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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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What is Delta 10 THC? Delta 10 Gummies and Delta 10 Cartridges explained

What is Delta 10 THC? Delta 10 Gummies and Delta 10 Cartridges explained

What is Delta 10 THC?
When the federal government legalized industrial hemp in 2018, it changed a lot of things. It also opened up plenty of loopholes.

After the explosion of CBD and just about every hemp producer trying to sell their CBD products, the market became extremely saturated. While the market for CBD products is still huge (and growing), there are other cannabinoids that have been discovered in hemp that provide different effects.

You may have heard of CBG and CBN, two cannabinoids similar to CBD that have been shown to have therapeutic effects without producing a psychoactive high. However, there have been new, synthetically produced cannabinoids that actually do provide psychoactive effects while staying in a grey area of legality due to being derived from legal hemp.

The latest in this evolution of grey market cannabinoid products is Delta 10 THC.

Delta 8 THC and THC O Acetate

Delta 8 THC was the first synthetic cannabinoid to blow up in popularity, with advertisements of a legal high nearly identical to traditional Delta 9 THC. For some, being synthetically manufactured can be a major turn off, bringing back memories of K2 or Spice — entirely synthetic “cannabinoids” created from scratch and sprayed on various herbs — which resulted in numerous injuries and deaths.

However Delta 8 is made a little differently. Instead of making it entirely from scratch, Delta 8 THC is most commonly made from CBD. Through an isomerization process, CBD can be converted in Delta 8 THC. There are lab tested Delta 8 products that are reliable, and just as many that are not, so buyer beware.

But what happens when you take Delta 8 — which is made through chemical processes — and add more chemical processes? You get 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.

However the high that THC O Acetate can produce is enough for many to overlook how it is made. According to anecdotal experiences form users, THC O Acetate has been shown to be nearly 3x more potent than Delta 9 THC, and has been described as psychedelic, producing visual hallucinations.

However there are currently very few reliable THC O Acetate manufacturers, with only one claiming to have a pure, clean process for making it. With over a dozen states banning Delta 8 THC, and not enough reliable producers or consumer information on THC O Acetate, consumers and producers are looking for yet another replacement.

They may have found it with Delta 10 THC.

What is Delta 10 THC?

The good news about Delta 10 THC, is that it’s made in a near identical way to Delta 8 THC. It appears in similar trace amounts to the point where it’s not worth the time or money to try and extract it purely from a hemp plant. This means it has to be created from something like hemp-derived CBD through a chemical process.

So in the case of how to consume Delta 10 THC, it will almost always be found in the form of Delta 10 THC gummies or other edibles and Delta 10 THC vape cartridges made from distillate. This is because there is no hemp flower that produces enough Delta 10 THC that could actually be felt through normal flower consumption.

User reports of Delta 8 THC claim that it provides a more relaxing and appetite stimulating effect, similar to what most would call an “indica”. Delta 10 THC users on the other hand report it to feel more like a “sativa”; uplifting, energetic, etc..

Neither Delta 8 or Delta 10 THC provide the same intense high that Delta 9 THC can. But according to David Reckles from Private Label Hemp Lab, Delta 10 could potentially surpass Delta 8 in popularity as it provides an uplifting high that isn’t overwhelming or accompanied by paranoia and anxiety that some feel from Delta 9 THC.

Is Delta 10 THC Legal?

Just like Delta 8 THC and THC O Acetate, Delta 10 THC exists in a legal grey area. Because it is technically derived from federally legal hemp which has a Delta 9 THC concentration below .3%, and the Farm Bill specifically mentions only Delta 9 THC concentrations, Delta 10 and other cannabinoids are technically legal.

However, in a ruling on CBD and other cannabinoids legalized by the Farm Bill, the DEA says, “For synthetically derived tetrahydrocannabinols, 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.“

Unfortunately as government is wont to do, the DEA failed to clarify what constitutes a “synthetically derived tetrahydrocannabinol”, leaving it up for interpretation. To Delta 10 THC producers, the fact that nobody is getting busted is enough to continue making it, whether it turns out to be illegal or not.

In the same vein, the caution is on the consumer when purchasing Delta 10 THC gummies or Delta 10 THC cartridges. Not just because of the lack regulation on producers which results in shady products that could potentially be dangerous, but also because it is still THC. In other words, it’s possible for someone who gets drug tested for THC to test positive, despite only using Delta 10.

While Delta 10 THC, Delta 8 THC and THC O Acetate may be “legal” alternatives to Delta 9 THC in states where cannabis is still prohibited, it could change at any moment. Whether that means you should stock up on all the Delta 10 and Delta 8 you can get your hands on or just wait for legalization to come your state is up to you.

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.”