TRANSCRIPT OF DOCUMENT NUMBER 31, Dec 28, l970 (part of the congressional
record)

Memorandum:

To:  Dr. Buzard
     Dr. Onien
     Dr. Jenkins
     Dr. Moe
     Mr. O'Bleness        Voluntary Submission Confidential-Trade Secret
                          Information

From:  Mr. Helling

Subject:  Food and Drug Sweetener Strategy

These are thoughts on the matter of sweetener strategy.  As I see it, our
objective is to obtain approval from the Food and Drug Administration of
SC-18362 for enough uses to permit consumption (and hence production) at a
level that will meet the economic requirements.  With that in mind, we
have to say what we need to do, know, or accomplish in order to bring
about this objective.

We must determine which application of the sweetener seems possible and
then select from these those that seem most likely to be approved.  We
must do this on a food category by food category basis for reasons which
will become obvious as you read on.  We must then estimate the consumption
potential and what portion of this we think we could get for each of these
uses to get a projected consumption level; this will allow us to estimate
selling price at each aggregate level of consumption (production).

We must decide what factors Food & Drug would be most concerned about and
determine which of these food items would present the least serious
concerns (after ranking the concerns in order of our difficulty to meet at
this time).

We should arrange an early informal meeting with Dr. Wodike and Dr.
Blumenthal.  At this meeting, the basic philosophy of our approach to Food
and Drug should be to try to get them to say "v.s." and to rank the things
that we are going to ask for so that we are putting first those questions
that we are likely to get "yes" to, even if we have to throw some in that
have no significance to us other than putting them into a yes-saying
habit.  We must create an affirmative atmosphere in our dealing with them.
It would also help if we can get them to get the people involved to do us
any sort of favor as this would also help bring them into a subconscious
spirit of participation.

My prime concern at this time is with the production of the DKP and our
lack of complete toxicological data on DKP if SC-18362 went -- out
completely to DKP.  If we select foods that have their storage in dry form
particularly if they are formulated so there is an acid ingredients, then
we would have confidence that the SC-18362 would not break down measurably
during the usual maximum storage periods.  We then must consider how much
DKP could be formed from the time the system is converted to a wet system
to the time of consumption allowing for MAXIMUM LIKELY ABUSE.  In this
way, I would say that the first category of items for which we should seek
approval would be these applications where the sweetener is used and held
in dry form and consumed within an hour of solution, where no heat is
involved.  All illustration of this is a pre-sweetened cereal product
that's consumed cold.  A second category would be where the sweetener
containing composition is held dry and consumed within about an hour, but
heat is involved.  An example of that is a mix that is pre-sweetened such
as a chocolate drink or tablets for table use; I exclude from this the
table top sweetener.

The next category would be where the acid food is kept cold but for
periods of more than a few hours and no heat is used in its preparation.
For example here would be a Kool Aid product that would have a maximum
likely exposure of about one day unrefrigerated and perhaps as long as a
week refrigerated.  For this, as an acid product, we would expect good
stability, but we must be prepared to have actual data on DKP formation
during one week's refrigeration storage of 24 hours at say 30 C before we
proceed to Food and Drug.  The next category that I would think would be
worth looking at would be a non-acid product stored cold that involved
heat such as a non-instant dietetic pudding or a pre-sweetened hot cereal.
Somewhere in here we would be also trying to fit in such things as a
non-dry, but still essentially non-aqueous system such as baccon and the
products that are stored frozen that are heated and consumed immediately
and then the products that are stored frozen that are cooked and not
consumed immediately and so on.

In effect then, I would first ask for an informal, but not necessarily off
the record meeting.  As a basis for this meeting, we would present a
series of assumptions.  These assumptions will be specifically stated and
any informal non-binding opinions would be predicated on the basis that we
can, do the right thing, convince them that the assumptions are true.  I
would first make the assumption that the material is stable in dry form
and that therefore the DKP exposure is limited to about 2-, which is the
normal contamination level in the sweetener.  I would not at this time
raise the question of restrictions on essential and non-essential amino
acids, but I would be prepared to respond if they raised it at this time
and would certainly want to raise it before the day was out.  Once we've
gotten this far, I would want to establish that with the level of
sweetener, as it's normally composed including the DKP, and with the
toxicity data that we have in the feeding studies, we expect to get
approvals now on the basis of the data on hand.  We would have to be
prepared with the average intakes of the sweetener that might be involved
and maximum likely intake involved in the presweetened cereal type use.  I
would proceed to the next food category, and take these food categories
one at a time to see which we begin to meet resistance.  Where we meet
resistance, having the data on average and maximum likely exposure for
each of the uses that would bring up, then I would want to explore the
nature of the resistance and what we would have to do to overcome it,
particularly in relation to studies that are going on.

I think it's vital to point out to the Food and Drug people at this
meeting that the sweetener is not suitable for all applications for
artificial sweeteners and at best would only be functional in part of the
market that we held by cyclamate or saccharin.  The approach from the
meeting standpoint must be made to or thru Virgil Wodicka, Head of the
Bureau of Foods, who is from an industrial back-ground and whom Dr. Scott
feels is quite good.

With the spoon-for-spoon, we have no way of estimating maximum likely
abuse and hence need to utilize data based on almost complete conversion
to DKP.  If we include this use in the original FAP, we stand a good
chance of ending up with nothing in the short run and nothing in the long
run whereas the other approach would give us something in the short run
and, quite likely as much as we would ever get in the long run.  I think
it becomes very important for us to start to get our sweetener into
commercial channels as soon as possible to minimize the incentive that
people now have to work on other sweeteners.  Actions in the U.S. will
tend to influence the actions in other countries as well.

Herbert Helling
HH:jad

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