FDA gutted years ago
The mechanisms for legalized non-regulation of biological products are very similar in structure to “Don’t ask, don’t tell.”
The ostensible reason was to relieve paperwork burdens and costs on pharmaceutical manufacturers. The changes are scientifically pseudo-justified with assertions that manufacturers have developed such excellent internal quality-control processes and technologies, that FDA validation of manufacturer claims about product purity, sterility and safety are no longer needed.
Briefly, since the mid-1990s, citing authority derived from Congressional acts and Presidential executive orders, the Food and Drug Administration has been quietly eliminating its own regulatory functions through Federal Register rule-making notices and Guidance for Industry publications.
FDA has essentially told biological product manufacturers:
“We’re not going to ask you what’s in the products that you send out of your factories, and you shouldn’t tell us what’s in the products that you send out of your factories.”
https://bailiwicknews.substack.com/p/deregulation-of-biological-product