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Is the FDA cracking down on Delta 8 THC?

Is the FDA cracking down on Delta 8 THC?

Delta 8 THC gummies under scrutiny from FDA

The FDA recently issued warning letters to several companies for selling Delta 8 THC gummies and other Delta 8 THC products. Is a crackdown coming?

On May 4 of this year, the FDA issued five warning letters to Delta 8 THC retailers. It is not uncommon for the FDA to send warning letters to companies that could be making false medical claims about their products.

But this is the first time the FDA gas written warning letters specifically to Delta 8 THC companies.

The FDA has also released a consumer advisory warning on their official website regarding Delta 8 THC gummies and other Delta 8 THC products. In other words, D8 has been on the FDA’s radar for some time.

It is possible that more scrutiny could be coming down on the Delta 8 THC industry, which is mostly unregulated at the moment.

The FDA is approaching Delta 8 similarly to how they deal with CBD and other hemp products. The Farm Bill passed in 2018 legalized “industrial hemp” on the federal level. Under the ruling any cannabis plant that has lower than .3% THC on a dry weight basis is legal to possess, grow and sell across state lines.

The Farm Bill is responsible for the rapid expansion of the CBD industry, and D8 is a product made from CBD in most cases.

This association implies that Delta 8 THC should be legal as it comes from the hemp plant and CBD, both of which are legal. Despite the size of the CBD industry, it still lacks proper oversight from the FDA. What the FDA will do is devote a limited amount of agency resources to enforce against companies making medical claims about their products.

Legally, a CBD company can’t put any sort of medical benefits on the label or marketing for their products. This is because the FDA doesn’t recognize CBD as a medical supplement. They don’t recognize D8 either.

Delta 8 THC FDA Warning Letters

The five letter issued by the FDA went specifically to companies that were making “misleading claims” about medicinal benefits in D8 products. In their letters to the companies the FDA included the claims that were made. Here are a few examples:

  • “Delta-8 consumers report many of the same effects as THC, such as . . . relief from some symptoms such as pain . . .. Delta-8 can also help with insomnia.”
  • “Delta-8 THC Syrup from Kingdom Harvest is ideal for anybody experiencing a sleeping disorder or other ailments looking to be relieved.”
  • “If you have cancer, rheumatoid arthritis, and migraines, Delta-8 THC can help alleviate the pain because it has immunosuppressant properties.”

According to the FDA, the presence of drug claims on the products technically classifies them as unapproved new drugs. Under the FDCA (Federal Food, Drug, and Cosmetic Act), new drugs may not be introduced into interstate commerce without being approved by the FDA. Because the products were not approved, they are technically illegal under the FDCA.

So does this mean that D8 gummies are going away any time soon? Unlikely.

Misleading branding

Misleading branding is nothing new to the cannabis industry. The illicit market is flooded with knockoff D8 products that are imitating popular brands like Doritos, or making Delta 8 THC gummies that look like Haribo gummy bears. Because the market isn’t regulated, there is very little oversight to keep these products off the market.

While some big companies like Skittles have fought back against their likeness being used in Delta 8 THC products, most don’t even know that their likeness is being used. When a customer sees a name-brand logo on a pack of Delta 8 THC gummies, unsurprisingly they are more likely to think it is a legitimate product.

Additionally, no D8 products are approved by the FDA as generally recognized as safe (GRAS). Due to this Delta 8 is not approved for use in human or animal products because the required safety data is lacking.

Because the ingredient in the products is not approved, any D8 product is technically “adulterated”, and cannot be sold over state lines. However anybody who has looked up Delta 8 THC gummies online was still probably able to have them shipped from a different state.

While it appears the FDA is beginning to look at D8 more closely, there is still no determining evaluation by the FDA deciding its true legality. Delta 8 THC may be a legal byproduct of industrial hemp, but adding it into food items and supplements is where the lines get blurry.

For this reason, one should always be extremely weary of any D8 product that makes a medical claim or markets the product to have specific benefits. There is no way to verify their claims, and they could be completely false.

The FDA is still devoting very limited resourced to enforcing rules against Delta 8 THC retailers. They have only sent out five letters, when there are thousands of Delta 8 THC gummies and other products being sold online across the country daily.

The longer it takes the FDA to reign in CBD and D8, the more out of control the market could become, making it too large to reign back in and increasing risk for consumers.

Delta 8 THC Banned in New York

Delta 8 THC Banned in New York

Delta 8 THC banned in New York by cannabis control board

Rules to allow for delta-8 THC could come in the “future,” but in the meantime, those for CBD in food and beverages have been finalized.

Delta-8 THC was front and center during the latest meeting of New York’s cannabis regulators, as officials work to stand up what will be one of the world’s biggest cannabis markets.

The state’s Cannabis Control Board (CCB) met on Wednesday, for the third time, to approve Cannabinoid Hemp regulations presented by the Office of Cannabis Management. The package of rules will now regulate hemp products, including CBD products, by creating “clear” guidelines for what kinds of products and activities are allowed, and which ones aren’t, “to help foster the development of a robust cannabinoid hemp industry.”

The rules also seek to enhance consumer protection and quality control through testing and labeling, and to “enforce against” products that don’t meet the bar and those that are explicitly banned.

“Delta-8, similar to delta-9 THC, is psychoactive, has psychoactive properties, particularly when synthesized through the processing process. Because of that, we’ve decided to hold off on including the regulations for those products in this package and that will be addressed in the future adult use packages,” Chris Alexander, executive director of the Office of Cannabis Management (OCM), within which the Board sits, said during a question and answer portion of the meeting, when asked specifically where delta-8 rules stood.

The regulations do, however, allow for cannabinoids, like CBD, to be added to foods and beverages, if they meet the state’s standards, which will require that each product be made using Good Manufacturing Practices. Last month, California Gov. Gavin Newsom signed AB 45, which will now allow hemp-derived CBD (or other cannabinoids) in supplements, foods, drinks, cosmetics, and pet food.

“I’m pleased that we will be advancing the cannabinoid hemp program today, just as we have done with the expansion of the medical marijuana program at prior meetings,” Tremaine Wright, chair of the Board, said at the start of the meeting. (As Cannabis Wire recently reported, the Board has already moved to allow for medical cannabis shops to sell flower products, which several have started to do, and released rules for patients to home grow.)

Board member Jen Metzger gave an overview of the hemp program in New York. In 2015, the Department of Agriculture and Markets launched the state’s Industrial Hemp Agricultural Research Pilot Program. Metzger said this program “exploded” after it launched, with 800 farmers registered to grow, most for cannabidiol (CBD).

When the Marijuana Regulation and Taxation Act passed in March, legalizing cannabis for adult use, the Cannabinoid Hemp Program was transitioned under the umbrella of the new Office of Cannabis Management.

Texas Hemp Harvested For First Time in 80 Years

Texas Hemp Harvested For First Time in 80 Years

farmers are harvesting hemp in Texas for the first time in decades

Hemp is being harvested in Texas for the first time in 80 years. 

The state created its own program as part of the Federal Farm Bill and this is the first year farmers in the Lone Star State are able to give it a shot and cultivate Texas hemp.

One of those farmers is Aaron Owens. He’s a first-time Texas hemp farmer but he’s not new to cannabis or tending to land. He spent 15 years ranching in Ozona, Texas, before moving to Central Texas to focus on hemp.

Besides being among the first to harvest in Texas, what makes his company, Tejas Hemp, unique is the type of hemp it’s growing.

“This particular cultivar has never been grown in the United States. No one has ever had it before. It’s the first-ever sativa hemp, meaning that where an indica will slow you down and help you relax and reduce shaking and make you go to sleep, a sativa actually increases awareness and focus and takes you into the other direction. It’s more of a stimulating thing,” explained Owens.

It’s not the type of cannabis that’ll get you high – that’s still illegal in Texas. But Democrats at the Texas State Capitol are again working to change that, saying legalizing and taxing marijuana could help the state’s economy recover from the pandemic. For now Texas hemp will have to suffice for farmers and consumers.

“It’s inevitable at this point, we’re going to federally legalize marijuana, there’s no question. Is it this year, next year, five years? We don’t know. What we do know is that every year that goes by in Texas that we don’t legalize, that’s another year that the other people get ahead of us,” said Owens.

Republicans have been hesitant to loosen restrictions on cannabis. But in the meantime, Tejas Hemp will be farming what is legal and even has plans for a Texas hemp “tasting room” on their land as the state’s laws around the plant also grow.

The Texas Hemp Coalition has been advocating legislators and consumers across the state on the different benefits of the crop. One of the things Hemp farmers would also like to see is for the state’s ban on smokable hemp to be lifted.

Next session they hope lawmakers will make it easier for farmers like Owens to reap the benefits of their crops here in Texas.

Read the original story on Spectrum News 1

First Year of Industrial Hemp: Is it Booming or Bust?

First Year of Industrial Hemp: Is it Booming or Bust?

Millions of pounds harvested. Tons of CBD extracted. But the market might not be ready for so much industrial hemp.

There was no shortage of farmers ready to make the switch to industrial hemp after the Farm Bill passed at the end of 2018. Many were looking for a new cash crop that they could get in on to make some real money.

The beginning of 2019 and outdoor grow season was an exciting time for just about everybody involved. More states passed legislation over time establishing their own ground rules for industrial hemp, and farmers licensed up, cleared out their land and made the transition.

The Industrial Hemp Boom

The mass migration of farmers and traditional cannabis cultivators to industrial hemp led to a massive increase in production. Everything from hemp seeds and hemp flower to CBD extracts and the plant’s fibers were all the sudden in extremely high demand. So much so that just about every dispensary, smoke shop and even gas stations started selling CBD products on their shelves.

Sales exploded with more and more articles vouching for the medicinal benefits of CBD and the potential financial gains the industrial hemp industry could provide the country. On top of the media exposure, plenty of celebrities hopped on the CBD band wagon, with actors and athletes alike sponsoring and being sponsored by CBD companies, and some even creating their own.

CBD is the first real aspect of cannabis to break into the mainstream, and even be celebrated on a massive scale. Recreational cannabis pales in comparison to the international attention CBD has received just in the last 12 months. But with any new industry that takes off sprinting from the gate, there are going to be some trip-ups.

The Industrial Hemp Bust

While industrial hemp production was regulated on the state level, there is very little regulation in the way of CBD production, and barriers to entry were (and still are) extremely low. The lack of regulation allowed a lot of untrustworthy and potentially dangerous products out into the market. While the producers of these products made a pretty penny, the consumers soon started to learn of the risks of bad CBD products.

A lot of shady CBD manufacturers got in, sold their bad product made from poorly grown “biomass” and got out with their money. There was an industrial hemp seed deal in which the buyer was promised feminized seeds but received more than half male seeds, resulting in a multi-million dollar law suit.

As the hemp harvest season came to a close, a lot of farmers were hit with a massive reality check; too many people are growing hemp. Farmers brought their hemp to auction, some hauling thousands of pounds hundreds of miles in the hopes of getting a big chunk of change in return. Almost every single farmer at the auction left without a sale.

The overflow of product, both in biomass and CBD extract has led to a crash in the price as supply for outweighs demand. While the consumer may benefit from lower prices, many farmers who were hoping the industrial hemp would be the answer to their financial problems are starting to second guess their decision.

What Does 2020 Hold for Hemp?

The industrial hemp industry is due to have some fat trimmed. A lot of farmers are going to ditch hemp after an unsuccessful harvest and go back to their traditional row crops. As consumers learn about unreliable CBD products, the shady companies will drop off, and very few might step up and raise their standards.

Farmers with the right connections that were able to secure deals ahead of harvest made a lot of money this year, and it’s only going to increase in 2020. Hemp genetics and seed breeding is going to become more of a desired job title, and more cannabis breeders will begin adding hemp to their repertoire. 

Overall, while many did not have a successful year with legal hemp, just as many did. Industrial hemp will keep expanding into different forays of the plant’s abilities, like using its fibers to create concrete, clothing, paper and more. While some states have made a push against it, smokable hemp flower is also getting bigger as people look for a cannabis alternative that still provides medicinal benefits without the THC high.

Frankly, the possibilities of hemp, just like cannabis, are nearly endless. We can only look forward in excitement and enjoy the ride!

Did the USDA Really Deschedule THC?

Did the USDA Really Deschedule THC?

The USDA did deschedule THC. Just not in the way people currently believe.

An article that has exploded within the cannabis community claims that the USDA quietly “legalized” THC last week. While this isn’t entirely wrong, it is incredibly misleading. This is because the descheduling of THC by the USDA only applies to THC in hemp.

For a quick refresher, The Farm Bill of 2018 legalized industrial hemp. This “legal” hemp is defined as any cannabis plant with a THC percentage of .3% or less. But if THC is still on the controlled substances list, how can that be?

The USDA on THC

In a memorandum submitted to the Secretary of Agriculture on May 28th, the USDA gives a legal opinion on provisions to the Farm Bill. They point out a specific amendment in the newest version of the bill that removed THC in hemp from the Controlled Substances Act (CSA). 

By amending the definition of marijuana to exclude hemp as defined in AMA §297A, Congress removed hemp from schedule 1 and removed it entirely from the CSA. This means hemp is no longer considered a controlled substance at all. With the amendment to exclude THC in hemp from schedule 1, Congress has also removed THC in hemp from the CSA.

Now, that last sentence from the memorandum is what people are getting excited about. When paraphrased to say, “Congress has removed THC from the CSA,” it’s easy to see why. But the key words in the entire amendment is “IN HEMP”.

THC in Hemp

This is where the entire article claiming THC is legal falls apart. Hemp has a very specific definition, that being the definition requiring a THC content of .3% or less to be considered hemp. It makes perfect sense that THC in hemp would need to be legal, in order for legal hemp to be able to contain any amount of THC. In other words, because hemp can contain up to .3% THC, that THC needs to be legal for the hemp to be legal.

Now, because of hemps legal definition pertaining to any cannabis plant with .3% THC or less, surpassing the .3% threshold disqualifies the plant as hemp. Under this legal definition, anything above .3% THC is considered psychoactive cannabis, which is still a controlled substance that is federally illegal.

Why it Matters

The article that broke this story hinted at future possibilities with this newly legal THC, like simply breeding hemp to have higher THC. And that’s what makes this article lose all credibility.

Remember when I said that to be legally considered hemp, the cannabis plant must have a THC content of .3% or less? And remember what happens when the THC content surpasses that .3%? It’s no longer hemp.

While this article suggests that the USDA basically just added a magic loophole that will now allow breeders to grow THC rich hemp, it forgets to mention that by doing so, the plant will no longer be hemp. If the author knew the origins of the cannabis plant, they would know that most of the THC-rich strains we consume today were bred to have that high content from what originally was European Hemp with almost no THC to begin with.

What this article is suggesting, is basically repeating the entire history of cannabis breeding, so we can turn the legal hemp we have now, back into illegal cannabis. If you want The Real Dirt’s legal advice, we suggest that you don’t do that. THC has been legalized in the sense that as long as it is in hemp, and does not surpass .3%, it is legal. Once it leaves the hemp, or surpasses .3%, you’re entering some dangerous territory.

But hey, you can judge for yourself! Read the full USDA Memorandum right here.