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FS5 – You cannot claim cannabis doesn’t relieve pain per the FDA

By June 3, 2022September 15th, 2022No Comments

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On the 7th, I’ll be tapping in for Grizzle’s CannabisCon (online) and talking all things cannabis consumer products. If you don’t see me on the website it may be because I’m a secret special guest, not to be announced until game time. Think 2016, when Drake brought out Kanye at OVO Fest, that kinda thing. As always, the first person to publicly air out any typos in this email on LinkedIn or Twitter gets a hoodie. Let’s get into Free Smoke:​

“I got big packs comin’ on the way,
I got big stacks comin’ out the safe”​
– Drake, Money in The Grave​

We can’t make claims about cannabis, you guys.

The year is 2022 and cannabis is widely recognized as the miracle plant that it is. Millions of consumers use it every day for everything from fun to pain relief, but there’s a problem: nobody invited the FDA to the party.

Here’s the deal: when a product claims to alter the physiology or function of any part of the human body, that’s a drug claim according to the FDA. Drug claims have to be substantiated by a Clinical Outcome Analysis that’s FDA approved… Clinical trials, baby! This not only applies to the Tylenols of the world, but to topicals (think Icy Hot) and dietary supplements (think Red Bull). Not every topical brand can put “pain relief cream” on the label. Consumers hardly notice it, but it’s a huge distinction.

Minus the bureaucracy of the FDA and expense of such approvals, I think this is conceptually pretty reasonable. It certainly cuts down on snake oil salesmen and magic elixirs. Long before cannabis enters the conversation, it gets objectively iffy when essential oils come into play, for example, in topicals. Essential oils, like frankincense and myrrh, have been used for hundreds (thousands?) of years for pain relief, but if I put it in a topical cream I absolutely cannot label it as “pain relief.” Not without spending six figs on a clinical trial.

Enter cannabis. Words and phrases the FDA considers drug claims are rampant in cannabis labels and marketing. One of my favorite examples of this is Rooted Apothecary who got busted by the FDA for marketing cannabis products that claimed to treat:

  • Teething pain and ear aches in infants
  • Autism
  • ADHD
  • Parkinson’s
  • Alzheimer’s disease

If you thought the FDA was an overreaching government agency a minute ago, it probably seems a little more reasonable after that. At the moment, the FDA’s formal stance on cannabinoids is “Idk fam gimme a few,” meanwhile, you can’t walk into a dispensary without being overwhelmed by drug claims that probably do provide the benefits they claim to. If they’re in the topical category, there’s a lot of other stuff in them that also provide pain relieving characteristics.

My solution is twofold:

1 – Cannabis is prolific. The FDA needs to get off their asses, do the studies, and be able to provide consumer guidance on its benefits in order for the magic of this plant to be fully realized.

2 – COAs and approval should be ingredient-based instead of product-based. This would level the playing field and make the entire system more efficient, seeing as we probably don’t need 100 different clinical trials on every Icy Hot-esc product that hits the market.

Disclaimer: You may have seen me mention that for ~10 years, my family’s business was skincare and cosmetic manufacturing. Long before my recreational cannabis days, I spent a lot of time finessing this kind of thing. Don’t even get me started on use of “Organic” in cannabis.

Things That Matter

  • A coalition of MSOs is suing the feds to end prohibition [Link]
  • Arizona did $72M in sales in March. AZ is blowing up, keep an eye on it [Link]
  • Verano will donate up to $13k/mo to Weldon Project’s Mission Green for cannabis clemency [Link]
  • 8th Revolutions June Cannabis Playbook is out and it’s thick. It also features some Free Smoke [Link]
  • The torch has been passed at The Green Paper, a more professional cannabis newsletter you should check out [Link]
  • Survey shows 26% of California operators are unprofitable, 37% nationally [Link]
  • Fox News says, “High potency cannabis may have played a role” in recent mass shootings:

 

In The Streets

It was pretty dry out there with the short week, but this guy in my DMs wants to know if his weed is any good:

Unrelated Vibes

E30 M3 is one of my favorite cars of all time, immaculate lines.


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Photo by Keenan Constance