FDA, FTC combine to tackle opiod claims in kratom warning letters

FDA and FTC have issued four joint warning letters to kratom companies centered on opioid claims. It’s a move that comes on the heels of FDA rejecting an NDI filing on the ingredient for the sixth time.

The companies involved are Herbsens Botanicals, Klarity Kratom, Kratom Exchange and Omni Consumer Products, LLC dba YoKratom. The warning letters were the result of an online search of the companies’ websites  and social media pages conducted in May and June 2022.

The warning letters allege that the companies have been making disease treatment claims on the products, which were sold primarily in capsule form.  Among the disease treatment claims were pain relief, blood pressure and depression indications.

Read the full story at nutraingredients-usa.com

4 Kratom Companies Sent FDA Warning Letters

Silver Spring, MD—On June 30, 2022, the Food and Drug Administration (FDA) issued warning letters, jointly with the Federal Trade Commission (FTC), to four companies selling kratom products. FDA stated that it has not approved kratom for the treatment or cure of opioid use disorder and withdrawal symptoms.

FDA also noted that it has received “concerning reports about the safety of kratom.” The agency is “actively evaluating all available scientific information on this issue and advises consumers not to use kratom or essential oils for the treatment or cure of opioid use disorder and withdrawal symptoms.”

The 4 kratom companies receiving letters:

  • Herbsens Botanicals
  • Klarity Kratom
  • Kratom Exchange
  • Omni Consumer Products LLC d/b/a YoKratom

Read more at Whole Foods Magazine

Pa. House passes ban on sale of kratom to minors; safeguards for adults not being considered – for now

HARRISBURG — The Pennsylvania House on Monday voted 197-3 to ban the sale of kratom to minors, after earlier legislative moves stripped from the bill safeguards for adults who use the substance taken from a tropical evergreen tree.

Bill sponsor Rep. Tracy Pennycuick, a Montgomery County Republican, said she was frustrated that the adult-targeted measures were taken out of the bill in a committee. She said they would be contained in a future bill.

Consumed in powder, capsule and beverage forms, kratom is a largely unregulated, but widely used substance. It can be mixed with things that make it more harmful, or have unpredictable effects if used in improper amounts.

“We have seen children in the ER,” Pennycuick said. “We have had children who have had seizures.”

Keep reading at mcall.com

House Committee Leaders Tackle Marijuana Research, Kratom, Impaired Driving And More In New Spending Measures

House Appropriations Committee leaders have released yet another set of spending bill reports that touch on marijuana and other drug policy issues like kratom, with this latest batch focusing on cannabis research barriers, impaired driving and preventing use by youth and pregnant people.

Additionally, at a committee markup on Tuesday, members separately approved an amendment aimed at removing a federal funding cap to reimburse local and state police departments that are partners in a cannabis eradication program targeting illicit growers.

The newly released reports, meanwhile, cover funding for the Departments of Labor, Health and Human Services (HHS), Education, Transportation and Interior for the 2023 Fiscal Year.

Much of the report language centers on studying cannabis, including one section that reiterates the committee’s ongoing concerns about barriers associated with investigating Schedule I drugs like marijuana that “effectively limit the amount and type of research that can be conducted.”

Keep reading at marijuanamoment.net

First pot, then magic mushrooms? Decriminalization is spreading

As cannabis legalization spreads across the globe, another mind-altering drug is trying to follow in its tracks: magic mushrooms.

Denver voted in May to decriminalize the fungus that contains psilocybin, a psychedelic compound popularized by ’60s counterculture. Oakland, California followed Denver’s lead a few weeks later and Oregon is trying to get a similar measure on the ballot for 2020.

Advocates say mushrooms have untapped medical potential that could be as big as cannabis, particularly for treating depression and addiction. The U.S. Food and Drug Administration granted “breakthrough therapy” status in October to Compass Pathways Ltd. to test the drug for treatment-resistant depression, expediting the development process. The London-based company says it’s now proceeding with a large-scale clinical trial in Europe and North America.

Read more at BNN Bloomberg

A bill regulating herbal stimulant kratom looked different after a Pa. House panel got done with it

A state House bill that was supposed to enhance consumer protections for kratom, an unregulated plant that has the properties of a stimulant when consumed at low levels and an opiate when consumed in high quantities, ended up looking very different when it came out of committee this week.

Instead of adding protections, the Republican-controlled House Health Committee amended the bill sponsored by Rep. Tracy Pennycuick, R-Mongomery, to remove all provisions about kratom manufacturing and production, and lowered the purchasing age to 18 years old from 21 years old.

The American Kratom Association, an industry trade group that advocates to keep kratom legal and pass kratom regulations, argued those provisions were necessary to keep consumers safe; supporters of the amendment argued most of the regulations struck from the bill were already in place. Legislators are discussing different amendments to the bill, but its future remains in limbo. 

Read the story at Pennsylvania Capital-Star

Readers respond: Kratom regulation protects Oregonians

Gov. Kate Brown recently signed into law the Oregon Kratom Consumer Protection Act, which took effect this month. This is vital legislation for Oregon and shapes the path for federal regulations of kratom, a popular herbal remedy, to keep all consumers safe.

As a member of Gov. Brown’s Opioid Task Force, I have learned how damaging opioids can be to individuals and their families. After years of scientific research showing that kratom is a significantly safer product than opioids and other drugs, many of us are relieved that Governor Brown has decided to take this step to protect Oregonians who rely on kratom. This passage marks a change in understanding why protecting and regulating kratom is so important.

Read the full story at The Oregonian

Colorado Governor Signs Bill To Regulate Kratom Sales

The governor of Colorado has signed a bill that provides a regulatory framework for the legal sale of kratom, a plant that advocates say can serve as a safer alternative to opioids and also help treat symptoms of addiction withdrawal.

The signing of the Regulation Of Kratom Processors Act, sponsored by Sen. Joann Ginal (D), makes Colorado the eighth state to take this kind of legislative approach to the substance at a time when calls for safe opioid alternatives are rising at all levels of government amid the ongoing overdose epidemic.

Gov. Jared Polis (D), who as a member of Congress was among several lawmakers in 2017 who pushed for federal agencies to research kratom’s health impacts, signed the bill last week. The American Kratom Association (AKA) celebrated the measure’s enactment.

Read more at Marijuana Moment

Kratom Vendors Association Announces Virtual Grand Opening

The Kratom Vendors Association (KVA) announced it has opened its virtual doors to offer its products and services specifically to kratom vendors in the United States. Founded by Stacey Lloyd in March 2022, the Kratom Vendors Association provides Good Manufacturing Practices (GMP) compliance support to kratom vendors doing business in the United States. KVA offers exclusive membership, standard operating procedures (SOPs), one-on-one GMP compliance support from GMP compliance specialists, GMP training courses, and a GMP Certification Program.

“We assist kratom vendors with GMP compliance to ensure product quality and consumer safety,” explains Stacey Lloyd.

“I began auditing kratom vendors for the American Kratom Association. During my experience working with kratom vendors, I found there was a critical need for compliance support. There currently isn’t an organization that assists kratom vendors with becoming GMP compliant, so they have no place to turn for help.”

Read more at Yahoo Finance

Kratom’s Future in Denver and Colorado After New Bill Becomes Law

The controversy over the Colorado General Assembly’s passage of a new bill related to fentanyl, which will allow individuals to be charged with a felony for possessing the drug even if they don’t realize it was mixed with another substance, overshadowed the legislature’s approval of another groundbreaking measure: Senate Bill 22-120, also known as Regulation of Kratom Processors, the first major bill in the state to focus on kratom, a popular organic substance of Southeast Asian origin.

Governor Jared Polis, who asked the federal Food and Drug Administration to lift its public-health warning on kratom while a member of Congress, is expected to sign Regulation of Kratom Processors — and that’s good news for Mac Haddow, senior fellow on public policy for the American Kratom Association, an advocacy organization that pushed hard for the measure’s approval.

Keep reading at Westword.com

FDA Head Wants New Regulations for Kratom and CBD

The head of the Food and Drug Administration says his agency will need new authority from Congress to regulate both kratom and cannabidiol (CBD), two natural substances used by millions of Americans to self-treat their pain and other medical conditions.

FDA Commissioner Dr. Robert Califf testified on Thursday before a House Appropriations subcommittee, where he was asked why the agency was slow in developing new regulations for CBD and why it remained opposed to the use of kratom. Califf said new regulatory pathways were needed for both substances because they fall between the cracks of existing law that gives the FDA broad authority to regulate food and drugs.

“I don’t think the current authority we have, on the food side and the drug side, necessarily gives us what we need to have to get the right pathway to move us forward. We’re going to have to come up with something new. I’m very committed to doing that,” said Califf.

Read more at Pain News Network

Top Federal Drug Official Pressed On Marijuana, Kratom And Drug Decriminalization At Congressional Hearing

Several congressional lawmakers pressed a top federal drug official on Wednesday about their concerns over marijuana legalization, though they seemed to signal that they view the reform as inevitable.

Members of the House Appropriations subcommittee for the Departments of Labor, Health and Human Services, Education, and Related Agencies directed several cannabis questions at National Institute on Drug Abuse (NIDA) Director Nora Volkow. Lawmakers also talked about the therapeutic potential of kratom, as well as broader drug decriminalization issues.

Ranking Member Tom Cole (R-OK) broadly asked Volkow about any “problems” she’s focused on with respect to cannabis legalization. But while he signaled he’s opposed to the reform, the congressman also said the “horse is already out of the barn probably” as more states adopt legalization and Congress moves to end federal prohibition.

Keep reading at Marijuana Moment

Does Law Protect Kratom Consumers?

With a shift in consumerism towards a more dynamic and natural outlook, it is time to cover grey areas like Kratom under laws. Apart from its popularity among users, Kratom is an excellent industry for investment and growth. The high craze for kratom strains like Red Horned kratom makes it imperative for authorities to keep a check. The last few years have seen a rampant rise in updates relative to the legal status of Kratom. While many blogs focus only on whether buying Kratom is legal or not, the current surge in consciousness demands to look beyond it. The laws related to commerce always protect consumers, and since Kratom is a product, it’s high time the debate to preserve kratom consumers is put forth.

Keep reading at programminginsider.com

Federal Agency Explores Benefits Of The ‘Controversial Tree’ Kratom

A top federal health agency hosted a meeting last week to explore the therapeutic potential of a “controversial tree” commonly known as kratom, which supporters say has pain relieving qualities and can be used as a substitute for opioids.

As part of a lecture series, the National Institutes of Health (NIH) invited University of Florida researcher Christopher McCurdy to provide an overview of the science of kratom and what role it could play in mitigating the overdose crisis.

McCurdy, who previously served as the director of an NIH research center, titled his lecture, “Can a Controversial Tree Help End the Opioid Crisis?” He went into detail about anecdotal experience and clinical research, explaining how there’s promising evidence that kratom could help alleviate pain, reduce withdrawal symptoms from opioids and lower dependence on methamphetamine, for example.

Read more at Marijuana Movement

Kratom regulations advance in Missouri Legislature

JEFFERSON CITY — The Missouri Senate endorsed legislation Monday requiring more regulations for kratom products.

The measure, sponsored by Rep. Phil Christofanelli, R-St. Peters, in the House, and Sen. Holly Rehder, R-Sikeston, in the Senate, will bar the sale of the product to anyone younger than 18, as well as require sellers to ensure that their products do not contain dangerous substances.

The legislation was approved on a 30-2 vote, with Republican Sens. Paul Wieland of Imperial and Jeanie Riddle of Mokane dissenting.

Kratom is a plant grown in Southeast Asia that affects the same opioid brain receptors as morphine. It is often used as a dietary supplement for pain relief and a natural alternative to treat opioid withdrawal, post-traumatic stress disorder, depression and other health conditions.

Keep reading at stltoday.com

Here’s what Florida’s lawmakers didn’t do: notable failed bills

A bill by Sen. Joe Gruters, R-Sarasota, who is also chairman of the Florida Republican Party, would have regulated a different drug, kratom, a medicinal plant with opioid properties. 

Gruters withdrew the bill after it passed two committees unanimously but then stalled. The Florida Kratom Consumer Protection Act was intended to protect people’s rights to consume the drug safely in Florida, Gruters said.

Sarasota County has banned possession of kratom, citing the decision by the U.S. Army and Navy to ban the drug. Their findings said the drug has addictive properties and causes symptoms like dry mouth, insomnia, anorexia, hallucinations and confusion.

Gruters said the drug is good overall and wants to prevent manufacturers from mixing the drug with harmful substances. The drug can be found in many smoke shops around the U.S. and is typically consumed in tea.

Keep reading at the Orlando Sentinel

Dispensaries selling illegal magic mushrooms in Vancouver could lead to the legalization of the substance, like they did with cannabis, shop keeper says

  • It’s not legal to sell psilocybin or “shrooms” in Canada, but one activist shop owner does anyway.
  • He’s trying to push Vancouver to manage or legalize it, as cannabis sellers did in 2015.
  • “If you’re like me, and you’re willing to take a risk and kind of push it forward, you find the resistance isn’t very strong,” he told Insider.

Psilocybin, also known as magic mushrooms or “shrooms,” is not allowed to be sold under Canadian federal law, but that hasn’t stopped some Vancouver store owners from selling it anyway.

“There’s not a strong resistance to people doing this kind of stuff. If you’re like me, and you’re willing to take a risk and kind of push it forward, you find the resistance isn’t very strong,” Dana Larsen, the owner of the Medicinal Mushroom Dispensary, told Insider.

Read more at Business Insider

National retailer CBD Kratom sues Radnor Township over ordinance

The prospect of a national CBD retailer locating in Wayne — the focus of community-wide unease over the last month — prompted the Radnor Township Board of Commissioners to take steps to block the shop’s opening.

In response, the retailer sued the township and its director of community development the same day. It hoped to stop the vote or, failing that, to get an injunction that would allow it to do business at the Wayne location.

The ordinance enacted by the commissioners Monday bans the sale of two controversial substances, kratom, and Delta-8, within 1,000 feet of a school, playground, or daycare center,  effectively halting the opening of the new shop by the company CBD Kratom. The ordinance also prohibits the sale, distribution, or offering of kratom or Delta-8 to individuals under the age of 21.

Read more at whyy.org

Radnor votes to regulate kratom, delta-8

RADNOR — Weeks after a store selling products called kratom and delta-8 opened in Wayne and was then ordered to shut down by the township, the board of commissioners has adopted an ordinance that would prevent the owners from reopening at that location.

This week, the Radnor Board of Commissioners passed an ordinance that bans the sale of kratom and delta-8 within 1,000 feet of a school, daycare center or playground. The ordinance also prohibits the sale of the products to anyone anywhere in the township under 21.

“[T]he Radnor Township Board of Commissioners (Board) hereby finds that mitragynine and 7-hydroxymitragynine, also known as Kratom, and Delta 8 THC, have the potential for abuse and can pose a health, welfare, and safety concern to the community and its residents; …

Keep reading at mainlinemedianews.com

How ‘magic mushrooms’ could follow in the footsteps of cannabis

What was something of a taboo issue half a decade ago is now the subject of bills from both Republicans and Democrats in more than a dozen states. They range from proposals to study the medical benefits of psychedelics to bills that would allow adults to consume such drugs under supervision.

“It’s gone viral and sparked an interest nationwide,” said Democratic Washington state Sen. Jesse Salomon, who is sponsoring a bill that would allow psilocybin use among adults over age 21 under supervision. “I just didn’t know there were so many like-minded people on this.”

Oregon led the nation when voters approved a ballot measure in 2020 to legalize and regulate psilocybin therapy, alongside another decriminalizing drug possession more broadly.

Read the full story at Politico