The FDA And CBD: Shaping Guidelines For Hemp As Medicine

Hemp for medicinal use has been conquering multiple markets. Hemp-derived CBD is in wellness shops, big brand stores like Walgreens and Walmart, and creeping into more and more cannabis dispensary lobbies.

Many are finding various wellness benefits. But it’s of utmost importance that more clinical research be completed thanks to hemp’s legalization with the 2018 Farm Bill. The drawback though, is when the FDA faced the American public with potential harms from CBD!

Cannabis is not a cure-all. It betters lives certainly. And there are negative side effects, which the FDA was upfront with the public about – but at what cost when hemp legalization is so new?

We’ll explore this from these angles:

  • the FDA’s Deal with CBD Hemp Medicinal Use
  • FDA loopholes that raise eyebrows
  • why the wait on hemp medicinal use is important
  • Federal organizations need to ease up on CBD

Now let’s dive into the matter.

hemp powder and capsules
Image By Iryna Khabliuk


The FDA’s deal with CBD hemp and its medicinal uses

If you tuned into the congressional assembly the week of January 13, 2020, you’re probably miffed by the circular arguments when it comes to legalizing cannabis. The DEA expressed a willingness to reschedule or deschedule with more research while also barring research on cannabis from happening.

It can feel very frustrating. Especially considering that FDA has been playing hard ball with the present and future of CBD since hemp was legalized with the 2018 Farm Bill. They’ve been very stringent with health claims (rightfully so), sending out warnings to 15 companies in 2019.

And the “potential harm of CBD” letter they released in Fall 2019 raised eyebrows and blood pressure with, well, how negative it feels. Here are the points they highlighted:

  • drug interactions
  • male reproductive toxicity
  • cumulative exposure
  • effects on special populations (the elderly, children, adolescents, pregnant and lactating women)
  • effects on animals (pets and “food-producing species”)


There’s the constant demand for research and public inquiry when it comes to hemp. And it is important for creating regulations around the sale of CBD and sifting through questionable product on the mark.

But there’s some very dark realities about medical products on the healthcare market that makes the process for CBD’s regulations seem awfully ridiculous and excessive.


FDA loopholes that raise eyebrows

There are CBD marketing gimmicks that the shiestiest of shiesty use that make it urgent for the FDA to establish guidelines and flesh out regulation for hemp.

Tweet about FDA registered CBD products, via Javier Hasse

“FDA Registered” is a term that Javier Hasse, notable cannabis reporter and the Managing Director of Benzinga Cannabis, has run into repeatedly. The fact that unethical CBD companies are trying to push this meaningless term into publications is a clear reflection of why the FDA could allocate its time and worries better.

But what makes this term believable?

The fact that there is a loophole around “FDA Approved” thanks to the 510 (k) process. When I spoke about the CBD issue with Hasse, he suggested Last Week Tonight’s episode covering “Medical Devices.”

It’s directly linked to the harmful fast-track companies use to get “FDA Cleared” to have implants—devices going directly into the human body—placed on the healthcare market. With over 800,000 deaths and 1.5 million reported cases so far, this discrepancy may merit the FDA’s slow pace with creating CBD hemp guidelines.

However, this process hasn’t slowed. Whereas with CBD, it seems like the FDA (along with the USDA and DEA) are being so cautious that it brings the industry to a screeching halt. But CBD companies are using wordplay to squeeze money out of people by lying to them now.

How long can we wait on clear direction with such a rapidly growing industry?


Why the wait on hemp medicinal use is so important

You may use CBD regularly for your daily or occasional discomforts and get great results.

But how long did it take you to figure out your dosing?

Did you have the help of a physician?

Are you consuming other medications while exploring CBD?

These are questions that are part of why the FDA needs the appropriate time to create regulations and guidelines.

As we know with cannabis, the plant can affect every person’s body differently. And (ideally) the government aims to keep risk and potential harm at an utmost minimum when approving products for the market.

Because there are CBD companies that have marketed to infants and children without dosing. That’s a high risk to run on a developing human’s body without the appropriate research to confirm there’s no major harm long-term.

The same risk lies with pregnant people who want to explore CBD. Without the appropriate clinical research, it is indeed difficult for the government to green light it for full use.

cannabis leaf on balloon
Image By Ayrat Gabdrakhmanov

Of course, with the opiate epidemic as rampant as it is, there’s mistrust in waiting on the results of this process. The same with the damage of many legal over-the-counter products that have wreaked havoc on those who suffer from chronic illnesses AND the side effects of consuming conventional medical solutions.

In the same breath, the FDA’s conservative pace may induce eye-rolling. But it’s this same commitment to gradual change that may be their attempt to not be as gungho about introducing newer health products into a country already scorned by its health care system.

Yes, there are many infants, children, pregnant individuals, veterans, seniors and many others who have found success with bettering their lives with CBD. However, we have to be upfront about learning the full range of potential side effects.

Still, with the hemp and cannabis community compiling its own resources, research and treatment plans with the help and resilience of physicians, when will the FDA lean more on that research?


The Feds need to ease up on CBD

The concern for safety can feel awfully overbearing. And with the stringent federal rules for growing hemp, it seems like the FDA, USDA and DEA are out of touch with the reality of the plant.

Hemp farmers and business owners feel squeezed to keep hemp’s THC content under 0.3% throughout the cultivation and drying process.

Image By OpenRangeStock

Some consider these regulations to be “harsh, disaster-driven.” Why? Because there’s multiple testing of hemp that require growers to go to offsite DEA labs. Which doesn’t account for the gradual deterioration quality and chances to spike THC levels.

2019 was the hemp’s first legal year. And with such tight rules, it begs the question if any officials in these federal organizations are knowledgeable about hemp. How many are getting first-hand experience to learn by actually showing up at the acres upon acres of hemp farms?

This needs to be encouraged.


Outro: So what can you do?

The FDA expressed that it holds public forum opportunities, so we’ll keep you posted for participation. Follow us on social media and join our email list so you know when to share your experiences with CBD to help shape the cannabis industry.

Fall 2019 was hard on the cannabis industry. And the FDA’s focus on harm reduction may seem like a negative step. But it reflects that the federal government is willing to move forward with hemp—just very cautiously.

Cannabis and hemp affect each individual differently. That’s the exciting thing about it as medicine.

But without a full range of knowledge, we can only be patient and seize as many opportunities as possible to keep the government up-to-date on studies.

Share this blog post with your initial thoughts on the FDA’s potential harm letter about CBD.

Come Back Again

You must be over 21 years of age to view this website.

Are you over 21 years of age?