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FDA CBD Regulations: A Look at the Food and Drug Administration on Cannabidiol

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FDA CBD Regulations: A Look at the Food and Drug Administration on Cannabidiol

Scott Gottlieb, the current Food and Drug Administration Commissioner recently discussed the agency’s plans to pursue alternative pathways for CBD regulations. He also discussed how the federal ban on marijuana research is causing medical marijuana research to go overseas.

During the hearing, which took place on Wednesday of the last week of February, Gottlieb stated that the FDA will be holding a public meeting in April to discuss how regulation will best serve hemp-derived CBD, which was legalized by the 2018 Farm Bill.

Representative Mark Pocan (D-WI) asked Gottlieb how active the FDA was in considering different pathways for food and dietary supplement regulation.

Gottlieb answered,

”I’ll say at the outset that we heard Congress loud and clear with respect to that legislation. I understand that Congress wants there to be a pathway for CBD to be available.”

He also added, though, that the issue is not straightforward. The only FDA approved CBD drug is Epidiolex, and of course, it cannot be added to food and it is also the subject of clinical investigations.

However, he added the current laws,

“allow us to go through a regulatory process and go through a notice and comment rule-making to establish a framework to allow it to be put into the food supply,”

and that the agency will work to that end starting with the public meeting in April.

Further, CBD ma eventually exist,

“in a high concentration, pure formulation as a pharmaceutical product” and “at a different concentration as a food product or dietary supplement.”

The agency promotes the separation to,

“preserve the incentive to study CBD as a pharmaceutical product.”

Gottlieb continued,

“We believe it does have therapeutic value and has been demonstrated. But I will tell you this is not a straightforward process. There’s not a good proxy for us doing this through regulation.”

However, the process is certainly complicated. The FDA must have discussions with Congress on how it may work together on further legislation.

Representative Andy Harries (R-MD) added to Pocan’s question and stated that when he looks at the CBD market, he notices,

“displays of CBD-containing products, and it’s not at the pharmacy behind the counter obtained with a prescription.”

Gottlieb stated,

“I will tell you that we’re deeply focused on this. We have taken on other hard challenges before. I think we have a good track record of trying to come to resolution on other challenges. You have my commitment that I’m focused on this one.”

Further, Gottlieb mentioned that he will announce soon,

“a high-level working group that’s going to report to me on this, with some senior officials in the agency who are going to be chairing that. I will tell you that if we make a determination that the pathway here is going to be a multi-year regulatory process that could take two, three, four years, I will come back to Congress to have a discussion about whether or not there are other frameworks that could help address this.”

He added that the FDA may,

“need statute that either addresses this as a whole framework or address CBD specifically.”

The Co-Chair of the Congressional Cannabis Caucus, Barbara Lee, stated that she was excited to discuss two her of favorite topics, “Cuba and cannabis.” Concerning cannabis, Lee stated that a UK company received drug approval for Epidiolex and that the company was interested in the drug’s final approval so that it could grow strains of cannabis for drug development. Lee asked whether it is possible for a US-based company to bring plant-derived cannabis through the FDA review and approval process.

Gottlieb answered,

“With respect to cannabis-derived compounds, it really depends on which active ingredient you’re talking about—whether you’re talking about THC or CBD and whether or not it’s being derived from marijuana or hemp.”

He continued that it is an “active question” as to,

“whether hemp-derived CBD was legalized under the 2018 Farm Bill, which would mean the compound “can be studied in a more fluid fashion.”

Gottlieb concluded that he would certainly support more research.

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Full Spectrum CBD vs Cannabidiol Isolate: Learn The Differences

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Full Spectrum CBD vs Cannabidiol Isolate

CBD has become a go-to option for many men and women looking for a natural and potentially reliable solution for issues such as pain, anxiety, irritation, and the like. Before choosing a CBD product, it is important to understand the difference between the two of the most common-types of formulas, which are full-spectrum and isolate. Fortunately, this post is here to help.

Full-spectrum CBD features all of the naturally-occurring compounds in the marijuana plant. These compounds include cannabidiol, terpenes, fatty-acids, and tetrahydrocannabivarin. These substances work together to provide users with the soothing effects that they are hoping for. Further, studies show that the full-spectrum substance may be much more effective than isolate.

Isolate, on the other hand, is stripped of all of these important substances. The purified CBD can be effective, though, when it comes to treating a number of ailments. For example, isolate may be more beneficial than full-spectrum when one needs a particularly strong and potent formula that can be controlled for a particular dosage. Unlike full-spectrum formulas, isolate products test to be free from odor, flavor, and they are also cheaper as well.

Both products interact with one’s endocannabinoid system. Of course, the product that one chooses depends upon what one is looking for. Those who are interested in receiving all of the natural substances that occur in the hemp plant may want to opt for a full-spectrum formula. One the other hand, those who are interested in a formula that is been stripped of the naturally-occurring elements and that is free from flavor, taste, and smell, may want to opt for an isolate.

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When Will Whole Foods Health Store Sell Medical Marijuana Products?

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Whole Foods market is one of the most popular health food stores in the country. John Mackey, the company’s CEO, recently attended a conversation hosted by The Texas Tribune.

During the conversation, an audience member directed a question to Mackey and inquired whether the company would consider selling “alternative proteins,” as in, insects. Mackey answered in the affirmative and then, turned the conversation to marijuana.

He stated,

“If Cannabis is ever passed in Texas, chances are good that grocery stores will be selling that too.”

And,

“You just never know what happens over time with markets. They change and evolve.”

The conversation’s monitor then inquired which will come first, the insects or the brownies.

Mackey responded,

“Let’s see what happens with the market and the government regulation over time.”

It comes as no surprise that Mackey is open-minded concerning cannabis products being sold at Whole Foods. As early as 2013, he expressed support for the legalization of marijuana during an interview with Mother Jones.

As Mackey stated,

“I am pro-choice, favor legalizing gay marriages, protecting our environment, enforcing strict animal welfare protection laws (I’ve been an ethical vegan for 10 years), marijuana legalization, having a welfare safety net for our poorest or disabled citizens, and a radically reduced defense budget and military presence around the world.”

Whole Foods’s entrance into the cannabis market may be coming at a good time. Since the company had been acquired by Amazon in 2017, it hired a trend-spotter who made a prediction concerning the hottest trends for 2019. One of the hottest trends was hemp products. As the company discussed on its website, hemp hearts, seeds, oils, and the like are nothing new to those who love food and body-care products. However, now, there is a ignited interest in the other parts of the plant, which may provide a range of other benefits.

Although it may take some time and legislative changes before Whole Foods is comfortable selling marijuana products, the first step may be hemp-derived CBD products due to the passage of the 2018 Farm Bill. Further, this week, the Food and Drug Administration announce that it is planning on holding sessions as it concerns “alternative” pathways allowing for hemp-derived CBD products to be included in food product and supplements.

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CBD and Bipolar Disorder: Can Hemp Cannabidiol Treat This Health Condition?

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cbd and bipolar disorder

Bipolar disorder can affect anyone and although it mainly has genetic roots, sometimes factors such as environment, age, and other factors can cause its development. There has been a great deal of research lately concerning potential remedies for bipolar disorder. One particular focus is cannabis. Although the research seems to be conflicted in that some studies show that it may work better than traditional drugs for mania and depression, other studies show that it may cause an increase in depressive symptoms. There is also the issue of whether cannabis is addictive, as there are some studies that show that those with bipolar disorder are nearly seven times more likely to use marijuana illicitly.

There are those that are taking a different approach to cannabis and bipolar disorder. Rather than focus on the effects of cannabis, it may be better to delve deeper and into the type of chemical makeup and amount of cannabidiol.

Understanding THC and CBD

The two most prominent compounds in marijuana are cannabidiol (CBD) and tetrahydrocannabinol (THC).Though both of these substances impact the endocannabinoid system that is responsible for appetite, mood, memory, and sensation, their impact varies depending upon the amount of each compound in the cannabis. Further, dissimilar from CBD, THC is a psychoactive substance. Therefore, it promotes that high feeling.

On the other hand, CBD is a calming substance that may be able to alleviate pain, it could reduce anxiety, inflammation, and other issues. There are also some studies that suggest that the properties of CBD may mitigate THC’s psychoactive properties.

Full-Spectrum or Isolate CBD

Given the psychoactive effects that THC can cause, it may be best to use CBD. When choosing a CBD product, there are two main types – isolate and full-spectrum. Isolate is stripped from powerful and potent compounds, such as cannabinoids, fatty-acids and terpenes. These substances are responsible for promoting a range of benefits. On the other hand, isolate is free from such substances, but there are studies that suggest that it may be more potent. The decision is, of course, a personal one.

CBD and Bipolar Disordar Summary

Overall, CBD may have the potential to treat bipolar disorder. However, at this point, there is no conclusive evidence on the issue. There is also an open question as to whether CBD with THC or just CBD on its own may be best, or whether it is better to use a full-spectrum product or an isolate. These questions may take time and of course, research to answer. The best thing that users can do is to stay abreast of new information and CBD development.

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