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174   Many 'Accepted' Additives May Be Cyclamate's Equal
      The Washington Post  October 25, 1969

     HEW Secretary Robert H. Finch's order banning the use of
cyclamate as an artificial sweetener puts a decisive period closure to
a messy controversy of great potential importance to public health.
My only criticism is that it was not done sooner, but this was
difficult in the face of ambiguities both in the legal authority
of the Food and Drug Administration and in the scientific evidence
that cyclamate is a hazard in man.

     We may never know the answer to this question, for it is more
likely that new compounds will be discovered as alternatives to
cyclamate than that cyclamate could be exonerated by further studies
(even if it is essentially innocent) once it had been indicted.

     Finch's decision does not answer the scientific question,
although the regulatory label of "safe" or "unsafe" is often confused
with a factual reality that can never be so categorical.  Nor does the
cyclamate affair set a satisfying precedent for the way such issues
should be dealt with in the future.

     Our principal need, of course, is for the improvement of methods
of scientific evaluation of safety.  There is no particular rationale
for banning an additive on the basis that it can be shown to induce
tumors in some experimental animal at high doses when we know nothing
of the way the additive works.

     On the other hand, Dr. Marvin Legator of FDA's research
laboratories had shown over a year ago that a derivative formed in the
body from cyclamate, cyclohexylamine, caused chromosome breaks in
rat germ cells when given in modest doses for short periods of time.
This information was administratively ignored, perhaps because the
language of the law is still innocent of any knowledge of genetic
damage.

     In fact, among the thousands of compounds "generally accepted
as safe" or specifically licensed as food additives by the FDA, there
are surely dozens which will prove to be at least as hazardous as
cyclamate but have yet to reach the same kind of public attention.

     Organic peroxides are proven mutagens -- but are widely used for
bleaching starch and maturing flour.  Mustard oil is historically
interesting as the first known chemical mutagen; it has, however, come
to legislative attention as a cruel blistering agent for "soring"
horses.  Phenethyl alcohol is a synthetic perfume essence, but
biochemists know it as a powerful inhibitor of DNA synthesis.

     Many other additives are suspect simply on the grounds of their
chemical reactivity, for they must then produce a wide and
unpredictable variety of secondary products when used in foods.  Many
other compounds belong to classes that we do not yet recognize as
having biological potency.

     If the FDA indeed had to give adequate scientific assurance about
the absolute safety of every additive, we might starve to death while
the necessary research was being done, and then again when new
insights into sources of peril emerged.  Nevertheless, the food
industry and the scientific community, as well as government, should
be sharpening their focus in dealing with these vital problems.

     Meanwhile, we must also think of more flexible legal and
regulatory approaches to these problems.  Abbott Laboratories should
not be charged with insincerity for having asserted its confidence
that cyclamates were safe, but the main risk was being borne by
millions of consumers, not the corporation.  On the other hand, a
government agency might be in the position of having little to lose
in responding to public arousal by banning a product before all the
evidence was in.

     The law could provide for unconditional liability for the
eventual hazard of a product when the FDA has certified a bill of
particulars, for example, about bladder cancer or mutation.  An
Abbott Laboratories would then have to back up its confidence by
sharing the risk that it was mistaken with its customers.

     It might also be required to post an insurance bond.  This device
would help to being the informed businessman's judgment of a third
party: the insurance underwriter who must make wise decisions about
the premium to charge.

     In the long run, the cost of insurance is embedded in what the
consumer has to pay.  But this would indirectly pay for important
research on hazards and for the development of safer alternatives,
as well as encourage greater discretion by the purveyors of unproven
products.
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