Hello Duncan and all,
In the 1990s Jeffrey Thayer, a quite smart (none of them are really dumb,
are they?) and experienced lawyer who has chosen not to be a member of the
ABA---a private trade union, not part of any government except that of Great
Britain---researched and wrote a paper titled, Scope of Federal Food and
Drug laws; What are the limits of FDA Jurisdiction?
Quoting from page 59 of 60:
"Thus, at the time of the changes or modifies its organizational structure
in some partial way, but fails to place the American public on notice by
publication. [sic. The sentence is garbled as above in my copy.] However, a
far more serious problem ensues when an agency fails to publish statements
of its entire organizational structure and has been remiss in its duty to do
so for many years. The above statutory requirement makes it plain that
current federal law commands that federal agencies publish their structure
within the Federal Register for the 'guidance of the public." Regarding the
FDA, Freedom of Information Act request to that agency seeking its
organization and staffing manual will result in the production of a several
hundred page, very detailed manual. But, this full and complete manual
simply is not published within the Federal Register. The ready question is
whether, due to this deficiency, the FDA really has any effect upon the
domestic American public. [Footnote 6]
FN6: "In the Spring of 1992, CNN ran an article concerning the inspection
requirements for domestically marketed fish products. That news article
stated that domestic fish producers submitted to inspection voluntarily, but
that foreign producers were compelled to comply with those FDA laws."
One of many cases discussed in the paper is; Pinkus v. Reilly 157 F.Supp.
548 (D.N.J., 1957)
>From page 57 of the paper: paraphrasing for brevity. This case involved the
post office, but the principles may apply to current FDA situations.
"Pinkus advertised and sold a weight gain program through the U.S. Mails.
Post office contended he was a fraud and stopped him from using the mails.
Pinkus sought judicial review of the fraud order and asserted that the
agency had through unpublished statements of organization, in essence
commingled the agency's prosecutorial and adjudicating authority in the
hands of one official, this latter commingling also being unlawful."
Excerpts from the courts opinion:
"The last above point raised by Pinkus seems to be directly and clearly
covered by the terms of the Administrative Procedure Act itself, which
provides that 'no person shall in any manner be required to resort to
organization or procedure not so published'" 157 F.Supp., at 549.
It is thus clear that Pinkus was 'required to resort to organization...not
so published'- in the Federal Register. This obviously violates the above
provision of the statute that 'no person shall ***. Thus the Department's
present proceedings against Pinkus are invalid," 157 F.Supp., at 551.
The fraud order was deemed "VOID" by the court. Most of what these dips do
is smoke and mirrors, backed up with guns.
The same principles will apply to the FDA. Times have changed, and without
looking, who knows what they are now up to.
One of the sections of Jeff's paper is, "Application of Principles to FDA
Laws". Subheading: "The Practice of Medicine is Beyond FDA Jurisdiction".
Subhead II "Local Manufacture is beyond FDA Jurisdiction"
Further, FDA seizure actions ("raids") are conducted by FDA District
Directors.
"21 C.F.R section 1.83 defines 'district director' means the director of the
district of the Food and Drug Administration having jurisdiction over the
port of entry through which an article is imported or offered for import..."
Quoting Jeff; "There is thus a real question as to whether a District
Director has any jurisdiction other than over a port of entry."
There is a bunch more in the paper, including holes in federal jurisdiction.
Some listers may wish to obtain a copy. I do not know if it is available,
and I do not know for sure how long it may take me to contact Thayer.
Anybody got time to search the Federal Register for FDA stuff?
Question; does advertising on the web grant Fed. Jurisdiction when the stuff
is sold only within the state in which it is manufactured?
Later,
JOH
James Osbourne Holmes
FTNWO
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