Tag Archives: FDA

"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…

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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.

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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.

###

SOURCE

 

RELATED:

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

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

 

Mitragyna speciosa111.JPGVarious forms of kratom and teas made from the plant’s leaves are sold in cafes and on the internet. Their primary effect is to provide a short-lived peaceful and calm feeling that is described as pleasant. Consistent with this effect being opioid-like, anecdotal reports indicate that some users have used kratom to successfully recover from physical and psychological dependence on prescription opioids and heroin. Comments on my last report on kratom have also indicated the successful use of teas made from the plant in managing chronic pain without the side effects and addictive potential of prescription opioids like oxycodone, hydrocodone and morphine. LINK

Due to be published in the “Federal Register” on August 31st, 2016 is the DEA’s “Intent to reschedule” the opioids mitragynine and 7-hydroxymitragynine  These are the “ingredients” of the plant Kratom and they are placing it into schedule I using the “temporary scheduling provisions” of the Controlled Substances Act.

Federal Register Kratom

The Department of Justice, Drug Enforcement Administration, issued this document:

DOJ Kratom

There is a petition at Whitehouse.Gov that is asking the Federal Government to not go thru with this decision. 

KRATOM PETITION

 

The “drug war” has taken enough of our plants and enough of our lives.  We cannot continue to let them regulate us out of every plant of food and medicine which were given to us as Our “inalienable rights” as Human Beings and laid out in Our Constitution as such, and regulate it out of our reach through the use of “Agenda 21” as laid out by the United Nations, in which the United States is one of only five “permanent members”!

First, PLEASE SIGN THE PETITION, and then make phone calls and write letters to your Representatives concerning this issue!

We hold these truths to be self-evident, that all men are created equal, that they are endowed by their Creator with certain unalienable Rights, that among these are Life, Liberty and the pursuit of Happiness.

RELATED STORIES:

“Rights and freedoms may in no case be exercised contrary to purposes and principles of the United Nations.” HOW THE UNITED NATIONS IS STEALING OUR “UNALIENABLE RIGHTS” TO GROW FOOD AND MEDICINE THROUGH THE U.N. CONVENTION ON NARCOTIC DRUGS AND AGENDA 21. Sheree Krider

The FDA Just Outlawed Hemp Oil – Secrets of the Fed.Com

FORBES announced today:  The DEA Is Placing Kratom And Mitragynine On Schedule I

Take Back Kentucky Legislative Action Alert

(KY) Oppose: Senate Bill 136: Banning of the Kratom Herb 2/22/2016

The FDA Just Outlawed Hemp Oil

The FDA Just Outlawed Hemp Oil — The #1 Cancer Treatment in The World

 

VIA/Hemp oil extracts containing CBDs (cannibidiols) are such a threat to the pharmaceutical industry that the FDA is now invoking totally insane justifications for outlawing them.

FDA’s own website: “12. Can products that contain cannabidiol be sold as dietary supplements? A. No. Based on available evidence, FDA has concluded that cannabidiol products are excluded from the dietary supplement definition…”

The FDA has also started sending aggressive warning letters to CBD product marketers.

Cannabis Oil - Banned by FDA

CBDs are non-psychoactive compounds found naturally in hemp plants. They work so well as powerful natural medicine that people everywhere are realizing CBDs work better than pharmaceuticals for treating epilepsy, seizures, neurological disorders and other serious health conditions (including HIV infections).

So the FDA has just launched a massive regulatory assault against CBDs by invoking the most insane logic you’ve ever heard. Here’s how it goes:

1) CBDs work so well that drug companies are now investigating them to be approved by the FDA as medicines.

2) Because CBDs are being investigated by drug companies, the FDA has granted CBDs status as being “investigated as a new drug.”

In the FDA’s own language from their website:

“FDA CONSIDERS A SUBSTANCE TO BE ‘AUTHORIZED FOR INVESTIGATION AS A NEW DRUG’ IF IT IS THE SUBJECT OF AN INVESTIGATIONAL NEW DRUG APPLICATION (IND) THAT HAS GONE INTO EFFECT.”

3) Because CBDs work so well and have been authorized for drug investigations, the FDA now OUTLAWS them being sold as dietary supplements.

Per the FDA’s own website:

“FDA HAS CONCLUDED THAT CANNABIDIOL PRODUCTS ARE EXCLUDED FROM THE DIETARY SUPPLEMENT DEFINITION UNDER SECTION 201(FF)(3)(B)(II) OF THE FD&C ACT.

“UNDER THAT PROVISION, IF A SUBSTANCE (SUCH AS CANNABIDIOL) HAS BEEN AUTHORIZED FOR INVESTIGATION AS A NEW DRUG FOR WHICH SUBSTANTIAL CLINICAL INVESTIGATIONS HAVE BEEN INSTITUTED AND FOR WHICH THE EXISTENCE OF SUCH INVESTIGATIONS HAS BEEN MADE PUBLIC, THEN PRODUCTS CONTAINING THAT SUBSTANCE ARE OUTSIDE THE DEFINITION OF A DIETARY SUPPLEMENT.”

4) Now the FDA has begun sending warning letters to CBD makers, claiming they are in violation of FDA regulations because they are selling “adulterated products.”

Adulterated with what, exactly? CBDs, of course!

“THE DEBATE OVER HEMP CBD’S LEGAL STATUS CONTINUES AFTER FDA SENT EIGHT WARNING LETTERS TO MANUFACTURERS OF CBD DIETARY SUPPLEMENT AND FOOD PRODUCTS EARLIER THIS MONTH,” REPORTS NUTRITIONAL OUTLOOK.

“THE WARNING LETTERS CITE IMPERMISSIBLE HEALTH CLAIMS USED TO MARKET THE PRODUCTS, AS WELL AS CBD’S INVALID STATUS AS A DIETARY INGREDIENT DUE TO ITS PRESENCE IN TWO DRUG APPLICATIONS CURRENTLY UNDER CONSIDERATION.”

The FDA just criminalized one of the most miraculous healing medicines in the world by handing it over to Big Pharma

In other words, the FDA just handed Big Pharma an absolute monopoly over CBDs (hemp oil extract) by ridiculously claiming such natural products are “adulterated” with molecules (CBDs) that the FDA says might one day become a drug.

“Drugs,” according to the FDA, are substances that are proven to treat, prevent or cure a disease, and thus the FDA’s own logic admits that CBDs must be able to treat, prevent or cure diseases, otherwise they would be useless as “drugs”.

But when a dietary supplement company makes the same claim, they are hit with aggressive warning letters from the FDA, threatening to shut them down, confiscate their products and seek criminal prosecution of the company executives.

This is how the FDA can instantly criminalize any vitamin or plant extract

Do you see how this twisted, corrupt regulatory tactic can allow the FDA to instantly criminalize any dietary supplement, vitamin, herb or plant extract?

Vitamin D, for example, could be outlawed by the FDA announcing that it has granted “Investigational New Drug application (IND)” status to any drug company studying vitamin D.

Using this same corrupt, mafia-style tactic, the FDA could outlaw resveratrol or even vitamin C, denying Americans the right to access safe, affordable, natural substances that are routinely found in nature.

It’s time to end the FDA’s monopolization over natural plant molecules

If humanity is ever to achieve medical freedom, we must end the FDA’s outrageous medical monopolization of plant molecules such as CBDs.

By allowing this corrupt, criminally-run regulatory agency to criminalize every molecule found in nature, our nation’s lawmakers condemn us all to life in what can only be called medical totalitarianism under FDA tyranny.

Any time a healing substances is found in nature, the FDA can simply assert that such molecules are now in the process of being studied as drugs and are therefore illegal to sell as dietary supplements even though they were developed by Mother Nature, not drug companies.

This FDA tactic is nothing more than the FDA proclaiming intellectual monopolies over all molecules of interest found in nature.

It is Monsanto-like in its arrogance and wickedness, and it deprives the People of their right to access medicinal plants and healing substances that have existed in nature for countless thousands of years long before the FDA ever came into existence (1906).

If we do not stop this FDA, we are all doomed to living under a totalitarian regulatory regime that will systematically criminalize every healing molecule found in nature, from the curcuminoids in turmeric root to green tea catechins and even phycocyanins found in spirulina.

That this federal agency has now resorted to such tactics of medical totalitarianism and outright tyranny is proof that we need to strip the FDA of regulatory powers over natural dietary supplements and limit its domain to pharmaceutical drugs only.

Coincidentally, a Presidential election is upon us that threatens to shake up the entire establishment if the right person wins.

“Establishment” candidates on both sides of the aisle would simply continue the FDA war on natural molecules that’s now under way, but there is one candidate who has openly threatened to challenge the authority of federal regulators like the EPA and FDA.

FDA begins crackdown by targeting inaccurate label claims… but it won’t end there

The FDA has now declared war on CBDs and hemp oil extracts. Its first targets are those companies who have inaccurate label claims or are committing outright fraud in claiming CBD concentrations that don’t even exist in their products.

On this point, I must agree that inaccurate label claims deserve regulatory enforcement. The CBD industry is heavily populated with fraudulent sellers whose products often contain no CBDs at all.

“THE FDA HAS TURNED ITS BACK ON THE CANNABIS INDUSTRY, CLAIMING THAT CBD PRODUCTS CANNOT BE SOLD AS DIETARY SUPPLEMENTS,” REPORTSCANNA BUSINESS.

“COMPANIES AFFECTED BY THE LATEST CRACKDOWN INCLUDE CALI STORES, DOSE OF NATURE, GREEN GARDEN GOLD, HEALTHY HEMP OIL, MICHIGAN HERBAL REMEDIES, MORGUE JUICE, PAIN BOMB AND SANA TE PREMIUM OILS. ACCORDING TO THE FDA’S ANALYSIS, ALL PRODUCTS CONTAINED DIFFERENT AMOUNTS OF 9-THC, THCA, CBDA, CBN AND CBD THAN THEY HAD CLAIMED.”

The second target of the FDA is companies that made disease treatment claims that their CBD products might treat epilepsy, cancer or other conditions.

The FDA, of course, routinely attacks any dietary supplement maker that tells the truth about the medicinal benefits of their products.

According to the FDA, there is no such thing as any food, nutrient, herb or natural molecule that has any ability whatsoever to treat, prevent or cure any disease.

This position is, of course, patently absurd and stands in total violation of nutritional science, but it is the “big lie” the FDA must maintain in order to keep putting dietary supplement companies out of business.

Once the FDA finishes destroying all the companies with inaccurate labels and disease marketing claims, it will target all the honest suppliers of CBDs who are selling genuine, honest products that contain accurate CBD labels.

This is the real goal of the FDA: to threaten, intimidate and destroy the entire CBD industry and thereby protect the medical monopolies of drug companies that can’t wait to cash in on these amazing molecules that really do treat disease (otherwise, Big Pharma would have no interest in them).

This is how the FDA keeps the medical racket marching along

And so the great medical monopoly racket marches on, with the FDA giving a big “F-YOU” to the American people while handing lucrative medical monopolies to its greed-driven friends in the pharmaceutical industry.

Meanwhile, the American people are denied healing medicine that works at a fraction of the cost of overpriced pharmaceuticals.

Entrepreneurial companies that offer such hemp oil extracts containing CBDs — natural medicines that could help reduce human suffering while lowering health care costs nationwide — are threatened by the FDA with devastating enforcement actions that could land their executives in prison.

This is all part of the FDA’s war on natural medicine that systematically criminalizes molecules found in nature and the people who seek to make those molecules available to patients in need.

While disease suffering skyrockets across America and medical expenses push more and more families over the threshold of bankruptcy and destitution, isn’t it comforting to know that your federal government is doing everything in its power to deny you access to safe, affordable natural medicine while protecting the profits of the drug giants?

What can you do to oppose this medical tyranny by the FDA?

None of this is ever going to change, by the way, if we keep electing establishment politicians to the White House.

If you want to see real change in the legalization of hemp extract components such as CBDs, you’d better vote for someone who terrifies the establishment and threatens to tear it down.

At the same time, you need to support health freedom organizations like the Alliance for Natural Health, which is fighting to keep dietary supplements legal in America.

You should also watch this video animation that exposes the anti-dietary supplement bias of PBS Frontline, which recently ran a totally dishonest hit piece documentary attacking supplements.

There is a nationwide effort under way right now to criminalize ALL dietary supplements and force every plant extract, vitamin or food concentrate to be regulated by the FDA as if they were prescription drugs.

This would utterly wipe out the entire dietary supplements industry and plunge America into an era of runaway disease, suffering and death as people are denying access to the healing nutrients that are presently preventing disease (and even reversing serious disease in some cases).

Finally, share this story and join the Natural News email list (below) to stay informed on all this.

As the editor of Natural News, I am fighting for your right to access CBDs and hemp oil extracts, as they are amazing natural medicines that can treat, prevent and in some cases even help cure serious health conditions.

The FDA is anti science and anti human rights

We have a fundamental human right to access healing plants found in nature, and the FDA has systematically sought to destroy that right and criminalize those who seek to express it.

Access to Mother Nature’s healing molecules is a fundamental human right that exists above and beyond the Bill of Rights. It is a DIVINE right.

To reestablish our access to these rights, we need a political revolution in Washington that puts people in power who are ready and willing to dismantle the FDA and end its devastating monopolies over dietary supplements, medicinal herbs and natural molecules found in nature.

We need to legalize health freedom in America and set this nation on a new path of disease prevention and drastically reduced health care costs through access to affordable, natural medicines.

The only way to accomplish this is to end the FDA’s reign of tyranny over the dietary supplements industry.

We need a new health freedom revolution in America, and it starts at the ballot box. It’s time to start electing outsiders, not insiders… people who the terrify the Washington establishment because they know their insidious grip on regulatory power will be challenged.

If you want medical marijuana legalized, or if you want access to CBD oil as an affordable dietary supplement, it’s time to start voting for people the establishment is desperately trying to destroy.

Because it is only those people who have any real hope of achieving the kind of political and legislative goals that will end the FDA’s stranglehold on natural medicine in America.

CONTINUE READING…