Print

Print


Michel Margosis wrote:
> 1) 'Natural Substances' have not been scientifically proven that
> they are safe and efficacious, in the manner the Code of Federal > > Regulations prescribe for human drugs.

Make no mistake, the 'natural substances', 'nutrition supplements'
or whatever, sold without FDA approval, may be DRUGS, and potent ones
at that. The big difference between those and the drugs approved by the
FDA for prescription by doctors is that the former have not passed the
rigorous, formal, placebo-controlled testing required by the FDA. Many
of the 'approved' drugs are also derived from natural sources, and the
reason why or how they work may be poorly understood, if at all. There
may be different reasons for marketing a 'supplement' that lacks FDA
approval: Perhaps it's just snake oil, and the owners know it. Or maybe
they don't want to gamble the huge investment in the approval process.
Or perhaps they simply don't survive the stringent trial. Ganglioside
GM-1 is a popular example: After selling it in health food stores for
a long time, the owners started an FDA-type trial a few years ago, but
I haven't seen any published results since then; maybe it's too early.
The other difference between approved drugs and diet supplements is
the latter need not meet rigid production standards of potency and
purity. But some supplements, such as vitamins, are quite reliable.
The main government restriction on supplement marketers is that they
aren't allowed to lie in their advertised claims, and some of the
elaborate circumlocutions that result can be unintentionally funny.
Cheers,
Joe

--
J. R. Bruman   (818) 789-3694
3527 Cody Road
Sherman Oaks, CA 91403-5013