Replies

You would think that is the requirement but in some of the early 1900 Administrative acts they gave the right to establish regulations (technically not laws, but enforceable by the regulating agency as a law) to enact the very vague requirements written into the actual Law. Actual Laws are passed by Congress are called statutes. Statutes, also known as acts, are laws passed by a legislature. Federal statutes are laws enacted by Congress with (and in some circumstances without) the approval of the President. Federal statutes are published in three formats: (1) initially as individual slip laws, (2) in compilations of slip laws known as session laws, and (3) as codified law incorporated into a code. Most commonly these are known by abbreviations PL or Pub. L for Slip Laws, SL or Stat. for Statute at Law for session laws, and United States Code or USC for Codified Law. (USC is the most common)

This did 2 things:

1) allowed congressmen to say they didn’t vote for the regulations and
2) allowed the unconstrained growth of the bureacracy to enact regulation with minimal congressional involvement and oversight.

For example I work in med devices. The law establishes the FDA and says they are to establish regulations to provide for oversight to ensure safe and effective products to the country.

The regulatory law requires that the agency propose a regulation and get submissions from the public before enacting it. Some times they take the input sometimes the explain why they are doing it anyway. Then it is published in the Code of Federal Regulation (CFR).

IN Med devices there is a regulation on how you have to run your quality system in the business - things like what is required for complaint handling, how you have to document your product design, how to deal with nonconforming product,, it’s all spelled out in 21 CFR 820.

I’ve spent the last 15 years of my life helping companies get out of trouble with the FDA because of issues complying with the 820 REGULATION - companies have had product seized and destroyed, plants have had doors locked, they couldn’t ship, produce or even design any more product - UNTIL the FDA said that they had come into compliance with the REGULATION.

The Regulation wasn’t passed by Congress - but the law that created the FDA and handed the regulatory power to the agency WAS.

THAT is the difference. And since Congress didn’t pass the reg they get to act like it isn’t their fault - when it’s 100% because they abdicated their authority to the bureaucratic state.