New FDA Labeling Rules Affect Food Importations (French)

Issue 509, January 25, 2006

The Food and Drug Administration (FDA) has recently issued press releases and reference information on new requirements that food labels must as follows;

1. clearly state if the packaged food products contain any ingredients (including a flavoring, coloring, or incidental additive) that is, or contains a protein from a "major food allergen"
2. list the amount of trans fat in the product

These new requirements are effective for food products that are labeled on or after January 1, 2006.

Labeling of Food Allergens
This new labeling requirement is required under the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), which applies to both domestically manufactured and imported packaged foods (including conventional foods, dietary supplements, infant formula, and medical foods) that are subject to FDA regulation. Among other things, raw agricultural commodities (generally fresh fruits and vegetables) are exempt from the new labeling requirement.

FALCPA identifies the following eight foods or food groups as major food allergens: milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans.

FALCPA requires food manufacturers to label food products that contain an ingredient that is or contains protein from a major food allergen in one of two ways:

First option: The first option is for the name of the food source to be included in parenthesis following the common or usual name of the major food allergen in the list ingredients in instances when the name of the food source of the major allergen does not appear elsewhere in the ingredient statement. For example: "enriched flour (wheat flour, malted barely, niacin, reduced iron, thiamin mononitrate, riboflavin, folic acid), whey (milk), lecithin (soy)."

Second option: The second option is to place the word "contains" followed by the name of the food source from which the major food allergen is derived, immediately after or adjacent to the list of ingredients, in type size that is no smaller than the type size used for the list of ingredients. For example: "contains wheat, milk, or soy."

FALCPA requires the type of tree nut (e.g., almonds, pecans, walnuts), the type of fish (e.g., bass, flounder, cod); and the type of Crustacean shellfish (e.g., crab, lobster, shrimp) to be declared.

Additional information on the food allergen labeling rule can be found at http://www.cfsan.fda.gov/~dms/wh-alrgy.html

Labeling of Trans Fat
FDA issued a final rule to require food labels to bear the gram amount of trans fat without a percent Daily Value (% DV) on the Nutrition Facts panel. The trans fat final rule amended 21 CFR 101.9 Nutrition Labeling of Food at § 101.9(c)(2). The effective date for the trans fat labeling final rule is January 1, 2006. Any product that is initially introduced into interstate commerce on or after January 1, 2006 must be labeled with trans fat. Sources of trans fat include partially hydrogenated oil and some animal-based foods. Additional information on the trans fat labeling rule can be found at http://www.cfsan.fda.gov/~dms/lab-cat.html#transfat

Importers of packaged food products should ensure the labeling of their imported products meets these new requirements. Non-compliant importations may be subject to clearance delays or refusal of entry by the FDA.