Import Alert 40-01
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(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 40-01
Published Date: 01/18/2012
Type: DWPE with Surveillance
Import Alert Name:
"Soy Drinks Milk Substitute Drinks and Other Drinks That May Serve as Infant Formulas"
Reason for Alert:
This import alert originally issued on June 26, 1985, as a result of the health hazard consequences of inadequate infant nutrition & 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
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 nformation, 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 lavor 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 nowarning 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.
Although none are expected, if any shipments of Edensoy Cranberry lavor 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 nowarning 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.
Product Description:
Edensoy and other soy drinks that may serve as Infant formulas from Hongkong, Belgium and Japan
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."
UNITED STATES
Great Eastern Sun Trading Co
Date Published : 01/18/2012
92 Mcintosh Rd , Asheville, NC 28806-1406 UNITED STATES
40 N - - 02 Soy Base Formula Product
Date Published: 01/18/2012
Desc:Ah Soy; Saniku; Japan
40 N - - 99 Other Formula Products, N.E.C.
Date Published: 01/18/2012
Desc:Ah Soy; Saniku; Japan
40 O - - 02 Soy Base Formula Product
Date Published: 01/18/2012
Desc:Ah Soy; Saniku; Japan
40 O - - 99 Other Formula Products, N.E.C.
Date Published: 01/18/2012
Desc:Ah Soy; Saniku; Japan
40 P - - 02 Soy Base Formula Product
Date Published: 01/18/2012
Desc:Ah Soy; Saniku; Japan
40 P - - 99 Other Formula Products, N.E.C.
Date Published: 01/18/2012
Desc:Ah Soy; Saniku; Japan
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