IA #40-01, 2/21/86
SUBJECT: EDENSOY AND OTHER SOY DRINKS THAT MAY SERVE AS
INFANT FORMULAS
BACKGROUND
This import alert originally issued on June 26, 1985, as a result of the
health hazard consequences of inadequate infant nutrition and the Edensoy
incident. Since then, additional information has been received which
necessitates updating the current status of Edensoy, soy drinks, and other
drinks that may serve as infant formulas.
1. Eden Foods Inc., advised FDA that as of October 1985, all Edensoy
(Plain and Carob Flavors) entering the country has new labeling
containing the warning statement "NOT FOR USE AS AN INFANT FORMULA or
AS A SOLE SOURCE OF NUTRITION". The label also reportedly contains
nutrition information. Hoever, due to the current market conditions
and printing difficulties, Edensoy, Cranberry Flavor, does not and
probably will not have the new warning and nutrition label. Eden Fods,
Inc. has advised us that they do not intend to import any Edensoy
Cranberry Flavor until further notice; however, they will notify FDA
prior to importing any Edensoy Cranberry Flavor. They have assured us
that the product will bear stick-on labels with appropriate warning and
nutrition information if and when it is imported.
2. A recent investigation/inspection program involving domestic
manufacturers and distributors identified the following additional
imported soy based products in domestic commerce that may be used or
promoted as infant formulas:
Product Manufacturer, Country of Origin Distributor
1. Soy Moo Belgium Health Valley,
Montebello, CA
2. Sun Soy Belgium
3. Ah Soy Saniku, Japan Great Eastern
Sun Trading Co.
Asheville, NC
4. West Soy Saniku, Japan Westbrae Health
Foods Berkeley
and Emeryville, CA
5. Vita Soy Hong Kong Soy
Bean Products Co., Hong Kong
6. Malteds Saniku, Japan
GUIDANCE
1. Edensoy (plain and carob flavors) may be released providing it bears
the new label containing the warning statement and nutrition
information, It is no longer necessary to sample these specific
products for label review by the Division of Regulatory Guidance,
CFSAN.
Although none are expected, if any shipments of Edensoy Cranberry
Flavor product are encountered, they may be released if the product
label contains a warning against using it as an infant formula or as
the sole source of nutrition. Edensoy Cranberry Flavor product with no
warning or nutrition information should be detained with the following
charge: "The product is adulterated within the meaning of 801(a)(3) in
that it appears to be an infant formula whose manufacturer has failed
to notify the Secretary that its nutrient composition complies with
section 412(g) of the Act."
2. All soy-base drinks that are not registered as infant formulas and
whose labeling either directly (labeled as an infant formula) or
indirectly (labeled as a complete or partial substitute for mother's
milk) implies use an an infant formula, shall be detained with the
following charge: "The product is adulterated within the meaning of
801(a)(3) in that it appears to be an infant formula whose manufacturer
has failed to notify the Secretary that its nutrient composition
complies with section 412(g) of the Act."
3. All soy-type drinks whose labeling either directly or indirectly makes
claims as a substitute for milk (other than mother's milk) should be
referred to the Division of Regulatory Guidance, CFSAN for label review
prior to release. Products labeled with terms such as "soy milk" are
included among those to be referred to the center. The center will
reviewits labeling to determine whether claims regarding the
substitution of the product for milk warrants specific action.
4. All soy-type beverages, whose labeling do not recommend or imply use as
an infant formula and do not make claims as a substitute for milk,
should be released with comment: "This product is not to be used as
an infant formula or as the sole source of nutrition. If this product
is subsequently found to be offered for those purposes, FDA will take
legal or administrative action against this and/or future shipments."
The labeling of these products should also be reviewed for compliance
with nutrition labeling requirements (21 CFR 101.9). If the product
does not comply with nutrition labeling requirements, comment to that
effect should be included in the release.
5. Additionally, surveillance of any other drinks (non soy-based) that may
be misconstrued as an infant formula or a substitute for mother's milk
is indicated. If any of these drinks are encountered, sample to check
labeling and process as applicable in accordance with instructions
contained in items 2,3, or 4 of this import alert.
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