| Editors’
note: The recent FDA ban on ephedra has sparked a
debate about natural remedies and how they are regulated.
But the FDA and the vitamin and food supplement industries
have been at odds for many years over regulation.
1966
— Recently the Food and Drug Administration
issued a series of regulations which affect vitamin
and mineral food supplements. Basically these regulations
would limit the ingredients of food supplement products
to those which the department determines they wish,
and at specific potencies which they would set. The
regulations therefore arbitrarily dictate what amounts
to a single formula, to which all manufacturers and
users would be restricted.
In
the light of current scientific knowledge, this type
of restriction is neither logical nor intelligent.
From the aspect of regulatory limitation, it goes
even further, in that it specifies, to a certain extent,
what can and cannot be taken nutritionally, whether
in food or in supplementation by the American public,
and further what can and cannot be recommended by
health practitioners, throughout the United States.
This type of regulation can have immediate consequences
and its far reaching effect is extremely serious in
view of the patient’s right and the doctor’s
wishes in the professional nutritional management
of health problems.
The
segments of industries which are directly affected
by these regulations are numerous — they encompass
food processing, pharmaceutical companies, food supplement
formulators and nutritional consultants at all levels.
They are of immediate concern to these people and,
just as when a similar regularity attempt was made
four years ago, all of these industries and all of
these people will again be filing objections to them.
On
a legal and scientific basis these regulations are
questionable. Their basic concept does not seem to
be rooted in public health, but more in departmental
opinion.
Understandably,
these problems are of vital concern to many doctors
of chiropractic, since they utilize food supplements
in their practice as part of their health program.
But it should be underlined here, at least at this
time, that the problem of combating these regulations
is an industry problem.
When
a situation of this type arises, just as in Aesop’s
Fables, many times the call of “wolf”
is heard. Individuals, groups and societies spring
up to take advantage of lack of understanding and
a feat of the situation to “raise funds to combat
it.” These many times well-meaning, but ill-informed
and ill-equipped groups seldom succeed in combating
a situation, but generally succeed in obtaining funds.
Funds which are depreciated without usefulness and
which, indeed, hamper the effectiveness of well orientated
intelligent opposition to regulatory imposition.
So
beware of the group or individuals who cry “wolf”
and ask for funds. Don’t be misled by any statements
that the affected industries are not vigorously opposing
this program. This problem must be met initially with
highly qualified clinical data, and experienced, astute
legal opposition. These are seldom a part and parcel
of the men who cry “wolf”. Theirs is an
emotional appeal and the effect of emotion instead
of facts and figures against regulatory action is
totally useless and wasteful.
The
time may well come when the profession and the public
may be able to add their opinion meaningfully, through
their legislative representatives to combat these
regulatory tactics, but that time is not yet here.
Indeed, premature action of this nature invariably
results in a worsening of a situation. Your recognized
professional associations and those industries who
have engendered your respect over the years are your
best source of information as to when you should add
the weight of your opinion and your patients’,
if it should be required. Until then, your concern
should be in turning away from the door, the man who
cries “wolf”.
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