There are plenty cases where people get around FDA-approval for drugs by operating like Lumina Probiotics. You aren’t allowed to say on the sales page that you are working to prevent a disease when you sell a drug, but you can still sell the product.
Whether or not the FDA will see the need to try a way to regulate it, highly depends on the politics of the situation. FDA leadership isn’t what it used to be and wants to reduce regulatory burden. Predicting how the current administration wants to regulate yeast-based vaccines is hard and is going to depend a lot on how the political winds are blowing.
If you’re going to tell people it prevents a disease, the FDA is going to (find a way to) regulate it like a drug, even if it is also legally a food.
There are plenty cases where people get around FDA-approval for drugs by operating like Lumina Probiotics. You aren’t allowed to say on the sales page that you are working to prevent a disease when you sell a drug, but you can still sell the product.
Whether or not the FDA will see the need to try a way to regulate it, highly depends on the politics of the situation. FDA leadership isn’t what it used to be and wants to reduce regulatory burden. Predicting how the current administration wants to regulate yeast-based vaccines is hard and is going to depend a lot on how the political winds are blowing.
I agree. It could be all shut down in a minute, or the FDA might have other priorities.
That’s true