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The shelves of infant formula in major supermarkets are empty, and many babies have even been hospitalized because they cannot eat infant formul.
In order to alleviate the tight supply of infant formula in the United States and solve the problems of various infant formulas, the US Food and Drug Administration ( FDA ) issued an industry guide on May 18, 2022, and began to implement freedom of enforcement for infant formu.
Discretionary Poli.
The industry guidance will be in effect until November 14, 2022, at which time it will be assessed whether an extension is necessary, and the document is not legally bindi.
Food Partner Network interprets the main contents of the guideline, so that relevant infant formula milk powder exporters can seize the opportunity in time and prepare for export in advan.
Discretionary Poli.
The industry guidance will be in effect until November 14, 2022, at which time it will be assessed whether an extension is necessary, and the document is not legally bindi.
Food Partner Network interprets the main contents of the guideline, so that relevant infant formula milk powder exporters can seize the opportunity in time and prepare for export in advan.
.
Implementation of discretionary policies
Implementation of discretionary policies
This guidance describes the information that infant formula manufacturers need to provide to the FDA if they want to sell safe and nutritionally complete but not necessarily all FDA requirements for infant formula in the.
This information should include a list of all nutrients and ingredients and Quantities, copies of product labels and packaging instructions, current or expected inventories of formula, microbiological test results and facility inspection histo.
Based on this information, FDA determines how to exercise enforcement discretion with respect to infant formula on a case-by-case bas.
This information should include a list of all nutrients and ingredients and Quantities, copies of product labels and packaging instructions, current or expected inventories of formula, microbiological test results and facility inspection histo.
Based on this information, FDA determines how to exercise enforcement discretion with respect to infant formula on a case-by-case bas.
For example, FDA may determine that enforcement discretion is appropriate for infant formula that does not list nutrients in the required order on the lab.
Conversely, infant formula containing specific nutrients that are below or free of the limits set forth in the.
Infant Formula Regulation (21CFR 107) may not be suitable for enforcement discretion; for certain labeling requirements, such as clearly identifying the presence of Any allergens, or adequate description of the safe use and safe preparation of the product, related to food safety, will be carefully considered when evaluating requests for law enforcement discreti.
Conversely, infant formula containing specific nutrients that are below or free of the limits set forth in the.
Infant Formula Regulation (21CFR 107) may not be suitable for enforcement discretion; for certain labeling requirements, such as clearly identifying the presence of Any allergens, or adequate description of the safe use and safe preparation of the product, related to food safety, will be carefully considered when evaluating requests for law enforcement discreti.
Applicable enterprises
(1) Manufacturers of domestically produced infant formula for export;
(2) There are currently no foreign infant formula manufacturers that export infant formula to the United States;
(3) Infant formula milk powder manufacturers that may increase the supply of infant formula milk powder by changing production locations or production methods, e.
;
;
Materials to be submitted
(1) The specific name of infant formula milk powder and other product identification informati.
(2) Information on the number and size of retail containers,e.
(3) Other identification information should include batch number, product identification code or stock keeping unit number,e.
(4) If the product has previously been notified to FDA, the product identification number shall be provided;
(5) The country where the product is sold and the market time in that country;
(6) Copy of product label; other information
Suggestions and opinions
The purpose of this guide is to help more overseas companies interested in exporting infant formula to the United Stat.
The discretion exercised by the United States means that, for example, the label may not fully meet the requirements of the US FDA, but the ingredients of the infant formula are all If it is healthy and suitable, it is possible to obtain the discretionary power of the US FDA, e.
If there are other non-compliance or even endanger food safety, the discretionary power cannot be exercis.
Dairy companies that intend to export infant formula to the United States It is also necessary to strictly abide by the US import access principles and food compliance requiremen.
The discretion exercised by the United States means that, for example, the label may not fully meet the requirements of the US FDA, but the ingredients of the infant formula are all If it is healthy and suitable, it is possible to obtain the discretionary power of the US FDA, e.
If there are other non-compliance or even endanger food safety, the discretionary power cannot be exercis.
Dairy companies that intend to export infant formula to the United States It is also necessary to strictly abide by the US import access principles and food compliance requiremen.
If exporting companies want to exercise the discretionary powers issued by the United States, FoodPartne.
com recommends that exporting companies should fully understand the product standards of American infant formula milk powder and other product access issues to ensure the compliance of export produc.
If the export enterprise has any problems in the process of implementing the discretionary power, you are welcome to discuss and communicate with each oth.
com recommends that exporting companies should fully understand the product standards of American infant formula milk powder and other product access issues to ensure the compliance of export produc.
If the export enterprise has any problems in the process of implementing the discretionary power, you are welcome to discuss and communicate with each oth.
