Regulation of Infant Formula

Infant Formula

shall contain for each 100 kcal:

FORMULA

• adding DHA and ARA

• https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-107
• https://www.govinfo.gov/content/pkg/USCODE-2020-title21/pdf/USCODE-2020-title21-chap9-subchapIV-sec350a.pdf

Label requirements

In addition to the applicable labeling requirements the product label shall bear:

(a) Under the heading “Directions For Preparation and Use”, directions for:

(1) Storage of infant formula before and after the container has been opened, including a statement indicating that prolonged storage at excessive temperatures should be avoided;

(2) Agitating liquid infant formula before opening the container, such as “Shake Well Before Opening”;

(3) “Sterilization” of water, bottle, and nipples when necessary for preparing infant formula for use;

(4) Dilution of infant formula, when appropriate. Directions for powdered infant formula shall contain the weight and volume of powdered formula to be reconstituted.

(b) In close proximity to the “Directions for Preparation and Use” a pictogram depicting the major steps for preparation of that infant formula, such as (for a concentrated formula):

(c) “Use by MM/YY” date

(d) The statement “Add Water” or “Do Not Add Water”, and symbol:

(e) A warning statement beneath or in close proximity to the “Directions For Preparation and Use” that cautions against improper preparation or use of an infant formula, such as “THE HEALTH OF YOUR INFANT DEPENDS ON CAREFULLY FOLLOWING THE DIRECTIONS FOR PREPARATION AND USE”.

(f) A statement indicating that parents should consult their physicians about the use of infant formulas, such as “USE AS DIRECTED BY A PHYSICIAN”.

DIRECTIONS FOR USE

FDA Registration

The manufacturer of the formula shall register with the FDA:

Center for Food Safety and Applied Nutrition,

Office of Nutrition,

Labeling, and Dietary Supplements,

Infant Formula and Medical Foods Staff (HFS-850), 5001 Campus Dr., College Park, MD 20740-3835.

FDA Registration

• The name of the new infant formula;
• The name of the manufacturer;
• Manufacturer's address (business & factory).

90 day submission

At least 90 days before a new infant formula is introduced to the market, the manufacturer shall submit notice of its intent to do so to the FDA

90 day Formula Submission

• Name and description of the physical form
• Explanation of why the formula is a new infant formula
• Quantity formulation
• Manufacturing flowchart
• Assurance that the it will not be marketed unless the formula meets the requirements for quality factors and the nutrient content requirements
• Quality factors: records, reports, data, etc from growth monitoring studies
• Assurance that the processing of the infant formula complies

Verification submission

A manufacturer shall, after the first production and before the introduction into commerce of a new infant formula, verify in a written submission to the FDA that the infant formula complies with the requirements of the Federal Food, Drug, and Cosmetic Act and is not adulterated.

Verification submission

• The name of the new infant formula; the filing date for the new infant formula submission; and the identification number assigned by the Agency to the new infant formula submission.
• A statement that the infant formula to be introduced is the same as the infant formula that was the subject of the new infant formula notification
• A summary of test results of the level of each nutrient required and any nutrient added, presented in units per 100 kcal at the final product stage.
• A certification that the manufacturer has established cGMP, including QC procedures, in-process controls, and testing

Changes in formula

When a manufacturer makes a change in the formulation or processing of the formula that may affect whether the formula is adulterated the manufacturer shall, before the first processing of such formula, make a submission to the FDA

*Submission of a change

• The name and physical form of the infant formula
• An explanation of why the change in formulation or processing may affect whether the formula is adulterated; and what steps will be taken to ensure that, before the formula is introduced into interstate commerce, the formula will not be adulterated; and
• A statement that the submission complies

Testing that provides formula provides the minimum nutrients

Label Claim

MICRO

MICRO

For 1 year after the expiration of the shelf life of the infant formula or 3 years from the date of manufacture, whichever is greater.

Records

The manufacturer shall maintain all records that pertain to:

• Food-packaging materials on whether such materials would cause an infant formula to be adulterated
• Nutrient premix testing and RM COA
• Quantitative tests conducted to identify the nutrient levels present when nutrient premixes exceed their expiration date or shelf life
• that demonstrate that the formula meets the quality factor of normal physical growth
• that demonstrate that a formula meets the quality factor of sufficient biological quality of protein.
• Production control, testing results, complaints, and distribution records.

RETAIN & RECORDS

Requirements & process for formula registration

Formula Registration

1. Qualified R&D production & testing practices

2. GMP

3. HACCP

4. QC inspection per lot

5. Proof of "scientificity" and safety of the formula

https://apps.fas.usda.gov/newgainapi/api/Report/DownloadReportByFileName?fileName=China%27s%20Material%20Requirements%20for%20Infant%20Formula%20Product%20Registration_Beijing_China%20-%20Peoples%20Republic%20of_03-09-2020

https://www.sfdachina.com/info/178-1.htm

Importing into China from New Zealand

Winston Nutritional Limited is a China approved facility for the importation of Infant formula

Importing into China from NZ