The FDA does not crack down on supplements. It's not their role. The FDA cracks down on “claims”. That’s what the FDA is about. If you don’t make a claim in the packaging or the advertising, then it’s not a “drug” in FDA-speak. If you make a claim, in the packaging, then it is claiming to be a “drug” and requires FDA approval. This is an important distinction. The FDA does not approve products, it does not approve drugs, it does not approve supplements, it approves claims.
This is an important aspect of freedom.
I am free to buy garlic, as plants, or as foods - bulbs, or as pills - as supplements. I’ve free to eat them whole, to roast them, to add them to anything I am cooking and to buy garlic sausage - and other foods that have garlic added.
Anyone is free to sell garlic, as plants, as food, as supplements or as pills, as long as their sales literature does not make a “health Claim” and as long as it makes no “substance function claim”.
I am free to believe what I want about garlic.
If someone sells garlic pills, or bulbs, or plants, claiming that they “are good for disease X”, they are selling a drug, not a supplement. The claim must be approved by the FDA, or the FDA will crack down. If someone sells garlic plants, or bulbs, or plants, with a printed claim that garlic “helps digestion”, they are making a substance function claim, which must be approved by the FDA or the FDA will crack down.
The FDA is the “Food and Drug Administration”. They regulate, and crack down on drug claims and on a substance function claims.
There is another important aspect to freedom.
Anyone can claim that garlic is good for colds, flu, for keeping vampires away. We are free to make claims - as long as we are not packaging and selling garlic.
Frankly, a lot of what the FDA does is a scam. The FDA approves CLAIMS, not products. The FDA does not evaluate any products, it only evaluates claims. The FDA does not care about disease, or illness, or health. They care about claims. It’s a bureaucracy.
The FDA approves HEALTH CLAIMS. What the FDA calls a “health claim” is actually a “disease claim”. It is not possible to submit a “health claim” to the FDA unless it contains reference to a disease. The FDA also approves “substance function claims” - which are closer perhaps to a health claim. However, it only approves, or refuses to approve, those claims when they are submitted as part of a product package or marketing initiative.
The FDA will accept minimal evidence for any “drug” if the drug is patented. If you manage to patent a “garlic extract pill” and then do a series clinical studies that demonstrate it helps people with disease X, a statistically significant percentage of the time (note statistically significant can be a very small percentage), then you can PAY THE FDA a lot of money and get it approved as a drug. Once you have it approved as a drug, you can label it as a drug. If your patented recipe is dangerous to the health of normal people, when taken in large quantities, it might become a “prescription drug”.
The FDA will not accept any scientific evidence for a product that is not marketed with a claim. In similar logic, the EEU drug approval agency was asked if they would approve 'water' as a drug, because they could claim it prevents the disease 'dehydration'. The response was basically "We only evaluate claims when the paperwork is completed. (and the fees are paid)" eg. Until someone prepares marketing material for a product, with a claim that it "prevents dehydration", the claim will not be evaluated.
The FDA does not care if you say “an apple a day keeps the doctor away”. They don’t care if it’s true or false. It’s not a “health claim” in FDA-speak. But if you print a message on your apple boxes that says “apples help treat patients with disease X”, they care, and they will ask for proof, or crack down and possibly confiscate your packaging, and your “dangerous product” as well.
to your health, tracy