Well folks, it finally happened. The FDA raided a CBD Manufacturing Site.
This wasn't the first presence that the FDA had in the CBD world. Several warning letters have been distributed over a course of the past few years - all of them focused on improper marketing by the CBD companies in which claims were made that the products could cure, mitigate, or treat diseases.
Although there have been correspondences, it wasn't until 7/31/2018 that the first CBD Manufacturing Site was raided. Signature Formulations, LLC in Arizona had their facility turned upside down by the FDA last month and was sent an extensive letter of manufacturing violations.
How a CBD Manufacturer Got Mixed Up With the FDA
Here's the deal - CBD products aren't classified as drugs or dietary supplements and therefore are slipping away from the jurisdiction of the FDA. This is all a gray area because technically the FDA considers CBD a narcotic, but that's a story for another time.
The FDA has been staying out of the CBD world in the long run, except in cases that the company has marketed their CBD product in a way that classifies it as a drug.
What is a Drug Claim?
The FDA defines as drug as any product "intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease". What is a "disease"? Well, the defintion is a little hazy, but essentially if it's got a name you can assume it's a disease. Heart attacks, cancer, epilepsy, fibromyalgia, and diabetes are all diseases. But so are obesity, addiction, and pain. The FDA also considers products that are anti-microbial, antibiotic, and anti-fungal to be drugs.
The companies were issued warning letters by bringing attention to themselves by making illegal drug claims in the eyes of the FDA.
What Happens if the FDA Comes to Your Door?
Well, if you are manufacturing your products in a safe GMP environment, you should have nothing to worry about should the FDA show up.
Unfortunately for consumers of CBD products, that is not the case. Many of the companies manufacturing CBD products are not doing so in a proper GMP manner. Very few CBD companies are GMP certified, and many do not have the proper controls in place.
It would be wise for all CBD companies to protect themselves against bad inspections by implementing a GMP system as soon as possible. Of course, we are here to help. But no matter how it's done, get GMP certified and do it quickly!
Doing a Social Media Sweep
To try and take your company out of the limelight and reduce the risk of FDA intervention, it's essential to do a sweep of all social media. The FDA considers ALL media to be advertisement. This includes websites, Facebook, Instagram, hashtags, and even customer comments and testimonials! If there are drug claims anywhere in any of these places, your company is a target for the FDA and is likely already on their radar.
I suggest hiring a company like ours to help you do a sweep and find all your drug claims. We also have a blog post here that explains the type of work that's done when properly advertising in the eyes of the FDA.
We Are Here to Help
Our number one goal in the industry is to promote a safe consumer. This can only be done by helping blossoming companies, like CBD manufacturers, navigate and understand the expectations of the government and the pillars of quality assurance.
We are happy to help you do a social media sweep, advise your company on safe practices, and even help you take the leap into GMP compliance.