FDA Issues New Rules on Use of the Term “Healthy” on Food Labeling

On December 19, 2024, the FDA announced a final rule to update the criteria that food must meet to qualify for use of the claim “healthy”.

New Requirements

To meet the updated criteria, a food product needs to:

  1. Contain a certain amount of food from at least one of the food groups or subgroups (such as fruit, vegetables, grains, fat-free and low-fat dairy and protein foods) recommended by the Dietary Guidelines for Americans, and
  2. Meet specific limits for added sugars, saturated fat and sodium.

The criteria vary for individual food products.

Under the new rule, nutrient-dense foods that are encouraged by the Dietary Guidelines with no added ingredients automatically qualify for the “healthy” claim. These include:

  • Vegetables
  • Fruits
  • Whole grains
  • Fat-free and low-fat dairy
  • Lean game meat
  • Seafood
  • Eggs
  • Beans
  • Peas
  • Lentils
  • Nuts
  • Seeds

Products that do not qualify for the healthy label under the updated rule include:

  • Fortified white bread
  • Highly sweetened yogurt
  • Highly sweetened cereal

These changes reflect current nutrition science and dietary guidance in the Dietary Guidelines for Americans.

What Food Manufacturers Should Do

The rule is effective February 25, 2025, and the compliance date of the rule is February 25, 2028. In preparation for the compliance date, food manufacturers should review their products to ensure that any product that uses a “healthy” label meets the new criteria. Diaz Trade Law has subject matter FDA expertise and can help you with a proactive compliance plan that meets the new requirements.

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USDA Proposes New “Made in the USA” Standard

U.S. consumers who seek animal food products labeled as “Made in the USA,” or who simply value transparency on food product labels, may finally catch a break. On March 6, 2023, the USDA released a proposed rule to help define what is meant when a food product is a “Product of USA” or “Made in the USA.”  Currently, Food Safety and Inspection Service (FSIS) regulated products may be labeled as “Product of USA” even when an animal product is derived “from animals that may have been born, raised, and slaughtered in another country but are minimally processed in the United States.”

As a result of the U.S. President’s Action Plan for a Fairer, More Competitive, and More Resilient Meat and Poultry Supply Chain, the proposed rule allows a “Product of USA” or “Made in the USA” label claim to be used on meat, poultry and egg products only when they are derived from animals born, raised, slaughtered and processed in the United States.

Albeit, a very significant caveat accompanies the proposed rule, which is, that, labeling a food product in accordance with the latter is completely voluntary. The U.S. Federal Trade Commission (FTC) takes a similar course of action. While the FTC regulates U.S. origin claims under its authority to act against deceptive acts and practices, foreign-origin markings on products are regulated primarily by U.S. Customs under the Tariff Act of 1930. The similarity in the rules is that neither Customs nor the FTC requires that goods made […]

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The U.S. Food and Drug Administration (FDA) is now  auditing Foreign Supplier Verification Program (FSVP) Importers to ensure they comply with the FSVP program. To date, over 92 warning letters have been issued against companies for FSVP violations. If your business is importing food into the U.S., or wants to start, our one-hour, NEI accredited, webinar on “Importing Food in Compliance with U.S. FDA & Surviving A FSVP Audit” will provide best practices and TOP tips to comply with FDA regulations and avoid, navigate, and mitigate any potential  FDA compliance action.

Register today to to hear directly from Senior Trade Advisor, Domenic Veneziano, DTL’s president, Jennifer Diaz, and Associate Attorney, Denise Calle, on the pathway to legally import food and best practices for surviving a FSVP audit.

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The U.S. Food and Drug Administration (FDA) is in full enforcement mode issuing 260 warning letters in 2021 alone! Now is the time to ensure your products are in compliance with the Federal Food, Drug, and Cosmetic Act (the Act) prior to importation. Manufacturers, importers, distributors, and others engaged in the production or sale of over the counter (OTC) drugs or cosmetic products must be aware of FDA’s various enforcement mechanisms, and more importantly,  how to avoid and/or mitigate such actions.  FDA’s most common enforcement activities include notices of FDA action, warning letters, seizures, voluntary recalls, injunctions, and criminal prosecution.

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