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FDA Food and Dietary Supplement Labeling Requirements

FDA Food Label Compliance

The Food Manufacturer or Distributor is responsible for ensuring their food product labeling complies with FDA regulations. FDA will not review or approve food labels. If the labels do not comply with FDA requirements, the FDA will consider the product as misbranded and may take regulatory action, including detention.
FDA Agent Pro's Label review service will help you confirm your product labels comply with FDA requirements. The FDA has set clear guidelines for labeling food and dietary supplements to protect public health. Brand owners, manufacturers, and importers of food items must follow these mandatory FDA regulations, ensure their labels provide accurate details, and remain updated on new changes. This is important because food labeling inaccuracies and possible FDA enforcement actions can significantly damage a food and dietary supplements brand’s market position.
Two primary food and supplement label considerations are 1) Food product ingredients and 2) Food product labels.

What are the Food Ingredient Considerations?

FDA has three pillars of regulations for food ingredients, which are listed below.
1) Generally Recognized as Safe (GRAS): a food substance is exempt from FDA premarket review because it is generally recognized as safe by qualified experts under the intended conditions of use.
2) Food additives: any substance added to food to improve the taste, texture, appearance, or nutritional value must be pre-approved unless generally considered safe.
3) Color additives: the FDA must pre-approve any color additive, regardless of whether it is derived from natural sources
The GRAS Substances (SCOGS) Database contains thousands of food substances, including additives, preservatives, colorings, flavor enhancers, and emulsifiers. As a general rule, food manufacturers must review and verify their substances in the GRAS database (not included in the label review service). Verifying the ingredients primarily indicates that the FDA has deemed the substance safe for use in food products, which can reassure consumers about its safety. Labeling issues are often the primary cause of delays in FDA shipment clearance. If you seek experienced regulatory specialists to evaluate your food labels before entering the US market, you are in the right place. FDA Agent Pro LLC conducts label reviews for food products and dietary supplements according to FDA labeling guidelines and regulations. This ensures that your product labels meet mandatory FDA requirements and are FDA-compliant.

FDA Food and Dietary Supplement Label Review Process

Cost: $499

  • Step 1
    Complete the initial form below, and tell us about your company
  • Step 2
    We will issue you a short and simple questionnaire and request label information
  • Step 3
    Comprehensive FDA Agent Pro LLC Review: Principal Display Panel PDP, Nutrition Facts Panel, Ingredient Statement
  • Step 4
    Review and Analysis of Label Layout and Other Statements
  • Step 5
    Final Label Review Report issued by us

FDA Food and Dietary Supplement Label Review Form

Include suffix e.g, LLC, Limited, Inc, Pte Ltd, Pvt Ltd, etc.
If you don't have a DUNS, we can help. Type 'No DUNS' in the field.
This should be the facility address where the products are manufactured, packed, processed, or stored.
I confirm that facility is engaged in the manufacturing processing packing or holding of foods
Was this facility was previously registered with the FDA?
I Agree With The Terms and Conditions and Scope of Services Below
FDA Food and Dietary Supplement Label Review Terms and Conditions / Scope of Services

What are FDA Label Considerations?

According to the new FDA regulation, food, beverage, and dietary supplement labels must contain Nutrition or Supplement Facts information that complies with new FDA requirements concerning the label formatting, nutrient names and the exact amounts, and percent daily value calculation. Food or supplement labels generally consist of four different sections described below:
● Principal Display Panel: a brand name, statement of Identity, and net quantity.●Information Panel: ingredients, directions for use, warnings, food allergen declarations, manufacturer’s name and address, and country of origin.●Nutrient or Supplement Panel: nutrient components labeling and serving sizes.● Labeling Claims: nutrient content, health, or other regulated claims
Nutrition or Supplement Facts Panel: Calculate and determine the serving size and the daily values in the U.S. metric system and prepare the nutrition or supplement facts panel. FDA has approved multiple chart formats (tabular, simplified, linear, etc.) to accommodate various label sizes.
Ingredient Statement: Review and advise for changes to the order or the nomenclature of the statement to follow an FDA-compliant and consumer-friendly ingredient statement.
Labeling Claims: Review and guidance for nutrient content claims, organic claims, health claims, and other regulated (i.e., pasteurized, natural, fresh, etc) claims that appear on the product label.
Label Layout and Format: Redesign and suggest a finished label that fits into the product profile in size, shape, layout, and formatting.
Other Considerations: include Allergen statements, structure and function claims, and nutrient claims.