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!
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.
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.
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.
The stuff that makes us kissable
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.
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:
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.
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.”
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]
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,
Example (a reference list for the comment we just read):
Reference List
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]
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.
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.
Go forth and conquer!
Your friends @GreenLotusHemp
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
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