Salmonella Outbreak Linked to Kratom Spreading

By Pat Anson, Editor

The number of people infected by a Salmonella outbreak linked to the herbal supplement kratom has more than doubled – with 87 illnesses now reported. Twenty-seven people have been hospitalized, according to a new CDC report.

Although this particular outbreak is small – there are about one million Salmonella cases every year in the U.S. – it covers a lot of territory. Illnesses have been reported in 35 states from New York to California. No deaths have been reported.

Evidence is also increasing that the outbreak involves kratom, an herbal supplement that millions of Americans use to treat chronic pain, depression, anxiety and addiction.

In a survey of 55 patients sickened in the outbreak, 40 said they had consumed kratom in pills, powder, or tea. Most reported consuming kratom in powder form.

"People who reported consuming kratom purchased it from retail locations in several states and from various online retailers," the CDC said in a statement.  “At this time, CDC recommends that people not consume any brand of kratom in any form because it could be contaminated with Salmonella and could make people sick.”

The origin of the contaminated kratom has not been identified, but three brands of kratom sold by PDX Aromatics of Portland, Oregon have been recalled. Health officials in California collected leftover kratom powder from one of PDX's brands (Phytoextractum) from an ill person in California, and the outbreak strain of Salmonella was identified in the sample. PDX blames the contamination on an unidentified "supplier" that it is no longer taking shipments from.

(Update: On March 16, after "additional positive findings of Salmonella" in its kratom products, PDX expanded the recall.)

Investigators in Oregon and Utah have also collected kratom powder from retail locations and online retailers where ill people reported purchasing kratom. Outbreak strains of Salmonella Okatie and Salmonella Thompson were identified in those samples. No brand information was available for the kratom collected in Oregon. The ill person in Utah purchased kratom powder from the website kratoma.com.

In a statement on its website, Kratoma said it "would not restock any kratom in future" and would close its online store by March 31, 2018.

The CDC now traces the start of the outbreak back to January 2017. The CDC says there could be more than the current count of 87 cases, because it takes an average of two to four weeks for a Salmonella illness to be reported.

Salmonella is a bacterial infection usually spread through contaminated food or water. Most people who become infected develop diarrhea, fever and stomach cramps. Salmonella causes an estimated one million food-borne illnesses a year in the United States, with 19,000 hospitalizations and 380 deaths.

Last month the Food and Drug Administration recalled three brands of kratom made by Missouri-based Divinity Products. The company agreed to the “voluntary destruction” of its kratom products, even though there have been no reports of illnesses associated with them.

Kratom Linked to Salmonella Outbreak Recalled

By Pat Anson, Editor

A kratom wholesaler and retailer based in Oregon is recalling three brands of the herbal supplement that may be contaminated with Salmonella bacteria.

PDX Aromatics of Portland, Oregon said the recall involves 10,000 packages of kratom powder that were sold to customers between January 18, 2018 and February 18, 2018 through company websites, under the brand names Kraken Kratom, Phytoextractum and Soul Speciosa.

“PDX Aromatics has identified a supplier in our supply chain as the source of Salmonella. The company has removed that supplier from our supply chain and all associated products from our facility. We have ceased distribution of products in order to perform a facility audit and have initiated a voluntary recall," the company said in a statement on its website.

(Update: On March 16, after "additional positive findings of Salmonella" in its kratom products, PDX expanded the recall.)

The company said it was notified by health officials in California that “certain lots of the product” tested positive for Salmonella bacteria and that there was one confirmed illness associated with its kratom powder.

Salmonella is a bacterial infection usually spread through contaminated food or water. Most people who become infected develop diarrhea, fever and stomach cramps. Severe cases can result in hospitalization or even death.

The Centers for Disease Control and Prevention announced last month that it was investigating a Salmonella outbreak linked to kratom – an herbal supplement imported from southeast Asia that millions of Americans use to treat chronic pain, addiction, depression and anxiety.

At least 40 people have been sickened by the outbreak in 27 states. Seventeen of them said they had consumed kratom in pills, powder or tea. Most said they had bought kratom online, but some purchased it at retail locations.

The first illnesses were reported in October 2017 – three months before the timeline of kratom products involved in the PDX Aromatics recall.  Until a common source of Salmonella bacteria is identified, the CDC has recommended that people stop consuming all kratom products.

PDX Aromatics said customers would receive a full refund once the recalled kratom products are returned. A complete list of the brands and lot numbers involved in the recall can be found here.

Last month the Food and Drug Administration recalled three brands of kratom dietary supplements made by Missouri-based Divinity Products. The company agreed to the “voluntary destruction” of its kratom products, even though there have been no reports of harm or illnesses associated with them.

Salmonella Outbreak Linked to Kratom Spreads

By Pat Anson, Editor

The Centers for Disease Control and Prevention says a dozen more people have been sickened by a Salmonella outbreak linked to the herbal supplement kratom – raising to 40 the number of suspected cases. The number of states where the illnesses have been reported rose from 20 to 27.

For the first time, investigators have also found Salmonella bacteria linked to the outbreak in kratom powder samples in North Dakota and Utah.

“The outbreak strain of Salmonella was identified in both samples. The ill person in North Dakota purchased S.K. Herbalist brand kratom powder from the website soapkorner.com. The ill person in Utah purchased kratom powder from the website kratoma.com,” the CDC said in a statement.

“Despite the information collected to date about where ill people purchased kratom, a single common brand or supplier of kratom has not been linked to the outbreak. At this time, CDC recommends that people not consume kratom in any form because it could be contaminated with Salmonella and could make people sick.”

STATES reporting SALMONELLA ILLNESSES

State and local health officials have interviewed 24 people sickened by Salmonella, asking them about food and other substances they were exposed to before they became ill.

Seventeen of the 24 reported consuming kratom in pills, powder, or tea. Three said they purchased kratom from retail locations and 10 said they bought kratom online.

Illnesses from the Salmonella outbreak began last October, with the most recent case reported on February 13. Fourteen people have been hospitalized. No deaths have been reported.

Salmonella is a bacterial infection usually spread through contaminated food or water. Most people who become infected develop diarrhea, fever and stomach cramps. Salmonella causes an estimated one million food-borne illnesses a year in the United States, with 19,000 hospitalizations and 380 deaths.

It generally takes about two to four weeks before a person infected with Salmonella is reported, so its possible there could be more than 40 cases in the current outbreak. 

Kratom comes from the leaves of a tree that grows in Southeast Asia, where it has been used for centuries for its medicinal properties. In recent years, millions of Americans have started using kratom to treat chronic pain, depression, anxiety and addiction, conceivably costing the pharmaceutical industry billions of dollars in lost revenue.

FDA Warns Utah Company

In a move apparently unrelated to the Salmonella outbreak, the Food and Drug Administration warned a Utah company this week not to launch a new dietary supplement that is based on mitragynine -- one of the alkaloids found in kratom.

The FDA said Industrial Chemicals was using “inaccurate and misleading statements” on its website to promote Mitrasafe. Among other things, the company said that Mitrasafe was “fully compliant with all FDA laws and rules.”  

“Today, we notified a company making claims for a compound in kratom that its product is an unapproved new drug and an adulterated dietary supplement,” FDA commissioner Scott Gottlieb, MD, said in a statement.

“The company is claiming that its product is a ‘natural substitute for opium,’ that it has ‘morphine-like effects,’ and that it can help relieve pain along with a litany of other ailments. Just as troubling, this company promotes kratom as effective in ‘curing addiction’ and treating ‘withdrawal symptoms.’ These unlawful practices not only mislead consumers, but can also prevent people suffering from addiction from seeking effective treatments.”

Industrial Chemicals planned to start selling Mitrasafe on February 28. A spokesman for the company said the launch date has been postponed while it appeals the FDA decision.

“We did not make any drug claims. On the contrary. We did not claim that Mitrasafe itself could do these things or have opium like qualities at all. We never even came close,” said attorney John VanOphem. “The FDA wants to be taken seriously on this stuff? I’m sorry, they haven’t followed their own guidance. This is alarming to me. To have us become the whipping boy poster child on this is just outrageous."

VanOphem told PNN the company has spent years trying to work with the FDA to get Mitrasafe approved.

“The FDA has done nothing to prove that they’re actually interested in addressing the substance of this. They’re just not credible and it’s a shame,” said VanOphem. “All they intend to do is ban kratom, period. There’s no other option for them. They’ve never acknowledged any other option.”  

Unlike pharmaceutical drugs, dietary supplements like kratom are -- for the most part -- loosely regulated by the FDA. But in recent months the agency has launched an unprecedented public campaign to discourage people from using kratom.

In November, the FDA released a public health advisory warning about kratom's potential health risks, especially when used to treat opioid addiction. Last month the agency released a computer analysis that alleged kratom contains over two dozen opioid-like substances that share structural similarities to painkillers such as morphine.

“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,”  Gottlieb said in a statement.

In 2016, the Drug Enforcement Administration attempted to ban kratom by scheduling it as an illegal controlled substance, but a public outcry and lobbying campaign forced the DEA to suspend its scheduling decision. Many kratom supporters fear that another attempt to ban kratom is imminent.

“We’re in for a fight,” said David Herman, president of the American Kratom Association, a pro-kratom consumer group. “There’s no question they want to ban it.”

FDA Recalls Three Kratom Brands

By Pat Anson, Editor

The U.S. Food and Drug Administration Wednesday announced the recall of three brands of dietary supplements containing kratom, the latest move in what appears to be a concerted government campaign to stop all sales of the herb.

The recall involves a large volume of kratom supplements sold under the brand names Botany Bay, Enhance Your Life and Divinity, which are manufactured and sold nationwide by Divinity Products Distribution of Missouri. The FDA said the company had agreed to the “voluntary destruction” of its kratom products, even though there have been no reports of illnesses associated with them.

“The company has also agreed to stop selling all products containing kratom. Based on the scientific evidence of the serious risks associated with the use of kratom, in the interest of public health, the FDA encourages all companies currently involved in the sale of products containing kratom intended for human consumption to take similar steps to take their products off the market,” the FDA said in a statement.

The move appears unrelated to Tuesday’s warning from the CDC linking kratom to a Salmonella bacteria outbreak in 20 states. The CDC said 8 of the 28 people who were sickened by Salmonella had recently used kratom, making it the "likely source." No actual bacteria was found in a kratom product.

In recent months, the FDA has released a public health advisory warning that kratom should not be marketed as a treatment for opioid addiction, chronic pain, depression or any other medical condition. The agency also released a computer analysis that found kratom contains over two dozen opioid-like substances.

“The extensive scientific data we’ve evaluated about kratom provides conclusive evidence that compounds contained in kratom are opioids and are expected to have similar addictive effects as well as risks of abuse, overdose and, in some cases, death. At the same time, there’s no evidence to indicate that kratom is safe or effective for any medical use,” FDA Commissioner Scott Gottlieb, MD, said in a statement.

“To protect the public health, we’ll continue to affirm the risks associated with kratom, warn consumers against its use and take aggressive enforcement action against kratom-containing products. We appreciate the cooperation of companies currently marketing any kratom product for human consumption to take swift action to remove these products from circulation to protect the public.” 

'No Question They Want to Ban It’

“We’re in for a fight,” said David Herman, president of the American Kratom Association, a pro-kratom consumer group. “This is clearly a disinformation campaign. They are creating through a grassroots effort what they can’t seem to be able to (prove) with science.

“This is a bazooka against a fly. What are they doing? We’ve got misinformation everywhere.”

Herman says there is little doubt the FDA is moving to have all kratom products taken off the market.

“This is a concerted movement and it’s had a lot of disinformation with it,” he told PNN. “This is clearly what FDA wants to do. We hope the DEA has some thoughts against it, but no, there’s no question they want to ban it.”  

In 2016, the Drug Enforcement Administration attempted to ban kratom by scheduling it as an illegal controlled substance, but a public outcry and lobbying campaign forced the DEA to suspend its scheduling decision.

Herman said any renewed attempt to schedule kratom as a controlled substance would have to go through a public comment and hearing process, which could take a year or longer. He sees it as part of a larger effort by the FDA to have greater control over the loosely regulated dietary supplement industry.

“The only logical conclusion is that this is the first salvo in controlling the supplement business. We are on the frontline of a fight that will encompass a whole lot more than kratom,” Herman said.

Kratom Linked to Salmonella Outbreak

By Pat Anson, Editor

Kratom just can’t get a break. In recent weeks, the herbal supplement used by millions of Americans to treat chronic pain, depression and addiction has been blamed by federal agencies for dozens of fatal overdoses and even been called an opioid.

Now the Centers for Disease Control and Prevention has linked kratom to a salmonella outbreak and is recommending that people "not consume kratom in any form."

The bacterial infection has sickened 28 people, eleven serious enough to be hospitalized, but there have been no deaths. The outbreak began in October 2017 and has reached 20 states scattered around the country, which are highlighted in the map below.

“Epidemiologic evidence indicates that kratom is a likely source of this multistate outbreak,” the CDC said in a statement.

“In interviews, ill people answered questions about the foods they ate and other exposures in the months before they became ill. Eight (73%) of 11 people interviewed reported consuming kratom in pills, powder, or tea. No common brands or suppliers of kratom have been identified at this time."

The CDC statement did not say that Salmonella bacteria had actually been found in any samples of kratom. Nor did it explain how kratom use in 8 out of 28 cases establishes a link or proves that it was "a likely source."

The only "epidemiologic evidence" that investigators have established is that when they compared bacteria samples from people who were infected, they found the bacteria were closely related genetically.

"This means that people in this outbreak are more likely to share a common source of infection," the CDC said. "At this time, CDC recommends that people not consume kratom in any form. The investigation indicates that kratom products could be contaminated with Salmonella and could make people sick."

Salmonella is a bacterial infection usually spread through contaminated food or water. Most people who become infected develop diarrhea, fever and stomach cramps. Salmonella causes an estimated one million food-borne illnesses a year in the United States, with 19,000 hospitalizations and 380 deaths.

In the current outbreak, the CDC says there could be more cases than the 28 reported, because salmonella infections typically take 2 to 4 weeks before the illnesses are confirmed.

salmonella bacteria

It was a July 2016 report from the CDC that claimed kratom was linked to several overdose deaths and was “an emerging public health threat” that led the Drug Enforcement Administration to attempt to schedule kratom as an illegal controlled substance. Kratom supporters said the CDC research was amateurish and flawed, and a public outcry and lobbying campaign eventually forced the DEA to suspend its scheduling decision.

Earlier this month, the Food and Drug Administration released a computer analysis that found kratom contains over two dozen opioid-like substances – a report that critics say was biased and amounted to “junk science.” The computer analysis and a recent FDA public health advisory may indicate the federal government is planning another attempt at scheduling.

Kratom comes from the leaves of a tree that grows in Southeast Asia, where it has been used for centuries for its medicinal properties.

Kratom Supporters Say Ban Would Worsen Opioid Crisis

By Pat Anson, Editor

Nine scientists are warning that a renewed effort to make the herbal supplement kratom an illegal Schedule I controlled substance would worsen the opioid crisis and lead to more overdoses.

“It is our collective judgment that placing kratom into Schedule I will potentially increase the number of deaths of Americans caused by opioids because many people who have found kratom to be their lifeline away from strong opioids will be vulnerable to resumption of that opioid use,” wrote lead author Jack Henningfield, PhD, in a letter to Acting DEA administrator Robert Patterson and White House advisor Kellyanne Conway.

“A ban on kratom that would be imposed by CSA Scheduling would put them at risk of relapse to opioid use with the potential consequence of overdose death. Similar unintended consequences are to be expected in some who would be forced to use opioids to manage acute or chronic pain.”

The letter was released by the American Kratom Association (AKA), a pro-kratom consumer group, in response to an FDA analysis this week stating that kratom contains risky chemical compounds that act as opioids.   

“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,” said FDA Commissioner Scott Gottlieb, MD, in a lengthy statement.

“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."

Kratom comes from a tree that grows in southeast Asia, where it has been used for centuries for its medicinal properties. Kratom leaves are typically ground up into powder to make tea or used in capsules. Millions of Americans have discovered kratom in recent years, using it to treat chronic pain, anxiety, depression, and addiction.

In 2016, the Drug Enforcement Administration tried to list two of kratom’s active ingredients as Schedule I substances, which would have made it a felony to sell or possess kratom. The DEA suspended its plan after a public outcry and asked for a full medical evaluation of kratom from the FDA.

KRATOM POWDER

The new report from the FDA -- which links kratom to dozens of overdose deaths – seems likely to trigger a new effort by the DEA to make the herb an illegal controlled substance. That would be a serious mistake, according to the scientists engaged by the AKA, because it would stifle kratom research.

“Placing kratom into Schedule I of the CSA (Controlled Substances Act) will also have a profound and pervasive chilling effect on this needed additional research,” they wrote. “The federal government should be encouraging additional research into the potential benefits of kratom, as well as the possibility that extracts of kratom and/or new medicines that are similar to kratom’s active ingredients might serve as breakthroughs in pain relieving medicines that are so desperately needed.”

The letter was signed by scientists and researchers affiliated with the Johns Hopkins University School of Medicine, Columbia University, Temple University School of Medicine, University of Rochester Medical Center, University of British Columbia, and other academic and medical institutions.

FDA Report Calls Kratom an Opioid

By Pat Anson, Editor

The herbal supplement kratom contains opioids and should not be used to treat any medical condition, according to a new analysis by the U.S. Food and Drug Administration. The report seems likely to trigger a renewed effort to classify kratom as an illegal Schedule I substance under the Controlled Substances Act.

“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,” said FDA Commissioner Scott Gottlieb, MD, in a lengthy statement.

“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.”

Kratom comes from the leaves of a tree that grows in southeast Asia, where it has been used for centuries for its medicinal properties.  Millions of Americans have discovered kratom in recent years, using it to treat chronic pain, anxiety, depression, and addiction.

In 2016, the Drug Enforcement Administration attempted to list two of kratom’s active ingredients as Schedule I substances. The DEA suspended its plan after a public outcry, and said it would wait for a scheduling recommendation and medical evaluation of kratom from the FDA.

The new report may prompt the DEA to try again.  In a computer analysis using what the FDA calls Public Health Assessment via Structural Evaluation (PHASE) methodology, FDA researchers identified 25 chemical compounds in kratom that share structural similarities with opioid analgesics such as morphine. Like painkillers, the substances bind to mu-opioid receptors in the brain and – according to the computer models -- act the same way as opioids.

“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,” Gottlieb said.

FDA Analysis Called ‘Junk Science'

Critics of the FDA analysis say it contains numerous errors and signs of confirmation bias.

"The failure of the FDA to justify its attempt to schedule kratom using traditional and well-accepted scientific methods has apparently driven the FDA to move into the world of junk science.  Using computer modeling is very susceptible to bias in the assumptions the are built into the computer algorithms.  In short, the old adage of 'garbage in – garbage out' applies to such dramatic testing standards," said Dave Herman, chairman of the American Kratom Association (AKA), a pro-kratom consumer group.

In addition to its analysis, the FDA released a detailed report on 36 deaths associated with kratom over the past several years. The agency admits all but one of the overdose deaths involved other drugs and “could not be fully assessed.” There was only one death involving a person who had no prior opioid use.  

“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,” Gottlieb said.

"It is more of the same useless rhetoric from FDA," says Jane Babin, a molecular biologist who authored a report last year for the AKA that discredited many of the reports linking overdoses to kratom.

"Bottom line:  36 deaths over 3, 5, 7 or more years that they can't prove were caused by kratom, versus 16,000 deaths from killer street opioids," Babin wrote in an email. 

In a survey of 6,150 kratom users by Pain News Network and the AKA, most reported they used kratom as a treatment for chronic pain, depression, anxiety or addiction. Many say the herb is safe, effective and has literally saved their lives

“Kratom is the one thing that has kept me from using opiates and other illegal substances. I've been able to stay clean for 3 years now. It's given me my life back,” one survey respondent wrote.

“Kratom is the only reason I was finally able to end my addiction to hydrocodone. It is nowhere near as potent as hydrocodone, and you can't overdose” said another.

“I've had several friends who have died from heroin overdose. If they knew about kratom they may still be alive today,” wrote another kratom user.

One of the dilemmas faced by the FDA and DEA is that kratom products are currently classified as dietary supplements, and there are few regulatory standards applied to their importation or ingredients. The only requirement for kratom vendors is that they don't make unsubstantiated health claims. Classifying kratom as a Schedule I controlled substance would radically change that, making it a felony to possess or sell kratom, and likely creating an underground black market for the herb.

FDA Warns Promoters of Herbal Addiction Treatments

By Pat Anson, Editor

The U.S. Food and Drug Administration is following through on its threat to crackdown on companies selling kratom and other herbal supplements as treatments for opioid addiction and withdrawal.

The FDA and the Federal Trade Commission (FTC) have sent joint warning letters to the distributors of 15 herbal supplements for illegally marketing unapproved products.

“The FDA is increasingly concerned with the proliferation of products claiming to treat or cure serious diseases like opioid addiction and withdrawal,” said FDA Commissioner Scott Gottlieb, MD. “People who are addicted to opioids should have access to safe and effective treatments and not be victimized by unscrupulous vendors who are trying to capitalize on the opioid epidemic by taking advantage of consumers and selling products with baseless claims.”

The companies used websites or social media to make claims about their products' ability to cure, treat or prevent opioid withdrawal and addiction.

TaperAid, for example, claims its “17 all-natural organic herbs” can relieve symptoms of withdrawal and even reduce tolerance to opioid painkillers.

“Use of TaperAid may increase sensitivity to opioids. You may need to lower your usual intake of opioids to account for reduced tolerance,” the company claimed. “People using short acting opioids (which includes many pain management medications and heroin) will notice a significant lowering of tolerance to their opiate of choice.”

TaperAid’s website and Facebook account have been taken down, although a TaperAid review can still be found on YouTube.

“Opioid addiction is a serious health epidemic that affects millions of Americans,” said acting FTC Chairman Maureen Ohlhausen. “Individuals and their loved ones who struggle with this disease need real help, not unproven treatments.”

In addition to the warning letters, the FTC released a “fact sheet” warning consumers about companies that promise miracle cures or fast results.

“Dietary supplements – such as herbal blends, vitamins, and minerals – have not been scientifically proven to ease withdrawal or to treat opioid dependence,” the FTC warned. “Products like Kratom, which some claim can help, are actually not proven treatments, and can be addictive and dangerous to your health.”

The FDA issued a public health advisory about kratom last November, saying there was “no reliable evidence to support the use of kratom as a treatment for opioid use disorder.”

Kratom comes from the leaves of a tree that grows in southeast Asia, where it has been used for centuries for its medicinal properties.  Millions of Americans have discovered kratom in recent years, and use it to treat addiction, chronic pain, anxiety and depression. The herb is not approved by the FDA for any medical condition. 

In 2016, the Drug Enforcement Administration attempted to list kratom’s two active ingredients as Schedule I controlled substances, which would have made it a felony to possess or sell kratom. The DEA suspended its plan after a public outcry, saying it would wait for a scheduling recommendation and medical evaluation of kratom from the FDA. Over a year later, that report has still not been released.

Lawmakers Ask FDA to Lift Kratom Warning

By Pat Anson, Editor

A bipartisan group of 17 congressmen is asking the Food and Drug Administration to lift a public health warning about kratom, an herbal supplement used by millions of Americans to treat chronic pain, addiction, depression and anxiety.

In a joint letter to FDA commissioner Scott Gottlieb, MD, the lawmakers said kratom was “a natural alternative to opioids” and was “found to be as safe as coffee.”  The letter was drafted by Rep. Jared Polis (D-CO) and Rep. Dave Brat (R-VA).

“We have heard from many constituents who have used kratom to successfully end their dependence on dangerous opioids, and maintaining legal access to kratom is important to many Americans to maintain sobriety,” the letter states. “We believe that if legal access to professionally-manufactured kratom were made difficult or illegal, instances of kratom laced with opioids or other dangerous compounds would likely become more common.”

The FDA issued a public health advisory in November, warning that there were “increasing harms associated with kratom” and that the herb was involved in 36 deaths. The agency did not say when or where the deaths occurred.

“There is no reliable evidence to support the use of kratom as a treatment for opioid use disorder. Patients addicted to opioids are using kratom without dependable instructions for use and more importantly, without consultation with a licensed health care provider about the product’s dangers, potential side effects or interactions with other drugs,” Gottlieb said in a statement.

Kratom comes from the leaves of a tree that grows in southeast Asia, where it has been used for centuries for its medicinal properties. The leaves are usually ground up to make tea or turned into powder and used in capsules. Most kratom users say the herb has a mild analgesic and stimulative effect.

Last year, the Drug Enforcement Administration attempted to list kratom as a Schedule I controlled substance, which would have made it a felony to possess or sell. The DEA suspended its plan after an outcry by kratom supporters and a lobbying campaign that enlisted the help of dozens of senators and congressmen.

“We need to improve access to alternative pain relief options beyond addictive opioids.  For some, kratom, a cousin of the coffee plant, can be that alternative.  Like cannabis, it should be legal and available,” Rep. Polis said in a statement. “The FDA must end its bogus ‘public health warning’ that has already led to several cities banning kratom.  Patients need and deserve options.”

Kratom Pioneer Calls for Government Regulation

One of the dilemmas faced by the FDA is that kratom products are considered dietary supplements, and there are few regulatory standards applied to their importation or ingredients. The only requirement for kratom vendors is that they don't make unsubstantiated health claims.

“I know that regulation is needed and I think that is something we conscientiously have to work towards,” says Duncan Macrae, the founder of Kratom.com and one of the first commercial suppliers to bring kratom products into the United States, Canada and Europe.

“I think that direct government regulation will eventually come about. But while everybody’s waiting for that to happen, I think that vendors in the industry that are making money from this should get together and start their own internal regulation to try to be more transparent,” Macrae told PNN.

“I can tell you for sure that there are a lot of adulterated products on the market, and vendors going in and out of business the whole time, changing names and companies. There’s no central body checking or controlling anything.”

Macrae says kratom vendors should certify their products and list their ingredients – or risk the government stepping in and banning kratom altogether.

“Right now the problem is that every vendor is labeling their product ‘not for consumption.’ And there’s no information about the product or what’s inside it,” he said. “This is the regulation we need to do from inside and hopefully the government won’t (ban kratom) because it is an extremely valuable medicinal herb and they will embrace some kind of regulation that makes sense, so that kratom can be administered safely and distributed safely and people will know exactly what they’re getting.”

Macrae is working to ensure the quality of his own products by growing kratom on farms in Indonesia, as opposed to just harvesting the leaves from trees growing wild in remote jungles. He’s planted hundreds of thousands of kratom trees, with hopes of somebody mass producing kratom tea, pills and extracts.

“I think this is the future for the industry and that is the product that we need to develop, and that’s what I’ve been working on,” he said.

FDA Head Tweets New Warning About Kratom

By Pat Anson, Editor

The head of the Food and Drug Administration is warning again about the marketing of kratom and other dietary supplements to treat opioid addiction – calling them “health fraud scams.”

“FDA believes strongly people addicted to opioids should have access to safe and effective, approved treatments for addiction. Unfortunately, unscrupulous vendors are trying to capitalize on opioid epidemic by illegally marketing products for these purposes,” FDA commissioner Scott Gottlieb, MD, warned on Twitter Friday.

Gottlieb was reacting to a story in The New York Times about the marketing of dietary supplements like “Opiate Detox Pro,” a blend of vitamins and amino acids said to have “amazing benefits” in reducing opioid withdrawal symptoms. 

Similar claims are made about kratom by websites such as HowtoQuitHeroin.com, which was founded by Jorge Fernandez, a recovering heroin addict.

“Kratom works. Kratom helps. It can help you to quit heroin. It can help you to quit Suboxone. It can help you to quit Oxycontin. And believe it or not, it can even help you to quit Methadone as well,” Fernandez claims.

Kratom is not approved by the FDA as a treatment for opioid addiction or any other health condition. But because kratom is classified as a dietary supplement, it’s not held up to the same regulatory standards as pharmaceutical drugs -- as long as vendors don’t make any misleading claims about its health benefits. That’s when the FDA can intervene by seizing kratom products or prohibiting their sale.

“They’re marketing products as dietary supplements with unproven claims about ability to treat addiction; or as all-natural alternatives to opioids. Health fraud scams like these can pose serious health risks,” Gottlieb tweeted. “FDA will continue to act when it learns of the deceptive sale or advertising of products that claim to effectively treat opioid use disorder, but which have not been proven safe and effective for these purposes.”

SCOTT GOTTLIEB, MD

Although Gottlieb didn’t specifically name kratom as one of those “health fraud scams,” there’s little doubt that’s one of the supplements he was referring to. Last month the FDA issued a public health advisory about kratom, warning that it was addictive and linked to dozens of overdose deaths.

“The FDA knows people are using kratom to treat conditions like pain, anxiety and depression, which are serious medical conditions that require proper diagnosis and oversight from a licensed health care provider,” Gootlieb said at the time.

“I understand that there’s a lot of interest in the possibility for kratom to be used as a potential therapy for a range of disorders. But the FDA has a science-based obligation that supersedes popular trends and relies on evidence.”

Kratom comes from the leaves of a tree that grows in southeast Asia, where it has been used for centuries for its medicinal properties. The leaves are usually ground up to make tea or turned into powder and used in capsules. Most kratom users say the herb has a mild analgesic and stimulative effect, similar to coffee.

In a survey of 6,150 kratom users last year by Pain News Network and the American Kratom Association, most said they used kratom as a treatment for chronic pain, depression or anxiety. But a fair number -- nearly 10 percent -- said the primary reason they used kratom was to treat opioid addiction.

“Kratom is the one thing that has kept me from using opiates and other illegal substances. I've been able to stay clean for 3 years now. It's given me my life back,” one survey respondent wrote.

“Kratom is the only reason I was finally able to end my addiction to hydrocodone. It is nowhere near as potent as hydrocodone, and you can't overdose” said another.

“It has saved my life. I am a mother of four and have anxiety, depression, acute back pain, and I am an opioid addict. It has kept all these at bay for me,” one woman wrote. “I want to be there for my children, but the sad truth is I know I can't live with these conditions and not find something. It's a sad day when I have to turn to the streets again to have any kind of life.”

“I've had several friends who have died from heroin overdose if they knew about kratom they may still be alive today,” wrote another kratom user.

Last year, the Drug Enforcement Administration attempted to list kratom’s two active ingredients as Schedule I controlled substances, which would have made it a felony to possess or sell kratom. The DEA suspended its plan after a public outcry and lobbying campaign by kratom supporters, saying it would wait for a medical evaluation and scheduling recommendation for kratom from the FDA. Although the FDA has warned the public about using kratom, its full report and recommendations have yet to be released.

Can Kratom Be Patented?

By Jane Babin, Guest Columnist

Discussions surrounding kratom are heating up following the Food and Drug Administration’s public health advisory, and questions have appeared about whether kratom and its constituents are patented or could be. 

The short answer is no.

Patents are important tools for protecting investment in innovation.  Without patent protection, far fewer new drugs would be developed.  An alternative is to keep details of an invention secret to ensure that no one will be able to copy it.  However, this approach isn’t possible in the pharmaceutical industry, where regulations require extensive public disclosure. 

To encourage inventors to share details about their inventions, the U.S. grants a patent right to prevent other people from making the same invention for a limited time, in exchange for publicly disclosing the details about the invention.  The public can read patents and apply their disclosures to other situations, which immediately advances science and technology.  After a patent expires, the invention itself can be made by anyone.

Patents Granted for a Limited Time

U.S. Patents 3,256,149 (“Compositions Compromising an Alkaloid of Mitragyna Speciosa and Methods of Using Same”) and 3,324,111 (“Speciofoline, an Alkaloid from Mitragyna Speciosa”), were both granted to Smith Kline & French Laboratories.

FDA Commissioner Scott Gottlieb has ties to GlaxoSmithKline (the successor to Smith Kline & French) and some have suggested a conflict of interest motivated his warning about kratom.

If there is a conflict, it isn't over these patents, which were issued in the 1960's and have long since expired.  Patents are granted for a limited time.  Currently, patents expire 20 years after filing.  Prior to 1995, a patent term was 17 years from the date of issuance.

Products of Nature are Not Patentable

Prior to their expiration, the two patents gave Smith Kline & French the right to prevent others from making, using, selling, and importing certain alkaloids isolated from kratom, but not the whole plant or leaf. 

Plants themselves and other substances found in nature have never been patentable, unless they are changed substantially by an inventor.  In the 1960s, isolating a substance from a plant was considered a substantial change to the substance. Today it isn’t. 

Courts have held that substances found in nature, even in impure form, cannot be patented whether they are isolated from a natural source or synthesized in a lab.  If a chemical has the same structure as a natural substance, it is not patentable.

Derivatives are Patentable

Derivatives of natural chemicals can be patented, however.  As good as a natural chemical may be, changing it slightly may make it even better -- or worse.  Scientists tweak a compound's structure to alter its properties, repurpose it, investigate interactions with other molecules, and design around compounds that are unpatentable. 

Patents have been granted for derivatives of kratom alkaloids, particularly derivatives of mitragynine and 7-hydroxymitragynine (e.g. U.S. Patent Nos. 8,247,428 & 8,648,090), which potentially may become new drugs that are improved over natural alkaloids. 

Even if they are never commercialized, studying how structural changes affect biological activity can lead scientists to modify other compounds to impart similar properties.  For example, making non-addictive kratom derivatives may show scientists ways opioids could be made non-addictive. 

U.S. patent law recognizes the importance of such inquiry and includes an exception under 35 USC §371(e), allowing scientists to use patented inventions in certain types of research.  Unlike scheduling under the Controlled Substances Act, no permission or pre-approval is needed to take advantage of this exception.

Distinguishing a Patent from a Published Application

Another misconception about patents is that every document that looks like a patent is one.  To obtain a patent, an inventor must first file an application, which doesn't become a patent until the Patent Office is satisfied that it meets all legal requirements. Whether granted or not, the application is usually published, and it looks very much like a granted patent. 

There are two ways to distinguish a U.S. patent from an application:

1. U.S. Patents have the words "US Patent" at the top of the first page, while applications have "US Patent Application Publication."
2. Current patents are identified by a 7 digit number.  Published applications numbers have eleven digits beginning with a 4 digit year. For example, 9,458,426 is a US patent, while 2014/0186948 is a published application.

Foreign countries also issue patents and an inventor must obtain a patent in each country where he or she wants to enforce patent rights.  Thus, there may be multiple patents covering the same invention in different countries.  Each country has its own numbering system and may or may not publish applications prior to granting them.  Instead of immediately filing multiple applications in foreign countries, inventors can initially file a single international application with the World International Patent Organization (WIPO) under the Patent Cooperation Treaty (PCT), which can be used as the first step toward patents in many countries.  

Requirements for a Patent and Examination

Applications don't automatically become patents.  They are first examined to see if a patentable invention that meets certain legal criteria is described and claimed.  In addition to claiming patentable subject matter, an invention must be novel, non-obvious, and the application must disclose sufficient description that someone in the field would be able to make and use the invention. 

Examination involves a dialogue between applicant and a patent examiner, often resulting in changes to the claims (the legally enforceable part of a patent).  Some applications are never granted.

US 2010/0209542 is a kratom-related application that is frequently discussed.  It claims a method for treating withdrawal from an addictive substance using a kratom extract.  When this application was first examined, it was rejected because existing literature described kratom itself as being addictive.  The applicant might have overcome this rejection by arguing that kratom is non-addictive or that other addictive substances are used to treat withdrawal.  However, the inventors faced bigger challenges because they didn't actually treat anyone for withdrawal with a kratom extract and described no studies of their own showing the method actually worked. 

Self-treatment using kratom had been reported, but that didn’t help the application because it meant that the applicant was not the first to "invent" the method and the invention was not novel.  Facing an uphill battle, the application was abandoned and never matured into an enforceable patent.

There may be many obstacles on the path to general acceptance of kratom as a beneficial herbal supplement.  Fortunately, patents are not one of them.

Jane Babin, PhD, is a molecular biologist and a biotechnology patent attorney in southern California. Jane has worked as a consultant for the American Kratom Association, a pro-kratom consumer group.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

FDA Issues New Kratom Warning

By Pat Anson, Editor

The Food and Drug Administration has issued a public health advisory about kratom, an herbal supplement used by millions of Americans to self-treat pain, anxiety, depression and addiction.

In a lengthy statement, FDA Commissioner Scott Gottlieb, MD, said the agency has “significant concerns” about the increasing use of kratom and its potential health risks – especially when it is used to treat opioid addiction.

“At a time when we have hit a critical point in the opioid epidemic, the increasing use of kratom as an alternative or adjunct to opioid use is extremely concerning. It’s very troubling to the FDA that patients believe they can use kratom to treat opioid withdrawal symptoms,” Gottlieb wrote.

“There is no reliable evidence to support the use of kratom as a treatment for opioid use disorder. Patients addicted to opioids are using kratom without dependable instructions for use and more importantly, without consultation with a licensed health care provider about the product’s dangers, potential side effects or interactions with other drugs.”

Kratom comes from the leaves of a tree that grows in southeast Asia, where it has been used for centuries for its medicinal properties. The leaves are usually ground up to make tea or turned into powder and used in capsules.

Most kratom users say the herb has a mild analgesic and stimulative effect, similar to coffee.

In his statement, Gottlieb claimed that kratom was addictive and was being used recreationally for its euphoric effects. But he also acknowledged that the herb could have legitimate medical uses.   

“The FDA knows people are using kratom to treat conditions like pain, anxiety and depression, which are serious medical conditions that require proper diagnosis and oversight from a licensed health care provider,” he wrote. “I understand that there’s a lot of interest in the possibility for kratom to be used as a potential therapy for a range of disorders. But the FDA has a science-based obligation that supersedes popular trends and relies on evidence.”

The evidence is lacking, in large part, because kratom and its active ingredients are natural substances that cannot be patented and have less potential for profit. That discourages pharmaceutical companies from investing in research and clinical studies to prove kratom's safety and efficacy.

"To date, no marketer has sought to properly develop a drug that includes kratom," said Gottlieb. "We believe using the FDA’s proven drug review process would provide for a much-needed discussion among all stakeholders. Until then, I want to be clear on one fact: there are currently no FDA-approved therapeutic uses of kratom."

Last year, the Drug Enforcement Administration attempted to list kratom as a Schedule I controlled substance, which would have made it a felony to possess or sell. The DEA suspended its plan after an outcry and lobbying campaign by kratom supporters.

The DEA said at the time that kratom was linked to several deaths, as well as psychosis, seizures and an increased number of calls to poison control centers. Gottlieb renewed those claims today and said the FDA was “aware of reports” of 36 deaths associated with kratom. But he did not go into detail about where or when those deaths occurred.

The American Kratom Association (AKA) – a pro-kratom consumer group – has strongly disputed recent autopsy reports linking kratom to sudden deaths in Florida, Georgia and New York, calling them a "rush to judgement."

The AKA filed a dispute resolution petition challenging the "weak scientific basis" of the FDA advisory and asked that it be withdrawn.

“For years, the FDA has published scientifically inaccurate information on the health effects of consuming kratom, directly influencing regulatory actions by the DEA, states, and various local government entities.  AKA believes the FDA health advisory on kratom will lead to more state and local bans, all based on discredited, incomplete, and mischaracterized scientific claims," the AKA said in a statement.

In a survey of 6,150 kratom consumers by Pain News Network and the AKA, over 90% said the herb was “very effective” in treating their medical condition, whether it was pain, anxiety, depression or addiction. Many predicted that if kratom were classified as a controlled substance and made illegal, it would only increase the use of alcohol, marijuana, prescription opioids and illegal substances like heroin.

Report Finds ‘Rush to Judgment’ in Kratom Deaths

By Pat Anson, Editor

Medical examiners in New York and Florida made significant errors when they attributed the recent deaths of two young men to the herbal supplement kratom, according to a new analysis commissioned by the American Kratom Association, a pro-kratom consumer group.

At issue are the sudden deaths of Matthew Dana in upstate New York in August and Christopher Waldron in Hillsborough County, Florida in July. Both men were 27.

A medical examiner listed Waldron’s cause of death as “intoxication by Mitragynine,” one of the active ingredients in kratom. The coroner who performed the autopsy on Dana blamed his death on a hemorrhagic pulmonary edema (blood in the lungs) caused by high levels of kratom.

“In both of these cited cases, the conclusions reported by the coroner and medical examiner citing ‘kratom overdose’ and ‘kratom intoxication’ appear to add to the long list of mistaken, inaccurate, and now discredited reports implicating kratom,” wrote Jane Babin, PhD, a molecular biologist and lawyer.

“These two cases, where it appears there was a rush to judgment to align with a political narrative promoted by the Drug Enforcement Administration on kratom use, undermine the credibility of the search for the actual cause of death for the benefit of the decedent’s family and the public.”

Babin said mitragynine has never been found to cause a pulmonary edema, and the medical examiner erred in not analyzing Dana’s blood for drugs such as anti-anxiety medication or anabolic steroids. Dana was a police sergeant and bodybuilder, who reportedly used steroids as part of his bodybuilding program.

Babin said the medical examiner in Florida also “rushed to judgement” in blaming Waldron’s death on kratom. Two prescription medications used to treat depression and muscle spasms, Citalopram and Cyclobenzaprine, were also found in Waldron’s blood. Labels on both drugs warn they can cause coma or death when taken together. Waldron also had ventricular hypertrophy, an enlarged liver and thyroid disease, which may have contributed to his death, according to Babin’s report.

“What I see here are very troubling indications that these deaths may have been incorrectly attributed to kratom in the face of other causes, including possible anabolic steroid use in one case and contraindicated prescription medication interactions that could kill on their own,” said Karl Ebner, PhD, a toxicologist who reviewed the report.

“These families are owed the best evidence about what happened to their loved ones, not what would appear to be some conclusions that are incompletely supported by the current evidence."

Millions of people use kratom to treat chronic pain, depression, anxiety and addiction. Last year, the DEA attempted to list kratom as a Schedule I controlled substance, which would have made it a felony to possess or sell. The DEA said kratom was linked to several deaths, as well as psychosis, seizures and an increased number of calls to poison control centers  

The DEA suspended its plan after an outcry and lobbying campaign by kratom supporters.

"Last year, the DEA tried to demonize kratom. In 2017, the kratom community finds itself in the same situation all over again,” said David Herman, chair of the American Kratom Association (AKA). “This time, we are being told that two deaths were supposedly the result of kratom use.  Let me be very clear about this:  We do not believe that kratom caused these deaths.  That's what the science tells us.

“Given that there are millions of kratom consumers in the U.S., if this botanical was dangerous it would stand to reason that there would be thousands … or even tens of thousands of deaths … and that is absolutely not the case."

The AKA backed another study last year that found kratom has little potential for abuse and dependence. Most kratom users say the herb has a mild analgesic and stimulative effect, similar to coffee.

Kratom Non-Profit Seeks Missing Financial Records

By Pat Anson, Editor

A widening rift in the kratom community erupted into a virtual earthquake today with the release of a statement by the American Kratom Association that accuses its founder and former chair of financial improprieties.

Susan Ash called the allegations against her “defamation” and suggested she would take legal action against the organization that she created.

Ash founded the American Kratom Association (AKA) in 2014 and played a prominent role in its successful campaign last year to prevent the Drug Enforcement Administration from listing kratom as a controlled substance. She resigned as chair in May after complaints arose about her management of the AKA, a non-profit that has grown considerably in size and funding in the past year.

“I regret to say that even during our biggest successes, I have heard ill-informed and malicious sniping about AKA and me," Ash said at the time. “I am an organizer and a front-line campaigner and that is where I need to be for kratom. I am stepping down from the AKA board effective immediately to concentrate more on those efforts.”

SUSAN ASH

Ash remained as national spokesperson for the AKA, but was suspended after an internal audit of the organization’s financial records.

“The preliminary financial review identified significant discrepancies and missing records in financial documentation for compensation and expense reimbursements paid to Ms. Ash over a significant time period. Several of the expenditures are substantial, and have raised significant questions as to whether they were appropriate for reimbursement from donor funds,” the AKA said in its statement.

“A formal request was made to Ms. Ash to provide receipts and justifications for expenses to allow for the financial review to be completed, but Ms. Ash has been unwilling and/or unable to provide the necessary receipts and records to justify these expenditures.”

The statement also said Ash refused to relinquish control of the AKA’s bank and PayPal accounts. Current AKA chairman Dave Herman told PNN the organization has “no idea how much money" is in those accounts and no longer has access to them.  It has since established new accounts. 

“The statement that the American Kratom Association put out about me today is defamation. That is the only comment I will make about it, as this matter is in the hands of lawyers,” Ash said in a statement on her Facebook page.

Ash worked tirelessly to promote the safe use of kratom, which she used to control her opioid addiction. Millions of others have found the herbal supplement effective in treating chronic pain, depression, anxiety and addiction.

Listing kratom as a Schedule I controlled substance, alongside heroin and LSD, would have made it a felony to possess or distribute. The DEA suspended its plan to list kratom after a very effective public relations and lobbying campaign by Ash and the AKA.

“I've never fought a harder, more public battle -- not just because of the terrible odds against us, but because this one opened up my private life, including my very personal struggles with addiction, to the world,” Ash wrote in a Facebook post last August.

“I wasn't prepared to be the poster child, or to have admirers, or to have haters, but I believed with every fiber of my being that kratom is safe and can change and save lives including my own, so this battle was worth it.”

The AKA’s political success led to an infusion of over $800,000 in donations last year, according to Herman, who says Ash was being paid over $5,000 a month when she resigned as chair.  Until this year she was paid only a small stipend.

Herman said Ash has ignored repeated requests to turn over receipts and other financial records, and has continued to “interfere” with the AKA. He told PNN the board preferred to keep the estrangement with Ash a private matter, but felt it had no choice but to go public.

susan ash at 2016 rally at white house

“I didn’t want to try this in the court of public opinion,” Herman said. “What I want to have happen, with all my heart, is for her to pony up the receipts, go quietly her way and let us go quietly our way with no disparagement of any kind. There’s no desire to do this. I fought hard to not do this. But when you’re given no choice, you got to go.”   

Will New Laws Punish Pain Patients?

By Pat Anson, Editor

Recent efforts by state and federal lawmakers aimed at punishing drug traffickers could wind up sending people to prison simply for seeking pain relief, according to critics.

This week the American Kratom Association (AKA) sent an action alert to members warning that a bill introduced by Sen. Chuck Grassley and Sen. Dianne Feinstein could be a “backdoor way” of banning kratom -- an herbal supplement that millions of people use as an alternative to opioid painkillers.

The “Stop the Importation and Trafficking of Synthetic Analogues Act of 2017” – also known as the SITSA Act – would give the Attorney General the power to list as a “Schedule A” substance any unregulated drug that has a chemical structure similar to that of a drug already listed as a controlled substance. A similar measure has been introduced in the House.

The bills are ostensibly aimed at banning chemical cousins or “analogues” of fentanyl, a powerful synthetic opioid blamed for thousands of overdose deaths that is increasingly appearing on the black market.

But kratom supporters fear the SITSA Act could also be used to ban kratom, something the Drug Enforcement Administration tried unsuccessfully to do last year, claiming it was an "opioid substance" with “a high potential for abuse.” Kratom is not an opioid, but it has opioid-like properties that reduce pain or act as a stimulant or depressant – much like a controlled substance.

“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,” said Susan Ash, the AKA’s founder and spokesperson. “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.”

Ash wants the SITSA Act to be amended to exclude natural botanicals like kratom. In its current form, she says the bill could impose prison sentences of up to 20 years for importers or exporters of kratom, which is made from the leaves of a tree that grows in southeast Asia.

Florida Law Stiffens Penalties for Fentanyl

A new law in Florida is also intended to crackdown on fentanyl dealers, but critics say it could wind up sending unsuspecting pain patients to prison as well.

Signed into law yesterday by Gov. Rick Scott, it requires mandatory minimum sentences for defendants convicted of selling, purchasing or possessing illicit fentanyl.

Anyone caught with as little as four grams of fentanyl would face a minimum of three years in prison. Sentences escalate depending on the amount of fentanyl seized and murder charges could be filed if someone dies of a fentanyl overdose.

Dealers often mix fentanyl with heroin or sell it in counterfeit pills disguised to look like oxycodone or other prescription painkillers. Many users have no idea they’re buying fentanyl, which is 50 to 100 times more potent than morphine.

"There's a massive problem with counterfeit pills," Greg Newburn, state policy director for Families Against Mandatory Minimums told the Miami New Times. "You have people who think they’re buying oxy pills who will end up getting labeled as traffickers in fentanyl.”

DEA PHOTO

Florida has been down this path before. According to an investigative series by Reason.com, mandatory minimum sentences in Florida for oxycodone and hydrocodone trafficking resulted in 2,300 people being sent to prison, most of them low-level drug users or patients who went to the black market seeking pain relief. 

“The signing of this bill by Gov. Scott is another example of using get tough drug policies for political gain,” said Tony Papa, Manager of Media and Artist Relations for the Drug Policy Alliance. “This is not going to stop the sale of heroin in Florida. It's another prosecutorial tool that will be used for bargaining by district attorneys in drug cases.  Under this new law many individuals will be subject to the death penalty for a 10 dollar bag of dope. It's totally insane!”

Wisconsin to Involuntarily Commit “Drug Dependents”

A bill that recently sailed through the Wisconsin legislature with little opposition would allow for the involuntary commitment of someone who is drug dependent. The bill’s sponsor, Assemblyman John Nygren, has a daughter who has struggled with heroin addiction and served time in jail.

Current Wisconsin law allows for the involuntary commitment of alcoholics if three adults sign a petition alleging that a person lacks self-control over their use of alcohol and whose health is substantially impaired. 

The new bill adds “drug dependence” to the list of reasons someone can by committed. Dependence is defined as a person’s use of one or more drugs that is beyond their ability to control and that substantially impairs their health or social functioning.

The bill is one of nearly a dozen anti-opioid measures sponsored by Nygren that Gov. Scott Walker asked to be approved in a special legislative session. It now heads to his office for consideration.