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GRAS Status of Soy
A key argument in PTI's recently approved health
claim was that soy protein was a GRAS foodstuff and that were
no risks associated with the daily consumption of between 25 g
and 100g of soy protein.
In fact, the FDA has never granted soy protein
GRAS status and the very real risks associated with consuming
soy protein have largely been ignored, firstly by PTI and, now,
by the FDA. These risks relate to exposures to isoflavones
and nitrosamines that will occur on daily exposure to soy protein.
PTI describe soy protein as a safe and lawful
food and claim GRAS status by self-determination based on common
use in food before January 1 1958. PTI also claim that the "FDA
has recognised soy protein products as having GRAS status"
and argue that the reason soy protein is not listed as GRAS is
because "it is impractical for FDA to list all substances
that are GRAS for their intended use".
Firstly, one must note that the self-determination
of GRAS status of soy protein by the soy industry is meaningless
and such self determinations should not be given any credence.
In order to protect consumers only independent bodies, or those
with recognised legal status, can perform legitimate determinations
on the safety of consumer products.
Secondly, PTI's claim that products such
as soy protein isolate were in common use in food before January
1 1958 is incorrect. The Select Committee of GRAS Substances (SCOGS)
provided an independent evaluation of soy protein in the form
of isolated soy protein in its ‘Evaluation of the Health
Aspects of Soy Protein Isolates as Food Ingredients' (1).
The SCOGS committee found that at the time of their review (some
20 years after 1958) the use of soy protein was uncommon. In their
determination of the likely average dietary exposure to soy protein
isolate, the SCOGS committee reported a maximum per capita daily
intake of soy protein isolate of about 150 mg from food items
and a negligible amount due to migration from packaging.
Thirdly, and quite simply, soy protein is not
legally a GRAS foodstuff, as the FDA has never codified it as
such. In their review of soy protein isolates the SCOGS committee
noted that such products were initially developed as binders in
paper coatings. Soy protein isolates were GRAS under the provisions
of the Code of Federal Regulations as substances migrating from
paper and paperboard products used in food packaging because it
was assumed that only very small amounts would be subject to human
ingestion.
The SCOGS committee concluded that there was
no evidence that soy protein isolates were a hazard when consumed
at levels typical at that time (or levels that might reasonably
be expected to be in future use) provided acceptable levels of
lysinoalanine, nitrite and nitrosamines were established. To this
end the committee recommended that food-grade soy protein isolates
have specified acceptable levels of lysinoalanine, nitrite and
nitrosamines. To date, acceptable levels of lysinoalanine,
nitrite and nitrosamines have not been established for food-grade
soy protein isolates and one might conclude that soy protein isolates
have not been granted GRAS status for this reason.
To claim, as PTI had done, that the FDA has
not codified soy protein isolate as GRAS because it is impractical
to list all substances that are GRAS for their intended is inconsistent
with the fact that other food items that the SCOGS committee found
were GRAS have subsequently been codified as such. Had the SCOGS
committee been satisfied that soy protein isolate was safe for
intended use, there is little reason to suggest that GRAS status
would not have been codified. Quite simply, soy protein was not
granted GRAS status because the SCOGS committee was not convinced
it was GRAS.
The findings of the SCOGS committee still have
particular relevance to the PTI health claim petition. The PTI
petition recommends a daily intake of 25 to 100 g of soy protein
and it is quite evident that at this level of intake is far greater
than the SCOGS committee ever anticipated when they were conducting
their GRAS review. Hence, the concerns expressed by the SCOGS
committee relating to exposure to lysinoalanine, nitrite and nitrosamines
take on additional significance. For example, a daily consumption
of 25 to 100 g of isolated soy protein may result in nitrosamine
exposures that exceed established No Significant Risk Levels (NSRL's).
Until such safety issues are adequately addressed soy protein
still cannot, and should not, be viewed as GRAS.
So what is soy protein isolate safe for?
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