Is the FDA Really 100 Days Away from Regulating CBD, Delta-8, and Other Hemp Cannabinoids?

The FDA says it’s months away from hemp-derived cannabinoid regulations after years of delay

Our wonderful overlords have said they are only “months” away from developing some regulatory processes for hemp-derived cannabinoids – despite the fact that hemp and related cannabinoids have been legal since 2018.

But hey – 5 years for the government is “lightning speed”.

Marijuana Moment recently gave a detailed overview of everything that happened. But since no one has time to read this long content, I decided to give you a quick summary of everything so that we are all on the same page.

After the recap, let’s take a look at why the FDA, which is making regulations almost 5 years after legalization, is simply not “good enough” and that these federal agencies need a major overhaul.

But first, let’s take a closer look at what the FDA actually said.

Here is a summary of the article;

The Food and Drug Administration (FDA) is currently conducting a scientific review of marijuana that will inform the status of federal approval. Senior FDA officials say they are months away from releasing a regulatory review for hemp-based products like CBD. The FDA has faced significant criticism in recent years for failing to regulate the marketing of cannabis in the food supply or as a dietary supplement. Hemp and its derivatives were legalized under the 2018 Farm Bill, but the agency has long maintained that more research needs to be done or Congress should step in again before regulations on consumable cannabinoid products are finalized.

In interviews with the Wall Street Journal, FDA Deputy Chief Commissioner Janet Woodcock and two other officials who guide the agency’s cannabis policy, Patrick Cournoyer and Norman Birenbaum, discussed next steps. Woodcock said, “Given what we know to date about the safety of CBD, this raises concerns for the FDA as to whether these existing food and dietary supplement regulatory avenues are appropriate for this substance.” Congress is advancing, as officials have previously said, may be necessary to forge a regulatory path for the plant.

By now, the market for hemp, CBD, and other novel intoxicating cannabinoids like delta-8-THC is already widespread across the country. As such, FDA officials increasingly seem to recognize the urgency of rulemaking. Birenbaum, a former state marijuana regulator in New York and Rhode Island, said, “I don’t think perfect can be the enemy of good when we look at such a huge market, so available and so exploited… you have a largely unregulated market.”

FDA officials said some of the points they are evaluating concern whether CBD is safe to use long-term and what the effects of consumption during pregnancy might be. The rise in popularity of delta-8 THC products, which the Drug Enforcement Administration (DEA) says are not on the CSA and are in fact unregulated.

Source: Marijuana Moment

It’s important to note that the Food and Drug Administration (FDA) has historically had a bias against cannabis and has been slow to recognize the plant’s potential therapeutic benefits. This is likely due to the long-standing federal ban on cannabis, making it difficult for researchers to study the plant and for the FDA to regulate it as a drug.

Despite this, there is growing evidence that cannabis has the potential to be an effective treatment for a variety of conditions, including pain, inflammation, seizures, and mental disorders. In recent years, the FDA has approved several cannabis-derived drugs, including Epidiolex, a drug used to treat epilepsy, and Marinol, a drug used to treat nausea and vomiting in cancer patients.

However, the FDA has also been criticized for its slow pace in approving additional cannabis-derived drugs and for its harsh regulatory approach to cannabis-based products. Some critics argue that the FDA’s bias against cannabis has hampered the development of new treatments and made it harder for patients to access the medicines they need.

In recent years there has been a growing movement to reform cannabis laws at the federal level and to allow for the wider use of medicinal cannabis. These include efforts to move cannabis under the Controlled Substances Act, which would allow for more research on the plant and allow the FDA to regulate more effectively.

Despite these efforts, the FDA has been reluctant to fully accept cannabis as a drug and has been slow to approve new treatments. As a result, many patients are forced to rely on unregulated products or to seek cannabis treatments in states where it is legal.

This is mainly due to the FDA/DEA Catch-22.

The FDA-DEA Catch-22 addresses the regulatory conflict between the U.S. Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA) when it comes to the approval and scheduling of cannabis-based products. Cannabis is currently a Schedule I controlled substance under the DEA, meaning it has a high potential for abuse and no accepted medical uses. This classification makes it difficult for researchers to study the potential medical benefits of cannabis and to have cannabis-based products approved by the FDA as medicines.

However, the FDA has the power to approve drugs and regulate the safety and effectiveness of products, including those containing cannabis or its derivatives. For a cannabis-based product to be approved by the FDA as a drug, it must go through the same clinical testing process as any other drug, including proving its safety and effectiveness through rigorous scientific research.

The Catch-22 arises because the DEA’s designation of cannabis as a Schedule I controlled substance makes it difficult for researchers to conduct the necessary clinical trials to meet FDA approval standards. This creates a regulatory barrier that has led to a shortage of FDA-approved cannabis-based medicines and frustrated proponents who believe the potential medical benefits of cannabis have not been fully explored.

Of course, that’s all bullshit too. Mainly because there are studies on cannabis.

It is difficult to accurately estimate the number of studies that have been published on cannabis, as this depends on how “cannabis” is defined and what types of studies are included. However, there are thousands of scientific studies on cannabis and its various components, including cannabidiol (CBD) and tetrahydrocannabinol (THC). These studies have covered a wide range of topics, including the effects of cannabis on the brain and body, its potential medicinal uses, and its potential risks.

The argument that there just aren’t “enough studies” is one that doesn’t work. What we do know is that cannabis is safer than alcohol on all counts, and alcohol is a celebrated substance in modern society.

If alcohol can be tolerated as a society, then it stands to reason that cannabis can too. Furthermore, it is empirically incorrect to claim that cannabis has no medicinal properties and a high potential for abuse. The fact that the DEA and FDA continue to play this game, “we need the other to sign the DE plan, could likely be due to the pharma-FDA connection.”

There is a potential conflict of interest when pharmaceutical companies provide funding to the Food and Drug Administration (FDA), as these companies may have a financial stake in the FDA’s decisions regarding drug approval and regulation. This can lead to a preference for drugs developed by these companies and result in the FDA putting the interests of these companies ahead of the needs of patients.

For example, if a pharmaceutical company has funded the FDA and developed a new drug, the FDA may be more likely to approve the drug even if there are potential risks or concerns about its safety or effectiveness. This can lead to a situation where drugs are approved and marketed that may not be in the best interests of patients, while other, potentially safer or more effective treatments are not.

Additionally, the FDA is more likely to approve drugs developed by companies that fund the agency, even if those drugs aren’t significantly different from existing treatments. This can create a monopoly for these companies, leading to higher drug prices and limited treatment options for patients.

Overall, the potential for a conflict of interest when pharmaceutical companies fund the FDA can undermine the credibility and integrity of the regulatory process and may not serve the best interests of patients. It is important that the FDA is transparent about its funding sources and ensures that its decisions are based on the best available scientific evidence and not financial considerations.

However, given that the FDA receives most of its funding from drug companies, there seems to be a clear conflict of interest.

Why is the FDA Delaying Cannabis?

However, I don’t think the FDA is stalling regulations on hemp-derived cannabinoids in this particular case. In fact, I think the entire US is about to invade the legal cannabis space. Pharma, however, wants their share.

So the FDA is waiting for Congress to take a step, which could potentially happen later this year. However, there is a lot of “talk” about reforms, judging by performance in 2022 – we don’t know if they will actually push them through.

However, I have a sneaking suspicion that there will then be provisions that would directly benefit pharmaceutical companies. If they’re trying to schedule cannabis into Schedule II, we know it’s a total drug takeover.

In all likelihood, they won’t because billions of private investments in recreational cannabis are tied up and a Schedule II category would essentially end 95% of all current legal operations.

In all likelihood, they’ll remove it from the CSA – which would be ideal. Nonetheless, the people currently trading cannabis and hemp derivatives are simply operating in a “wild west” situation. You have to hope there isn’t a federal agent having a hard time blasting people while lawmakers take the time to set the framework.

We’ll see how the next few months develop!

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