Us revises Industry Guidelines on Infant Formula Labeling

In the United States, the Infant Formula Food Labeling Industry Guidelines (the "Industry Guidelines") were originally published in 2016. On March 8, 2023, the United States Food and Drug Administration (FDA) revised it, which only related to the types of allergens in food, adding sesame as a major food allergen and not related to other parts of the revision. The purpose of this guidance is to reasonably guide manufacturers and distributors of infant formula foods to comply with the appropriate labelling requirements for infant formula foods, including special claims and appropriate characterization requirements for labels. Food Partner network will be the key content of the guide sorted out for industry reference.

A declaration of product attributes

The main display panel (PDPS) of the pre-packaged food label must include a declaration of the commodity's attributes as one of its key features. For standardized foods, the attribute declaration shall comply with 21 CFR 101.3(b); For non-standardized foods, the common or generic name of the food must accurately identify or describe the basic attributes, characteristics or ingredients of the food, such as "milk base" or "bean base", on the basis of being as simple and straightforward as possible. In addition, if the food exists in a different form, such as "powder" or "liquid concentrate", the product form must be labeled as part of the product attribute.

The company brand name is not mandatory identifying information, nor is it part of the product attribute statement. However, if the brand name is the most prominent printed information on the PDP, the font size of the product property name must be reasonable relative to the size of the brand name.

In the case of exempt infant formula (i.e., our infant formula for special medical purposes), the information on the applicable population and the description of the product characteristics must be part of the product attribute declaration. Therefore, it is not enough to state that "infant formula food" is used. It should be labeled "High protein (3.5g/100kcal) lack-based infant Formula for preterm and low birth weight infants".

Two nutrient content claims

Infant formula foods may only make nutrient claims specified in 21 CFR Part 101, 105 and 107 or related to vitamins or minerals described under 21 CFR 101.13(q)(3), except that no nutrient claims may be made on infant formula foods.

Exempt infant formula food labels from the nutrient claims in the above regulations. In order to avoid misleading information that may be given to consumers by the exempted infant formula, manufacturers should make claims based on the formula and intended use of the exempted infant formula. The following are examples of exempt infant formula claims that FDA believes are not misleading: Exempt infant formula powders used for premature and low birth weight infants should make claims about the amount of protein added because higher protein content is essential for growth and development in these populations.

Health claims and conditional health claims

Infant formula foods may be labeled with health claims allowed in 21 CFR Part 101 Subpart E, 21 CFR 101.70 that governs how to apply to the FDA for health claims. In addition, the FDA allows the use of certain conditional health claims, including 100% partially hydrolyzed whey protein infant formula and reduced risk of atopic dermatitis, where manufacturers label health claims that meet certain conditions.

Other requirements for labelling infant formula food

In addition to complying with the labeling requirements of 21 CFR Parts 101 and 105, the manufacturer shall indicate specific "Instructions for Use" on all infant formula foods, including instructions for preparation and use, diagrams, dates of use, declarations and diagrams for adding water, warnings, and medical recommendations.

5. General Label Requirements

The industry guidelines refer to general food labelling requirements for infant formula, including intrusive materials, foreign language and religious claims (to meet the needs of a particular religion), and allergen labelling requirements. The following describes only the labeling requirements for food allergens.

The Federal Food, Drug, and Cosmetic Act defines nine major food allergens: milk, eggs, fish, shellfish, tree nuts, wheat, peanuts, soy, and sesame. If infant formula contains a major food allergen or contains a protein derived from one of nine foods, the source of the ingredient must be indicated on the ingredient list or in a declaration beginning with the word "contains". For example, if an infant formula contains enzymatically hydrolyzed isolated whey protein, it must be labeled "enzymatically hydrolyzed isolated whey protein (milk)" on the list of ingredients or in the declaration beginning with the word "contains" as "contains milk".

summary

The Industry Guidelines are not required to be enforced and are intended only as a recommendation and reference to the industry. Manufacturers and distributors of infant formula food should ensure that their products are labeled in accordance with mandatory U.S. laws and regulations and are properly labeled in conjunction with the Industry Guidelines. Food partner network to provide domestic and foreign food label audit services, more label problems welcome to discuss with us!