do over the counter medications reqire FDA approval?

Answer 1

OTC medications such as cold preparations, antacids, ophthalmic products do require FDA approval, however herbal products do not. Many consumers are under the impression that because some products are natural, they are safe. It is always a good idea to check with your pharmacist for drug interactions with any current medications being taken.

Answer 2

They become OTC medicines only after FDA approval. Aspirin and other pain killers are examples. If it is not governed by FDA, it must say so on the label clearly.

Answer 3

Yes - unless they are within grandfather clauses and they have now upped their regulation of vitamins.

The regulation is killing millions of people a year, because only drugs that deal with popular and regular afflictions can meet the cost of analysis and testing - e.g. diet drugs.

On the other hand, antibiotics for drug resistant strains of tuberculosis, etc., have such a small market that the game is not worth the candle.

Stupid films attacking drug company testing on humans in Africa are cutting off the only short circuits on this, so humans are to die naturally of course.

So, unless it is grandfathered, it is caught. There are a lot of generics that are grandfathered, but the margins in them are not great because anyone can make them. They are not patentable.