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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.

Why you should stop calling it “marijuana”

Why you should stop calling it “marijuana”

history of the word marijuana

The majority of Americans now approve of cannabis legalization on the federal level. Yet the majority of the country still refers to the plant by much different name: marijuana.

If you walked up to someone in their mid-forties and asked them their opinion on cannabis, there’s a chance they wouldn’t know what you were talking about. However if you asked them if they supported the legalization of marijuana, there’s a higher likelihood of them supporting it than not.

So where is the confusion?

When we have been referring to cannabis as “marijuana” for nearly a century, it isn’t as easy to telling people that the name has changed. But the reality is that cannabis was always, well, cannabis.

Origins of cannabis

Cannabis has been a known and used plant for medicine and recreation for centuries. With use dating back to 8,000 B.C. in Mesopotamia, those studying medicine throughout the generations have had plenty of time to learn about the origins of the cannabis plant.

Through these studies, this is where the plant’s name originates. Actually, it has several names for the various types of cannabis that can be found across the globe.

Cannabis Ruderalis (northern/central Asia), Cannabis Sativa (Eastern Europe/Central Asia), and Cannabis Indica (China, Korea, Southeast Asia, Himalayas, Middle East) are the most studied and well known biotypes of cannabis. These are the scientific names for the plant. Notice that none of them have the word “marijuana” or anything close to it in their title.

So if cannabis had held that name for centuries of scientific study, what changed?

The answer to this question is why you should stop using the word “marijuana” when talking about cannabis.

Origins of “marijuana”

The origins of the word “marijuana” or “marihuana” are debated among the cannabis community. But one thing is inarguable; the word is racist.

Cannabis,  AKA hemp, was a major cash crop in the United States for decades, with the government even requiring its production by farmers during the Revolutionary War. Now, why cannabis became illegal in the first place is highly debated.

Many argue that cannabis became illegal because major paper manufacturers and big cotton producers partnered together to phase out hemp as a material for paper. However there is very little historical information to back this up. The more recognized and historically traced reason for the criminalization of cannabis goes back to the introduction of Mexican immigrants to the United States.

Prior to their arrival, recreational use of cannabis was not widely accepted. The plant’s main uses were medicinal and manufacturing. Hash and concentrated forms of cannabis were commonly used by doctors to treat a variety of ailments. The fibers of the hemp plant were great not only for creating boat sails which were vital to the war effort, but hemp was also a vital material in clothing and paper for decades.

However it was when Mexican immigrants arrived and brought their preferred method of cannabis consumption with them that the plant would begin to gain notoriety. Opposed to consuming it in a medicinal form such as a tincture which was common in the country at the time, the immigrants would roll up loose cannabis flower into cigarettes or pack it into pipes and smoke it.

Just like today, immigration of Mexicans to the United States stirred up xenophobia. In the 1930s a man named Henry Anslinger, the head of the Federal Bureau of Narcotic (now the DEA), made a distinct effort to link cannabis use to Mexican immigrants to stir up fear in the community and build support for prohibition.

Keep in mind this is the 1930s, and alcohol prohibition had already been in effect for almost a decade. So the idea of banning a substance through provoking fear in the public was by no means a new concept.

Anslinger would coin the term “marihuana” to replace cannabis. He chose the word because of its foreign sounding nature that could be attached to Mexican immigrants. But Mexicans weren’t the only victims of Anslinger’s racist campaign against cannabis.

Henry Anslinger held such views on cannabis as, “Reefer makes darkies think they’re as good as white men,” and, “Marihuana leads to pacifism and communist brainwashing.​” One of his most famous quotes is as revealing as we need it to be to recognize the racist intentions of the word “marijuana”:

“There are 100,000 total marijuana smokers in the US, and most are Negroes, Hispanics, Filipinos and entertainers. Their Satanic music, jazz and swing, result from marijuana usage. This marijuana causes white women to seek sexual relations with Negroes, entertainers and any others.​​”

Need I say more?

In the end as we all know, Anslinger’s plan would be a success. In 1937 the United States passed the Marihuana Tax Act which would be the basis for criminalizing the plant nationwide in the years to come.

After the Marihuana Tax Act of 1937 went into effect, the Bureau of Narcotics arrested Moses Baca for marijuana possession. Baca was a Mexican-American and was the first victim of the federal government’s war against drugs.

It’s time to move on

To make a long story short, the only reason the word “marijuana” even exists in the first place is because of racism. And that same racism has fueled the drug war that has plagued the United States for decades, with that word being at the forefront of the campaign.

Does this make everybody who calls cannabis marijuana a racist? Of course not. Don’t attribute malice to that which can be explained by ignorance.

It’s not like the history and prohibition of cannabis is taught the same way prohibition of alcohol is in high school. Politicians don’t want to talk about the dark, tattered history of the plant and why it became illegal in the first place. Anybody who wanted to know the history of cannabis had to seek it out themselves, and in most cases still do!

Let’s not forget that cannabis is still illegal on the federal level, all because of the racist campaign Henry Anslinger started in the early 20th century. Well, we’re in the 21st century now, and it is time to move on from the outdated, racist terms used to describe a plant that thousands use as medicine and recreation.

It isn’t snobby to call cannabis by its proper name to combat the decades of racism its former helped promote. It isn’t elitist or trying to be cool to use the proper terms for a plant that the majority of us want to be legal.

How can we expect legalization of cannabis when we can’t agree on what to call it?

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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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.

USPS Bans Mailing Hemp, CBD and Vape Cartridges

USPS Bans Mailing Hemp, CBD and Vape Cartridges

USPS bans mailing hemp, CBD and vape cartridges

The U.S. Postal Service (USPS) on Wednesday released its final rule on the mailability of vapes, asserting that even devices designed for federally legal hemp derivatives like CBD generally cannot be shipped through the U.S. mail.

The agency has been developing the regulations to comply with a bill passed by Congress last year that is mostly aimed at stopping nicotine vaping devices from being mailed—though it has broader implications. Despite significant public comment on an earlier proposed version of the rules that urged USPS not to interpret the law in a way that restricts hemp businesses, the agency ultimately said that cannabis vapes fit the definition of what lawmakers moved to ban.

There are some exceptions, but stakeholders are disappointed by the final rule.

During public comment, some argued that the bill was specifically meant to restrict mailing of nicotine-based vapes. But while the legislation refers to limitations on “electronic nicotine delivery systems,” or ENDS, it defines that term as “any electronic device that, through an aerosolized solution, delivers nicotine, flavor, or any other substance to the user inhaling from the device.”

USPS explained in the rule, which is set to be published in the Federal Register on Thursday, that by the letter of the law, that includes hemp and marijuana vapes.

“It goes without saying that marijuana, hemp, and their derivatives are substances,” the agency said. “Hence, to the extent that they may be delivered to an inhaling user through an aerosolized solution, they and the related delivery systems, parts, components, liquids, and accessories clearly fall within the [Preventing Online Sales of E-Cigarettes to Children Act’s] scope.”

Other commenters argued that USPS shouldn’t impose the restriction on cannabis products because the ban could conflict with state or local marijuana laws—or because Congress has approved spending legislation that prohibits the use of Justice Department funds for interfering in state-legal medical cannabis programs.

USPS said those arguments are not valid because, 1) it’s part of the federal government and is, therefore, unaffected by state or local marijuana policies and 2) it’s not part of the Justice Department, which is the only branch of the government restricted by the state protection rider in appropriations legislation.

The agency further clarified that hemp containing up to 0.3 percent THC is federally legal and is generally mailable, but only “to the extent that they are not incorporated into an ENDS product or function as a component of one.” As such, while business can generally mail out legal hemp-derived products, that’s only the case if they are not vaping products covered under the new law.

“The POSECCA and the Agriculture Improvement Act overlap, but they do not conflict. The Agriculture Improvement Act merely excludes certain products from the CSA. It does not affirmatively declare hemp and hemp derivatives to be mailable in any and all circumstances, superseding all other relevant laws (such as the POSECCA). For its part, the POSECCA restricts the mailability of only certain hemp-based and related products; hemp-based non-ENDS products are unaffected, as are ENDS products falling within one of the PACT Act’s exceptions. That Congress has rendered some subset of a class of goods to be nonmailable while leaving the remainder mailable is not some sort of legal conflict, but, rather, how mailability regulation typically works.”