.

    In February 2014, the FDA issued an import alert regarding imported dietary supplements and bulk dietary ingredients that are, or contain, kratom without physical examination.

    Health care professionals and consumers should report any adverse events related to products containing kratom to the FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The completed form can be submitted online or via fax to 1-800-FDA-0178.

    The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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    SOURCE

     

    RELATED:

    The DEA has filed notice of intent to add Kratom to schedule 1