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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.

Bill filed in Tennessee to regulate and tax CBD and Delta 8 THC

Bill filed in Tennessee to regulate and tax CBD and Delta 8 THC

Tennessee might regulate and tax CBD and Delta 8 THC products

A Republican lawmaker is seeking to tax and regulate the existing cannabis industry in the state.

Rep. Chris Hurt (R-Halls) filed House Bill 1690 this week. The bill seeks to regulate psychotropic hemp-derived cannabinoids, which include products that have more than 0.1 percent THC. (Current federal regulations limit THC to 0.3 percent.) That includes products containing the newly popular Delta-8 THC but not pure CBD products, which do not contain THC.

As a member of the Agriculture and Natural Resources Committee, a former hemp farmer and current co-owner of CBD ProCare — a CBD company in Dyersburg — Hurt says he filed the bill in an effort to “legitimize the industry.”

According to Hurt and Joe Kirkpatrick of the Tennessee Growers Coalition, who collaborated with Hurt on the writing of the bill, no other state has legislation that specifically taxes and limits the sale of hemp-derived cannabidiol products.

“People think that Tennessee is the last to do anything when it comes to the hemp industry,” Kirkpatrick says, “but they are forgetting that Tennessee was the first state to allow and define smokable hemp and the first state to allow the feeding of hemp to livestock.”

HB1690 would do three things: create a licensing requirement for retailers and wholesalers, establish a 6.6-percent excise tax on the wholesale of hemp-derived cannabinoids and limit sale of psychotropic hemp-derived products like Delta-8 to those 21 and older.

The bill would require retailers and wholesalers to apply for an annual $200 license through the Tennessee Department of Agriculture. Based on the licensing structure outlined, Kirkpatrick says he would expect the state to collect $160,000 annually in fees. (The legislative Fiscal Review Committee has not yet analyzed the potential economic impact of the legislation.) Licenses could be revoked or suspended at the discretion of the Department of Agriculture.

Kirkpatrick estimates that the proposed 6.6 percent tax, modeled after the tax on tobacco, could generate as much as $4-5 million in annual revenue for the state. Hurt and Kirkpatrick would like to see the money collected from licensing and the wholesale tax used to increase the resources at the Department of Agriculture to ensure product safety.

Florida Bill Would Regulate Delta-8 and Overhaul Medical Cannabis

Florida Bill Would Regulate Delta-8 and Overhaul Medical Cannabis

Florida bill would regulated Delta 8 THC and overhaul medical cannabis industry
A Florida bill seeks to place strict limits on delta-8 THC and overhaul the state’s medical cannabis program, which would include a new cannabis oversight agency and new rules preventing the sale of dispensary licenses for monetary gain.

bill in Florida would place strict limits on THC potency of synthetic and hemp extracts, such as delta-8 THC, and include other reforms to the state’s medical cannabis law, Florida Politics reports. The bill’s sponsors, Democratic Rep. Andrew Learned and Republican Rep.

Spencer Roach describe the proposal as the “first major update” to the state’s medical cannabis statute since voters approved the reforms five years ago.

Under the proposal, sales of hemp products designed for consumption, including delta-8 products, would only be permitted to individuals 21-and-older.

Additionally, the measure would increase the terms of medical cannabis patient licenses and the time between required doctor appointments, which the bill sponsors say combined would cut an estimated 60% of the cost of participation in the medical cannabis program.

It would also remove physician appointments for medical cannabis patient recertification under specific guidelines, allow recertification via telehealth, end the practice of selling medical cannabis dispensary licenses for monetary gain, create new industry testing requirements, and increase the transparency of state regulations.

Under the proposal, the course required by Florida for physicians that recommend medical cannabis would triple from two to six hours.

The bill was introduced on Monday November 29, but has not yet been moved to any committee.

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THC-O Acetate: Will it replace Delta 8 THC?

THC-O Acetate: Will it replace Delta 8 THC?

What is THC-O Acetate and is it like Delta 8 THC?

As more states begin banning and regulating Delta 8 THC, manufacturers are looking for alternatives to skirt the rules. Bring in THC-O Acetate.

Before we dive into the latest designer cannabinoid that aims to replace Delta 8 THC as it becomes banned in several states and regulated in some others, let’s briefly run through what Delta 8 THC is itself.

All cannabinoids, from CBD to THC and beyond begin as CBGA. Because of the shared molecular structure of cannabinoids, manipulating them is simpler than it may seem. While Delta-8 is relatively new, producers have been using these methods to manipulate cannabinoids for a long time to find exotic new cannabinoids.

While Delta-8 THC exists in a wide range of cannabis strains, it is in minuscule, trace amounts. To extract and purify Delta-8 from raw plant material with less than one percent of the targeted cannabinoid is unprofitable. This is why producers have begun converting other, more prevalent cannabinoids like CBD and Delta-9 THC into Delta-8.

Through a synthetic isomerization process, CBD is combined with a solvent to create Delta-8 THC. This is why the most popular products are vape cartridges and gummies. Cannabis cannot produce enough Delta-8 on its own.

Why Delta 8 THC is being banned

If you read the above section and started thinking, “That sounds pretty similar to those designer cannabinoids like spice that hurt a lot of people”, you would be on the right track. That is why over a dozen states have already banned Delta 8 THC.

Due to grey areas in the 2018 Farm Bill which legalized hemp and all of its derivatives (besides Delta 9 THC), producers of Delta 8 believe they technically aren’t breaking any laws. However unlike CBD which was immediately popular and thus regulated by the FDA for safety, Delta 8 has had no such treatment.

In 2020, the DEA released a set of rules for hemp production in the country. This ruling states that any naturally occurring tetrahydrocannabinols in the hemp plant that has a Delta 9 THC percentage below .3% is not a controlled substance under the Controlled Substance Act. In other words, it would seem like Delta 8 in the clear.

However the DEA also includes that for synthetically derived tetrahydrocannabinols (like Delta 8 which is created synthetically), the concentration of D9 -THC is not a determining factor in whether the material is a controlled substance. All synthetically derived tetrahydrocannabinols remain schedule I controlled substances. In other words, maybe Delta 8 is not so in the clear.

For the states that have already banned Delta 8 THC, it seems the easiest solution to a product that the FDA and DEA have made no mention of regulating. For producers however, THC-O Acetate is the solution.

What is THC-O Acetate?

While Delta 8 THC occurs in low concentrations in cannabis that must be extracted and isolated, THC-O Acetate — commonly called ATHC or THC-O — is not naturally occurring in the cannabis plant and can only be made synthetically.

THC-O is a man-made cannabinoid produced by using specific chemicals to acetylate THC. Acting as a metabolic prodrug for THC itself, THC-O works in the same manner as heroin does as a metabolic prodrug for morphine. That alone is enough to rub many cannabis users the wrong way, especially whole plant advocates.

THC-O Acetate can also be made from Delta 8 THC, so in states where it has been banned and producers may have a bulk supply of Delta 8, it can be converted relatively easily. And what truly makes THC-O so popular is the effects users feel.

Traditional THC Molecule:

Delta 9 THC vs THC-O AcetateTHC-O Acetate Molecule:

What is THC-O Acetate and is it safe?

A better high than Delta 9?

According to user reports and the little science behind it, THC-O Acetate has been shown to be two to three times stronger than Delta 9 THC. You read that right. THC-O can be 300% more potent than traditional Delta 9 THC.

Users have claimed that THC-O Acetate is a much more introspective and psychedelic experience compared to Delta 9 or Delta 8 THC, which is likely due to the extreme potency. Similarly to Delta 8 THC, THC-O can only be made through isolation, which means most products will be either a vape cartridge or edibles.

While for most, normal Delta 8 or Delta 9 THC does the trick just fine and taking such a concentrated product would be excessive, there is a real appeal for medical applications of THC-O Acetate. For some, traditional Delta 9 doesn’t provide enough relief from pain, anxiety or other issues.

Due to its potency, many believe that THC-O could be a great beneficial medicine for those who want to use cannabis but need a more concentrated dose that isn’t easily attainable through traditional consumption. With that said, THC-O Acetate is treated similarly to Delta 8 currently.

That means in states where Delta 8 has already been banned, you may be unable to have THC-O products delivered, or find them at smoke shops. However since there is so little information on THC-O, few states actually know about it, which means distributors may be able to get away with it for a while.

Is THC-O Acetate the new designer drug?

Of course for now it is too soon to say if THC-O is likely to end up in a similar grave to Spice or K2. These were synthetically created cannabinoid products that ended up hurting a lot of people, leading them to be banned across the country. However the way these products skirted the law was by minutely adjusting their chemical makeups every time one was banned.

Because the government would ban specific makeups of these products, small adjustments made them different products technically. It is always possible, being a fully synthetic creation, that THC-O befalls a similar fate. In grey markets, profits typically rise above safety. As competition grows, just like Delta 8 became more widespread, the same will likely happen to THC-O Acetate.

Producers will try to create stronger and cheaper versions of the drug, the latter effort being that which leads to danger. We all saw what happened when illicit market vape cartridge producers tried to cut costs by including Propylene Glycol and Vitamin E Acetate in their products. This resulted in hundreds of hospitalizations and even deaths.

With any grey or black market cannabis products, it is always on the user to ensure they are getting a safe and reliable product. If demand for THC-O Acetate grows enough, you can bet there will be a market for it.

However as a non-natural cannabinoid, THC-O isn’t measured with most testing methods used for cannabis currently. While some have claimed to created a reliable process for measuring THC-O, nothing has become the standard. Due to this it might be a while before there are truly reliable providers of THC-O products, but that hasn’t stopped consumers before, and likely won’t this time around either.

Michigan Governor Signs Legislation to Regulate Delta-8 THC

Michigan Governor Signs Legislation to Regulate Delta-8 THC

michigan delta 8 law has been passed

MICHIGAN — Today Gov. Whitmer signed legislation that will regulate, and cover delta-8 THC derived starting October 11, 2021.

This bill will update definitions regarding cannabis plant products making sure all intoxicating substances will be safety-tested and tracked through the MRA’s statewide monitoring system Michigan Executive Office of the Governor.

“This package of bills continues to show Michigan is the model for the nation in regard to protecting its residents and making sure that those who consume marijuana products do so in a safe manner,” said Gov. Whitmer. “I am glad to see Michigan continuing to lead on the implementation and regulation of a safe, secure marijuana industry, which has already brought tens of millions of dollars in new tax revenue to the state, as well as thousands of well-paying jobs.”

“The team at the MRA has always been committed to transparency and forward thinking and this was once again the case regarding delta-8,” said MRA Executive Director Andrew Brisbo. “We were proud to work with legislators and industry stakeholders to pro-actively address this issue and move an untested, unlicensed intoxicating synthetic product into our licensed and regulated system.”

“The voters of Michigan chose to legalize and regulate marijuana in the interests of justice and public health,” said Rep. Yousef Rabhi, D-Ann Arbor. “We know that banning these substances is not the best way to keep the public safe. But we also know that these psychoactive compounds are currently being sold with no public health standards to anyone, regardless of age. Instead of allowing these new hemp derivatives like Delta 8 to circumvent our world-class regulated system, this new law will apply the same rigorous testing and commercial standards that currently protect consumer safety in the legal marijuana marketplace.”

“I appreciate the support of Governor Whitmer and my legislative partner Representative Rabhi in helping Michigan take an important step in streamlining regulations for the safety of cannabis businesses and people around our state,” said Rep. Jim Lilly, R-Park Twp. “By mirroring Michigan’s existing liquor dram shop law and clearly defining the requirements for a proper injury lawsuit, we are bringing clarity to a previously murky area of our cannabis laws. I am extremely excited to see the Governor not only sign these bills, but also sign bills to protect Michigander’s from unregulated and untested Delta-8 hemp products. This legislation does the right thing by taking these products out of the unregulated marketplace and bringing them under the purview of a well-functioning Marijuana Regulatory Agency.”