CBD AND THE FDA HEARING: WE’RE SHARING WHAT WE LEARNED AND KEY TAKEAWAYS

Whether you have been watching the news, or friend or family member has mentioned it, you have probably heard the letters C-B-D recently. Recently, you have heard the letters C-B-D in conjunction with the FDA.  The Federal Department of Agriculture held an important hearing on CBD on May 31st and we would like to take this opportunity to explain what the presenters shared with the FDA and our key takeaways from the hearings–we watched every second.

The questions the FDA posed to the speakers today were primarily centered around issues of consumer guidelines and manufacturing processes CGMP).  It was clear from the discussion that the FDA seeks to prevent mislabeling and misinformation.

The FDA, through the hearing, heard manufacturers report on scientific data and information related to safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds, such as CBD.  

At Elder Farms, what we grow and provide is the mark of not only the quality of our products but also our character.  As the FDA and the government at large work to ensure the CBD products we ingest are safe, at Elder Farms, we will continue to provide top quality CBD to enhance your wellbeing.  But before we explain more about our responsibility to you, our customers, let’s take a close look at what CBD is and specifically, how Elder Farms Hempberry is not your average CBD.  You can find information on our third-party testing in our FAQs.

The Federal Department of Agriculture (FDA) is announcing a number of important new steps and actions to advance its framework for the lawful marketing of appropriate cannabis and cannabis-derived products under existing FDA authorities. These new steps include:

  • A public hearing held on May 31, as well as a broader opportunity for written public comment, for stakeholders to share their experiences and challenges with these products, including information and views related to product safety.
  • The formation of a high-level internal agency working group to explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed; including a consideration of what statutory or regulatory changes might be needed and what the impact of such marketing would be on the public health.
  • Updates to the FDA Webpage with answers to frequently asked questions on this topic to help members of the public understand how the FDA’s requirements apply to these products.
  • The issuance of multiple warning letters to companies marketing CBD products with egregious and unfounded claims that are aimed at vulnerable populations.

The public hearing gave stakeholders (from stockholders to manufacturers to doctors) an opportunity to provide the FDA with additional input about the FDA’s regulatory strategy related to existing products, the lawful pathways by which appropriate products containing cannabis or cannabis-derived compounds can be marketed, and how the FDA can make these legal pathways more predictable and efficient.

For example, the FDA posed numerous questions to the presenters about the terms “full-spectrum” and “broad spectrum” and it became apparent, through the discussions during the hearing, that the FDA will likely define these terms formally and require manufacturers to only promote and sell products that meet these defined labels/terminology as they will be defined by the FDA.  

The FDA is continuing to seek comments, data, and information on a variety of topics including what levels of cannabis and cannabis-derived compounds cause safety concerns; how the mode of delivery (e.g., ingestion, absorption, inhalation) affects the safety of, and exposure to, these compounds; how cannabis and cannabis-derived compounds interact with other substances such as drug ingredients and you can read the full announcement about the May 31 Hearing and continued steps regarding the FDA process here.

WHAT IS CBD?

CBD Molecule

Let’s dive into what CBD is. CBD stands for cannabidiol, a compound found in both marijuana and hemp plants. The marijuana plant and the hemp plant are not exactly the same. Hemp plants produce more CBD than THC, while marijuana produces more THC than CBD. Interestingly, research has shown that CBD acts to reduce the psychoactive effects of THC, separating hemp further from marijuana. For a thorough explanation of the difference, of the difference between the plants, including the differences in cultivation, genetics and differing uses, you can read more on that subject here. It is vital that we explain and underscore that CBD is not THC.

They are actually very different and affect the human body very differently. The least processed form of the cannabis plant is hemp. The use of cannabis recreationally, to produce a “high” is what most people associate with the term cannabis. However, hemp, a cannabis plant is viable in many different industries from wellness to manufacturing. Hemp contains most of the CBD that people use medicinally.

Project CBD explains it well: “Cannabidiol — CBD — is a cannabis compound that has significant medical benefits, but does not make people feel “stoned” and can actually counteract the psychoactivity of THC. The fact that CBD-rich cannabis is non-psychoactive or less psychoactive than THC-dominant strains makes it an appealing option for patients looking for relief from inflammation, pain, anxiety, psychosis, seizures, spasms, and other conditions without disconcerting feelings of lethargy or dysphoria.”

It is here we work to be highly responsible about the claims we are able to make at this juncture.  The FDA hearing seeks to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds, such as CBD. So let’s dive a little deeper into what CBD is and how it works.

The compound CBD (Cannabidiol) is one of 113 identified cannabinoids found in cannabis sativa. CBD is one of many compounds, known as cannabinoids, in the cannabis plant. For many years now, researchers have been looking at the possible therapeutic uses of CBD. All cannabinoids, including CBD, produce effects in the body by attaching to certain receptors.

The human body produces certain cannabinoids on its own. It also has two receptors for cannabinoids, called the CB1 receptors and CB2 receptors.

CB1 receptors are present throughout the body, but many are in the brain. It is these CB1 receptors in the brain deal with coordination and movement, pain, emotions, and mood, thinking, appetite, and memories, and other function including inflammation and pain.

Researchers once believed that CBD attached to these CB2 receptors, but it now appears that CBD does not attach directly to either receptor. Instead, it seems to direct the body to use more of its own cannabinoids which is why we recommend keeping a log of your dosage each day. For some people, over time, they can utilize a consistent dosage and gain maximum benefit from that dosage because the CBD is directing the body to also use more of its own cannabinoids. Other people find that increasing the dosages during a flare-up of pain and inflammation, for example, also yields benefits and they then return to their usual dosage when the flare-up subsides.

WHY YOU NEED TO KNOW MORE ABOUT IT: HEALTH BENEFITS

Science publications, medical publications and lifestyle publications alike have been addressing the many benefits of CBD. As noted in an article from Science Trends, “Given its rise, researchers are now looking into clarifying exactly what CBD can be used to treat. Dr. Esther Blessing, a researcher at New York University, has begun research on CBD and alcohol use disorder (AUD) in patients with PTSD in hopes of understanding CBD’s role in treating addiction and other addictive behaviors.”

And that is just the tip of the iceberg in terms of the benefits that scientists and doctors continue to research and confirm.  Again, the FDA hearing will open doorways for more data and information and ensure the claims made about CBD are real and factual rather than supposition.

We fully and wholeheartedly believe in the wellness benefits of CBD. From pain relief to reduced anxiety and acne treatment, the list of CBD benefits is long and growing. But you don’t have to take out word for it. Healthline.com ( a general wellness and well-being site) cites a number of benefits in the article by Jon Johnson titled “Everything you need to know about CBD oil” As Mr. Johnson notes, “Recommended dosages vary between individuals, and depend on factors such as body weight, the concentration of the product, and the health issue.”

There is no scientific data establishing a recommended dose of CBD due to the FDA’s current stance regarding CBD. According to current FDA guidelines, no one can say that any amount of CBD will cure, help, or treat any health condition. For example, a doctor provided the FDA information on their testing and studies and shared that the participants reported “an overwhelming sense of well-being” after using CBD products.  The FDA responded with questions regarding how doctors (and patients) define “overwhelming sense of well-being” and how that is measured.

This leads us to the question of how to advise our customers on dosage.  Heretofore we have recommended our customers consider, their body weight and the severity of the condition or problem they are attempting to address through the use of CBD.  We have consistently recommended customers start with a low dose and increase as needed. Following the hearing, we continue to feel confident in this recommendation.

Like other supplements intended to enhance wellbeing, the dosage may be very specific to the individual.  For example, we have a client who has been taking Alfalfa tablets his entire life and firmly believes in its benefits.  Another client takes somewhat expensive butterbur supplement for migraines and central nervous system health in addition to CBD.  Our customers buy and use our products because they experience benefits.

ELDER FARMS CBD IS A DIFFERENT KIND OF CBD

Elder Farms CBD is a blend of broad-spectrum (again, one the terms the FDA will seek to formally define) hemp extract which contains all of the essential cannabinoids, terpenes, and flavonoids found in hemp. We use a proprietary process to remove THC while retaining all of the other benefits of the plant. Infused with Organic MCT Oil (from coconuts) and blended with our farm fresh elderberry concentrate for maximum immune support.

The difference lies in the elderberry.  For hundreds of years, elderberry has been consumed not only for its delicious taste but for its perceived health benefits as well.  Elderberry is a strong source of antioxidants and vitamins that may boost your immune system. They can help tame inflammation, lessen stress, and help protect your heart, too.  Some experts recommend elderberry to help prevent and ease cold and flu symptoms. But you don’t have to take our word for it, you can read more about reported benefits of elderberry on WebMD.

At Elder Farms, we press our naturally grown elderberries and use a delicate water process to extract and concentrate the antioxidants and nutrients.

You won’t find any added alcohol, sugars, artificial sweeteners, or emulsifiers in our HempBerry. CBD tincture.  It is a power-packed combination of elderberry and CBD and because HempBerry is powered by plants and is 100% natural, you will need to shake your bottle of HempBerry thoroughly before use.

Each bottle of HempBerry is a 2 month supply if taking 1 dropper full a day, or a 1 month supply for a couple to share.

ELDER FARMS RESPONSIBILITY TO OUR CUSTOMERS

Having carefully watched and reviewed the information in the FDA hearing on May 31, 2019, we can report to you, our customers, that your health and wellbeing is our top priority.  We do not make claims about the benefits of our products that cannot be supported by scientific research and data.

Rather, we share the information we have to date on CBD and elderberry benefits and we encourage our customers to share their experiences with each other as well.

At the core of our work is to take the stigma out of CBD and underscore that CBD does not have the psychotropic effects of THC.  It is a health supplement that many report has significant benefits for their overall wellbeing.

FDA provided a Webcast for this public hearing that we assume (and hope) will be available for viewing after the May 31st hearing date.

Click here to view the hearing via webcast. Additionally, the FDA plans to post a link to the recorded webcast after the hearing (barring any technical difficulties).

We look forward to learning more about the decisions that stemmed from this hearing and we will do our best to keep you informed.

Here’s to your health!

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