May
Make Your Voice Heard
From April 3rd to July 2nd, the Federal Drug Administration (FDA) is accepting public comments on the safety and sale of products containing cannabinoids, including CBD.
We have an unprecedented opportunity to speak directly to the largest regulatory agency in the world and make a case for hemp and hemp-derived products. We can’t afford to waste it!
As of May 11th, approximately five hundred comments have been posted to the Federal Register. A hefty portion of those comments support the kind of expansive and invasive regulation that could potentially cut off access to hemp-derived products for millions of Americans.
The outcome of this first public hearing will determine the nature of the debate — whether hemp advocates play a defensive or offensive game in the coming years. We have a little under two months to make a case for the value of hemp-derived products, and why access to them is so important to the nation’s health and well-being. It’s time to leave our mark!
Why the FDA? Some Backstory
Thanks to the 2018 Farm Bill, growing and harvesting “industrial hemp” is federally legal. Hemp is off the list of controlled substances and beyond the reach of the Drug Enforcement Agency (DEA).
However, the Farm Bill explicitly preserves the authority of the FDA to regulate hemp and its derivatives (CBD, THC) in food, cosmetics and supplements. It hasn’t taken long for the FDA to flex its regulatory muscles.
In a high-profile series of warning letters to CBD brands, the FDA made clear that it would not tolerate “unsubstantiated therapeutic claims” made by companies marketing cannabis-derived products as medicine or supplements.
The FDA is going to be involved in the hemp industry. It’s just a fact of life. This first public comment period is a kind of coming out party — a party without presents, cake, or beer and with lots and lots of clowns.
We need to come together as consumers, brands, vendors, advocates and human-beings and make our voices heard. The FDA, to its credit, is ready to listen.
The Path to Hemp in American Households
Do we want to win? Do we want to see hemp-derived products get to the people who need them most? Do we want to free the plant? Yes, we do.
That means we’ve got to be cold-blooded. We have to swallow our pride and tailor our comments to appeal to our audience, the FDA. If we allow this comment period to become an outlet for our frustration, we’ve missed the point.
Right now, most of the comments in favor of increased regulation for hemp-derived products are detailed, well-written and supported by evidence. Meanwhile, a majority of the comments supporting hemp-derived products are either brief testimonials, rants or insults.
At least, that’s how the FDA will see it.
Comments which are not supported by scientific data, or which criticize the underlying principles of western medicine or the policies of the FDA, will do more harm to the cause than saying nothing.
That being said, the time for action is now. The FDA has asked to be educated, so let’s educate them.
Writing a good comment is pretty easy. Let’s get into specifics.
A Hemp Advocate and the FDA Go on a Date
We’re taking the FDA out for dinner and a movie, and we’re hoping to get a peck on the cheek, maybe a second date. If we mention any of the following issues or themes, we might as well have cheese breath.
- Evil Pharmaceutical Companies
- The Drug War
- Marijuana Prohibition
- Criticisms (non-constructive) of the FDA
- Criticisms of western medicine
- Criticisms of empirical data
- Praise for homeopathic, naturopathic, natural or eastern medicine.
- Recreational Weed in all forms, from the tokeable to the tasty.
- Cannabis culture slang
- Aggressive Tone
- Cursing
The stuff that makes us kissable
- Utilizing sources to back up claims
- Providing links or citations to the sources
- Aligning argument with the mission of the FDA
What Not to Say to the FDA
Billy’s Bad Letter to the FDA
What did Billy do right? Not a lot.
What did Billy do wrong? Everything. From the very first sentence, the very first word, it’s apparent that Billy intends to run the airliner into the mountain.
He is combative and accusatory. He starts by issuing an order, and he follows that order with a full on attack against the FDA, the same people he should be flattering. Billy has a lot to say, but virtually all of what he has to say is irrelevant to the issue at hand.
Now, could Billy be kinda, sorta, a little bit…right? In spirit, perhaps Billy is right. But the first public comment period on cannabis-derived products is not the venue for ranting and veiled threats.
How to Write an Effective Public Comment
It’s About Quality, Not Quantity
One high-quality comment is worth more than one-hundred low-quality comments. What is the measure of “quality?” In our case, the FDA is searching for new facts about hemp-derived products. A high-quality comment supplies the Agency with new facts. Is the comment useful? That’s the general rule.
Comments will be considered high or low quality based on the following factors:
- Is it relevant to the point of the hearing?
- How much evidence is presented?
- Is there a strong link between the presented evidence and the claims?
- Is it well-written? (No need to impress the FDA with beautiful language, just utilize a spell checker and proofread it for obvious mistakes.)
- Does the commenter have any credentials that give he or she special authority on the subject? (A neuroscientist’s opinion carries more weight than a writer’s opinion, for example. Author’s note: sad face)
Address the Goal of the Comment Period
To find the goal of the comment period, look no further than the name: “Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds.”
The goal is to collect data and information on the “safety,” “manufacturing,” “marketing,” and “quality” of products containing cannabinoids like CBD.
To move the needle on FDA policy, we have to put data and information in the driver’s seat.
Find the Big, Relevant Points in a Personal Story
Does the importance of “data” and “information” mean that we can’t use our personal stories? No! (And blast the one who says otherwise!)
However, it’s easy to retool testimonials into effective arguments that are relevant to the purpose of the hearing. All we need to do is make a slight change in what we prioritize, letting available evidence dictate what we choose to include or exclude from our comments.
Take the statement, “I don’t know what I would have done if I hadn’t found CBD products.” How do we make that relevant?
What about “…if I hadn’t found CBD products”? That sounds a lot like, “…if CBD were not available.” Thinking about what might cause CBD to become unavailable, we discover some relevant themes like “Regulation,” “Access,” and “Priorities.”
Let’s put the ideas into action:
I don’t know what I would have done without affordable access to CBD products, and that’s why I urge the Agency to avoid imposing sudden and unnecessary regulation that would put enormous pressure on a growing industry and likely dry up the funding needed to conduct further studies into the potential of cannabinoids like CBD.
To reduce the risk of pulling the rug out from under current users, the FDA should take a more measured approach to regulation — especially considering that multiple clinical reviews have found that CBD, “has no psychoactive effects and does not affect cognition; has an adequate safety profile, good tolerability, positive results in trials with humans, and a broad spectrum of pharmacological actions. [1]
Include a List of Your Sources
Every quotation or summary we use has a source, and we have to reference that source in a list at the end of our comment. Remember the “Works Cited” page from high school? That’s what we’re doing, minus all the rules and formatting. Simply write,
- Name or title of the source
- Internet address of the source
Example (a reference list for the comment we just read):
Reference List
- “Safety and side effects of cannabidiol, a Cannabis sativa constituent.” https://pubmed.ncbi.nlm.nih.gov/22129319/
An “in-text citation” is just a way to show the connection between a quotation (in the text) and its source (in the reference list). It’s easy.
To create an in-text citation, take the number of the source (for now, we’ll stick to 1) and put that number at the end of the quotation, in brackets.
Example:
“CBD has no psychoactive effects.” [1]
Another example, this time with both an in-text citation and a reference list:
Bunny Rabbits are cuter than every bird species, with the exception of ducklings (when waddling after their mother and occasionally stumbling over small branches and other obstacles in a cute way). [1]
- “Comparative Cuteness in Mammals and Birds.” https://www.NewEnglandJournalofthe PreciousandAdorable.org/comparativestudies/comparative-cuteness-mammals-birds
Get the Resources to Make it Easy. Write a Comment to the FDA.
Do you feel ready? We think you’re ready, and we’re offering our friends and partners access to our own list of CBD-related research, studies, and reviews on Pubmed.
Want to write about CBD and anxiety? We’ve got just about all the studies you need — all in one place.
Selected Clinical Trials and Research Reviews
- Cannabidiol in Anxiety and Sleep: A Large Case Series. (Recommended!)
- CBD as an anti-anxiety drug, Review
- CBD as a treatment for Panic Disorder (PD), Review
- CBD as an antipsychotic drug, Review (It does implicate THC as capable of inducing psychosis. However, the abstract states quite clearly, “this cannabinoid can be a safe and well-tolerated alternative treatment for schizophrenia.”)
- ECS and Pain, Review
- Cannabinoids and Pain Management, Review “Cannabinoid analgesics have generally been well tolerated in clinical trials with acceptable adverse event profiles.”
Our example of a high-quality comment:
What did Billy do right? Almost everything. Billy is not a medical specialist, so he has to stick to making simple, direct points that don’t require a background in biochemistry. He also included the docket number (FDA-2019-N-1482) at the top of his comment.
Though far more detailed, Billy’s final comment is actually less ambitious than his first and second comments. The fewer, and the more specific the claims, the easier it is to support them with evidence.
- “Safer than pharmaceuticals” became “safe.”
- Instead of taking on both “addiction” and “anxiety,” Billy chose one to focus on. As a result, he was able to write a great comment without spending his entire Saturday at the computer.
- He made the difficult choice to remove an intensely personal part of his journey with CBD — how be beat an opioid addiction. The hard truth is that including references to addiction without the kind of evidence the FDA likes to see would hurt, not help, CBD users.
Go forth and conquer!
Your friends @GreenLotusHemp
To send by mail or deliver by hand:
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
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