Prior to the 90's the FDA regulated all medications. It required two elements to be documented prior to marketing... Safety and efficacy. These are relative terms. A medication for a cold needs to be much "safer" than a cancer chemotherapy agent. In the 90's a powerful Utah senator with a huge number of companies in his state that made enormous campaign contributions to him, had the law changed to allow companies to market "general" claims without any data and exempted those products from requiring prior FDA review. In other words the Sumter Natural Foods Company can sell a pill that "stimulates your immune system" and "supplements your nutrition" and "may help with joint pain" and the pill can be just randomly ground up plants and rocks. The FDA can do nothing to protect the consumer and can only act after patients are harmed as thousands are alleged to have been over the years. The FDA is trying to protect the consumer. Sometimes regulation is needed. You probably would like to know what is in the pill you are swallowing, and whether it is safe and whether it is effective. If you take a regulated medication, and have a significant side effect, the manufacturer is required by law to report that side effect to the FDA. This post marketing surveillance helps identify rare side effects that may slip through the pre-marketing testing. The supplement industry is even exempt from that regulation. So if Sumter Foods get a bunch of calls that users are being identified with lead poisoning, or failing drug screens due to steroids in their pills, they are not required to do anything about it. The newly proposed regulations will not even address either of these problems for any product introduced prior to 1994, only those new drugs as was allowed in the 1994 legislation.
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