CBD oils pulled from store shelves in Wyoming

By Emily Mieure
Source: jhnewsandguide.com

Certain cannabidiol products have disappeared from shelves at Jackson Whole Grocer and Lucky’s Market after the stores received a visit from police.

An ongoing investigation has sparked a debate on the legality of the substance in Wyoming.

After being told the store would face charges if they didn’t pull CBD products, employees at Whole Grocer complied.

“They were very kind,” Whole Grocer Vice President and General Manager Tom Scott said. “They didn’t come in here guns blazing.”

The Wyoming Division of Criminal Investigation claims a product the stores were selling contains traceable amounts of THC, which it says makes it illegal to possess or sell.

“They gave us seven days to get rid of it,” Whole Grocer Herbalist Heather Olson said. “We’re sad to see it go. It’s a great category for our department. It was a huge move forward for herbal medicine. But psychoactive chemicals in the product are not appropriate in Wyoming.”

DCI agents say the only exception to possessing THC in Wyoming is if you have a “hemp extract registration card” issued by the Wyoming Department of Health.

Those cards are rare, state officials said.

One of the CBD products police say is testing positive for THC comes from CV Sciences, a CBD hemp-oil manufacturing and distributing company.

“We will address this like any issue with our lobbyists and attorneys,” said Josh Hendrix, director of business development at CV Sciences. “It should be an easy conversation. But we need clear-cut legislation.”

Hendrix disagrees with DCI on the product’s legality.

“We don’t get our products from marijuana,” he said. “This has happened enough times that the misinterpretation gives us an opportunity to educate.”

Olson said the product is popular with Whole Grocer customers. She turned away half a dozen customers on Tuesday alone. More than 50 bottles are now in a cardboard box in the back of the grocery store.

CBD is often used by people who suffer from epilepsy, anxiety, depression, seizures and chronic pain.

Olson said the stores will rely on the CBD companies to send certificates of analysis to confirm none of their other products have THC in them.

Lucky’s Market also took products off shelves last week.

“We’ve pulled the products in a gesture of good faith,” said store director Chris Martinez. “There were multiple brands we had to pull.”

The Division of Criminal Investigation said lab analysis confirmed the presence of THC in “many of the items” it received.

According to CV Sciences, CBD oil is derived from agricultural hemp, does not make you high and has “a remarkable safety profile.”

The World Health Organization does not consider it a controlled substance.

“Cannabidiol does not appear to have abuse potential or cause harm,” its website states.

A World Health Organization expert committee continues to review the extracts.

DCI Operations Commander Ronnie Jones told the News&Guide that his agents have been collecting CBD around Wyoming since late last year.

“We are still conducting an investigation,” Jones said.

DCI Deputy Director of Operations Forrest Williams said the investigation began because of inquiries from the public and law enforcement officers about CBD’s legality.

“We have bought from stores in Casper, Cheyenne, Laramie, Gillette, Rock Springs, and whatever products we’ve bought we submit them to the lab for testing, and if it contains any amount of THC it’s illegal,” Williams said.

Jones wouldn’t say that the ongoing investigation is a priority for DCI. But several agents around the state are involved.

“They are wasting their time,” Hendrix said. “This is a very disruptive thing. Cannabis has been demonized for so long. I’ve grown hemp on my farm. You can’t get high off it.”

Hendrix says the investigation is based off misinformation.

“They have bigger things to worry about,” he said. “There are hard drugs on the steeets. This doesn’t harm anyone. It helps people.”

Hendrix says his company plans to clear it up any confusion surrounding levels of THC in their products and where it comes from.

“It’s kind of like decaf coffee or Kombucha,” Hendrix said. “There are kids that take this product.”

 

China Grows Half Of The World's Cannabis

By Calvin Hughes
Source: civilized.life

Nowadays, all eyes in the cannabis industry are trained on Canada, which is poised to become a major game-changer once recreational cannabis becomes legal on October 17. But as exciting as that is, we shouldn't overlook the silent giant in the cannabis industry: China, which by some estimates produces 50 per cent of the world's cannabis. That includes all forms of cannabis, including hemp.

Hemp has a long history in China, going back some 12,000 years. Today, while smokeable cannabis remains illegal, hemp continues to play a large role in Chinese culture - and commerce.

There are 606 cannabis related patents held worldwide - 309 of these belong to Chinese companies. That means China has vastly outpaced the cannabis innovations of any other country and stands to gain a lot from the developing cannabis industry in the West, according to the Ottawa-based biochemist Dr. Luc Duchesne.

"Because cannabis in Western medicine is becoming accepted, the predominance of Chinese patents suggests that pharmaceutical sciences are evolving quickly in China, outpacing Western capabilities," Duchesne told Forbes.

This mass of expertise puts them in a good position to take hold of a massive slice of the world's cannabis economy. Currently, they are already dominant in the production of hemp for textiles and fiber, says Bryan DeHaven - owner of the Colorado clothing brand Chiefton Supply Co.

"You can’t make hemp clothing in the U.S. because the country no longer has sufficient expertise in textile production."

Despite those advances, China has remained relatively quiet about cornering the cannabis market. And many entrepreneurs might not realize it until they wake up one day and realize that the silent giant has pushed them out of the market.

10 TIPS FOR BUYING HEMP-DERIVED CBD PRODUCTS

Source: projectcbd.org

A guide for the perplexed


 
Choose full spectrum CBD-rich hemp extracts, not isolate,
distillate or products labeled “pure CBD” or "no THC"

With Congress seemingly poised to legalize the cultivation of industrial hemp for many uses, including the production of biomass for CBD oil extraction, many questions remain unanswered. How will the DEA reschedule CBD now that Epidiolex has been approved as a pharmaceutical CBD isolate? To what extent will the FDA reguate hemp-derived CBD? What policies should be implemented to ensure wide and easy access to high quality, lab-verified CBD-rich products?

Project CBD encourages consumers to seek out products made from the unfertilized female flower tops of high-resin CBD-rich cannabis (sometimes referred to as marijuana), which is much better suited for medicinal oil extraction than low-resin fiber hemp or industrial hemp grown for seed oil and protein.

Currently, the most prolific source of cannabidiol is high-resin CBD-rich cannabis that slightly exceeds 0.3% THC, so technically it doesn’t qualify as industrial hemp. The 2014 Farm Bill defines hemp as cannabis with no more than 0.3% THC in any part of the plant; if the THC level tops 0.3%, it’s considered to be marijuana under federal law.

The debate over sourcing CBD from marijuana rather than hemp is quickly becoming moot, as plant breeders focus on developing high-resin cannabis varietals that satisfy the Farm Bill’s criteria for industrial hemp – with CBD levels exceeding 10% by dry weight and THC measuring less than 0.3%. If grown, extracted, and processed well, such plants qualify as decent starter material for producing CBD-rich oil concentrates.

As for those who don’t live in a state or country with a robust medical marijuana or adult use program, they can access CBD products via online storefronts or, in some states, actual storefronts. But choosing among the many unregulated CBD brands – which “typically have less manufacturing oversight than kitty litter,” as one industry insider put it – can be problematic.

Many hemp-derived CBD products are mislabeled. A study reported in the Journal of the American Medical Association indicated that 69% of 85 products surveyed had an incorrect amount of CBD and/or THC on the product label.

Another survey found significant discrepancies among some of the leading hemp-derived CBD brands that falsely claim full-spectrum CBD-rich oil is in their products; lab tests of several samples revealed only one cannabinoid – CBD – was present, indicating that these products were made with a CBD isolate rather than a more efficacious whole plant CBD-rich extract.

Another problem: Some overly processed hemp-derived CBD products are tainted with toxic solvent residues, corn syrup, artificial flavors and colors, and other contaminants.

But good quality CBD-rich products are also available. Which products deserve our trust?

Here are some tips when shopping for hemp-derived CBD:

1. Choose CBD products made with American-grown hemp (from Colorado, Kentucky, Oregon, Vermont, Tennessee, etc.) rather than foreign sources. Consumer Reports suggests looking for companies in states that have legalized the recreational and medical use of cannabis “since they tend to have stricter standards.”
2. Choose “full spectrum” CBD-rich hemp extracts, not isolate, distillate or products labeled “pure CBD” or “no THC.” Full spectrum means it includes numerous cannabis compounds, including a small amount of THC (0.3% or less) in keeping with the legal definition of hemp. If THC is completely illegal in your state, opt for so-called “broad spectrum” CBD oil products that include other cannabis components but no THC.
3. Look for product labels that indicate the amount of CBD and THC per serving – not just the total cannabinoid content for the entire bottle.
4. Beware of companies that make explicit health claims about CBD products (this is not allowed by the FDA).
5. Seek out CBD-rich products derived from high-resin cannabis grown sustainably in accordance with certified regenerative organic standards.
6. Avoid CBD hemp oil vape cartridge products with toxic thinning agents (such as propylene glycol and ethylene glycol), flavor additives, and other harmful ingredients.
7. Avoid poor quality CBD gummies made with corn syrup and artificial colors.
8. Think twice about brands that claim their CBD is derived from the seed and stalk of the hemp plant. CBD is not present in hempseed and barely any CBD is present on the stalk of the hemp plant.
9. Beware of multilevel marketing schemes and companies that seek to sign you up right away for recurring purchases.
10. Don’t be afraid to contact CBD hemp oil companies directly and ask questions. And if you cannot reach them directly, try another brand.

 

HHS Secretary Could Legalize CBD in Supplements

By Josh Long
Source: naturalproductsinsider.com




The strategy could—at least theoretically—salvage the future of a budding industry selling cannabidiol (CBD) in dietary supplements. Reach for a lifeline with the very leviathan that stands in its way: the federal government. But some regulatory experts are skeptical.

The strategy could—at least theoretically—salvage the future of a budding industry selling cannabidiol (CBD) in dietary supplements. Reach for a lifeline with the very leviathan that stands in its way: the federal government.

The secretary of the U.S. Department of Health and Human Services (HHS)—currently Alex M. Azar II—has authority to avoid potentially years of litigation between the hemp industry and FDA over the legality of CBD by making it lawful in dietary supplements through the issuance of a regulation.

The legal status of CBD in dietary supplements is mired in controversy, largely due to a provision in the Federal Food, Drug & Cosmetic Act (FDCA) aimed to protect the gargantuan investment required to develop new pharmaceutical drugs shown to be effective and safe.

Citing clinical investigations by GW Pharmaceuticals plc, FDA has determined on its website and in warning letters that CBD is excluded from the definition of a dietary supplement. FDA in June approved GW’s CBD drug, Epidiolex, to treat seizures associated with severe and rare forms of epilepsy: Lennox-Gastaut syndrome and Dravet syndrome.

In interviews with the media and in letters to state regulatory agencies, the hemp industry has argued CBD can be lawfully sold in supplements because the requirements to trigger the drug-related exclusionary clause in the law haven’t been met.

The debate could end up in federal court, leading to years of uncertainty over the legality of CBD in supplements, stymieing investment and research into the compound’s potential benefits to general health and wellness.

There is another avenue to possibly settling the matter: petition the government, requesting the secretary of HHS invoke his authority under the FDCA to issue a regulation following notice and comment, finding CBD lawful in dietary supplements. FDA is an agency within HHS.

Michael McGuffin is president of the American Herbal Products Association (AHPA), whose committees include one focused on “issues related to the safe use and responsible commerce of legally marketed products derived from cannabis species.”

In an emailed statement for this article, he said, “FDA should expressly confirm that the Federal Food, Drug, and Cosmetic Act permits the sale of dietary supplement products containing cannabidiol … if necessary by exercising its current rulemaking authority.”

McGuffin added: “This would allow FDA to more effectively regulate safety, quality and marketing claims under the comprehensive regulatory framework currently used for dietary supplement products in the U.S.”

Others are skeptical HHS would choose to invoke its authority in the case of CBD. Even if the federal government received such a request, several sources with regulatory expertise said they would anticipate strong opposition from GW Pharmaceuticals.

The company intends to bring its CBD medicine to the U.S. market through its subsidiary, Greenwich Biosciences Inc., following an anticipated scheduling action by DEA.

Daniel Fabricant, Ph.D., previously led FDA’s Division of Dietary Supplement Programs and is the CEO and president of the Natural Products Association (NPA).

He discussed two theoretical petitions filed with the HHS Secretary: a petition covering material comparable to Epidiolex, and a petition for material incorporating various cannabinoids and a lower amount of CBD than the doses in Epidiolex.

Fabricant suggested the HHS secretary would be more likely to grant a petition in the latter scenario, but he cautioned a supplement marketer couldn’t rely on GW Pharmaceuticals’ science to make any claims. Many companies sell “hemp extracts” in dietary supplements that are said to contain various cannabinoids—including CBD—as well as other substances derived from hemp like terpenes and flavonoids.

FDA, HHS and GW Pharmaceuticals did not respond to requests for comment for this article.

Rend Al-Mondhiry is senior counsel to Amin Talati Upadhye LLP, a law firm that advises dietary supplement companies on federal regulations. Even though FDA has approved Epidiolex, she and McGuffin—in consultation with his general counsel—see nothing in the language of the law that would bar HHS from issuing a regulation authorizing the use of CBD in dietary supplements.

However, in an email for this article, Al-Mondhiry cautioned, “[T]he purpose of the IND [investigational new drug] preclusion is to protect the drug industry’s investment, so authorizing use as a dietary ingredient after drug approval seems counter to that purpose and would likely draw the ire of the drug industry.”

Regulatory attorney Steven Shapiro said GW Pharmaceuticals has likely invested hundreds of millions of dollars to develop its drug, if not more.

“The way the statute is set up, clearly it is to encourage companies to make this investment because obviously discovering new drugs to treat disease is critical to our health and well-being,” Shapiro, of counsel to Rivkin Radler LLP, said in an interview. “And if a company makes that investment, the idea of the statute is they will be able to sell their drug product and not have other companies coming in.”

If the government granted a petition to legalize CBD, “where’s the incentive for anybody to go develop a new drug?” asked Shapiro’s colleague, Marc Ullman, of Rivkin Radler.

Others have noted policy considerations in favor of making CBD lawful in supplements. For instance, in an interview before FDA approved Epidiolex, regulatory attorney Todd Harrison of Venable LLP cited evidence that CBD has health benefits beyond the treatment of disease, and he said GW’s drug is for a narrow indication so it “would be absurd from a policy standpoint to exclude its use for general health.”

In reviewing a petition to authorize CBD in dietary supplements, the federal government is likely to thoroughly examine the compound’s safety. Subject to an exception in the law, companies seeking to market a new dietary ingredient (NDI) in a supplement must notify FDA 75 days in advance, providing evidence the ingredient “will reasonably be expected to be safe.”

To date, based on public records, FDA has received two NDI notifications related to CBD. FDA didn’t provide a response in either notification whether there was an adequate basis to meet the safety standard because it concluded CBD, as well as tetrahydrocannabinol (THC)—the psychoactive compound in marijuana—don’t meet the definition of a dietary supplement.

“Should it (CBD) be legal as a dietary ingredient?” Bob Hoban, an attorney whose practice is focused on CBD and other cannabis issues, asked in an interview. “Should it be a supplement? Should it be accepted as having GRAS (generally recognized as safe) status?

“The answer to all of those things, I believe, is yes,” he proclaimed, “so long as … we understand that these will not have an adverse impact on human beings, and that furthermore, it’s not psychoactive or intoxicating.”

CBD is currently subject to varying degrees of oversight by the states throughout the nation. Speaking during a conference in Washington in May, McGuffin suggested the availability of CBD as a product unregulated by the federal government would be contrary to FDA’s mission to protect the public health.

“It occurs to me that FDA cannot accept the scenario where American consumers—in order to exercise their choice to access this natural product—will only have the option of using unlawful and unregulated products,” he said.

Minnesota farmers hope for hemp in 2018 Farm Bill

By Naomi Pescovitz
Source: fox9.com

As the 2018 Farm Bill makes its way through Congress, some Minnesota farmers are eyeing a measure that would legalize industrial hemp. 

Often called "marijuana's kissing cousin,” the plant won't get you high. Right now, however, it is still a controlled substance, only grown legally in the US through experimental research. 

At a hemp field off the interstate in Woodbury, the ancient plant is in bloom once again.

“This is our third growing year. We were the first growers in the state of Minnesota,” said John Strohfus, Founder and CEO of Minnesota Hemp Farms. 

Growing hemp without a special permit is illegal. So, Strohfus and other farmers plant and harvest it through a pilot program with the Minnesota Department of Agriculture. 

“There is really no difference genetically between hemp and marijuana except for the varieties, which have low THC,” Strohfus said. “Literally, you could smoke a field of this and you'll just get a headache.”

An entrepreneur at heart, Strohfus saw the crop as a business opportunity. After harvest, the hemp is processed and used in products like clothing, rope, oils and food.  

“Hemp is not a new crop, but there's a renaissance in growing hemp in the United States, and I knew that with that would come a lot of opportunity to be one of the early adopters,” Strohfus said. 

 

Now Strohfus and other Minnesota hemp farmers are looking to congress to pass the recent Farm Bill. Both the House and Senate have passed their own versions, and the Senate’s bill includes full legalization of industrial hemp. If passed, it would remove hemp from the federal list of controlled substances, allowing farmers to apply for crop insurance and federally funded programs. 

“The United States is the number one importer of hemp in the world. And so for us not to be able to grow it is quite silly,” Strohfus said. 

“It grows very well here. We also got in pretty early on the ground floor,” said Andrea Vaubel, Assistant Commissioner at the Minnesota Department of Agriculture. “There are now 39 states that have these pilot programs, but we are certainly one of the leaders amongst others like Colorado and Kentucky. So we're really proud of that and we feel like we can continue to be a leader, particularly if this becomes law.” 

“I think it would be a relief that we don't have to constantly address the issue of is it legal or not,” Strohfus said. 

Because the plants look so similar there have been concerns from law enforcement on how they would be able to tell a legal hemp field from a field of marijuana. 

At the University of Minnesota’s St. Paul campus, scientists are working to resolve that very problem. 

“We've been working on cannabis genetics in my laboratory for the last 15 years, including both hemp and marijuana. Our work started with an effort to understand how hemp and marijuana are different. We know that now,” said Dr. George Weiblen, University of Minnesota Professor in the Department of Plant and Microbial Biology. 

In the lab, Weiblen and his team dissect hemp seeds down to their DNA. 

“We're working on being able to confirm the test so that we can distinguish seed that would have the potential to be marijuana versus seed that would be considered to be hemp,” said Research Associate and Hemp Project Manager, Jonathan Wenger.  

As scientists do their work and politicians do theirs, Minnesota hemp growers are still watching and waiting, hoping hemp will prove fruitful on and off the farm. 

“No one is making any money off of this crop in Minnesota right now. It's going to require the development of processing facilities, markets and products that consumers are willing to buy,” Weiblen said. 

“The farm bill really legitimizes hemp for the forseeable future,” Strohfus said. 

“Minnesota, in particular, I think is well positioned to take advantage of this Farm Bill. Should it include these provisions, I think we will be one of the nation's leaders in pushing hemp,” Weiblen said. 

According to one estimate, Hemp-Derived Cannabidiol, or CBD, could become a $1-billion dollar industry by 2020. CBD is only one type of product derived from hemp.  

“You combine nature's engineering with what we can do now with industrial technologies and you can make some very strong, resilient, durable and sustainable products. And that's where a lot of the interest is,” Weiblen said. 

The House and the Senate will now attempt to sort out the differences in their respective versions of the 2018 Farm Bill. The current Farm Bill expires on Sept. 30.