New Study Confirms Safety of CBD

A new comprehensive study of more than 1,000 people has confirmed the safety of orally-ingested cannabidiol products and provides data that addresses the U.S. Food and Drug Administration’s concerns about the safety of CBD. The two-part study found that daily consumption of CBD across a range of typical retail products and serving sizes is not associated with elevated liver tests, low testosterone levels, or daytime drowsiness.

To conduct the study, the research firm Validcare contracted with 17 CBD companies to study safety concerns previously expressed by the FDA. Validcare acted as the contract research organization, which included obtaining feedback from the FDA on the research protocol, conducting the study and publishing the results.

“The data in this study looks really good; it’s highly significant, and the chances of it being wrong are very, very small,” Dr. Robert Kaufmann, director of research for Validcare and a former professor at Southern Illinois University School of Medicine, said in a statement from the U.S. Hemp Roundtable. “I am very hopeful that this data will allow the FDA to regulate these popular CBD products.”

The first cohort of the study, which was peer-reviewed and published in Cannabis and Cannabinoid Medicine last year, studied how CBD products from 12 different manufacturers affected the liver function of 839 study participants. The second cohort included 222 additional individuals taking CBD products produced by five additional companies. The participation of the additional study subjects strengthened the statistical reliability of both the liver safety results and achieved statistical relevance for both sleep and testosterone results, according to the researchers.

The participants in the research were all adults aged 18 to 75 who had been taking oral CBD products for at least 30 days. Participants were recruited by the 17 CBD companies involved in the research for the decentralized observational study. The companies provided participants with their standard CBD regimen during the study period. All product companies supplied a third-party certificate of analysis (COA), which was confirmed by a neutral third party to ensure the composition of the supplied product matched both the label and the supplied COA.

FDA Still Has Not Regulated CBD

After hemp was legalized with the signing of the 2018 Farm Bill, the FDA recognized the “clear interest of Congress in fostering the development of appropriate hemp products” and noted that the agency “has the authority to issue a regulation,” which would allow for the legal marketing of CBD as a dietary supplement. The FDA said it would work to further clarify a regulatory approach for CBD products, “using science as our guide and upholding our rigorous public health standards.” However, the agency has not taken any substantial steps to regulate CBD, claiming that it needs more real-world data to move forward.

In March 2020, the FDA released a congressional report and public statement on potential regulatory pathways for the sale of hemp-derived CBD products, listing liver injury as the top concern for consumer safety, along with “male reproductive toxicity, or damage to fertility in males or male offspring of women.”

“We are excited to report that the ‘real-world data’ that FDA has been soliciting addresses the agency’s safety concerns,” stated Jonathan Miller, general counsel to the U.S. Hemp Roundtable, the hemp industry’s national advocacy organization. “The time has come for FDA to regulate CBD and other hemp derivatives.”

The results of the study have renewed calls from CBD producers and the hemp industry for the FDA to expedite the regulation of CBD products.

“Participating in this study has allowed us to help provide regulators, scientists, product formulators, and other stakeholders with the evidence needed to prove the safety profile of CBD,” said Blake Schroeder, CEO of Medical Marijuana Inc. and its subsidiary, Kannaway, one of the companies that participated in the research. “We hope that this, in addition to our other research efforts in Brazil and Mexico, will not only help break the stigma around CBD but that it will also help legislators understand the importance of free, legal access to the entire cannabis plant.”

If the FDA still does not act to regulate CBD products, the U.S. Hemp Roundtable is calling on Congress to pass relevant legislation. There are currently three pending bills, H.R. 841, H.R. 6134 and S. 1698, that would require the FDA to develop regulatory pathways for the sale of hemp extracts such as CBD in ingestible form.

“We are proud to have participated in this ground-breaking study on CBD products and feel verified in our products’ excellent results in the testing. These results bode very well for supporting the hemp industry against the fears that FDA had previously stated which had been a hurdle in their regulatory process,” said Vince Sanders, the owner CBD American Shaman. “We are excited they can now rely on this study in verifying CBD products as safe for the human liver, have no effects of day-time drowsiness, and no negative effect on low testosterone levels or reproductive harm of male participants or the male offspring of women in the study.”

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FDA Sounds Alarm About Cereal and Candy Edibles that Appeal to Children

The U.S. Food and Drug Administration (FDA) once again cautioned people to keep their edibles out of reach from children, especially the ones with sketchy, colorful packaging that might appeal to children.

On May 13, the FDA issued a warning, sounding the alarm about lookalike products that mimic candy and more recently—children’s cereal.

Copycat products that were highlighted in the warning mimic Cap’n Crunch, Cocoa Pebbles, Cocoa Puffs, Froot Loops, Fruity Pebbles, Nerds Ropes, Starbursts, Sour Patch Kids, and Trix, among others.

There are two reasons not to support gray area cannabis products like these: the potential appeal to children being one, and the other being the ethical violation of blatantly ripping off the intellectual property of mainstream food companies. But the FDA was mainly concerned about the physical symptoms that could occur in children.

“The FDA is aware of multiple media reports describing children and adults who accidentally consumed copycat edible products containing THC and experienced adverse events,” the organization wrote. “Additionally, from January 2021 through April 24, 2022, the FDA received over 100 adverse event reports related to children and adults who consumed edible products containing THC.”

Symptoms to look out for include “hallucinations” and “vomiting.”

“Some individuals who ate these edible products reportedly experienced adverse events such as hallucinations, increased heart rate and vomiting, and many required medical intervention or hospital admission,” the warning continues. “Seven of the reports specifically mention the edible product to be a copycat of popular foods, such as Cocoa Pebbles, Nerds Rope, Skittles, Sour Patch Kids, and Starburst.”

Separating Dangers from Myth

Both CBD and THC show promise in pediatrics for mental and physical conditions in controlled doses, such as intractable epilepsy, but children’s small bodies usually can’t withstand THC like an adult. If a small child (or pet) consumes them by accident, it can quickly become “a situation.” All adults carry the responsibility of keeping their edibles out of reach, and most do.

But sometimes, hysteria makes these warnings seem less credible. For children and adults, a “whiteout” can be a scary experience, but “overdoses solely by marijuana are unlikely,” even the CDC admits. At the crack of October 1, we receive our annual warning about supposed cannabis-infused candy being passed out to children on Halloween, but sometimes said stories are debunked.

The FDA gave three recommendations in the event that a child consumes an edible:

  • Call 9-1-1 or get emergency medical help right away if you or someone in your care has serious side effects from these products. Always keep these products in a safe place out of reach of children.
  • Call the local poison control center (1-800-222-1222) if a child has consumed these products. Do not wait for symptoms to call.
  • Contact your healthcare provider if you or someone in your care recently ingested these products and you have health concerns.

The FDA also gave three ways to file a complaint in a dark warning to people with nosy neighbors, living in fear of people dropping the dime and calling Child Protective Services. It’s unclear if the complaint avenues are intended for parents themselves or others.

“Health care professionals, patients and consumers are encouraged to report complaints and cases of exposure and adverse events to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program,” the warning reads.

Last year, over 100 people dialed in.

Copycat Edibles Are a Problem, Not Only for Children

As it turns out, mainstream food companies essentially want the same thing, but mostly for a different reason. On April 27, a group of a dozen major food companies called on Congress to crack down on the growing number of THC-infused copycat knockoffs.

“Children are increasingly threatened by the unscrupulous use of famous brand logos, characters, trademarks, and trade dress on THC-laced edible products. While cannabis (and incidental amounts of THC) may be legal in some states, the use of these famous marks, clearly without approval of the brand owners, on food products has created serious health and safety risks for consumers, particularly children, who cannot tell the difference between these brands’ true products and copycat THC products that leverage the brand’s fame for profit,” the companies wrote in the letter.

Parents with small children and teens are advised to double check that their edibles are out of reach from children.

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FDA Sounds Alarm About Cereal and Candy Edibles that Appeal to Children

The U.S. Food and Drug Administration (FDA) once again cautioned people to keep their edibles out of reach from children, especially the ones with sketchy, colorful packaging that might appeal to children.

On May 13, the FDA issued a warning, sounding the alarm about lookalike products that mimic candy and more recently—children’s cereal.

Copycat products that were highlighted in the warning mimic Cap’n Crunch, Cocoa Pebbles, Cocoa Puffs, Froot Loops, Fruity Pebbles, Nerds Ropes, Starbursts, Sour Patch Kids, and Trix, among others.

There are two reasons not to support gray area cannabis products like these: the potential appeal to children being one, and the other being the ethical violation of blatantly ripping off the intellectual property of mainstream food companies. But the FDA was mainly concerned about the physical symptoms that could occur in children.

“The FDA is aware of multiple media reports describing children and adults who accidentally consumed copycat edible products containing THC and experienced adverse events,” the organization wrote. “Additionally, from January 2021 through April 24, 2022, the FDA received over 100 adverse event reports related to children and adults who consumed edible products containing THC.”

Symptoms to look out for include “hallucinations” and “vomiting.”

“Some individuals who ate these edible products reportedly experienced adverse events such as hallucinations, increased heart rate and vomiting, and many required medical intervention or hospital admission,” the warning continues. “Seven of the reports specifically mention the edible product to be a copycat of popular foods, such as Cocoa Pebbles, Nerds Rope, Skittles, Sour Patch Kids, and Starburst.”

Separating Dangers from Myth

Both CBD and THC show promise in pediatrics for mental and physical conditions in controlled doses, such as intractable epilepsy, but children’s small bodies usually can’t withstand THC like an adult. If a small child (or pet) consumes them by accident, it can quickly become “a situation.” All adults carry the responsibility of keeping their edibles out of reach, and most do.

But sometimes, hysteria makes these warnings seem less credible. For children and adults, a “whiteout” can be a scary experience, but “overdoses solely by marijuana are unlikely,” even the CDC admits. At the crack of October 1, we receive our annual warning about supposed cannabis-infused candy being passed out to children on Halloween, but sometimes said stories are debunked.

The FDA gave three recommendations in the event that a child consumes an edible:

  • Call 9-1-1 or get emergency medical help right away if you or someone in your care has serious side effects from these products. Always keep these products in a safe place out of reach of children.
  • Call the local poison control center (1-800-222-1222) if a child has consumed these products. Do not wait for symptoms to call.
  • Contact your healthcare provider if you or someone in your care recently ingested these products and you have health concerns.

The FDA also gave three ways to file a complaint in a dark warning to people with nosy neighbors, living in fear of people dropping the dime and calling Child Protective Services. It’s unclear if the complaint avenues are intended for parents themselves or others.

“Health care professionals, patients and consumers are encouraged to report complaints and cases of exposure and adverse events to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program,” the warning reads.

Last year, over 100 people dialed in.

Copycat Edibles Are a Problem, Not Only for Children

As it turns out, mainstream food companies essentially want the same thing, but mostly for a different reason. On April 27, a group of a dozen major food companies called on Congress to crack down on the growing number of THC-infused copycat knockoffs.

“Children are increasingly threatened by the unscrupulous use of famous brand logos, characters, trademarks, and trade dress on THC-laced edible products. While cannabis (and incidental amounts of THC) may be legal in some states, the use of these famous marks, clearly without approval of the brand owners, on food products has created serious health and safety risks for consumers, particularly children, who cannot tell the difference between these brands’ true products and copycat THC products that leverage the brand’s fame for profit,” the companies wrote in the letter.

Parents with small children and teens are advised to double check that their edibles are out of reach from children.

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FDA Sends Warning Letters to Businesses Improperly Selling Delta-8

The FDA recently sent letters with a new emphasis towards companies selling delta-8 THC products with purported benefits. 

Some of the companies sold pet products containing CBD, the announcement highlighted hemp-derived delta-8 products, marketed for human consumption. This marks the first time individual companies have received such a letter warning about delta-8 THC.

Specifically, the FDA says the products are marketed in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act), and most of the concern surrounds medical claims on the labeling. Per the announcement, any delta-8 THC product claiming to “diagnose, cure, mitigate, treat, or prevent diseases” is considered an unapproved new drug. 

The FDA sends continual reminders that it has not evaluated whether unapproved delta-8 THC products are effective for medical claims, which involves dosages, interactions, or whether they have potentially dangerous side effects. These products can be found just about everywhere including gas stations and CBD shops.

“The FDA is very concerned about the growing popularity of delta-8 THC products being sold online and in stores nationwide. These products often include claims that they treat or alleviate the side effects related to a wide variety of diseases or medical disorders, such as cancer, multiple sclerosis, chronic pain, nausea, and anxiety,” said FDA Principal Deputy Commissioner Janet Woodcock, M.D. 

“It is extremely troubling that some of the food products are packaged and labeled in ways that may appeal to children. We will continue to safeguard Americans’ health and safety by monitoring the marketplace and taking action when companies illegally sell products that pose a risk to public health.” 

The FDA recently published a consumer update giving a general warning to consumers about the potential health hazards of delta-8 THC products. 

“Several months ago, they came out with questions regarding delta-8 and made it clear that it was their opinion that ‘buyer beware,’ and that there are many unsafe delta-8 products here in the marketplace that are injuring people,” U.S. Hemp Roundtable’s General Counsel Jonathan Miller told High Times on the phone. “This is now step two in terms of sending out warning letters.” 

The U.S. Hemp Roundtable is a coalition of dozens of leading hemp companies and organizations committed to safer practices. The organization receives questions swirling around the murky topic of delta-8 THC regularly.

Should businesses that deal with delta-8 THC products be concerned? That depends. “I would not be surprised to see actual enforcement actions in the not-so-distant future. We’re seeing a tide of action right now at the state level, and I think that’s going to continue,” Miller said, but added that he expects the delta-8 THC market to continue to thrive in places such as adult-use markets. 

“The general consensus—maybe not from everybody—is that D8 products that use good manufacturing practices in adult-use marketplaces have a future,” Miller added. “I don’t think anyone’s talking about a ban of delta-8 products in the sense that delta-9 is banned, but I think those folks who are selling poorly manufactured products at gas stations without any controls should be forewarned that public policy is moving strongly against them.”

This applies to questionable psychoactive products that are sold in stores that are generally not authorized to do so. “Stop making medical claims, use good manufacturing practices and sell them in adult-use marketplaces,” he said.

Regarding hemp products, the FDA went on to remind that Epidiolex alone has been fully approved at all levels for medical claims. Even Charlotte’s Web full-spectrum CBD extract was denied FDA approval as a dietary extract. 

The FDA issued individual warning letters to the following companies:

ATLRx Inc.
BioMD Plus LLC
Delta 8 Hemp
Kingdom Harvest LLC
M Six Labs Inc.

Businesses involved with delta-8 THC products should take note about the pattern the FDA is taking.

The post FDA Sends Warning Letters to Businesses Improperly Selling Delta-8 appeared first on High Times.

FDA Sends Warning Letters to Businesses Improperly Selling Delta-8

The FDA recently sent letters with a new emphasis towards companies selling delta-8 THC products with purported benefits. 

Some of the companies sold pet products containing CBD, the announcement highlighted hemp-derived delta-8 products, marketed for human consumption. This marks the first time individual companies have received such a letter warning about delta-8 THC.

Specifically, the FDA says the products are marketed in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act), and most of the concern surrounds medical claims on the labeling. Per the announcement, any delta-8 THC product claiming to “diagnose, cure, mitigate, treat, or prevent diseases” is considered an unapproved new drug. 

The FDA sends continual reminders that it has not evaluated whether unapproved delta-8 THC products are effective for medical claims, which involves dosages, interactions, or whether they have potentially dangerous side effects. These products can be found just about everywhere including gas stations and CBD shops.

“The FDA is very concerned about the growing popularity of delta-8 THC products being sold online and in stores nationwide. These products often include claims that they treat or alleviate the side effects related to a wide variety of diseases or medical disorders, such as cancer, multiple sclerosis, chronic pain, nausea, and anxiety,” said FDA Principal Deputy Commissioner Janet Woodcock, M.D. 

“It is extremely troubling that some of the food products are packaged and labeled in ways that may appeal to children. We will continue to safeguard Americans’ health and safety by monitoring the marketplace and taking action when companies illegally sell products that pose a risk to public health.” 

The FDA recently published a consumer update giving a general warning to consumers about the potential health hazards of delta-8 THC products. 

“Several months ago, they came out with questions regarding delta-8 and made it clear that it was their opinion that ‘buyer beware,’ and that there are many unsafe delta-8 products here in the marketplace that are injuring people,” U.S. Hemp Roundtable’s General Counsel Jonathan Miller told High Times on the phone. “This is now step two in terms of sending out warning letters.” 

The U.S. Hemp Roundtable is a coalition of dozens of leading hemp companies and organizations committed to safer practices. The organization receives questions swirling around the murky topic of delta-8 THC regularly.

Should businesses that deal with delta-8 THC products be concerned? That depends. “I would not be surprised to see actual enforcement actions in the not-so-distant future. We’re seeing a tide of action right now at the state level, and I think that’s going to continue,” Miller said, but added that he expects the delta-8 THC market to continue to thrive in places such as adult-use markets. 

“The general consensus—maybe not from everybody—is that D8 products that use good manufacturing practices in adult-use marketplaces have a future,” Miller added. “I don’t think anyone’s talking about a ban of delta-8 products in the sense that delta-9 is banned, but I think those folks who are selling poorly manufactured products at gas stations without any controls should be forewarned that public policy is moving strongly against them.”

This applies to questionable psychoactive products that are sold in stores that are generally not authorized to do so. “Stop making medical claims, use good manufacturing practices and sell them in adult-use marketplaces,” he said.

Regarding hemp products, the FDA went on to remind that Epidiolex alone has been fully approved at all levels for medical claims. Even Charlotte’s Web full-spectrum CBD extract was denied FDA approval as a dietary extract. 

The FDA issued individual warning letters to the following companies:

ATLRx Inc.
BioMD Plus LLC
Delta 8 Hemp
Kingdom Harvest LLC
M Six Labs Inc.

Businesses involved with delta-8 THC products should take note about the pattern the FDA is taking.

The post FDA Sends Warning Letters to Businesses Improperly Selling Delta-8 appeared first on High Times.

FDA Seeks Ban on Menthol Cigarettes

The Food and Drug Administration on Thursday proposed new rules that would prohibit the sale of menthol cigarettes in the United States.

Health and Human Services Secretary Xavier Becerra said that the new rules, which would also include a ban on flavored cigars, “would help prevent children from becoming the next generation of smokers and help adult smokers quit.”

“Additionally, the proposed rules represent an important step to advance health equity by significantly reducing tobacco-related health disparities,” Becerra said in a statement.

The move was made possible back in 2009, when Congress passed the Family Smoking Prevention and Tobacco Control Act that was then signed into law by President Barack Obama.

The statute empowered the FDA to regulate tobacco products, and the regulatory body responded by imposing on a ban on virtually all flavored cigarettes.

But menthol cigarettes were exempted in that ban, due in part to opposition from the Congressional Black Caucus at the time.

As The New York Times reported Thursday, the proposed ban “would most likely have the deepest impact on Black smokers, nearly 85% of whom use menthol cigarettes, compared with 29% of white smokers.”

According to The Washington Post, “many members [of the Congressional Black Caucus] now support a ban” on menthol cigarettes.

“The authority to adopt tobacco product standards is one of the most powerful tools Congress gave the FDA and the actions we are proposing can help significantly reduce youth initiation and increase the chances that current smokers quit. It is clear that these efforts will help save lives,” said Robert M. Califf, the commissioner of the Food and Drug Administration. “Through the rulemaking process, there’s an important opportunity for the public to make their voices heard and help shape the FDA’s ongoing efforts to improve public health.”

The FDA said that, as of 2019, “there were more than 18.5 million current menthol cigarette smokers ages 12 and older in the U.S., with particularly high rates of use by youth, young adults, and African American and other racial and ethnic groups.”

“Menthol is a flavor additive with a minty taste and aroma that reduces the irritation and harshness of smoking. This increases appeal and makes menthol cigarettes easier to use, particularly for youth and young adults,” the administration explained. “Menthol also interacts with nicotine in the brain to enhance nicotine’s addictive effects. The combination of menthol’s flavor, sensory effects and interaction with nicotine in the brain increases the likelihood that youth who start using menthol cigarettes will progress to regular use. Menthol also makes it more difficult for people to quit smoking.”

The Times reported that the FDA’s exemption on menthol in 2009 “rankled public health groups and a cadre of former U.S. cabinet health secretaries, who noted the 47,000 Black lives lost each year to smoking-related disease.” Those former secretaries, The Times said, argued that keeping menthol on shelves “caves to the financial interests of tobacco companies and discriminates against African Americans.”

But the FDA made it clear last year that it would renew its efforts to ban menthol cigarettes, saying at the time that it was “working toward issuing proposed product standards within the next year to ban menthol as a characterizing flavor in cigarettes and ban all characterizing flavors (including menthol) in cigars; the authority to adopt product standards is one of the most powerful tobacco regulatory tools Congress gave the agency.”

The Times reported that White House records “show recent meetings with supporters of a ban, including the American Heart Association and American Academy of Pediatrics,” but that others, such as the Rev. Al Sharpton, remain staunchly opposed.

Sharpton, The Times said, “recently secured a meeting with White House officials along with King & Spalding, a lobbying firm with an extensive record of advocating for RAI Services Company, the cigarette maker formerly known as R.J. Reynolds.”

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Sen. Cory Booker Hints Cannabis Administration and Opportunity Act is Nearly Ready

Sen. Cory Booker, Senate Finance Chair Ron Wyden, and Senate Majority Leader Chuck Schumer plan to release cannabis legislation to both end the federal prohibition of cannabis and help communities that are most impacted by the War on Drugs, possibly by the end of the month.

Sens. Booker, Wyden, and Chuck Schumer introduced a discussion draft of the Cannabis Administration and Opportunity Act (CAOA) last July, which would decriminalize cannabis at the federal level and allow states to decide whether to make it legal. It would also expunge nonviolent cannabis crimes, and taxes would be allocated to help communities hit hardest by the War on Drugs.

Since releasing the outline of the bill, lawmakers called for feedback on what to include and exclude from the final bill. The community responded. NORML, for instance, called for strengthening civic protections to clear records, revising outdated testing requirements, and providing a pathway for small businesses to compete with large ones. Others showed concern about tax rates.

Senate Majority Leader Chuck Schumer announced at a press conference in February that he intends to formally introduce the bill in April. NJ.com reports that the bill is almost written, and due to drop towards the end of the month. While the media is targeting April 20 as a good symbolic date for an announcement, the Senate is in recess through April 22, so a bill being introduced during the week of April 25 is more likely.

“I don’t mean this to be fully in jest but there’s been a lot of conversation about doing it on 4/20,” Booker told news outlets at the U.S. Capitol. “Aspirationally, I would love to see it done on 4/20 but I can’t speak to that, given all the things that are sort of backing up in the Senate.”

The U.S. House approved another comprehensive cannabis bill on April 1, the Marijuana Opportunity Reinvestment and Expungement (MORE) Act, but that gained support from only three Republicans. Booker needs the support of at least 10 GOP senators if the Senate is to pass any sort of legislation, but remains optimistic about ending prohibition the right way.

“This cannot just be about simple legalization,” Booker said. “It has to be about restorative justice. We had a really awful run of prohibition. This war on drugs has been not a war on marijuana. It’s been a war on people. This idea that you can just suddenly legalize or decriminalize and have so many Americans still suffering the consequences for having a criminal conviction where they can’t get a job, a loan from a bank, that’s just patently unfair. So this is a bill built around those ideas of restorative justice.”

Steven Hawkins is president and CEO of the U.S. Cannabis Council (USCC), as well as the former executive director of Marijuana Policy Project. Hawkins said that we don’t have the full bill quite yet, but a few things stand out. A full list of the USCC’s guidance for the draft discussion was released last September, but a few immediate issues come to mind.

“First of all, the proposed tax, at least in the draft, had the federal tax at 25% on top of high state taxes that exist currently,” Hawkins told High Times. “It would just make it impossible for the industry to succeed in most states. So that would have to be addressed. And then the question of primary jurisdiction. The draft proposed that the FDA have primary jurisdiction. We certainly have concerns with the role of the FDA. We’d rather see the Tax and Trade Bureau have primary jurisdiction.” 

The CAOA would also establish a regulatory framework for cannabis under the U.S. Food and Drug Administration (FDA) and the Alcohol and Tobacco Tax and Trade Bureau (TTB). Descheduling would also normalize income tax for legal cannabis businesses, meaning existing businesses would no longer be subject to Section 280E of the Internal Revenue Code. But some argue cannabis should be regulated more like alcohol. “The Tax and Trade Bureau is already dealing with adult-use products with alcohol and tobacco,” Hawkins said. “We’d want that agency to have jurisdiction over cannabis as well.” 

The bill, once introduced, will head to the Senate, where it will pass through several committees and converge with more. “The bill—to our knowledge—will intersect with at least a dozen committees,” Hawkins said.

The CAO Act (or CAOA) has been characterized as a states’ rights bill, allowing states to choose, and differs from bills such as Rep. Nancy Mace’s States Reform Act, mostly due to the inclusion of items such as social equity provisions.

“Normally legislation this comprehensive doesn’t pass on the first go,” Hawkins said. “You have to build support. What we saw with the MORE Act, was that there were some Republicans asking questions: How do we protect children. How do we deal with intoxication. There were a couple people who said, absolutely not, we should not allow this ever, but there were not anywhere close to the majority in terms of comments during the hearing. What we’re seeing is the maturity of our movement. There are now competing bills in the House of Representatives with Nancy Mace’s bill, the MORE Act, etc.”

While some leaders worry about the bill’s odds in the Senate under the current Congress, others worry about the tax implications. Rep. David Joyce opposed the MORE Act, issuing an announcement citing that it has no chance of passing the Senate, while others disagree.

“The movement towards cannabis descheduling and legalization is growing stronger and stronger,” Hawkins said. “We now have competing visions in the House. We’ll see what Republican support emerges in the Senate. It may be—given the partisan nature of the Senate—that the CAO bill will just be seen—rightly or wrongly—as simply a Chuck Schumer bill. But that doesn’t mean if a Republican bill were to emerge in the Senate, that there would not be [more supporters].”

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U.S. House Passes MORE Act To Decriminalize Cannabis at the Federal Level

Cannabis advocates have a reason to rejoice this Friday with federal legislation moving forward to decriminalize cannabis at the federal level, which would change everything. The U.S. House of Representatives approved the Marijuana Opportunity, Reinvestment, and Expungement (MORE) Act, or H.R. 3617, in a floor vote Friday. It’s the second time the House approved the bill as the historic piece of legislation makes its way to the Senate.

The MORE Act was approved April 1 on a mostly party-line 220-204 vote. A previous version of the bill was approved in December 2020—also on a mostly party-line vote—which was the first comprehensive cannabis policy reform legislation to receive a floor vote or be approved by either chamber of Congress.

The MORE Act would remove cannabis from the Controlled Substances Act, allowing states to legalize cannabis markets without fear of federal interference. It would include provisions for the expungement or resentencing of people with nonviolent federal cannabis convictions.

It would also promote diversity in the cannabis industry at the state level, and help repair the disproportionate harms caused by America’s War on Drugs. According to a recent Congressional Budget Office analysis, the Act, if passed, would increase tax revenues by over $8 billion over a 10-year period and would also drastically reduce federal prison costs.

High Times obtained several statements from leadership of national cannabis organizations.

“At a time when the majority of states regulate marijuana use and when the majority of voters of all political ideologies support legalization, it makes no sense from a political, fiscal, or cultural perspective for federal lawmakers to continue to support the ‘flat Earth’ failed federal prohibitionist policies of the past,” NORML Deputy Director Paul Armentano told High TImes. “It is time for members of the Senate to follow the House’s lead and take appropriate actions to comport federal law with majority public opinion and with the plant’s rapidly changing legal and cultural status.”

“It is time for the Senate to have the courage to do what the House of Representatives has now done twice, vote to end our failed and racist war on marijuana consumers,” NORML Executive Director Erik Altieri told High Times. “The American public, no matter their political persuasion, overwhelmingly support legalization and the federal government should acknowledge the will of the people and promptly send the MORE Act to the president’s desk.”

“This vote is a clear indicator that Congress is finally listening to the vast majority of voters who are sick and tired of our failed marijuana criminalization policies and the damage they continue to inflict in communities across the nation every day,” said NORML’s Political Director Morgan Fox. “It is long overdue that we stop punishing adults for using a substance that is objectively safer than alcohol, and that we work to address the disparate negative impacts that prohibition has inflicted on our most vulnerable individuals and marginalized communities for nearly a century.”

Fox replaced outgoing NORML staffer Justin Strekal last January when he assumed the role as political director, and already, federal legislation is moving forward quickly.

“The time has come for federal lawmakers to put aside partisan differences and recognize that state-level legalization policies are publicly popular, successful, and are in the best interests of our country,” Fox added. “Now that the House has once again supported sensible and comprehensive cannabis policy reform, we strongly urge the Senate to move forward on this issue without delay.”

Other organizations agreed about the urgency of the legislation. The US Cannabis Council (USCC) is a leading force for ending federal prohibition—particularly creating an equitable and values-driven cannabis industry, which is one of the defining factors between the MORE Act and similar legislation.

“Descheduling of cannabis is on the march across the United States, and the House has now passed the MORE Act in two successive sessions of Congress,” USCC CEO Steven Hawkins said in a statement sent to High Times. “Today’s historic vote comes as the Senate prepares for the formal introduction of the Cannabis Administration and Opportunity Act. Taken together, Congress is strongly signaling that the end of federal cannabis prohibition is nearing.”

Hawkins also acknowledges the uphill battle the bill will face.

“There is much more work to be done before any bill reaches the President’s desk, but we are approaching the end of the cannabis prohibition era,” Hawkins said. “As more states launch medical and adult-use cannabis programs, as the majority of Americans who support reform continues to grow, and as more Americans have jobs in an industry that already employs over 400,000 people, the pressure will build on Congress to act.

“Despite the April 1 timing, cannabis reform is serious business. USCC broadly supports descheduling alongside specific reforms such as banking reform, expungement and tax relief.”

The bill now heads to the Senate where it needs 60 votes to advance. There is currently no companion bill in the Senate, however Majority Leader Schumer along with Senators Booker and Wyden are expected to introduce a comprehensive cannabis reform bill in the next month.

“With voter support for legal cannabis at an all-time high and more and more states moving away from prohibition, we commend the House for once again taking this step to modernize our federal marijuana policies,” stated NCIA Chief Executive Officer and co-founder Aaron Smith. “Now is the time for the Senate to act on sensible reform legislation so that we can finally end the failure of prohibition and foster a well regulated marketplace for cannabis.”

The MORE Act is certainly not the only federal bill moving forward. Meanwhile, on March 24, 2022, the Senate unanimously passed the Cannabidiol and Marihuana Research Expansion (CMRE) Act. The current version of the CMRE Act would streamline the application process for researchers, allowing them to study cannabis and push the U.S. Food and Drug Administration (FDA) to promote and develop cannabis-based pharmaceuticals.

In addition, Sen. Nancy Mace introduced the States Reform Act, which some advocates believe has better chances in the Senate, while others disagree.

Because 10 Republican Senators are needed to pass the MORE Act in the Senate, some worry about its chances of crossing the finish line. George Macheril, CEO of cannabis industry lender Bespoke Financial, is one of those people. “While the House vote on the MORE Act is expected to pass again, we see this as more of a symbolic gesture which will have very little chance of surviving the Senate,” Macheril told High Times on March 25.

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US vs EU: How Drugs Are Approved

Some drugs we get as prescription only, others we can buy over the counter (OTC). We rarely think about the whole process that exists behind the products becoming available to us, or how long, arduous, and scandalous it may be. We also rarely concern ourselves with the differences in process that occur in different parts of the world. So today let’s take a look. Here are some basics of the US VS the EU when it comes to how drugs are approved.

The US and the EU have their own processes to have drugs approved, but not everything exists within regulation. Take the new cannabinoids market in the US, which includes the likes of delta-8 THC, THCV, HHC, and more. These compounds can be bought outside of dispensaries, and even online. Make sure to subscribe to The THC Weekly Newsletter for all the latest news and industry stories, as well as exclusive deals on flowers, vapes, edibles, and other products including Delta 8Delta 9 THCDelta-10 THCTHCOTHCVTHCP & HHC. You can find them in our “Best-of” lists!


The US VS EU for how drugs are approved: How does the US do it?

Most people should be aware of the organization, the FDA, or Food & Drug Administration. The FDA is a federal department that resides under the Department of Health and Human Services. The FDA regulates the food industry, the tobacco industry, all dietary supplements, all medicine – whether OTC or by prescription, vaccines, biopharmaceuticals, blood transfusions, all medical devices, anything that emits electromagnetic radiation, the cosmetics industry, animal food, and veterinary products.

In fact, the FDA is the only governing body for these things. And how much it does regulate these things can vary, often with strange laws attached. For example, the cosmetics industry isn’t actually regulated at all except for the use of ingredients for coloring. So though its under FDA regulation, there isn’t technically much of anything being regulated. Then there’s that pesky law that states that once a compound is an active ingredient in an approved medication, that it can no longer be marketed as a food or dietary supplement. Does this matter? Sure, it makes any supplement or food product containing CBD illegal federally.

The caveat to all this? States have their own rights, and these rights can go up against FDA (and general federal) policy. Take cannabis as the best example. According to the federal government, via the FDA and DEA, cannabis is federally illegal, yet 18 states (though it should be 19) have decided to implement recreational legalization policies that go against this. Realistically, states can do this with any drug if they can pass legislation within the state to change policy. Think of how Oregon legalized medical psychedelics and decriminalized recreational psychedelics use statewide. Or how Michigan and California are both floating bills for recreational psychedelics legalizations statewide.

US drugs approved

The FDA might be the sole regulator, which holds all the power for US federal regulation on things like food, drugs, and medicines, but the ability for states to create their own functional systems at odds with the FDA, means that that regulation only holds if it matches state regulation.

The US VS EU for how drugs are approved: How does the EU do it?

The EU and the US federal government have one major similarity. They are similar in that they are both a federal entity that is composed of ‘states’ that are able to formulate their own laws. The US is one country with 50 states, whereas the EU is a union of 27 countries that all operate as their own countries, but under overall regulations set by the EU.

Regulation for the EU is a bit more complicated than the US, since the EU takes into consideration the desires of its member states, and must work to synchronize regulations that can cover 27 countries, without anyone getting mad. While the FDA was developed for consumer protection specifically, the European Commission was put together to integrate the commercial interests between member countries, while still allowing these independent countries to function on their own, and by their own rules.

The European Commission is an organization that “promotes the general interest of the EU by proposing and enforcing legislation as well as by implementing policies and the EU budget.” It is the sole organization that is responsible for creating proposals for new legislation, and it’s tasked with overseeing the implementation of any decision put in place by the European Parliament, or the Council of the EU, two other governing bodies.

It is made up of a team of commissioners, with each member country offering one representative. It is centered in Brussels, Belgium, and is a politically independent executive arm, meaning it doesn’t support any specific party from any specific country. This means that for any policy that needs to be set by the European Commission in regards to medical drugs and devices, it must do this within a network of many centralized and decentralized agencies throughout the entire EU. Contrary to this, if the FDA wants to set a policy, it doesn’t have to check with any individual state to do so, or consider the needs of any individual location.

So, how do the US and EU have their drugs approved?

In the end, the two locations don’t have widely differing ways of actually approving drugs, and the processes are pretty similar. Here is the general process, and how it differs between the US and EU for getting drugs approved.

EU drugs approved

– The application. In the US, an investigator who wants to study a compound must submit an application to the FDA for permission to conduct the desired trials, and as a part of this, to be able to transport the compound across states. For EU countries, the application is directed at the government of the particular country where trials are being held. If they are being held in more than one country, an application must be submitted in any country where the research would take place.

– Clinical Trials. This is when the drug is tested in a study for safety and efficacy. This step is exactly the same whether it’s the US or the EU trying to have drugs approved. It consists of these stages:

  1. Phase 0 and 1 Trials – A small number of healthy subjects are tested to understand pharmacology and dosing.
  2. Phase II – Hundreds of patients with the specific condition the medication is being made for, are tested to establish responses to different doses.
  3. Phase III – Hundreds or thousands of patients are tested to establish overall safety and efficacy.

– Emergency use and orphan drugs. In the US, an application for an ‘orphan drug’ indicates a special approval process for a drug that may help with a lesser-known illness that fewer than 200,000 patients in the US have. In the EU, an orphan drug application is for special consideration of a compound that could be useful for medical conditions that no more than one in 50,000 patients have yearly.

Along with this are emergency drug applications. In the US, an ‘emergency drug application’ (EIND) provides for a shorter application process in the interest of getting an approval in a life-threatening situation. In these instances, full approval of a final product is not necessary, as treatment can be initiated upon approval of the application. In the EU, the use of an emergency drug in a life-threatening situation can start as long as clinical trials for the drug are underway.

– Drug approval. The US and EU are very different when it comes to the part of actually having drugs approved. In the US, following clinical trials, a ‘new drug application’ is submitted to the FDA, and the FDA is tasked with making a judgement as to whether to approve the medication or not.

In the EU, it’s a bit more complicated at this step, with four possible avenues that are used depending on the kind of drug, and what the manufacturer prefers. These four options are:

  1. A centralized process through the (EMA) European Medicines Agency, for use with designated drugs. This process must be taken in some circumstances, like for HIV/AIDS medications, cancer treatments, drugs for neurodegenerative diseases, drugs for autoimmune diseases, and drugs for viral diseases.
  2. A process that occurs within a member state by applying to the relevant national agency within the specific country. These measures may be different than standard EMA requirements.
  3. Through mutual recognition, which allows a drug that has been approved in one country, to be applied for approval by another member state, or to the EMA for approval throughout the EU.
  4. A decentralized process in which applications are submit simultaneously within different countries in the EU for the same drug, by the same manufacturer. In the past this has been the most-traveled avenue for approval, and though these numbers go back a bit, in 2008, 1,400 applications came through this way, vs 100 through the centralized process.
Drugs approved

A few things to be aware of

I think we know by now that there are tons of things to be wary of when it comes to big pharma and drugs. Here are some things to know between both the US and the EU about these processes.

  • While these drugs merely fill a space where perhaps nothing existed, they are often treated as so detrimentally important that not all data collected is peer-reviewed, or released to the public, meaning the public is given approved medications, based on research which could be quite faulty.
  • Pharmaceutical companies often pay for their own research, or pay for it to be done, creating a massive conflict of interest. Adding onto that, the governments often fund such research making the idea of being objective practically impossible.
  • Supposedly, the FDA makes nonpublished data on new drug applications available online (begging the question of why its not just released to the public), whereas the EU’s EMA will not release such information, even if products are being based on the research.
  • It has been proposed in both places to allow drugs to be released after Phase II trials, with surveillance kept on patients afterwards to ensure safety. This is meant to quicken necessary drugs to market, but the question should really be asked, if this is to the benefit of pharmaceutical companies, or to individuals, as these trials are literally there to establish safety, and there is a long track record of unsafe medications being recalled.
  • And let’s remember, that one of the biggest pharma-induced travesties of today is the constant and growing opioid epidemic in the US and abroad. More relevant than it existing, is that it exists because of regulation by these governmental bodies, allowing wide and continued use of these dangerous substances, even despite knowing the risks.
  • The regulations put in place often make very little sense, which implies other interests besides the well-being for consumers. Consider that while psychedelics have been constantly talked down, that DXM has been in products on US shelves since 1958, and has maintained OTC status despite being known for abuse. DXM is in dozens of products that can be accessed by children.
  • Western medicine has repeatedly ignored anything derived by Eastern medicine, regardless of the thousands of years of use of some compounds, and the extensive written information on them that often traverses many different cultures over many centuries of time. This seems to be uniformly done in favor of today’s pharmaceutical companies.

Conclusion

In the end, the processes are close enough, with both leaving plenty of room for both good and useful work to be done, as well as corruption to be had. How much should these medications or these agencies be trusted? Well, you can decide for yourself. But in order to do that, you’ll probably want to check legal suits against these entities, drug recalls, and the numerous reports in both the US and EU for safety issues related to drugs that the public was told were tested and safe.

Welcome readers! Thanks for dropping by CBDtesters.co, the #1 web source for the most important and necessary cannabis and psychedelics-related news relevant to today. Join us whenever possible to stay in-the-loop on the ever-changing universe of legal drugs and industrial hemp, and check out The THC Weekly Newsletter, so you’re first to find out what’s going on.

DisclaimerHi, I’m a researcher and writer. I’m not a doctor, lawyer, or businessperson. All information in my articles is sourced and referenced, and all opinions stated are mine. I am not giving anyone advice, and though I am more than happy to discuss topics, should someone have a further question or concern, they should seek guidance from a relevant professional.

The post US vs EU: How Drugs Are Approved appeared first on CBD Testers.

Proposed Hemp Bill Aims to Federally Regulate CBD Products

A bipartisan group of lawmakers wants to establish federal standards for the CBD market that has blossomed in recent years.

U.S. House Reps. Kathleen Rice (D-NY), Morgan Griffith (R-VA), Angie Craig (D-MN) and Dan Crenshaw (R-TX) introduced a bill last week that they say will help set standards for CBD-based food and beverage products “to protect consumers and provide marketplace stability for farmers, producers and retailers.”

The bill, called the “CBD Product Safety and Standardization Act of 2021,” “will establish the clear regulatory framework needed to provide stability for business and ensure unsafe products stay off the shelves,” Rice said in a statement.

The legislation “would allow [the Food and Drug Administration] to regulate CBD as it would any other food ingredient and subject these products to enforceable safeguards to ensure Accountability,” a press release explained, while also charging the agency “with establishing CBD content limits and packaging and labeling requirements and determining in which categories of food CBD is appropriate for use.”

“This bill will help distinguish responsible players from bad actors that ignore federal requirements for quality, manufacturing, labeling and claims, and it will bring safety and clarity to the market,” the press release said. 

The 2018 Farm Bill removed hemp and its derivatives from the list of federal controlled substances, clearing the way for states to pass their own laws governing its cultivation. In April, with Idaho’s passage of its own measure, all 50 states had legalized industrial hemp. Market research data released last week found that “industrial hemp accounted for USD 3.91 billion in 2020.”

The data from Brandessence Market Research found that the industry’s projections “are on a promising trajectory to grow at promising 16.27 percent CAGR during 2021-2027 period.”

“The legalization of marijuana in 18 states in the United States has increased the promise of already robust growth of the hemp market. At its peak, industrial hemp fetched $45 to $50 per pound in 2018,” Brandessence said in its report. 

“The COVID-19 crisis has had a negative impact on industrial hemp with a slowdown in demand. The United States Agriculture Department (USDA) estimates farmers can produce as much as two to 12 ton dry-stem yields per acre. Similar estimates are projected in Europe, where farmers produce 3.6 to 8.7 ton per acre. The USDA also estimated that the variable, fixed and operator cost accounted for $286 per acre for hemp fibre, $233 for certified seed and $196 for seed. While these estimates are age-old, the promising new growth due to legalization of marijuana in 18 states is a promising new driver for growth of the industrial hemp market.”

But despite the industry’s growth, and the ubiquity of CBD-based products, there remains “a lack of clear federal standards in the CBD industry [that] has left businesses guessing and customers at risk,” Craig, the Democrat from Minnesota, said in a statement.

“It’s clear that this growing industry needs regulatory clarity in order to continue selling their products safely and effectively,” said Craig. “I’m proud to join my colleagues in introducing this bipartisan legislation to create enforceable safeguards and ensure accountability in the industry.”

The press release from congressmembers said that the “discrepancy between the Controlled Substances Act and FDA law has created a regulatory gray area in which CBD is widely available but unregulated—and considered illegal—by FDA.”

Griffith, the Virginia Republican, said that “demand for CBD products has surged, but Food and Drug Administration regulations do not reflect this new reality.”

“As a result, adulterated or unsafe products are available that threaten consumer health, and businesses lack clarity,” Griffith said. “The CBD Product Safety and Standardization Act would require the FDA to address the issue and ensure more certainty in the CBD marketplace. I’m pleased to join this bipartisan effort.”

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