'To reschedule marijuana through the executive branch, the secretary of
the Department of Health and Human Services (HHS) or an outside party
would have to file a petition, which would then be reviewed by the
attorney general, who has usually delegated that responsibility to the
Drug Enforcement Administration (DEA).
The attorney general can also initiate the process on their own, requesting a scientific review directly to HHS. Under HHS, the Food and Drug Administration (FDA) would then assess the scientific, medical and public health implications before submitting that review to the Justice Department, which would then effectuate the appropriate reclassification under federal law.'
The attorney general can also initiate the process on their own, requesting a scientific review directly to HHS. Under HHS, the Food and Drug Administration (FDA) would then assess the scientific, medical and public health implications before submitting that review to the Justice Department, which would then effectuate the appropriate reclassification under federal law.'
- Marijuana Moment
'The FDA’s objection rested in part on its prior approval of Epidiolex, a
CBD drug to reduce seizures, which the agency said precludes it from
authorizing CBD for dietary purposes. Even if the drug hadn’t been
approved, though, the FDA said in the letter to Charlotte’s Web dated
July 23 that it “has concerns about the adequacy of safety evidence”
that the company submitted. The agency would have wanted more data on
potential liver and reproductive toxicity.'
- Bloomberg
'“The existing FDA approval system is designed for the assessment of
privately produced compounds that go through conventional P1, P2, and P3
trials – so the Pfizer vaccine comports with the existing regulatory
model. Cannabis does not. It is an illicit botanic product,” Armentano
said.
Armentano went on to explain the FDA approval process is not designed to evaluate such products.
“In fact, under the existing regulatory and legal environment, there is no process for which the FDA could review or approve herbal cannabis – as acknowledged by the DEA and others who are familiar with the process,” Armentano said. “The DEA acknowledged this publicly in 2016 and has done so repeatedly since.'
Armentano went on to explain the FDA approval process is not designed to evaluate such products.
“In fact, under the existing regulatory and legal environment, there is no process for which the FDA could review or approve herbal cannabis – as acknowledged by the DEA and others who are familiar with the process,” Armentano said. “The DEA acknowledged this publicly in 2016 and has done so repeatedly since.'
- LA Weekly
Cannabis, as a herb, is basically out of the scope of government bodies, such as the US Food and Drug Administration (FDA) and the US Drug Enforcement Agency (DEA). The scope of these bodies is essentially human-made, synthesized compounds that need to be assessed for safety when it comes to human consumption. This glaring fact has been continuously ignored, and the FDA and DEA have repeatedly created hurdles in the legalization of cannabis. The presence of cannabis in the US Controlled Substances Act, a huge mistake in the first place, gives these bodies the authority to continue to do what is wrong when it comes to public health and safety.
In India - before the 19th century when cannabis was prohibited by the then ruling government to promote the vested interests that sought to cash in on tobacco, alcohol and opium - cannabis was completely unregulated. Society self-regulated its use. Women used cannabis for a lot of gender-specific conditions, such as irregular menstruation and menstrual bleeding, and even as a sedative during pregnancy. Children were given cannabis, in the form of sweetmeats, to treat restlessness and insomnia. Cannabis was a common ingredient in food, beverages and medicines, and was considered one of the most important natural medicines in India. The amount of THC or CBD was not at all a consideration. This was a practice that had been followed for thousands of years without causing any harms to society. Of course, the cultivation of cannabis in those days was completely organic, and there was no risk of chemical contaminants entering the body through the usage of the herb. The situation is different today, when all food and drugs need to be inspected for outside contaminants and adulterants, given the nature of the environment, and the contamination that humans have caused to it.
Recently, the FDA's key arguments against cannabis legalization have centered around the gender-specific impacts of the herb, especially on pregnant women, and the possible toxicity to the liver that its consumption may cause. Both these concerns have already been addressed by numerous scientific studies, but the FDA does not appear to want to listen.
The FDA of the US plays a key role in what reaches the American people in terms of food and drugs. All food and drugs are tested for contaminants, and levels of dangerous substances or chemicals. The FDA can approve or ban a food or drug based on its inspection. Cannabis and the FDA have suddenly come into the spotlight in recent times due to a number of reasons. The legalization of cannabis for recreational use has led to an increase in the number of businesses that are including cannabis as an ingredient in their food, confectionery, edibles, beverages and wellness products. This has brought the attention of the FDA, since cannabis is listed federally as a Schedule 1 banned substance in the US, and the FDA has to test and certify that the food, drink, beverage or edible is safe for consumption and Schedule 1 substances are not present.
The FDA may have had it easy in the case of regulating a specific human-made synthetic compound in the past. The cannabis plant however contains hundreds of cannabinoids, flavinoids and terpenes. Many of these compounds are found in hundreds of other plants that are consumed by humans all the time. But the FDA appears to have decided to narrow down its attention on two specific compounds Cannabidiol (CBD) and tetrahydrocannabidiol (THC) for practical purposes. These are known to be two of the most medicinal compounds in the cannabis plant. The UN has decided to remove the cannabis plant from its most restrictive Schedule 4 list of banned substances, which is the equivalent to the US Schedule 1 list of banned substances, though THC is still restricted in the UN Schedule I list. The WHO has recommended that CBD be entirely removed from any of the restricted compound lists. Given the ill-thought out prohibition of cannabis, which resulted in both the plant and one of its compound's existing in the US Schedule 1 list (and in the UN's Schedule 4 list), we are talking about a scenario in which everything is a bit tangled.
The human body is said to contain endocannabinoid systems (ECS) in many parts of the body, including the brain, skin and digestive system. The endocannabinoid receptors in the digestive system are now believed to play a key role in regulating the production of enzymes, hormones, maintaining the microbiome balance, and to play a key part in treating a number of diseases, including cancers of the digestive system, inflammatory bowel disease, diabetes, non-alcoholic fatty liver disease, etc. The presence of the ECS indicates that the human body has evolved over time to live in synergy with the 28 million year old cannabis plant that has been around way before humans. Cannabis is known to increase appetite, help in maintaining a healthy body mass index (BMI), reduce nausea, and increase the sense of taste clearly indicating that the herb has beneficial effects with regard to food.
Many countries like India, and other traditional communities all over the world, have been using cannabis in their food and beverages for thousands of years, and this has been consumed by all age groups. Cannabis seeds are said to be one of the super foods, in terms of nutritional value, with the ability to grow in adverse climatic conditions. CBD was ranked among the top 10 food trends in the US in the past year in some reports. The World Anti Doping Association (WADA) that monitors drug usage in sports has quietly removed CBD from its list of prohibited substances.
The only cannabis based drug approved in the US by the FDA is the anti-epilepsy drug Epidiolex, manufactured by the US subsidiary of the British pharmaceutical company GW Pharmaceuticals. Now, on the basis of its approval of Epidiolex as a drug, the FDA is imposing restrictions on the use of CBD in food products. How about that? This clearly shows the bias that this regulatory body has for the big businesses, especially the synthetic pharmaceutical industry. The FDA has taken action in recent times to remove food products containing cannabidiol (CBD) saying that it is against federal rules, the same federal rules which say that cannabis has no known medicinal value. To add to the confusion, cannabis with THC less than 0.3%, called hemp, has been legalized through the 2018 Farm Bill. Cannabidiol extracted from hemp could be legal as against cannabidiol extracted from cannabis with more than 0.3% THC though the composition and purity of cannabidiol in either case is essentially the same. It is interesting to note that the EU Commission recently ruled that CBD is not a narcotic, paving the way for its inclusion in food products.
The FDA may have had it easy in the case of regulating a specific human-made synthetic compound in the past. The cannabis plant however contains hundreds of cannabinoids, flavinoids and terpenes. Many of these compounds are found in hundreds of other plants that are consumed by humans all the time. But the FDA appears to have decided to narrow down its attention on two specific compounds Cannabidiol (CBD) and tetrahydrocannabidiol (THC) for practical purposes. These are known to be two of the most medicinal compounds in the cannabis plant. The UN has decided to remove the cannabis plant from its most restrictive Schedule 4 list of banned substances, which is the equivalent to the US Schedule 1 list of banned substances, though THC is still restricted in the UN Schedule I list. The WHO has recommended that CBD be entirely removed from any of the restricted compound lists. Given the ill-thought out prohibition of cannabis, which resulted in both the plant and one of its compound's existing in the US Schedule 1 list (and in the UN's Schedule 4 list), we are talking about a scenario in which everything is a bit tangled.
The human body is said to contain endocannabinoid systems (ECS) in many parts of the body, including the brain, skin and digestive system. The endocannabinoid receptors in the digestive system are now believed to play a key role in regulating the production of enzymes, hormones, maintaining the microbiome balance, and to play a key part in treating a number of diseases, including cancers of the digestive system, inflammatory bowel disease, diabetes, non-alcoholic fatty liver disease, etc. The presence of the ECS indicates that the human body has evolved over time to live in synergy with the 28 million year old cannabis plant that has been around way before humans. Cannabis is known to increase appetite, help in maintaining a healthy body mass index (BMI), reduce nausea, and increase the sense of taste clearly indicating that the herb has beneficial effects with regard to food.
Many countries like India, and other traditional communities all over the world, have been using cannabis in their food and beverages for thousands of years, and this has been consumed by all age groups. Cannabis seeds are said to be one of the super foods, in terms of nutritional value, with the ability to grow in adverse climatic conditions. CBD was ranked among the top 10 food trends in the US in the past year in some reports. The World Anti Doping Association (WADA) that monitors drug usage in sports has quietly removed CBD from its list of prohibited substances.
The only cannabis based drug approved in the US by the FDA is the anti-epilepsy drug Epidiolex, manufactured by the US subsidiary of the British pharmaceutical company GW Pharmaceuticals. Now, on the basis of its approval of Epidiolex as a drug, the FDA is imposing restrictions on the use of CBD in food products. How about that? This clearly shows the bias that this regulatory body has for the big businesses, especially the synthetic pharmaceutical industry. The FDA has taken action in recent times to remove food products containing cannabidiol (CBD) saying that it is against federal rules, the same federal rules which say that cannabis has no known medicinal value. To add to the confusion, cannabis with THC less than 0.3%, called hemp, has been legalized through the 2018 Farm Bill. Cannabidiol extracted from hemp could be legal as against cannabidiol extracted from cannabis with more than 0.3% THC though the composition and purity of cannabidiol in either case is essentially the same. It is interesting to note that the EU Commission recently ruled that CBD is not a narcotic, paving the way for its inclusion in food products.
For a regulatory body that should be focusing its resources on protecting the American people from dangerous food and drugs, especially the dangerous synthetic man-made drugs, fertilizers and pesticides, it is spending undue time and resources trying to keep the natural medicinal herb cannabis away from consumers, all in the name of following the confusing classifications provided by the DEA, which is essentially a law enforcement agency. This seems to indicate that the food and drug regulatory authority in the US is dictated by a drug enforcement agency. The drug enforcement agency whose performance numbers are greatly bolstered by cannabis enforcement, decides that the cannabis plant is not to be consumed, despite of all the evidence that shows cannabis's safe usage profile and long history of use worldwide as a part of food, beverages and recreational smoking. The FDA is said to have requested the DEA to remove cannabis from the Schedule 1 list, but then why should the DEA in the first place be dictating what is safe or not in terms of food and drugs and not the FDA? The chaos caused by these scenarios and many more has resulted in a head of the FDA having had enough and quitting recently. Recent statements by the FDA that trying to regulate CBD, despite the overwhelming public demand for it, is a 'fool's errand' seems to show that the regulatory body is finally starting to see the light of wisdom.
In the meantime, fatty foods, sugar based soda drinks, artificial coloring agents, plastics and synthetics are a regular part of the food consumed by society, especially children. Now could the powerful junk food and sugar based drinks industry also be exerting pressure on the FDA, using its financial influence along with the other opponents of cannabis, including the pharmaceutical industries, to keep cannabis banned federally for as long as possible? When the FDA head was asked which is more dangerous, tobacco or cannabis, he is said to have refused to comment. Yes, the FDA should ensure that the cannabis sold in retail outlets are safe from adulterants, such as chemical and metallic contaminants. It should ensure that cannabis accessories, such as vaping devices and the concentrates they use, are safe for human consumption. It should ensure that synthesized cannabis compounds, such as delta8-THC, are safe for human consumption. Beyond that, the amount of regulation that the FDA should have in place is the same amount of regulation that it has in place for tea or coffee.
Listed below are articles taken from various media related to the above subject. Words in italics are the thoughts of your truly at the time of reading the article.
'On Wednesday, October 6, 2021, California Governor Gavin Newsom signed into law Assembly Bill 45 (AB-45) that "prohibit[s] restrictions on the sale of dietary supplements, food, beverages, cosmetics, or pet food that include industrial hemp or cannabinoids, extracts, or derivatives from industrial hemp based solely on the inclusion of those substances." AB-45 is highly significant amongst the cannabis regulatory landscape because it constitutes a departure from the U.S. Food and Drug Administration's (FDA) guidance that CBD cannot be introduced to food products or dietary supplements sold in interstate commerce.'
https://www.mondaq.com/unitedstates/cannabis-hemp/1125042/california-splits-from-the-fda-cbd-now-permitted-in-food-beverages-and-more
https://www.mondaq.com/unitedstates/cannabis-hemp/1125042/california-splits-from-the-fda-cbd-now-permitted-in-food-beverages-and-more
'“We have a contract with DEA. We are growing cannabis for [Food and Drug Administration] clinical trials and selling it to the DEA,” she said. “It’s unconscionable the way they are behaving—and further proof that the word ‘cannabis’ continues to be completely radioactive even though this is a 100 percent federally legal operation.”
“Fortunately, there are banks that care about the progress of federally regulated and federally legal research and are eager to step up and support us immediately,” Sisley added. “We will be moving our funding from Bank of America and never returning there. Our research continues without harm because other banks that care about scientific freedom were able to step up. Bank of America doesn’t even have the decency to provide an explanation after a decade of banking with an openly plant-touching business.”'
https://www.marijuanamoment.net/bank-of-america-cancels-account-of-marijuana-and-psychedelics-research-institute-registered-with-dea/
“Fortunately, there are banks that care about the progress of federally regulated and federally legal research and are eager to step up and support us immediately,” Sisley added. “We will be moving our funding from Bank of America and never returning there. Our research continues without harm because other banks that care about scientific freedom were able to step up. Bank of America doesn’t even have the decency to provide an explanation after a decade of banking with an openly plant-touching business.”'
https://www.marijuanamoment.net/bank-of-america-cancels-account-of-marijuana-and-psychedelics-research-institute-registered-with-dea/
'Research into the use of cannabinoids for disease treatment have led to FDA-approved drugs for seizures, nausea, and vomiting caused by cancer chemotherapy; and for decreased appetite and weight loss in people with HIV/AIDS. For a wide variety of conditions and symptoms (including chronic pain), cannabis has gained increasing acceptance in society. The effects of cannabidiol (CBD) and tetrahydrocannabinol (THC) in pain pathways have been significantly elucidated. An increasing number of retrospective studies have shown a decrease in pain scores after administration of cannabinoids, as well as long-term benefits such as reduced opiate use. Yet, there is no FDA-approved cannabis product for headache or other chronic pain disorders. More is being done to determine who is likely to benefit from cannabis as well as to understand the long-term effects and limitations of the treatment.'
https://link.springer.com/article/10.1007/s11916-021-00974-z
https://link.springer.com/article/10.1007/s11916-021-00974-z
'Delta-8 THC is an isomer of the psychoactive cannabinoid that occurs naturally in the cannabis plant, delta-9 THC.
Delta-8 THC is rare in nature but can be easily synthesized from CBD, giving rise to products that offer intoxicating effects without needing to be sourced from marijuana, which isn’t legal in all states and remains illegal under federal law.
The FDA warned, without elaborating, that delta-8 THC “may have potentially harmful by-products (contaminants) due to the chemicals used in the process.”'
https://mjbizdaily.com/fda-cdc-issue-delta-8-thc-warnings-after-100-plus-in-us-end-up-in-hospitals/
Delta-8 THC is rare in nature but can be easily synthesized from CBD, giving rise to products that offer intoxicating effects without needing to be sourced from marijuana, which isn’t legal in all states and remains illegal under federal law.
The FDA warned, without elaborating, that delta-8 THC “may have potentially harmful by-products (contaminants) due to the chemicals used in the process.”'
https://mjbizdaily.com/fda-cdc-issue-delta-8-thc-warnings-after-100-plus-in-us-end-up-in-hospitals/
'When the U.S. Food and Drug Administration approved CBD as an ingredient in Epidiolex, a prescription drug used to treat severe epilepsy, the molecule’s path for over-the-counter products was sealed.
Hemp industry members say that drug approval has been the major holdup in the FDA’s willingness to regulate CBD as a dietary supplement or ingredient, and impacted the agency’s most recent decision to reject two new dietary ingredient applications.'
https://hempindustrydaily.com/federal-cannabis-legalization-may-affect-fdas-approach-to-cbd-regulation-experts-say/
Hemp industry members say that drug approval has been the major holdup in the FDA’s willingness to regulate CBD as a dietary supplement or ingredient, and impacted the agency’s most recent decision to reject two new dietary ingredient applications.'
https://hempindustrydaily.com/federal-cannabis-legalization-may-affect-fdas-approach-to-cbd-regulation-experts-say/
'While hemp-derived cannabidiol was legalized under the 2018 Farm Bill, the Trademark Trial and Appeal Board (TTAB) said it remains illicit to sell as a beverage under the Food, Drug, and Cosmetic Act because FDA still hasn’t issued rules allowing it, and, therefore, the application couldn’t be granted.
Petitioners attempted to make the case that Joy Tea has bona fide intent to use in lawful commerce because a federal policy change is forthcoming. FDA has said repeatedly that it is working to develop regulations to allow CBD in the food supply—but the TTAB didn’t accept that as sufficient evidence.'
https://www.marijuanamoment.net/new-ruling-in-cbd-trademarking-case-highlights-challenges-of-fdas-rulemaking-delays/
Petitioners attempted to make the case that Joy Tea has bona fide intent to use in lawful commerce because a federal policy change is forthcoming. FDA has said repeatedly that it is working to develop regulations to allow CBD in the food supply—but the TTAB didn’t accept that as sufficient evidence.'
https://www.marijuanamoment.net/new-ruling-in-cbd-trademarking-case-highlights-challenges-of-fdas-rulemaking-delays/
'“The existing FDA approval system is designed for the assessment of privately produced compounds that go through conventional P1, P2, and P3 trials – so the Pfizer vaccine comports with the existing regulatory model. Cannabis does not. It is an illicit botanic product,” Armentano said.
Armentano went on to explain the FDA approval process is not designed to evaluate such products.
“In fact, under the existing regulatory and legal environment, there is no process for which the FDA could review or approve herbal cannabis – as acknowledged by the DEA and others who are familiar with the process,” Armentano said. “The DEA acknowledged this publicly in 2016 and has done so repeatedly since.”'
https://www.laweekly.com/the-difference-between-the-fda-approving-vaccines-and-weed/
Armentano went on to explain the FDA approval process is not designed to evaluate such products.
“In fact, under the existing regulatory and legal environment, there is no process for which the FDA could review or approve herbal cannabis – as acknowledged by the DEA and others who are familiar with the process,” Armentano said. “The DEA acknowledged this publicly in 2016 and has done so repeatedly since.”'
https://www.laweekly.com/the-difference-between-the-fda-approving-vaccines-and-weed/
'The FDA’s objection rested in part on its prior approval of Epidiolex, a CBD drug to reduce seizures, which the agency said precludes it from authorizing CBD for dietary purposes. Even if the drug hadn’t been approved, though, the FDA said in the letter to Charlotte’s Web dated July 23 that it “has concerns about the adequacy of safety evidence” that the company submitted. The agency would have wanted more data on potential liver and reproductive toxicity.'
https://www.bloomberg.com/news/articles/2021-08-11/fda-objects-to-cbd-dietary-supplement-as-regulatory-haze-lingers
https://www.bloomberg.com/news/articles/2021-08-11/fda-objects-to-cbd-dietary-supplement-as-regulatory-haze-lingers
'To reschedule marijuana through the executive branch, the secretary of the Department of Health and Human Services (HHS) or an outside party would have to file a petition, which would then be reviewed by the attorney general, who has usually delegated that responsibility to the Drug Enforcement Administration (DEA).
The attorney general can also initiate the process on their own, requesting a scientific review directly to HHS. Under HHS, the Food and Drug Administration (FDA) would then assess the scientific, medical and public health implications before submitting that review to the Justice Department, which would then effectuate the appropriate reclassification under federal law.'
https://www.marijuanamoment.net/bernie-sanders-talks-marijuana-differences-with-biden-who-he-says-could-enact-reforms-but-chooses-not-to/
The attorney general can also initiate the process on their own, requesting a scientific review directly to HHS. Under HHS, the Food and Drug Administration (FDA) would then assess the scientific, medical and public health implications before submitting that review to the Justice Department, which would then effectuate the appropriate reclassification under federal law.'
https://www.marijuanamoment.net/bernie-sanders-talks-marijuana-differences-with-biden-who-he-says-could-enact-reforms-but-chooses-not-to/
'“Well, it depends on the tobacco. I mean, cigarettes are the number one preventable cause of death in the United States,” Woodcock said. “So when you take that figure into account, the fact that marijuana, cannabis, is a Schedule I drug, it’s hard, It’s apples and oranges. There is a great deal of mortality and morbidity from cigarette smoking, and that’s been well-established.”
While smoking any combustable product is a health risk, it’s frustrating to advocates that the commissioner was unwilling to acknowledge that federal policy on marijuana is severely at odds with laws on tobacco in a way that doesn’t serve public health interests.
If cigarette smoking is the number one preventable cause of death in the U.S., it stands to reason that the official could at least recognize that marijuana is not “much more dangerous.”'
https://www.marijuanamoment.net/fda-head-refuses-to-say-whether-marijuana-is-more-dangerous-than-tobacco/
While smoking any combustable product is a health risk, it’s frustrating to advocates that the commissioner was unwilling to acknowledge that federal policy on marijuana is severely at odds with laws on tobacco in a way that doesn’t serve public health interests.
If cigarette smoking is the number one preventable cause of death in the U.S., it stands to reason that the official could at least recognize that marijuana is not “much more dangerous.”'
https://www.marijuanamoment.net/fda-head-refuses-to-say-whether-marijuana-is-more-dangerous-than-tobacco/
https://newfrontierdata.com/cannabis-insights/fda-investigating-sex-gender-differences-in-cannabinoids/
'In a notice set to be published in the Federal Register on Wednesday, FDA’s Office of Women’s Health announced the event, emphasizing that as interest in CBD and other derivatives of marijuana and hemp continues to grow, there’s a need to explore the science of these cannabinoids in the context of gender and sex. That’s particularly true when it comes to cannabis use among pregnant women, the agency said.
“Researchers, educators, clinicians, and patients may benefit from attending this multidisciplinary scientific conference on CBD and other cannabinoids,” FDA said. “Presentations will address patient and healthcare provider perspectives on CBD and other cannabinoid use, sex differences in the effects of CBD and other cannabinoids, use of CBD and other cannabinoids in pregnancy, and government agency perspectives on CBD research and evaluation.”'
https://www.marijuanamoment.net/fda-explains-effects-of-cbd-and-marijuana-compounds-based-on-sex-and-gender-differences/
“Researchers, educators, clinicians, and patients may benefit from attending this multidisciplinary scientific conference on CBD and other cannabinoids,” FDA said. “Presentations will address patient and healthcare provider perspectives on CBD and other cannabinoid use, sex differences in the effects of CBD and other cannabinoids, use of CBD and other cannabinoids in pregnancy, and government agency perspectives on CBD research and evaluation.”'
https://www.marijuanamoment.net/fda-explains-effects-of-cbd-and-marijuana-compounds-based-on-sex-and-gender-differences/
'The DDB affirmed the Food and Drug Administration (FDA)’s warning against a mamon or chiffon cake-flavored vape refill named “Gluttony” that has been found to contain liquid cannabis.
“Cannabinol, being a cannabinoid extracted from the cannabis plant, is prohibited under the Comprehensive Dangerous Drugs Act. Therefore, the manufacture, distribution, sale, purchase, possession and use of products containing cannabinol is banned,” the DDB said.'
https://www.philstar.com/nation/2020/09/08/2040761/ddb-warns-public-vs-marijuana-flavored-vapes
“Cannabinol, being a cannabinoid extracted from the cannabis plant, is prohibited under the Comprehensive Dangerous Drugs Act. Therefore, the manufacture, distribution, sale, purchase, possession and use of products containing cannabinol is banned,” the DDB said.'
https://www.philstar.com/nation/2020/09/08/2040761/ddb-warns-public-vs-marijuana-flavored-vapes
'The new FDA approval, granted July 31 to GW’s U.S. subsidiary, Greenwich Biosciences, means the drug can now be used in the United States to treat seizures associated with tuberous sclerosis complex (TSC), a genetic disease believed to affect one in 6,000 people.
The FDA approved Epidiolex to treat TSC patients 1 year old and up and also expanded the age range for the use of Epidiolex to treat seizures caused by Lennox-Gastaut and Dravet syndromes, lowering the minimum age from 2 years old to 1, GW Pharma said.'
https://mjbizdaily.com/fda-approves-gw-pharmaceutical-cannabis-drug-epidiolex-for-new-indication/
The FDA approved Epidiolex to treat TSC patients 1 year old and up and also expanded the age range for the use of Epidiolex to treat seizures caused by Lennox-Gastaut and Dravet syndromes, lowering the minimum age from 2 years old to 1, GW Pharma said.'
https://mjbizdaily.com/fda-approves-gw-pharmaceutical-cannabis-drug-epidiolex-for-new-indication/
So we contaminate our environment, food and water with dangerous man-made chemicals in the pursuit of quick money. These chemicals cause cancers in our bodies. To treat these cancers we make dangerous synthetic drugs, in the pursuit of quick money, that not only fail to treat the cancers, but also result in a collapse of most other body systems. This leads to a weakening and collapse of humans on increasingly larger scales as time goes by. But we do nothing to stop the contamination and weakening of our bodies that evolved over hundreds of millions of years and the contamination of our environment, food and water. Instead we continue searching for more powerful man made chemicals, to make more money faster, in the name of medicine for our environment, bodies and minds believing that we are masters of nature or, if not that, smarter than nature, whom we can fool like our gullible fellow men...but nature is not looking to make more money faster..she only deals in life and death...
'The full scope of the dangerous interaction of chemicals is as yet little known, but disturbing findings now come regularly from scientific laboratories. Among this is the discovery that that the toxicity of an organic phosphate can be increased by a second agent that is not necessarily an insecticide. For example, one of the plasticizing agents may act even more dangerously than another insecticide to make malathion more dangerous. Again, this is because it inhibits the liver enzyme that would normally 'draw the teeth' of the poisonous insecticide.
What of other chemicals in the normal human environment? What, in particular, of drugs? A bare beginning has been made on this subject, but already it is known that some organic phosphates (parathion and malathion) increase the toxicity of some drugs used as muscle relaxants, and that several others (again including malathion) markedly increase the sleeping time of barbiturates.' - Silent Spring, Rachel Carson, 1962
'Unfortunately for all of us, opportunities for this sort of thing to happen are legion. A few years ago a team of Food and Drug Administration scientists discovered that when malathion and certain other organic phosphates are administered simultaneously a massive poisoning results - up to 50 times as severe as would be predicted on the basis of adding the toxicities of the two. In other words, 1/100 of the lethal dose of each compound may be fatal when the two are combined.
The discovery led to the testing of other combinations. It is now known that many pairs of organic phosphate insecticides are highly dangerous, the toxicity being stepped up or 'potentiated' through the combined action. Potentiation seems to take place when one compound destroys the liver enzyme responsible for detoxifying the other. The two need not be given simultaneously. The hazard exists not only for the man who must spray this week with one insecticide and the next week with another; it exists also for the consumer of sprayed products. The common salad bowl may easily present a combination of organic phosphate insecticides. Residues well within the legally permissible limits may interact.' - Silent Spring, Rachel Carson, 1962
'The full scope of the dangerous interaction of chemicals is as yet little known, but disturbing findings now come regularly from scientific laboratories. Among this is the discovery that that the toxicity of an organic phosphate can be increased by a second agent that is not necessarily an insecticide. For example, one of the plasticizing agents may act even more dangerously than another insecticide to make malathion more dangerous. Again, this is because it inhibits the liver enzyme that would normally 'draw the teeth' of the poisonous insecticide.
What of other chemicals in the normal human environment? What, in particular, of drugs? A bare beginning has been made on this subject, but already it is known that some organic phosphates (parathion and malathion) increase the toxicity of some drugs used as muscle relaxants, and that several others (again including malathion) markedly increase the sleeping time of barbiturates.' - Silent Spring, Rachel Carson, 1962
'Unfortunately for all of us, opportunities for this sort of thing to happen are legion. A few years ago a team of Food and Drug Administration scientists discovered that when malathion and certain other organic phosphates are administered simultaneously a massive poisoning results - up to 50 times as severe as would be predicted on the basis of adding the toxicities of the two. In other words, 1/100 of the lethal dose of each compound may be fatal when the two are combined.
The discovery led to the testing of other combinations. It is now known that many pairs of organic phosphate insecticides are highly dangerous, the toxicity being stepped up or 'potentiated' through the combined action. Potentiation seems to take place when one compound destroys the liver enzyme responsible for detoxifying the other. The two need not be given simultaneously. The hazard exists not only for the man who must spray this week with one insecticide and the next week with another; it exists also for the consumer of sprayed products. The common salad bowl may easily present a combination of organic phosphate insecticides. Residues well within the legally permissible limits may interact.' - Silent Spring, Rachel Carson, 1962
'There is still very limited awareness of the nature of the threat. This is an era of specialists, each of whom sees his own problem and is unaware or intolerant of the larger frame into which it fits. It is also an era dominated by industry, in which the right to make a dollar at whatever cost is seldom challenged. When the public protests, confronted with some obvious evidence of damaging results of pesticide applications, it is fed little tranquilizing pills of half truth. We urgently need an end to these false assurances, to the sugar coating of unpalatable facts. It is the public that is being asked to assume the risks that the insect controllers calculate. The public must decide whether it wishes to continue on the present road, and it can only do so when it is in full possession of the facts. In the words of Jean Rostand, 'The obligation to endure gives us the right to know.' - Silent Spring, Rachel Carson, 1962
'The fisheries of fresh and salt water are a resource of great importance, involving the interests and the welfare of a very large number of people. That they are now seriously threatened by the chemicals entering our waters can no longer be doubted. If we could divert to constructive research even a small fraction of the money spent each year on the development of even more toxic sprays, we could find ways to use less dangerous materials and to keep poisons out of our waterways. When will the public become sufficiently aware of the facts to demand such action? - Silent Spring, Rachel Carson, 1962
'This system, however - deliberately poisoning our food, then policing the result - is too reminiscent of Lewis Carroll's White Knight who thought of 'a plan to dye one's whiskers green, and always use so large a fan that they could not be seen.' The ultimate answer is to use less toxic chemicals so that the public hazard from their misuse is greatly reduced.' - Silent Spring, Rachel Carson, 1962
'In 1937, weed was placed under the Harrison Narcotics Act. Narcotics authorities claim it is a habit-forming drug, that its use is injurious to mind and body, and that it causes the people who use it to commit crimes. Here are the facts: Weed is positively not habit forming. You can smoke weed for years and you will experience no discomfort if your supply is cut off. I have seen tea heads in jail and none of them showed withdrawal symptoms. I have smoked weed myself off and on for fifteen years, and never missed it when I ran out. There is less habit to weed than there is to tobacco. Weed does not harm the general health. In fact. most users claim it gives you an appetite and acts as a tonic to the system. I do not know of any other agent that gives as definite a boot to the appetite. I can smoke a stick of tea and enjoy a glass of California sherry and a hash house meal.' - Junky, William S Burroughs, 1977, originally published in 1953
'I once kicked a junk habit with weed. The second day off junk I sat down and ate a full meal. Ordinarily, I can't eat for eight days after kicking a habit.' - Junky, William S Burroughs, 1977, originally published in 1953
'According to the survey, 81 percent of respondents believe that tobacco cigarettes are "very harmful." Fifty-one percent of respondents similarly view alcohol as "very harmful." By contrast, only 26 percent of those surveyed ranked marijuana as "very harmful." '
https://norml.org/news/2019/08/29/poll-americans-view-cigarettes-and-alcohol-as-more-harmful-than-cannabis
'According to the agency's filing in the Federal Register, it "intends to promulgate regulations" to evaluate several dozen applications before it from private entities that wish to cultivate cannabis for FDA-approved research. However, this is not the first time the agency has made such a promise. In 2016, the DEA similarly announced the adoption of new rules to expand to supply of research-grade cannabis, but failed to take any further action.'
https://norml.org/news/2019/08/29/dea-promises-progress-on-federal-cultivation-applications-but-provides-no-timetable-for-action
'As such, hemp and hemp-derived CBD preparations that have 0.3% THC or less are not controlled substances, the DEA confirmed. “DEA registration is not required to grow or research” them.
The confirmation will be good news to the CBD industry, which has exploded recently. But any manufacturers making health claims about the CBD-containing products will still receive scrutiny from the Food and Drug Administration. Additionally, individual state laws and restrictions may apply.'
https://arstechnica.com/science/2019/08/dea-may-finally-let-others-grow-cannabis-for-research/
'Cannabidiol (CBD) is an illegal drug with no redeeming value. It is also a useful prescription medicine for epilepsy, with considerable potential for treating numerous other conditions. And it is a natural dietary supplement or ‘nutraceutical’ with countless evangelists in the health and wellness community. Although contradictory, all three statements are true from different perspectives, and clinical researchers are frustrated.'
https://www.nature.com/articles/d41586-019-02524-5
'A few things that do not work well should be phased out, including the excessively detailed labelling of cannabis products, a cap on the THC percentage that is permitted in such products and overzealous drug-awareness campaigns and messaging. These measures have had the opposite of their intended effects. The priority should be to facilitate research, which will help to inform education and policy agendas as the cannabis industry takes root.
Incremental progress is being made in pursuing policies that support crucial medical research that might unearth discoveries that could benefit millions of people and protect public health, in both the United States and abroad. Here’s to a dab of optimism about what the future could hold.'
https://www.nature.com/articles/d41586-019-02531-6
'And no matter the outcome, the study will do little to curb people selling CBD products. If the pudding does do something, CBD oil brands will have a paper to add to their marketing arsenal. If the special puddling doesn’t do anything for people with chronic pain, it will be easy to ignore; manufacturers can easily word claims about products’ benefits vaguely enough to avoid out-and-out false advertising. But more importantly, once something is in the public imagination as being useful, it’s hard to oust it. CBD has benefited from early studies that suggest legitimate uses from pain management to anxiety to insomnia. It doesn’t matter much that these are typically small, and often in rodents. There’s also the simple fact that it comes from marijuana; that it would do something positive seems logical, in the same way that buying face creams boasting antioxidants seems logical, even though they may only wind up being present in trace amounts. One only really has to note that a product has CBD in order to sell it. '
https://slate.com/technology/2019/09/unfortunately-the-cbd-horse-is-pretty-definitively-out-of-the-barn-so-to-speak.html
'With 332% growth year-on-year and $52 million in sales, cannabidiol (CBD) has taken the top spot as the best-selling herbal supplement in the natural channel, according to the 2018 HerbalGram Herb Market Report by the American Botanical Council.'
https://www.nutraingredients-usa.com/Article/2019/09/23/CBD-supplement-sales-rocket-to-take-top-spot-in-the-US-natural-channel
'Highlights from laboratory studies and clinical trials.'
https://www.nature.com/articles/d41586-019-02532-5
'Federal agriculture officials will delay the requirement that all THC testing on hemp crops must be performed at laboratories registered with the U.S. Drug Enforcement Administration.
And food and drug regulators say it’s a “fool’s errand” to get people to stop taking over-the-counter CBD'
https://hempindustrydaily.com/usda-drops-dea-testing-requirement-while-fda-acknowledges-demand-for-cbd/
'More than half of the studies, however, have shown that cannabis and alcohol are substitutes, meaning that the increased use of one substance reduces the use of the other. Other researchers have also suggested that cannabis, especially cannabis for medical use, may serve as a substitute for alcohol, tobacco and other drugs, including prescription drugs.' - United Nations Office on Drugs and Crime, World Drug Report 2020, https://wdr.unodc.org/wdr2020/field/WDR20_BOOKLET_4.pdf
'According to the new cannabis regulations, the federal Government of Canada is responsible for setting the requirements for those who grow and produce cannabis, including the types of cannabis products available for sale. For example, the regulations were amended in October 2019 to allow the production and sale of edible cannabis, cannabis extracts and topicals, and the sale of those products began gradually from December 2019. The provincial and territorial governments, for their part, are Responsible for developing, implementing, maintaining and enforcing systems to oversee the distribution and sale of cannabis.' - United Nations Office on Drugs and Crime, World Drug Report 2020, https://wdr.unodc.org/wdr2020/field/WDR20_BOOKLET_4.pdf
'While most cannabis users had used more than one product, over three quarters of users purchased and consumed dried cannabis flower or leaf for smoking. Although the sale of edibles and extracts started only at the end of 2019, a substantial share of cannabis users reported using edible cannabis products (26 per cent), cannabis oil or vape pens (19 per cent), hashish (16 per cent) and solid cannabis concentrates (14 per cent) during the same year.' - United Nations Office on Drugs and Crime, World Drug Report 2020, https://wdr.unodc.org/wdr2020/field/WDR20_BOOKLET_4.pdf
'"With hundreds of new companies rushing into the CBD space, many in the industry are looking beyond CBD towards other minor cannabinoids," New Frontier reports. "For farmers feeling the effects of CBD oversupply, minor cannabinoids can offer higher prices and less regulatory oversight."
Both the New Frontier report and several members of the hemp industry with whom we've spoken see CBN (cannabinol) and CBG (cannabigerol) as the next big thing in the hemp and cannabis industries. Despite not being as popular or studied as CBD (which is new to clinical research itself), both CBN and CBG have shown potential in wellness areas such as fighting inflammation, pain, nausea and potentially even certain cancer cells.'
https://www.westword.com/marijuana/as-cbd-prices-drop-will-cbn-and-other-cannabinoids-become-more-alluring-to-hemp-farmers-11746876
'According to Witte, as the science behind CBD formulation affords more consistency, brands will begin to focus on whatever added value that they may provide beyond CBD itself.
“The way to think about CBD is as a compound no more interesting than caffeine or electrolytes, just a commoditized functional ingredient that’s ultimately going to be added to many types of products,” Witte explained. “The value is in being able to determine the right application to utilize it and being able to build a brand on top of the ingredient.”
Drawing a comparison with both Starbucks coffee and Red Bull energy drinks (“CBD is the caffeine of the 21st century,” he asserted), Witte pointed out how those brands essentially offer products with the same active ingredient; the differences are how the companies brand themselves and what kind of promises they offer their consumers.'
https://newfrontierdata.com/cannabis-insights/webinar-details-the-industry-buzz-about-cbd-infused-food-and-beverages/
'The fisheries of fresh and salt water are a resource of great importance, involving the interests and the welfare of a very large number of people. That they are now seriously threatened by the chemicals entering our waters can no longer be doubted. If we could divert to constructive research even a small fraction of the money spent each year on the development of even more toxic sprays, we could find ways to use less dangerous materials and to keep poisons out of our waterways. When will the public become sufficiently aware of the facts to demand such action? - Silent Spring, Rachel Carson, 1962
'This system, however - deliberately poisoning our food, then policing the result - is too reminiscent of Lewis Carroll's White Knight who thought of 'a plan to dye one's whiskers green, and always use so large a fan that they could not be seen.' The ultimate answer is to use less toxic chemicals so that the public hazard from their misuse is greatly reduced.' - Silent Spring, Rachel Carson, 1962
'In 1937, weed was placed under the Harrison Narcotics Act. Narcotics authorities claim it is a habit-forming drug, that its use is injurious to mind and body, and that it causes the people who use it to commit crimes. Here are the facts: Weed is positively not habit forming. You can smoke weed for years and you will experience no discomfort if your supply is cut off. I have seen tea heads in jail and none of them showed withdrawal symptoms. I have smoked weed myself off and on for fifteen years, and never missed it when I ran out. There is less habit to weed than there is to tobacco. Weed does not harm the general health. In fact. most users claim it gives you an appetite and acts as a tonic to the system. I do not know of any other agent that gives as definite a boot to the appetite. I can smoke a stick of tea and enjoy a glass of California sherry and a hash house meal.' - Junky, William S Burroughs, 1977, originally published in 1953
'I once kicked a junk habit with weed. The second day off junk I sat down and ate a full meal. Ordinarily, I can't eat for eight days after kicking a habit.' - Junky, William S Burroughs, 1977, originally published in 1953
'According to the survey, 81 percent of respondents believe that tobacco cigarettes are "very harmful." Fifty-one percent of respondents similarly view alcohol as "very harmful." By contrast, only 26 percent of those surveyed ranked marijuana as "very harmful." '
https://norml.org/news/2019/08/29/poll-americans-view-cigarettes-and-alcohol-as-more-harmful-than-cannabis
'According to the agency's filing in the Federal Register, it "intends to promulgate regulations" to evaluate several dozen applications before it from private entities that wish to cultivate cannabis for FDA-approved research. However, this is not the first time the agency has made such a promise. In 2016, the DEA similarly announced the adoption of new rules to expand to supply of research-grade cannabis, but failed to take any further action.'
https://norml.org/news/2019/08/29/dea-promises-progress-on-federal-cultivation-applications-but-provides-no-timetable-for-action
'As such, hemp and hemp-derived CBD preparations that have 0.3% THC or less are not controlled substances, the DEA confirmed. “DEA registration is not required to grow or research” them.
The confirmation will be good news to the CBD industry, which has exploded recently. But any manufacturers making health claims about the CBD-containing products will still receive scrutiny from the Food and Drug Administration. Additionally, individual state laws and restrictions may apply.'
https://arstechnica.com/science/2019/08/dea-may-finally-let-others-grow-cannabis-for-research/
'Cannabidiol (CBD) is an illegal drug with no redeeming value. It is also a useful prescription medicine for epilepsy, with considerable potential for treating numerous other conditions. And it is a natural dietary supplement or ‘nutraceutical’ with countless evangelists in the health and wellness community. Although contradictory, all three statements are true from different perspectives, and clinical researchers are frustrated.'
https://www.nature.com/articles/d41586-019-02524-5
'A few things that do not work well should be phased out, including the excessively detailed labelling of cannabis products, a cap on the THC percentage that is permitted in such products and overzealous drug-awareness campaigns and messaging. These measures have had the opposite of their intended effects. The priority should be to facilitate research, which will help to inform education and policy agendas as the cannabis industry takes root.
Incremental progress is being made in pursuing policies that support crucial medical research that might unearth discoveries that could benefit millions of people and protect public health, in both the United States and abroad. Here’s to a dab of optimism about what the future could hold.'
https://www.nature.com/articles/d41586-019-02531-6
'And no matter the outcome, the study will do little to curb people selling CBD products. If the pudding does do something, CBD oil brands will have a paper to add to their marketing arsenal. If the special puddling doesn’t do anything for people with chronic pain, it will be easy to ignore; manufacturers can easily word claims about products’ benefits vaguely enough to avoid out-and-out false advertising. But more importantly, once something is in the public imagination as being useful, it’s hard to oust it. CBD has benefited from early studies that suggest legitimate uses from pain management to anxiety to insomnia. It doesn’t matter much that these are typically small, and often in rodents. There’s also the simple fact that it comes from marijuana; that it would do something positive seems logical, in the same way that buying face creams boasting antioxidants seems logical, even though they may only wind up being present in trace amounts. One only really has to note that a product has CBD in order to sell it. '
https://slate.com/technology/2019/09/unfortunately-the-cbd-horse-is-pretty-definitively-out-of-the-barn-so-to-speak.html
'With 332% growth year-on-year and $52 million in sales, cannabidiol (CBD) has taken the top spot as the best-selling herbal supplement in the natural channel, according to the 2018 HerbalGram Herb Market Report by the American Botanical Council.'
https://www.nutraingredients-usa.com/Article/2019/09/23/CBD-supplement-sales-rocket-to-take-top-spot-in-the-US-natural-channel
'Highlights from laboratory studies and clinical trials.'
https://www.nature.com/articles/d41586-019-02532-5
'Federal agriculture officials will delay the requirement that all THC testing on hemp crops must be performed at laboratories registered with the U.S. Drug Enforcement Administration.
And food and drug regulators say it’s a “fool’s errand” to get people to stop taking over-the-counter CBD'
https://hempindustrydaily.com/usda-drops-dea-testing-requirement-while-fda-acknowledges-demand-for-cbd/
'More than half of the studies, however, have shown that cannabis and alcohol are substitutes, meaning that the increased use of one substance reduces the use of the other. Other researchers have also suggested that cannabis, especially cannabis for medical use, may serve as a substitute for alcohol, tobacco and other drugs, including prescription drugs.' - United Nations Office on Drugs and Crime, World Drug Report 2020, https://wdr.unodc.org/wdr2020/field/WDR20_BOOKLET_4.pdf
'According to the new cannabis regulations, the federal Government of Canada is responsible for setting the requirements for those who grow and produce cannabis, including the types of cannabis products available for sale. For example, the regulations were amended in October 2019 to allow the production and sale of edible cannabis, cannabis extracts and topicals, and the sale of those products began gradually from December 2019. The provincial and territorial governments, for their part, are Responsible for developing, implementing, maintaining and enforcing systems to oversee the distribution and sale of cannabis.' - United Nations Office on Drugs and Crime, World Drug Report 2020, https://wdr.unodc.org/wdr2020/field/WDR20_BOOKLET_4.pdf
'While most cannabis users had used more than one product, over three quarters of users purchased and consumed dried cannabis flower or leaf for smoking. Although the sale of edibles and extracts started only at the end of 2019, a substantial share of cannabis users reported using edible cannabis products (26 per cent), cannabis oil or vape pens (19 per cent), hashish (16 per cent) and solid cannabis concentrates (14 per cent) during the same year.' - United Nations Office on Drugs and Crime, World Drug Report 2020, https://wdr.unodc.org/wdr2020/field/WDR20_BOOKLET_4.pdf
'"With hundreds of new companies rushing into the CBD space, many in the industry are looking beyond CBD towards other minor cannabinoids," New Frontier reports. "For farmers feeling the effects of CBD oversupply, minor cannabinoids can offer higher prices and less regulatory oversight."
Both the New Frontier report and several members of the hemp industry with whom we've spoken see CBN (cannabinol) and CBG (cannabigerol) as the next big thing in the hemp and cannabis industries. Despite not being as popular or studied as CBD (which is new to clinical research itself), both CBN and CBG have shown potential in wellness areas such as fighting inflammation, pain, nausea and potentially even certain cancer cells.'
https://www.westword.com/marijuana/as-cbd-prices-drop-will-cbn-and-other-cannabinoids-become-more-alluring-to-hemp-farmers-11746876
'According to Witte, as the science behind CBD formulation affords more consistency, brands will begin to focus on whatever added value that they may provide beyond CBD itself.
“The way to think about CBD is as a compound no more interesting than caffeine or electrolytes, just a commoditized functional ingredient that’s ultimately going to be added to many types of products,” Witte explained. “The value is in being able to determine the right application to utilize it and being able to build a brand on top of the ingredient.”
Drawing a comparison with both Starbucks coffee and Red Bull energy drinks (“CBD is the caffeine of the 21st century,” he asserted), Witte pointed out how those brands essentially offer products with the same active ingredient; the differences are how the companies brand themselves and what kind of promises they offer their consumers.'
https://newfrontierdata.com/cannabis-insights/webinar-details-the-industry-buzz-about-cbd-infused-food-and-beverages/
See cannabis anywhere, FDA?
'Drug overdose deaths involving selected drug categories are identified by specific multiple cause-of-death codes. Drug categories presented include: heroin (T40.1); natural opioid analgesics, including morphine and codeine, and semisynthetic opioids, including drugs such as oxycodone, hydrocodone, hydromorphone, and oxymorphone (T40.2); methadone, a synthetic opioid (T40.3); synthetic opioid analgesics other than methadone, including drugs such as fentanyl and tramadol (T40.4); cocaine (T40.5); and psychostimulants with abuse potential, which includes methamphetamine (T43.6). Opioid overdose deaths are identified by the presence of any of the following MCOD codes: opium (T40.0); heroin (T40.1); natural opioid analgesics (T40.2); methadone (T40.3); synthetic opioid analgesics other than methadone (T40.4); or other and unspecified narcotics (T40.6).'
https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm
'The purpose of this systematic review was to explore available peer-reviewed evidence related to the use of cannabis as a potential alternative to opioids in the treatment of chronic pain. The Johns Hopkins Nursing Evidence-Based Practice model was used to review 32 peer-reviewed articles published between 2008 and 2018. Findings suggest cannabis as a promising alternative to opioids and supports the medical use of cannabis as a safer first-line pharmacological treatment for chronic pain compared to opioids. The use of cannabis as a safer alternative to opioids can promote social change directly and indirectly across a variety of social and economic dimensions due to increased access to medication at reduced cost, elimination of opioid-related death due to overdose, diminished individual and social harms related to cannabis. A medical alternative to opioids may also lead to a reduction of the inequitable incarceration of cannabis users across demographic categories of ethnicity and race.'
https://search.proquest.com/openview/a69d6774a45ea04c630c10a84ea2cc8e/1?pq-origsite=gscholar&cbl=18750&diss=y
'“It’s a lot safer than alcohol. It’s safer than narcotics. It ought to be used more widely and we can’t even study it that easily because of the way it’s regulated,” he said. “You know what, I called the DEA—they said, ‘we don’t want this to be illegal. Your government ought to change that. But we got to enforce the law.’ I call the FDA that regulates the drugs, they say, ‘we think it ought to be used, but until the DEA says it’s allowed, we can’t let people prescribe it everywhere.”
While Oz didn’t disclose specifics about his conversations, such as who he spoke to or when the phone calls happened, it is the case that federal marijuana reform outside of Congress falls largely within the jurisdictions of both agencies. And DEA has denied multiple rescheduling requests, justifying the inaction by stating that FDA has determined that cannabis doesn’t have proven medical value and carries a risk of abuse.'
https://www.marijuanamoment.net/dr-oz-claims-dea-and-fda-blame-each-other-for-keeping-marijuana-illegal/
https://www.visualcapitalist.com/cbd-oil-vs-hemp-oil-whats-the-difference/
'The current crisis of fentanyls appears to be more supply-driven than earlier waves of increases in the use of pharmaceutical opioids or heroin. Fentanyls are being used as an adulterant of heroin, are used to make falsified pharmaceutical opioids, such as falsified oxycodone and hydrocodone – and even falsified benzodiazepines – which are sold to a large and unsuspecting population of users of opioids and other drugs; users are not seeking fentanyl as such.
It seems that some local distributors are not able to distinguish between heroin, fentanyl and fentanyl laced heroin, nor between diverted pharmaceutical opioids and falsified opioids containing fentanyl. A general problem with fentanyls is dosing by nonprofessional “pharmacists”, where small mistakes can lead to lethal results. Furthermore, as the overdose death data suggest, even people using cocaine and psychostimulants, such as methamphetamine, are also exposed – probably unintentionally – to fentanyls or other potent synthetic opioids mixed with those substances' - United Nations Office on Drugs and Crime, World Drug Report 2020, https://wdr.unodc.org/wdr2020/field/WDR20_BOOKLET_4.pdf
'All factors driving fentanyl use converged from 2013 onwards in the United States and Canada, which may explain the unprecedented spread of the fentanyls in those markets: factors such as the diffusion of simpler, more effective methods of manufacture of synthetic opioids and their analogues (primarily fentanyls), assisted by the availability on the Internet of instructions for their manufacture; a shift from preparation by a limited number of skilled chemists to preparation by basic “cooks” who could simply follow the posted instructions; the discovery of ever more fentanyl analogues; a lack of effective control of precursors and oversight of the industry; expanding distribution networks that reduced the risk of detection through the use of postal services and the Internet; and increased licit trade including e-commerce.' - United Nations Office on Drugs and Crime, World Drug Report 2020, https://wdr.unodc.org/wdr2020/field/WDR20_BOOKLET_4.pdf
'Overall, in 2018 overdose deaths attributed to synthetic opioids, comprising mainly fentanyls, accounted for nearly half of the total overdose deaths in the United States. Among the reasons for the high number of overdose deaths attributed to fentanyls are their often small lethal doses relative to other opioids: fentanyl, for example, is approximately 100 times more potent than morphine, and carfentanil may be as much as 10,000 times more potent than morphine for an average user. A lethal dose of carfentanil for a human can be as low as 20 micrograms.
The rapid expansion of fentanyl use in the United States is also visible in the data on seizures and the drug samples analysed, with a considerable increase since 2014 in the number of samples identified as fentanyl. In 2018, fentanyl accounted for 45 per cent of the pharmaceutical opioids that were identified in different samples, while oxycodone accounted for 14 per cent' - United Nations Office on Drugs and Crime, World Drug Report 2020, https://wdr.unodc.org/wdr2020/field/WDR20_BOOKLET_4.pdf
'Such uneven approaches toward CBD have largely arisen due to the U.S. Food and Drug Administration (FDA)’s ’s slow approaches in regulating the substance. At the heart of the issue is whether to classify CBD as a dietary supplement, or as a pharmaceutical ingredient. To date, the FDA has approved the sale and marketing of but one CBD product (the prescription medication Epidiolex), to treat forms of epileptic seizures.
While the FDA formulates its federal policy, the agency has maintained its stance that it remains illegal either to add CBD to food or market it as a dietary supplement. Impatient with the FDA’s attitude as demand for CBD has expanded, several states have adopted independent stances, including allowing CBD in food products.
In 2018, Colorado became the first state to accept CBD as a food ingredient. Subsequently, 15 other states have passed laws also allowing CBD in food and beverages. Meantime, 27 states have taken steps to explicitly forbid CBD in food products, including otherwise cannabis-friendly states like California.'
https://newfrontierdata.com/cannabis-insights/fda-still-moving-slow-as-appetites-for-cbd-grow/
'In reality, the FDA has effectively banned CBD foods. "It is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement," the agency declared, also noting it would study the matter indefinitely.
In other words, soon after Congress legalized growing hemp, the FDA banned the single most profitable use of hemp.'
https://reason.com/2020/05/30/the-fda-is-stunting-the-growth-of-americas-nascent-legal-hemp-industry/
'“People in the high concentration group were much less compromised than we thought they were going to be,” said co-author Kent Hutchison, a professor of psychology and neuroscience at CU Boulder who also studies alcohol addiction. “If we gave people that high a concentration of alcohol it would have been a different story.”
One reason that higher THC blood levels didn’t translate to higher highs could be that the body’s finite number of cannabinoid receptors, which THC molecules bind to, become saturated regardless of whether higher- or lower-THC products are used. Any excess THC in consumers’ blood plasma, in that case, would be metabolized and not contribute to further impairment'
https://www.marijuanamoment.net/do-highly-potent-marijuana-concentrates-get-users-more-high-not-exactly-study-finds/
Finally...some positive action from the FDA...will legal action be taken against those who made false claims regarding the drugs' anti-Covid powers?
'Citing its ongoing scientific review, the agency said in a statement: “FDA has determined that CQ [chloroquine phosphate] and HCQ [hydroxychloroquine sulfate] are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA. Additionally, in light of ongoing serious cardiac adverse events and other serious side effects, the known and potential benefits of CQ and HCQ no longer outweigh the known and potential risks for the authorized use.'
https://www.sciencemag.org/news/2020/06/fda-just-gave-thumbs-down-trump-s-favorite-covid-19-drugs
0.3% or 1% THC...having a threshold for naturally growing cannabis is ridiculous and unscientific..more and more studies are emerging that concentrations of THC as high as 30% to 40% are not as much of a health hazard as it is made out to be..definitely not as much of a hazard as 30% to 40% alcohol is...
'Despite a glut in the 2019 CBD market that has left many farmers saddled with their 2019 crop, shady processors and a meager THC (Tetrahydrocannabinol) threshold of .3% that led to the destruction of thousands of acres hot-hemp (hemp considered to be marijuana for going over the threshold), the major obstacles in the way of the hemp industry are the Food and Drug Administration and the United States Department of Agriculture.'
https://www.messenger-inquirer.com/news/local/national-hemp-politics-become-main-focus-of-2020-grow-season/article_4b61173d-575d-5eb9-8d11-a874dfafaf3a.html
'With the regulatory path forward for hemp-derived CBD in foods and supplements no clearer a year after the FDA’s May 2019 public meeting, trade association The Council for Responsible Nutrition (CRN) has filed a citizen’s petition urging the FDA to regulate CBD as a legal dietary supplement.'
https://www.foodnavigator-usa.com/Article/2020/06/18/CRN-files-petition-proposing-way-forward-for-CBD-supplements-leaves-foods-beverages-to-be-dealt-with-later
'Federal action on marijuana policy is inevitable and will happen “soon,” according to Food and Drug Administration (FDA) Commissioner Scott Gottlieb.
Exactly what kind of action he’s anticipating is unclear, though. After dismissing the idea that botanical cannabis has therapeutic value, Gottlieb said in a CNBC appearance on Friday that there’s “probably going to be a policy reckoning around this at some point in the future.”
“Obviously it’s happening at the state level, and I think there’s an inevitably that it’s going to happen at the federal level at some point soon,” he said.'
https://www.marijuanamoment.net/federal-marijuana-action-is-an-inevitability-trump-fda-chief-says/
'States like New York have similarly issued orders to crack down on restaurants and bakeries offering CBD-infused foods. While critics claim that states are overreacting to the influx of CBD products, state officials have justified their actions by pointing out that the FDA has not deemed CBD to be a safe food additive.
For its part, the FDA remains cognizant of its regulatory responsibilities and the influx of CBD products. In a statement released when the Farm Bill was enacted, the FDA reiterated its authority to regulate CBD products, and pledged to hold public hearings to gather more information about CBD.
“We’re aware of the growing public interest in cannabis and cannabis-derived products, including cannabidiol (CBD),” the statement reads. “This increasing public interest in these products makes it even more important with the passage of this law for the FDA to clarify its regulatory authority over these products.”
https://newfrontierdata.com/marijuana-insights/confusion-about-cbd-legalities-stymies-manufacturers-consumers-alike/
'“We’re planning to seek broad public input on this pathway, including information on the science and safety behind CBD. But we know that this process could take time,” Gottlieb said. “So we’re also interested in hearing from stakeholders and talking to Congress on possible alternative approaches to make sure that we have an appropriately efficient and predictable regulatory framework for regulating CBD products.”'
https://www.marijuanamoment.net/fda-is-exploring-alternative-approaches-to-cbd-regulation-commissioner-says/
'"FDA, in cooperation with the National Institute on Drug Abuse, will consider the comments on behalf of [the Department of Health and Human Services] in evaluating the WHO scheduling recommendations," it says. "Then, under section 201(d)(2)(B) of the [Controlled Substances Act], HHS will recommend to the Secretary of State what position the United States should take when voting on the recommendations for control of substances."
The new request for comments is at least the third time that the Trump administration has asked the public to weigh in on marijuana's international scheduling status, but it is the first since WHO formally recommended reclassification.'
https://www.forbes.com/sites/tomangell/2019/03/01/trump-administration-wants-more-input-on-marijuana-rescheduling/#53f751533606
'In the last few days, more t[h]an 1,000 people have submitted comments to the Food and Drug Administration (FDA) supporting the rescheduling of marijuana.
The FDA opened the public comment period on Friday to gather input ahead of a United Nations meeting on global drug policy, where the U.S. representative will have the opportunity to cast a vote on World Health Organization (WHO) recommendations to reschedule cannabis, THC and CBD under international drug treaties.
So far, the federal agency has been flooded with comments that overwhelmingly endorse a cannabis reclassification. Support for the policy change has been nearly unanimous, but the reasoning behind those sentiments varied.'
https://www.marijuanamoment.net/fda-flooded-with-comments-urging-that-marijuana-be-reclassified/
'The U.S. Food and Drug Administration (FDA) has denied a request from an anti-legalization group to place marijuana and its derivatives on a list of restricted substances that are not “generally recognized as safe and effective.”'
https://www.marijuanamoment.net/fda-rejects-petition-to-further-restrict-marijuana/
Legalize marijuana for adult recreational use globally....
'"Any comments received will be considered by [the U.S.Department of Health and Human Services] when it prepares a scientific and medical evaluation for drug substances that is responsive to the WHO Questionnaire for these drug substances," the new FDA notice says. "HHS will forward such evaluation of these drug substances to WHO, for WHO's consideration in deciding whether to recommend international control/decontrol of any of these drug substances."'
https://www.forbes.com/sites/tomangell/2018/10/10/trump-administration-seeks-public-comments-on-marijuana-reclassification/#7729951c749a
Legalizing marijuana at the federal level will go a long way in easing up pressure on the FDA and many other federal institutions that are hampered from acting more freely because of the ambiguity around the schedule 1 status of marijuana. The stepping down of the FDA Commissioner looks like the result of the federal status of marijuana on the one hand and the pressure from all quarters on the FDA on the other hand.
'But having the FDA send down its new guidelines will also help spur states to act, along with providing consumers with the knowledge that they can trust the products labeled CBD at their local stores. That’s why lawmakers and advocates continue to exert pressure from every angle they can, which for federal lawmakers starts with pressuring the FDA to act.
“We’re really trying to grab this from the grassroots up and make sure that they get out of the bureaucratic mode and actually put out the rules and state affirmatively: You can do it, because guess what? Quaint idea — it’s federal law,” Sen. Wyden of Oregon said. “It’s what Congress said. The law says hemp and its derivatives.'
https://www.rollingstone.com/culture/culture-features/cbd-cannabis-pot-legal-fda-803567/
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