| HN Mirror

> Yes, the FDA does make it harder/impossible to treat yourself. You are an idiot as far as they are concerned.

FWIW, the FDA doesn't even think about the end-consumer. They're the government's labelling-standards body. They just care that:

1. if you sell a product labelled 'X' (e.g. "milk", or "ibuprofen"), then it should contain only the ingredients—and the concentrations of such—listed in The Big FDA Book of What Products Labelled 'X' Contain. (This covers both the "no salmonella" cases, the "you can't call Cheez Whiz 'cheese'" cases, and the "beef withdrawn from the market for containing more iodine than beef usually contains" cases.)

2. if you make up a new product 'X'—really, a new product label 'X'—then "FDA approval" just means convincing them to add a page to their Big Book. You have to write that page: you must claim all the expected effects of consuming an 'X', and exhaustively list all potential side-effects of consuming an 'X'. Then, you must submit evidence that proves to their satisfaction that your reference-product for the label 'X' has all of those effects you listed; and that it has no other side-effects than the ones you listed.

Food manufacturers usually just have to deal with #1. Drug manufacturers have to deal with #2 and then #1. (Or just #1 if they're making existing drugs.)

The FDA was, for most of its life, just about #1: enforcing product integrity. They also did #2, but #2 wasn't a big deal—getting approval from the FDA for a new drug wasn't supposed to be hard or even expensive, as long as your drug really did something. It could even have disastrous side-effects. If you thought it was still marketable despite those, then you could just tell the FDA about them and they'll approve it. (See: all chemo drugs.) Just give the FDA a proven-accurate page for their Big Book, and they're happy.

But then the pages of the FDA's Big Book began to get taken as truth by various other standards bodies, that regulate what can or cannot be sold (sold at all, or sold over-the-counter, etc.)

And, because of that, manufacturers wanted their page in the Big Book to list great effects and few side-effects. Because then the barriers between them and their market are lower.

And what this means, is that that manufacturers started lying to the FDA, submitting a page describing what they wish the product was like, rather than what it is like. That's the only reason the FDA ever "does not approve" (note: not "rejects", just "does not approve") of a new label—the manufacturer can't prove their claims. I.e., the label isn't true.

Thus began the adversarial and expensive relationship between modern pharma companies and the FDA: the pharma companies want to make everything OTC and want to make a million claims about what each drug does; and the FDA just stands there, shakes its head, and tells them to come back with numbers proving their claims. And then the pharma companies burn through millions/billions of dollars trying to "prove" things that they know aren't true. Until they either eventually fail and just register a realistic monograph; or, rarely, they succeed (due to p-hacking) and end up with a drug that now is being taken by all the wrong people for all the wrong reasons.

Hate the ADA, or the DEA, or any number of other groups that use the FDA's Big Book, but don't hate the FDA themselves. All they're doing is taking a set of words (like "milk" or "ibuprofen"), defining them precisely, and then requiring companies that use those words in their marketing, stick to the definitions those words have in their Big Book.