The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the control and supervision of a variety of consumer-level products.

Our concern with the FDA is the regulation of cannabis products. Keep in mind that the FDA is a federal United States agency. No equivalent to the FDA exists at the state level. As such, they have to abide by federal law, where currently marijuana is still a schedule-1 substance on the Controlled Substances list, and federal policy is still based on the War on Drugs.

Is any cannabis product FDA-approved at all?

The Food and Drug Administration is an encumbered, heavily bureaucratic organization. They are not under obligation to approve anything at all, but they have an extreme liability if they approve something by mistake. As you might guess, a federal branch which is better off when it’s doing nothing tends to sit on its hands a lot. Remember also that the FDA must hold every approved product to the standard of being not just safe, but effective. It’s easy to prove cannabis-derived products safe. Proving a product is effective for a medical treatment takes years of research.

So far, the FDA has approved “one cannabis-derived and three cannabis-related drug products” available only by prescription, for a narrow range of medical conditions.

So what if the FDA never fully approves cannabis?

A lot of people seem to have a misconception as to the FDA’s role and function within government substance regulation. You’d be amazed at all the products which have been sold for years without FDA approval:

  • Veterinary medicine – The FDA is functioning within the department of “Human Services,” after all.
  • Human stem cell products – In fact, anything involving human tissue.
  • Tobacco products – The FDA takes the stance that there is no such thing as a safe tobacco product, full stop.
  • Infant formula – It’s been stocked on every store shelf for at least a century without FDA approval.
  • Dietary supplements – The entire vitamin aisle at your local drug store functions without FDA approval.

This is how conservative the FDA is: They do not support what is called “structure function claims” on supplements or foods. Structure function claims would be statements like “calcium builds strong bones,” “vitamin C is good for your immune system,” or “soluble fiber helps lower cholesterol.” It doesn’t matter how common sense it is, how much every doctor agrees on the truth of the statement, how many clinical studies prove it. The FDA will not sign off on the statement “water keeps you hydrated.”

As you can see, the FDA is not the final arbiter in everything you can put into your body. Some products are considered outside its jurisdiction, and others just function by special laws. The Dietary Supplements Health and Education Act of 1994 (DSHEA) allows dietary supplements to go to market without any input from the FDA. If a dietary supplement product is bad for you, the burden of proof is on the FDA to prove that.

So why does the FDA go after CBD products?

CBD is federally legal under the 2018 Farm Bill, being derived from hemp as opposed to cannabis. The problem is in how you sell it. Since CBD is classified as a “drug” still, it falls under the jurisdiction of the FDA. However, CBD is not approved for more than a few prescriptions. Still, its classification as a drug also prevents it from being sold as a dietary supplement. Hence, the FDA has become entangled in legal actions taken against several CBD companies for alleged health claims:

The point here is all in how you label something. As far as the FDA is concerned, you can sell hemp and hemp-derivatives by the bushel out the back of your car trunk, as long as you make no claims for what it does. The second you call it a “dietary supplement” or claim that it cures anything, you’re in trouble. So even though there is some research that CBD may help treat PTSD, and even if a PTSD sufferer decides to buy it and try it out, you can’t sell a bottle of CBD oil with the words “helps treat PTSD” on the label.

CBD and hemp products are in the grayest of gray legal areas right now. Until we get relaxation of marijuana policy on the federal level, it looks like that won’t change.

 

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