Under the FD&C Act, any product intended to diagnose, cure, mitigate, treat or prevent a disease, and any product (other than a food) that is intended to affect the structure or function of the body of humans or animals, is a drug.
So it’s not selling CBD they have a problem with, it’s the claims these companies are making.
Funny, we just met with lawyers who interface with the FDA concerning the same thing for our human health side of business just to be proactive. They are cracking down hard across the board.
And they totally should. You cannot make medical claims - full stop.
Make them and the government will come and take away your toys and your candy.
Good for the regulators for enforcing the rules that keep us all safe.
We get what - 10-15 warning letters and other enforcement actions about this a year on the CBD side. As soon as, THC is descheduled (bets on how long anyone?) I expect we’ll be seeing A LOT more on the THC side of things, because people are making claims left, right, and center on that.
If you want to make claims - get with a clinical research organization and start doing the work.
Or better yet, join me in asking the FDA to create a new category for cannabis and cannabis derived products that is separate from food, drugs, nutraceuticals, and medical devices. Getting lumped in with those other things will be brutal and really reduce consumer access to these products.
What if the claim is true? That is where it really bothers me. If I have customers who say it helps with a medical problem and then the next prospective customer asks me what cbd is good for…what am I supposed to say? Is it the law that I have to lie to people…or else get fined for the crime of lying to people?
The fda exists to protect the profits of the pharmaceutical industry. They care nothing about any one person’s health or safety.
But anecdotal evidence isn’t “truth”. And if you trick someone into believing that your CBD cures cancer, because you told em it would, and they die anyways, the liability might fall on you or the FDA, and thus we, the tax payers.
I personally would prefer no government and personal accountability. But our current situation leads me to think finding suitable loopholes is much better than kicking the FDA $75k
This is a common misconception. You do not LIE to your customer. You also do not market (specifically list for sale and/or label a product specifically) things that have not been approved by the FDA in the United States as drug products.
There’s nothing in the law that says you cannot verbally talk to people about your personal experience or as @Future said testimonials from your other customers. Its really about using media to share information that claims specific medical benefits without clinical support where the benefit is not generally recognized by the scientific community (which includes government agencies, institutes, universities, and loads of peer-reviewed journals).
So if a person comes to your shop and asks what can I use this for - make personal statements or reference your testimonials, instead of concrete statements which might be construed to be making a medical claim. All of the people in these warning letters were making specific label claims or claims on their website that their products treated or cured a specific ailment. Most of us agree that many of these claims work for some people and knowing just how well they work is research that is still on-going.
The FDA exists for more than pharmaceuticals - and its been put in place by the power of the people due to some pretty terrible things that corporations did (knowingly, unknowingly…) that lead to people getting really sick and dying. I’ve worked with amazing regulators from the FDA for almost 20 years - a majority of these government employees want nothing more than to keep patients safe. Many of them are just as frustrated with pharmaceutical company over-reach as you appear to be.
In general - I’d say most pharmaceutical companies HATE the FDA and all the hoops, loop dee loops, and general government wonkiness they have to spend millions of dollars handling each year. The FDA makes life very uncomfortable for most of us - cannabis is getting a cheap ride along with them right now because of Federal scheduling. And as all the hemp folks out there are learning, playing in the legal unscheduled space is not for the weak of heart.
The warning letters will continue and the regulatory landscape will continue to shift as the FDA works its fastest (which is generally pretty slow…) to handle issues with bad actors (people making stuff you don’t want to sell to your customers) and with all the questions from consumers.
Remember - the FDA isn’t out there looking for this stuff. They are getting customer complaints and investigating those complaints and then knocking on the doors of the producers.
One of the specific allegations from the fda was “misleading testimonials.” According to whom? The misled people? Probably not. Where is the harmed individual? The fda is unilaterally defining what it means to be misleading. Amazon sellers have destroyed the cbd oil market with worthless hemp oil products. Where was the fda then?
The leaders of big pharma, the fda, and the dea are sometimes literally the same people, because they bounce back and forth from working in one industry to being a consultant for another. Corporate regulation in the us is an incestuous mirage.