Food Label Review Done Right

FDA has authority over many of the products people use every day, including food, beverages, and dietary supplements. Generally, labels must be truthful and not misleading to prevent being deemed misbranded (and subject to enforcement action by FDA). This applies to products manufactured domestically as well as products manufactured outside of the U.S. and imported.

Regulations in Title 21 of the Federal Code of Regulations require that specific statements appear on these products’ labeling. FDA has also published many guidance documents to assist industries in understanding the regulations and how FDA will apply them.

The core requirements for foods include :

• the declaration of a statement of identity,
• net quantity of contents,
• nutrition facts information,
• ingredients list,
• and the identity of the manufacturer, packer, or distributor.

FDA’s regulations and guidance documents also offer specific content and formatting requirements, like mandatory type size and how ingredients should be named. The “Nutrition Facts” panel has additional graphic elements (i.e., the chart) that must be used on the labeling.

FDA’s new rules came into effect for all firms on January 1, 2021. All food products bearing nutritional information must now show the updated version of the Nutrition Facts label.

Certain products (such as ice cream, jam, and mixed nuts) are subject to “standards of identity,” or regulations that describe conditions that a product must meet to be called by a certain name. These may include required or prohibited ingredients, specific manufacturing processes, or certain characteristics (such as milkfat percentage).

FDA publishes regulations for standard of identity and issues guidance documents for naming other types of products, such as chocolate, foods with foreign names, spices, and seafood.

Many of the same labeling requirements for conventional foods also apply to dietary supplements, with a few notable exceptions. Instead of a “Nutrition Facts” panel, supplements must declare a “Supplement Facts” panel that has very different formatting and content. Supplements must also include a domestic U.S. phone number and mailing address so consumers can report serious adverse events.

Any claims being made that reference the structure or function of the body must be accompanied by a disclaimer statement: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” This disclaimer also has its own type size, formatting, and placement requirements.

FDA has jurisdiction over animal feed, which includes pet food and supplement products. The agency works with the Association of American Feed Control Officials (“AAFCO”), a voluntary membership organization of U.S. state and federal government agencies that govern the production, labeling, distribution, use, and sale of animal feed.

FDA labeling requirements include a statement of identity, net quantity of contents, ingredients list, and identity of the manufacturer, packer, or distributor. Pet food labels are usually supplemented by requirements specified by AAFCO in their Official Publication (“OP”). These include individual state requirements such as a “Guaranteed Analysis,” purpose statements, and additional limitations on the types of claims that can be made in reference to a product or its ingredients.

Ingredient regulations can vary widely from market to market. Ingredients considered acceptable outside the U.S. may not have the same status with FDA. One important example of this is color additives. Color additive violations are common, as FDA requires that every color additive (even naturally sourced ones) be approved by them.

Conventional food ingredients must either be approved as food additives or be generally recognized as safe (“GRAS”) for their intended use. Dietary ingredients found in supplements are exempt from this requirement but are subject to a “new dietary ingredient notification” requirement if they were not marketed in a supplement in the U.S. prior to October 15, 1994.

Companies should conduct a thorough review of the ingredients found in all products they intend to market in the U.S. Inappropriate or illegal ingredients can result in a shipment being detained at port of entry. The importer must then either re-export or destroy the product, which can cause significant supply chain disruptions and financial losses. Registrar Corp’s Label Review service includes an analysis of the product ingredients to ensure that they are permitted in the U.S. market.

Permitted claims depend upon your product category (e.g., food, supplement, drug). Conventional food and dietary supplement products may make claims about levels of certain nutrients in the product, the effects on the structure and function of the body, certain disease risk reduction claims, and characteristics such as “gluten free” or “healthy.”

Most claims are also subject to limitations described in the Code of Federal Regulations, FDA guidance documents, or other publications.