FDA Exec: Don’t Expect an Exception for CBD

FDA Exec: Don’t Expect an Exception for CBD

CBD treatments are promising, but far more research needs to be done before federal authorities can allow them in foods and dietary supplements, according to a leader of the U.S. Food and Drug Administration’s new cannabinoid work group.

Talking to the National Industrial Hemp Council, Lowell Schiller warned CBD producers in attendance that the FDA plans to treat hemp extracts like any other new ingredient going into foods or drugs – meaning that without research on dosing and drug interactions, the agency is unlikely to approve over-the-counter use.

“We don’t hold a grudge against (cannabinoids), but we also don’t hold them to a lower standard of safety or absolve them of other requirements,” he told the gathering in Portland, Oregon.

“Consumers have a right to expect the same level of FDA protection with respect to hemp and derivatives like CBD as they would expect with respect to any other substance.”

Schiller repeated FDA concerns about:

  • Potential adverse effects from CBD use, including liver damage.
  • The lack of data on long-term use of CBD.
  • Unproved claims of therapeutic benefits from CBD.

“If we don’t think we’ll have the data to say that some level of CBD can be safely added to a food or dietary supplement, then we wouldn’t want to create an exception for CBD,” he said.

Schiller told the industry group the FDA is excited about cannabinoids’ potential for therapeutic use, but more research is needed. He said the agency would report progress on its cannabinoid review in “early fall.”

COMMENTS:

Ray: There is that “more research” propaganda again. No one believes the FDA simply because they play the Fake News card and because they know they picked the wrong side when it came to the cannabis plant. There is plenty of research and testimonials on the side effects and benefits of cannabis including CBD if they really want to find it.The FDA gave us Fentanyl and:Infliximab. Brand Name: Remicade.
Used For: Crohn’s disease, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, and ulcerative colitis.
Side Effects: Cancer (Skin, Lung, breast cancer, gastrointestinal) labored breathing, joint pain, pneumonia.Do you know what product helps patients with Chron’s disease? Yep, cannabis. And cancer is not a side effect.

Deetew: Wow, the FDA wants a lot of information on CBD before jumping to conclusions. Keep in mind that the GW Pharmaceuticals study that showed liver damage from CBD used acute doses of 180,000 mg of pure isolated CBD in a 75 kg individual —beyond anything anyone would ever use or afford. Also, I can buy a barrel of Ibuprofen and destroy my kidneys and stomach lining, and the FDA won’t care about my safety. —Why, because it already gave me chronic gastritis, and the FDA doesn’t care. Don’t believe that the FDA isn’t biased against CBD, because they most certainly are either receiving revolving door promises from GW Pharmaceuticals, or they are getting straight up bribed. Investigate.

Mike: Hopefully we can unmark the alleged “proprietary” chemovar that GW PHarma is using and show that the same effects can be achieved with hemp and cannabis extracts.

Bev: The FDA allows neurotoxic, endocrine disrupting, fluoride to be given to children. Fluoride was NEVER tested, but can be prescribed because it was grandfatered! Spare us your concern about CBD products, oh font of wisdom FDA, you merely want control.Fluoride is a drug that has only been approved for topical application. Children’s sodium fluoride anti-cavity supplements were never found safe or effective by the Food and Drug Administration (FDA). Sodium fluoride supplements are routinely fed to little children to prevent tooth decay. They are drugs requiring a dentist’s or physician’s prescription. FLuoride supplements were “grandfathered in” before the 1938 law was enacted requiring drug testing. So, products on the market before 1938 were presumed safe by the FDA who allowed grandfathered drugs to be sold without any testing. Once a drug is on the market for any reason, doctors can use them to treat any disease or condition. Sodium fluoride was on the market pre-1938, but not to stop cavities and not for any medical reason. Sodium fluoride sold as a rat poison.

Cyrus Emerson: CBD needs to be approved before Hemp can move into the textile market. Ha ha. As an investor this has been a painful adventure with my stock going lower and lower all the time.Even after becoming Federally legal my investment continues to find all time lows.If the FDA doesn’t approve CBD a lot of other investors will feel the pain too.

Poncietta M Chavez: It would seem to me that the FDA would want a drug with few side effects. CBD has been proven to help many medical conditions when nothing else could. The testimonials are out there, it is no big secret. When one look at the side effect of many of the drugs that are currently on the market and are FDA approved, I do not understand how they can even consider that the side effects far outweigh the disease/condition that is being treated. Many of these approved drugs are more harmful than the condition that they are treating but doctors do not hesitate to prescribe these to their unsuspecting patients because they have something to gain from the big pharmaceuticals. The big pharmaceutical could care less because it’s the bottom line that counts … to heck with human life … consider it collateral damage. I’d bet anything that none of these individuals would take or allow their loved ones to take any of these meds. Through the years, there have been drugs that have been approved and it’s not until there is a rash of deaths or other serious side effects does the FDA decide to pull the drug from the market.PRIME EXAMPLE: Celecoxib Safety DebatedThe safety of the COX-2 inhibitor celecoxib (brand name Celebrex) came under scrutiny when the other COX-2 inhibitors were taken off the market more than a decade ago.The medical literature includes studies showing an increased risk of serious cardiovascular problems with celecoxib.
The Food and Drug Administration (FDA) position is that the risk for certain patients is worth the benefit of celecoxib. Taking the lowest effective dose of celecoxib, for the shortest time possible, is advised by the FDA, and prominent warnings are required on packages for all nonsteroidal anti-inflammatory (NSAIDS), including celecoxib, highlighting the risks.6

Results of a long-term, multinational clinical trial that began in 2006 to assess and compare the risk of celecoxib with other common NSAIDs have not yet been released.7NEED I SAY MORE?

Serg: This is such an absurdity. The FDA does not care about your safety, all they care about is the almighty dollar. Their line about research on long term effects is a farce. The perfect example: Just watch any commercial on medication and listen to the ridiculous amount of side effects on each and every product, some of which include death or suicidal tendencies. All they say is consult your doctor or discontinue use. What a joke.

Mike: Big Pharma knows the benefits of CBD and is pushing the FDA to delay it as long as possible so they can corner the market. They obviously control FDA just they and the other big corporations do congress….

This story originally appeared at Hemp Industry Daily.

New Film Focuses on Farmers, Criteria for Hemp Farmers

New Film Focuses on Farmers, Criteria for Hemp Farmers

The U.S. Farmers & Ranchers Alliance has unveiled a new film that highlights the urgency needed in the fight against climate change.

Despite uncertain economic times, farmers are front and center as the agents for change in “30 Harvests.”

The docudrama follows the plight of farmer Jay Hill of Dell City, Texas and farmer and soil scientist Meagan Kaiser of Bowling Green, Missouri.

In the short film, they articulate the challenge farmers face while embracing the opportunity to meet the increasing demands for food, and ultimately help solve one of the greatest challenges of this generation: climate change.

If you would like to watch “30 Harvests”, it’s now available in its entirety on You Tube.

The Montana Department of Agriculture is reminding hemp growers that verification of license information and additional fees are required before growers can be issued their hemp production license, which is needed to harvest and process or sell their crop.

The Department sent letters to each license holder at the beginning of July asking growers to verify the crop information that will be printed on each grower’s license certificate.

The information provided should be sent to the Department asap as it helps the Department track production and develop timelines for sampling and testing.

If you are a grower who did not receive a letter from the Department, please contact Andy Gray at (406) 444-0512. 

This story originally appeared at ktvq.com

Key Congressional Chairman Sends Marijuana Email To NORML Activists

Key Congressional Chairman Sends Marijuana Email To NORML Activists

The chairman of the influential House Judiciary Committee authored a message to NORML’s email list on Monday—a notable signal of how the cannabis legalization movement has entered the mainstream corridors of power on Capitol Hill.

Rep. Jerrold Nadler (D-NY), who last month filed legislation to remove marijuana from the Controlled Substances Act and begin repairing the harms of prohibition enforcement, asked the advocacy group’s supporters to write their own members of Congress in support of his bill, the Marijuana Opportunity, Reinvestment, and Expungement (MORE) Act.

“America has a moral responsibility to pass my legislation to end the prohibition of marijuana and take on the oppression at the heart of the War on Drugs,” Nadler wrote. “I’m proud to work with NORML to create a more just national marijuana policy.”

The bill will “once and for all end the destructive policy of federal marijuana prohibition in America” and “remedy the widespread inequities and injustice this policy has brought upon tens of millions of Americans,” the chairman told the legalization group’s members.

Beyond descheduling cannabis, the MORE Act would create processes for the expungement and resentencing of prior convictions and prevent government agencies from blocking access to federal benefits or impeding citizenship status for immigrants due to marijuana use.

Additionally, it would levy a five percent federal tax on cannabis sales, with some revenue earmarked for job training and legal aid programs for people impacted by prohibition enforcement as well as loans for small marijuana businesses owned by socially and economically disadvantaged people.

Its introduction comes amidst what observers are saying is the most marijuana-friendly Congress in history. Less than eight months into the two-year session, dozens of cannabis proposals have been filed, seven hearings have been held on the issue and legislation to increase marijuana businesses’ access to banking services has cleared a key committee.

“With Chairman Nadler’s leadership, we believe that the MORE act will likely be the first bill to end federal marijuana criminalization ever to pass in a chamber of Congress,” NORML Political Director Justin Strekal said in an interview. “Representative democracy is not a spectator sport. Now is the time for the majority of Americans who support legalization to demand reform from their legislators, just as Mr. Nadler’s message to our members indicated.”

Sen. Kamala Harris (D-CA), a 2020 presidential candidate, filed a companion version of Nadler’s bill in the Senate.

“In 1977, I cast my first vote as a freshman member of the State Assembly to decriminalize marijuana in my home state of New York,” the chairman wrote to NORML’s supporters. “Since then, I have been committed to ending the criminalization of marijuana. The criminalization of marijuana is a mistake and caused grave harm, disproportionately to those who are poor or people of color, and we must take action.”

Nadler’s bill was endorsed by a group of justice-focused organizations such as ACLU and NAACP in a letter to House leaders earlier this month.

“Criminal justice involvement deprives individuals from low-income communities of color equal access to economic opportunity,” the groups wrote. “Incarceration robs families and communities of breadwinners and workers. Thus, any marijuana reform bill that moves forward in Congress must first address criminal justice reform and repair the damage caused by the war on drugs in low-income communities of color.”

Calling the proposal an important step “to bolster communities ravaged by the war on drugs,” the groups are pushing congressional leadership to see that it is “swiftly marked up and immediately scheduled for floor consideration” following the August recess.

“The hysteria around marijuana is starting to lift as states across the country lead the way in reforming their marijuana laws. It is time for the federal government to follow suit,” Nadler wrote in the new message to NORML’s list. “Marijuana is a public health and personal freedom issue, not a criminal one. We can no longer afford the moral or financial costs of the War on Drugs.”

The New York congressman sent a separate email to his own campaign list last month asking his supporters to sign a petition backing his cannabis bill.

Also last month, a Judiciary subcommittee held a hearing on marijuana prohibition at which members of both parties express broad support for ending or scaling back federal prohibition, with disagreement mostly focusing on the details or competing proposals to do so.

This story originally appeared on Forbes.

Hemp Biofuel: No Green New Deal Without It

Hemp Biofuel: No Green New Deal Without It

Industrial hemp is paramount to anyone supporting radical environmentally-tied economic measures like the Green New Deal in America to overhaul our energy sector. In fact, hemp can do most of the greenering work in terms of both addressing climate change realities and economic inequality. No, not female hemp which is being used for CBD flower extracts, but male hemp.

Introduction

Unlike the Green New Deal, recent developments with industrial hemp don’t get the PR despite the American hemp farming industry being capable of bringing us to a 100% clean, renewable energy sector by 2030…and we don’t need much government stimulus to pull this off…

Just let farmers farm hemp.

If anything, the government should be incentivizing and helping farmers plants millions of acres (like they did during the war in 1942, although at a much smaller scale for those days — 400’ish thousand acres). I know that’s what the 2018 Farm Bill was about, but should something similar to the Green New Deal be adopted, how much is going to hemp farmers, processors, and hemp biolfuel companies?

Let’s talk hemp biofuel.

While sifting through currently available info on hemp biofuel at the beginning of 2019, you continuously run into a collective ‘if only’ statement in pre-2018 Farm Bill articles:

Industrial hemp is perfectly capable of fueling the modern world without displacing food or adding to the greenhouse effect, if only it were embraced…

Pertaining to America, where tons of the world’s most ardent hempsters reside,

We could easily fuel America with completely green carbon-neutral plant energy if only we had a domestic supply of hemp and it were federally legal to farm…

The fact America could fuel herself through plants was demonstrated decades ago, hemp being the wisest of choices for a wide variety of economic, agronomic, and ecological reasons. After passage of the 2018 Farm Bill and the reclassification of industrial hemp as an agricultural crop, this if-only statement’s no longer relevant with respect to prohibition. Not only is the industrial hemp plant legal to farm on U.S. soil (now defined as a Cannabis Sativa L. plant with equal or less than 0.3% THC), but the plant’s natural compounds are also federally legal as well — which includes up to 0.3% THC with no restrictions on other naturally-occurring elements like CBD, CBN, CBG, terpenes, etc.

If you’re wondering why the recent law’s so wide open, well, the USDA said one of their goals with the Agricultural Improvement Act of 2018 in regards to hemp was to give states as much room as possible to come up with their own sets of regulations regarding the crop and its compounds.

So… now what?

Going back to Henry Ford’s original Model T partly made of and and run on hemp, not to mention the original diesel engine being designed for biofuel, a mind-blowing fact remains:

Dried biomass has a heating value of 5000–8000 Btu/lb. with virtually no ash or sulfur produced during combustion. About 6% [to now 10%] of contiguous United States land area put into cultivation for biomass could supply all current demands for oil and gas. And this production would not add any net carbon dioxide to the atmosphere.” [1]

Do you know how tempted I am to go off on how hemp fiber could turn the fashion industry completely green? Ugh…and today I was shown an article freaking out about the fact the fashion industry (apparel & footwear) accounts for closing in on 10% of human-caused global climate impacts…

Here’s a quote from an April 2019 CBS News article, “Fashion industry’s carbon impact bigger than airline industry’s”,

“Total greenhouse gas emissions related to textiles production are equal to 1.2 billion tons annually — more than those of all international flights and maritime shipping trips combined, according to the Ellen MacArthur Foundation.”

But let’s get back to the biofuel angle which would inevitably mesh with the fashion industry in countless ways.

A biofuel-based infrastructure would create a completely decentralize power grid and no more ultra-mega power companies. Each county and state could provide its own energy using easily renewable plants. Let that seed sink into the garden of your mind…

Example: In Colorado a company called Vega Biofuels offer bio-coal — which is renewable, comparable in price to conventional coal and produced using terrefaction technology — and biochar which can sequester carbon in the soil for hundreds to thousands of years without the negative impacts. Imagine this happening on a wider scale across 5, 10, or 20 states.

Yep, biofuel’s a reality and hemp’s the ticket, backed by scientific research from multiple countries who’ve experimented with a variety of biofuels alongside hemp like Canada, Nigeria [2], across Northern Europe [3], Latvia [4], and so on.

According to some, industrial hemp biofuel performs second only to algae.

  • While it can vary depending on cultivar used and where it’s growing, male hemp-cannabis yields an average of nine dry tons per acre. [5]
  • This means if allowed to flourish, hemp would quickly reach a point where it’s producing greater biomass tonnage per acre annually in more regions of America than either pulpwood or kenaf.
  • Hemp is 80% cellulose: both a low-moisture herbaceous and woody plant.
  • Industrial hemp, in comparison to corn’s 34% energy gain because of its high cellulose content, has an estimated 540% energy gain! [6]
  • According to our very own USDA (who the 2018 Farm Bill designates as the overseer of the U.S. Hemp industry along with the U.S. Attorney General), one acre planted in hemp produces as much pulp as 4.1 acres of trees. But you can harvest hemp at least 3 times a year…

That last one comes from a 1916 report where they predicted by the 1940s all paper would come from hemp and no more trees would need be cut down. But here we go again, none of this is novel information (except to a good percentage of the younger generations supporting Green New Deal-style initiatives)…it’s included in every ‘Hemp 101’ handbook.

Colorado’s also been producing hemp paper for a couple years now. I bought a few pages just to see how it smelled and it smelled like environmental salvation…

Interested? Yeah, hemp paper posters, postcards, envelopes, flyers and much more all made from Colorado-grown male hemp stalk. Check out Tree Free Hemp. Expect to see similar options coming from many different states within a matter of years…hopefully!

The End of Hemp Farming Prohibition in America

Guess what, this means the reinforced double-sided industrial hemp door just opened after being nailed shut for nearly a century. Thankfully, today we have a MASSIVE resources ready to be transitioned into leveraging hemp as a multi-purpose crop where we can create ample (protein and fatty acid-rich) food AND biofuel. All we can hope is ‘the people’ getting behind efforts like the Green New Deal rally and really surf this 21st century agricultural revolution.

Again, the hemp farming industry by itself can accomplish most of what the Green New Deal is setting its sights on by itself if supported and allowed to flourish outside the confines of Big Ag — although we need them on board as well.

How America Will Produce Hemp Biofuel

Hemp biofuel comes from hemp seed oil — the same seed oil you can drizzle on salads, add to a smoothie or feed to livestock — and the rest of the plant can be made into either ethanol or methanol.

North America has absolutely no problem extracting oil from seed we can then use to make biofuel. Furthermore, most of the ethanol added to gasoline we currently put into our cars comes from less efficient and environmentally-friendly food crops like wheat and corn. We can use hemp to efficiently make both — ethanol/methanol and biofuel/biodiesel. University of Connecticut’s research shows hemp seed oil provides a 97% conversion rate into biodiesel [7]. America and Canada both have the infrastructure to switch to industrial hemp-based supply chains within a decade — far less with enough public and corporate involvement.

And well, according to a relatively small survey conducted early April 2019 by Morning Consult (they talked to just shy of 2,000 voters across age, education and political spectrums),

Voters say 100% renewable electricity by 2030 is more important than other steps to fight climate change.

For more info-nuggets we can turn to statistics from Health Canada who regulates their industrial hemp industry, showing Canadian hemp farmers planted 138,000 acres in 2017. Most of this Canadian hemp seed is processed into seed oil (as well as hemp seed protein and hearts), which oddly enough was/is sold to Americans where we already have a robust food processing infrastructure.

I hope this is coming across.

What I’m saying here is America and Canada have everything we need already in place in terms of land and plant processing equipment to create a completely human/environmentally-friendly energy system. That’s the truth. Soon, both countries will have more hemp than we’ll know what to do with and all the astounding wonders hempsters have been preaching for decades can manifest. Watch YouTube videos of ordinary people making vegetable oil-based biofuel in their backyard to drive their vehicles right this moment if you want. It’s no secret.

What’ll shock the American populace will be the tremendous amount of industrial hemp seed flowing across the country by the mid-2020s. I love the stuff and try to eat a cup of raw whole hemp seed a day.

When cold-pressed, 8,000 pounds of hemp seed yields over 300 gallons of hemp seed oil and a byproduct of 6,000 pounds of high protein hemp flour.”[8]

A healthy, irrigated acre of seed-based hemp in Colorado in late 2018, as an example, produced 1,100–2000 pounds of seed. [9]

Let’s not even mention what Kentucky could produce on a larger scale…or Oregon…North Dakota and North Carolina…Montana, and so on. We could EASILY spread out hemp farms to collectively 6–10% of the U.S. and cover our energy needs — completely eradicating the need for fossil fuels. Idealistic sure, but what if by 2025, thanks to hemp America became 50% less dependent on conventional dirty fuels — across allsectors of our country?

When I sit back and begin to fathom the overall impacts of what that would mean worldwide…

Reclamation into Fuel Efforts

One of the core uses of planting industrial hemp across greater America between I’d say 2019–2022 could be for use in farmland reclamation — bioremediation — efforts. This is going to clean up the soil, restoring American farms to their glory with dramatically less heavy metals, petrol-based pesticides, herbicides, and fertilizers, along with anything else poisoning our land. Another note in every Hemp 101 handbook is how the plant’s been used around toxic waste dumps and even radioactive events like Chernobyl to effectively absorb cadmium from the soil, etc…wow! Obviously none of this reclamation hemp should go to human or livestock consumption…but what to do?

We most definitely shouldn’t just burn or toss it. Let’s transform it into energy!

I’m no chemist, but my bet’s that the plant can successfully be used as energy without causing more of a mess. Hemp’s astounding ability in this respect will finally be able to be heavily studied. Because myself and many others would like to know what happens within the plant to these toxins. Are they still there when the plant’s harvested? Or, does it somehow convert a good percentage to clean energy within itself? Can it be successfully transformed into hemp biofuel? If so, let’s use all that reclamation hemp while cleaning up our toxic soil.

A Note on Pyrolysis

From my own amateur research, it seems like Pyrolysis is going to be the most efficient process for hemp biomass conversion — capable of competing against initially, and then potentially becoming a replacement for fossil fuels.

Pyrolysis is the thermochemical process that converts organic materials into usable fuels. Pyrolysis produces energy fuels with high fuel-to-feed ratios, making it the most efficient process for biomass conversion…the technique of applying high heat to organic matter (lignocellulosic materials) in the absence of air or in reduced air. The process can produce charcoal, condensable organic liquids (pyrolytic fuel oil), non-condensable gasses, acetic acid, acetone, and methanol. The process can be adjusted to favor charcoal, pyrolytic oil, gas, or methanol production with a 95.5% fuel-to-feed efficiency” [10]

The people of this world need our Hemp Billionaires and Zillionaires to step up. We need people with capital and the government to get behind and support these types of industrial hemp farming initiatives. We need to fund research and do things by the book. We need farmers to start hemp growing for biofuel along with the ultra-lucrative hemp-derived CBD concentrates/extracts. And textiles!

We need energy companies to start converting from using other less efficient sources of biofuel to hemp. It’s going to be a wild ride…but I’m alive so I have a ticket.

Originally published on www.DarbyHemp.com

References

[1] Environmental Chemistry, Stanley E. Manahan. Willard Grant Press, 1984.

[2] “Biomass resources and biolfuels potential for the production of transportation fuels in Nigeria” Juliet Ben-Iwo, Vasilije Manovic, PhilipLonghurst, ScienceDirect.

[3] “Biomass and energy yield of industrial hemp grown for biogas and solid fuel” ThomasPrade, Sven-ErikSvensson, et al, ScienceDirect.

[4] “Industrial hemp for biomass production” Rudite Sausserde, Aleksandris Adamovics, ResearchGate, 09/2013.

[5]Lyster H. Dewey, Jason L. Merrill, Hemp Hurds As Papermaking Material, U.S.D.A. Bulletin №404, 1916.

[6]“The Legalization of Industrial Hemp and What It Could Mean for Indiana’s Biofuel Industry”, Nicole M. Keller, Indiana University — Purdue University Indianapolis, pg. 24.

[7] “Hemp Produces Viable Biodiesel, UConn Study Finds” Christine Buckley, UConn Today, 10/06/2010.

[8] “Hemp is the ultimate cash crop, producing more fiber, food and oil than any other plant on the planet” Wm. Conde, Fiber Alternatives PDF.

[9] “Myth-Busting: Hemp Needs More Water than Many Think”, Hemp Industry Daily, May 7, 2018.

[10] “Biomass Resources for Energy and Industry” Lynn and Judy Osburn, 1993.

[7] “Hemp Biodiesel: When the Smoke Clears”, Biodiesel Magazine, Holly Jessen, January 24, 2007.