U.S. Food and Drug Administration (FDA) Archives - Page 4 of 42

FDA Issues Proposed Rule on Front-of-Package Nutrition Labeling
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FDA Issues Proposed Rule on Front-of-Package Nutrition Labeling
Food, U.S. Food and Drug Administration (FDA)

FDA Issues Proposed Rule on Front-of-Package Nutrition Labeling

The U.S. Food and Drug Administration (FDA) issued a proposed rule that would require a front-of-package (FOP) nutrition label on most packaged foods.

Rule Details

The label, referred to as the “Nutrition Info Box,” must contain the amounts (per serving) of three nutrients:

Saturated fat
Sodium
Added sugar

The label must also list whether the amount of these ingredients per serving is “Low,” “Med,” or “High.”

The FDA is proposing a compliance date of three years after the final rule’s effective date for businesses with $10 million or more in annual food sales. Businesses with less than $10 million in annual food sales would have four years to comply.

FDA Intent

The FDA stated that the Nutrition Info Box would complement the Nutrition Facts label that is already required on most packaged food. While the Nutrition Facts label is helpful to many consumers, the FDA found that some segments of the population do not regularly read the label.

Therefore, this rule is intended to provide accessible, at-a-glance information to help consumers quickly and easily identify how foods can be part of a healthy diet.

The agency conducted a literature review that included focus group testing and a peer-reviewed experimental study to explore consumer reactions and responses to various FOP nutrition labels.

The results indicated that interpretive FOP nutrition information is helpful for consumers and easy to understand.

Input on the Rule

The FDA is currently seeking public input on the proposed rule. The deadline to submit comments is May 16, 2025. If you will be impacted by the new requirements, […]

FDA Issues New Rules on Use of the Term “Healthy” on Food Labeling
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FDA Issues New Rules on Use of the Term “Healthy” on Food Labeling
FDA Issues, Food, U.S. Food and Drug Administration (FDA)

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:

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
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.

Updated “Healthy” Claim Factsheet
Webinar: Importing Food in Compliance With […]

By Jennifer Diaz|2025-01-10T09:59:17-05:00January 10, 2025|FDA Issues, Food, U.S. Food and Drug Administration (FDA)|0 Comments

Reminder: Listing of OTC Monograph Drug Products No Longer Certifiable through Old Categories in the FDA’s Listing System
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Reminder: Listing of OTC Monograph Drug Products No Longer Certifiable through Old Categories in the FDA’s Listing System
U.S. Food and Drug Administration (FDA)

Reminder: Listing of OTC Monograph Drug Products No Longer Certifiable through Old Categories in the FDA’s Listing System

As of October 1, 2024, listing of over-the-counter (OTC) monograph drug products will not be able to be certified under the old marketing categories and old application number fields in FDA’s Electronic Drug Registration and Listing System (eDRLS). Instead, the listing of such products will need to include the current Marketing Category and Application Number values.

New Certification Requirements Background

The FDA utilizes the eDRLS for several key programs including drug quality reports, adverse event reports, and drug import and export compliance.

On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law. The law amended the Federal Food, Drug and Cosmetic Act (FD&C Act) and modernized the OTC drug review process.

The amendments required the FDA to update the marketing category and application number fields for OTC monograph drugs in the eDRLS.

eDRLS Field Updates

The change in current values to be used effective October 1st, 2024, are:

For the marketing category field, the categories “OTC monograph final” and “OTC monograph not final” are permanently replaced with the single term “OTC monograph drug,” to be used for nonprescription drug products marketed without an approved new drug application.
For the application number field, the use of OTC monograph CFR parts was discontinued starting October 2023 and the old submissions referencing the CFR parts must now be updated to include the appropriate Monograph ID.

As of October 1, 2024, drug listing records that refer to the old marketing categories and CFR parts citations will no longer be available for certification.

OTC drug […]

By Jennifer Diaz|2024-10-18T12:26:55-04:00October 18, 2024|U.S. Food and Drug Administration (FDA)|0 Comments

FDA’s Proposed New National Drug Code – What You Need to Know
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FDA’s Proposed New National Drug Code – What You Need to Know
U.S. Food and Drug Administration (FDA)

FDA’s Proposed New National Drug Code – What You Need to Know

The Food and Drug Administration (FDA) is proposing to amend their regulations governing the format of the National Drug Code (NDC). The NDC is a standard for uniquely identifying drug products marketed in the United States. The current standard has several acceptable formats. If the proposal is finalized, it will standardize the format of all NDCs.

What is the NDC?

The National Drug Code is a unique, three-segment identifier that the FDA assigns to each drug on the U.S. market. It’s a universal product identifier that appears on all prescription and over-the-counter medication packages and inserts.

Current formats:

10-digit identifier

The FDA’s standard NDC is a 10-digit numerical identifier that includes a labeler code, product code, and package code.

There are 3 FDA-assigned formats for the standard NDC:

4-4-2
5-3-2
5-4-1

HIPAA Format

The Health Insurance Portability and Accountability Act (HIPAA) adopted a uniform 11-digit NDC format that must be used when a HIPAA-covered transaction includes an NDC. This 11-digit format is standardized into a 5-4-2 format and created by adding a leading zero to either the labeler, product, or package code.

Upcoming 6-Digit Format

The FDA will run out of 5-digit labeler codes in 10-15 years. Per FDA regulations (21 CFR 207.33), once FDA runs out of 5-digit labeler codes, it will start assigning 6-digit labeler codes. Without this proposed change, there would be five NDC formats, 3 in 10- digits and 2 in 11-digits. There may be confusion […]

By Jennifer Diaz|2024-09-20T10:04:53-04:00September 20, 2024|U.S. Food and Drug Administration (FDA)|0 Comments

MoCRA Enforcement is Right Around the Corner! Are You Ready?

The Food and Drug Administration (FDA) is set to start enforcing the requirements of the Modernization of Cosmetics Regulation Act (MoCRA) on July 1, 2024. Manufacturers, distributors, or packers of cosmetic products must comply with the requirements to avoid an enforcement action.

MoCRA Background

In recent years, the cosmetics industry has experienced exponential growth, with new products being introduced almost daily. The average American consumer uses six to 12 cosmetics products daily. This growth has resulted in a need for more comprehensive regulation of cosmetic products to ensure consumer safety.

MoCRA was passed in 2022 and aims to modernize and strengthen cosmetic regulations in the United States. MoCRA replaced the previous Cosmetic Act, which had not been updated since 1938.

Subsequent to the bill’s passage, the FDA issued regulations implementing the law. In issuing MoCRA regulations, FDA’s aim was to help ensure the overall safety of cosmetic products, and expand the Agency’s ability to trace and track non-compliant products and facilities. MoCRA brings significant changes to the cosmetic industry and regulations under MoCRA impact the entire lifecycle of cosmetics products from manufacturing to marketing.

MoCRA Requirements

New MoCRA requirements include:

FDA registration for cosmetics facilities
Product listings for each cosmetic product
Adverse event reporting
Safety […]

By Jennifer Diaz|2024-06-11T09:59:49-04:00June 11, 2024|Cosmetics, U.S. Food and Drug Administration (FDA)|0 Comments

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