The Annoying Double Edged Sword of FDA’s Strict Rules on Medical Claims
When I’m mad about something complicated and really want to lay into someone, I have to slow myself down and analyze who’s actually guilty of making me mad so that I can appropriately focus my anger to whoever or whatever deserves it. It turns into a good ‘ol fashion ‘Who done it’ mystery like And Then There Were None. But in my mystery, we’re trying to find the asshole instead of the murderer (Even though you probably are an asshole if you’re murdering people).
I read an article this morning about a CBD Company is California getting fined $336,000 by the FDA for making medical claims. That really set me off because the FDA rules about medical claims are bullshit, BUT ALSO, very necessary. The reason I call them BS is because they make my life so much more difficult in trying to run and good business. I know I make a great product that does what it’s supposed to, but I can’t say what it does and why it does it. I have to tip toe around the truth because the truth can get me fined $336,000 apparently.
My kneejerk reaction was to immediately start cussing about The FDA – “You’re agency is tasked with protecting consumers from food and drugs and the only thing you protect is big pharma’s profits and stock dividends.”
As I heard myself muttering that, I realized that The FDA has become a puppet for big pharma and Big Pharma was the real asshole because they bribe the FDA.
Here’s a very short overview view of what the FDA defines as a medical claim and how companies are allowed to make them
The FDA considers a ‘medical claim’ as a statement that describes a relationship between a food substance (a food, food component, or dietary supplement ingredient), and reduced risk of a disease or health-related condition. That seems fair, until you see how the definitions of “A relationship” and “health related conditions” changes based upon what company/product/industry they’re reviewing.
Examples of health claims are “Pain Relief”, “Anti-Inflammatory”, “Anti-Anxiety”, and tons more. You can see how this makes writing about why our products are awesome very difficult.
To be able to legally make a medical claim, a company has to prove that their product does what it says.
Again, this is fair and good. You don’t want companies to say their product does something it doesn’t. DUH. BUT, proving it is a ‘pay to play’ game that only Big Pharma can afford to play. Pre-pandemic, it costed over a $1 million to get the most basic type of OTC approval. I’m sure it costs more now because everything does. If you’re developing a cancer drug, then yeah, it’s gonna cost you a $100 million and several years to get approval. But if you’re just trying to prove that something relieves pain, then that shouldn’t cost $1,000,000 to be able to say. That should cost like $30,000 MAX.
But here’s my real beef with this.
You can make a claim about something that’s already been proven about an ingredient you’re using. For instance, GW Pharmaceuticals sells 3000mg CBD oil for like $5k/month (Yes. that’s crazy). It’s literally CBD dissolved into a carrier like safflower oil. They are legally allowed to say that their CBD decreases seizures and is an anti-inflammatory. However, I can’t say that my molecularly identical CBD has the same properties.
That’s f-ed up, right?
I understand that they paid millions to “prove’ that CBD does the things they say, but that doesn’t mean that only their CBD does that. CBD is CBD. It doesn’t matter if you’re charging $3 or 3 cents a milligram, CBD does what it does. In fairness, GW has huge overhead to pay for like lobbyists bribing politicians and buying doctors expensive gifts to write scrips.
Now back to my ‘who done it’.
Now, I’ve settled on blaming big pharma for the BS selective and over enforcement of medical claim laws against the hemp industry.
But it still didn’t seem right. I felt that I was letting someone off the hook because there are a ton of pieces of $hit in the CBD industry that need to be fined and shut down.
You hear about these greedy, evil bastards that exploit sick people’s desperation by saying their CBD will cure brain cancer and charge them a fortune for it. Terminally ill people will believe a lot of crazy stuff because they need to. They want hope. It’s despicable that there are people who will exploit that. I overheard a former colleague on a call say, “Oh. Oh. Oh. You have cancer. Ok. If you want to cure cancer, you need the pure oil. That’s going to cost about $3000.” He walked into my office right after like, “Dude, I just made a good sale.”
I was so shocked and angry that my vision went blurry. I went crazy screaming at him, “Dude! You’re not just gonna get us fined and locked up. You’re going to get us sent to Hell, too!” He was an atheist, so he responded with something a bitchy 17 year old punk kid would say, but I don’t remember. I fired him soon after than because he was an all around terrible person, not just in that one instance. However, he’s still around Atlanta selling his cures for cancer and he’s probably got new cures that make him a lot of money.
This story made me understand why the FDA has strict rules about making medical claims. They have to because there are too many people who have no morals or integrity when it comes to getting money.
At this point, I was madder than when this whole rant started because I had also confused myself.
And then it hit me.
I should be mad at scumbag assholes.
Scumbag assholes are the reason for all of the problems in world. Think about politics, Russia, pollution, problems at your job or church. There’s always at least 1 scumbag asshole that’s responsible for a disproportionate amount of problems.
It doesn’t matter if they work for the FDA, Big Pharma, or a CBD Company – an asshole is an asshole and they all stink.
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