FDA labeling regulations govern the information that must be provided on the labels of various FDA-regulated products, including food, drugs, medical devices, cosmetics, and dietary supplements. Here’s an overview of FDA labeling requirements:

Principal Display Panel (PDP)

The PDP is the part of the label most likely to be displayed to consumers at the point of sale. It typically includes the product name, net quantity of contents, and any necessary product claims or information.

Information Panel

The information panel is where additional required labeling information is located. This may include the ingredient list, nutrition facts, directions for use, warnings, precautions, and contact information for the manufacturer or distributor.

Nutrition Labeling

Most packaged food products must include a Nutrition Facts panel, which provides information about serving size, calories, nutrients, and percent daily values based on a 2,000-calorie diet.

Ingredient Declaration

Food, drug, cosmetic, and dietary supplement labels must include an ingredient list, which lists all ingredients in descending order of predominance by weight.

Allergen Labeling

Food labels must clearly identify any major food allergens, such as peanuts, tree nuts, dairy, eggs, wheat, soy, fish, and shellfish, either in the ingredient list or through a separate allergen statement.

Drug Facts Label

Over-the-counter drug products must include a Drug Facts label, which provides information about active ingredients, uses, warnings, directions, and other important information for consumers.

Cosmetic Labeling

Cosmetics must include the name of the product, net quantity of contents, ingredients, warnings, and directions for safe use.

Medical Device Labeling

Medical devices must include essential labeling information such as the device name, intended use, instructions for use, warnings, and any necessary precautions or contraindications.

Dietary Supplement Labeling

Dietary supplements must include a Supplement Facts panel, which provides information about serving size, nutrients, and percent daily values based on a 2,000-calorie diet.

Special Labeling Requirements

Certain products may have additional labeling requirements, such as country of origin labeling for imported products or special warnings for products with specific health risks.

Compliance with FDA labeling regulations is essential for ensuring that consumers have access to accurate and truthful information about the products they purchase. Failure to comply with labeling requirements may result in regulatory action, including product recalls, warning letters, or enforcement actions by the FDA.

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