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FDA Food and Dietary Supplement Labeling Requirements
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The FDA has established specific food labeling requirements to protect consumers and ensure accurate product information. Accordingly, brand owners, manufacturers, and importers must comply with applicable FDA labeling requirements and keep their labels up to date as regulations change. Accurate labeling is important because labeling violations can lead to FDA enforcement actions and negatively affect a food or dietary supplement brand’s market position.
Two key considerations in FDA food and dietary supplement labeling 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.
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.
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 Listing Inc. 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. We offer a free 30-minute consultation to discuss our findings and provide guidance on necessary changes.
Service Details & Fees
Food Label Review
Time Required
Current Label Assessment
60 Days Unlimited Revisions
Discount on Multiple Labels
495 USD
5-7 Days
_______ Related Services _______
Frequently Asked Questions (FAQ)
Does the FDA review or approve food and supplement labels before you launch?
No, the FDA does not pre-approve or certify labels before products go on sale. You are fully responsible for ensuring your label meets all federal rules before shipping.
What must be included on an FDA-compliant food or supplement label?
Your label must include the product name, total weight or volume, an ingredient list, allergen warnings, a Nutrition or Supplement Facts panel, and your company name and address.
How must ingredients be listed on the label?
No, the FDA does not accept or review your dietary supplement labels. Instead, it is the manufacturer’saIngredients must be listed in order by weight, starting with the ingredient used in the largest amount and ending with the smallest amount. responsibility to ensure the product labels are FDA-compliant.
How do you declare major food allergens on the package?
Major allergens (like milk, eggs, nuts, wheat, soy, and sesame) must be declared either inside the ingredient list or listed in a “Contains” statement directly under the ingredients.
What is the difference between a Nutrition Facts panel and a Supplement Facts panel?
Nutrition Facts panels are required for everyday foods and drinks. Supplement Facts panels are reserved specifically for dietary supplements like vitamins, herbs, or protein powders.
Can you put health claims on a dietary supplement label?
Yes, but health claims must follow strict FDA guidelines, include a required disclaimer stating the product is not meant to cure or treat diseases.
Service Details & Fees
Food Label Review
545 USD
Time Required
5-7 Days
Current Label Assessment
60 Days Unlimited Revisions
Discount on Multiple Labels
_______ Related Services _______