FDA Food Labeling Requirements
FDA Food Labeling Requirements: Label Review Service
FDA food labeling rules are detailed, and the responsibility for getting them right is yours. FDA does not pre-approve food labels before they reach the market. That means by the time a problem is caught, it is usually at the port or on a retailer's shelf.
FDABasics reviews your label against current federal requirements and tells you exactly what needs to change. You get a written report and an annotated label file, not a list of regulations to sort through on your own.
What FDA Requires on a Food Label
Food labeling in the United States is governed by the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). The core requirements are found in 21 CFR Part 101. Most packaged foods must include all of the following elements to be considered properly labeled.
Statement of Identity This is the name of the product. It must appear prominently on the principal display panel (PDP) in bold type, using the food's common or usual name. If a standard of identity applies (for example, "mayonnaise" or "ice cream"), the name specified in regulation must be used.
Net Quantity of Contents The amount of food in the package must be declared on the PDP in both metric and U.S. customary units. Packaging weight is excluded.
Ingredient Statement All ingredients must be listed by their common or usual name in descending order of predominance by weight. Sub-ingredients within a compound ingredient are listed in parentheses. Certain additives, such as preservatives, must also be identified by their function on the label.
Allergen Declaration Under the Food Allergen Labeling and Consumer Protection Act (FALCPA) and the FASTER Act, foods containing any of the nine major allergens must clearly disclose that information. The nine major allergens are: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame. Allergen disclosure can appear within the ingredient statement or in a separate "Contains:" statement.
Nutrition Facts Panel Most packaged foods must include a properly formatted Nutrition Facts label under 21 CFR 101.9. This covers serving size, servings per container, calories, and a defined list of mandatory nutrients with percent Daily Values. The format itself is regulated, and errors in layout or declared values can make a product non-compliant even if the underlying nutrition data is correct.
Name and Place of Business The label must identify the manufacturer, packer, or distributor by name and address, including city, state, and zip code. If the business named is not the manufacturer, a phrase like "manufactured for" or "distributed by" is required.
What a Label Review Covers
When you send us your label, we check it against the current requirements in 21 CFR Part 101, relevant FDA guidance documents, and standards of identity where applicable. Our review covers:
- Statement of identity: correct name, placement, and type prominence
- Net quantity: format, units, and placement on the PDP
- Ingredient statement: order, naming conventions, sub-ingredient disclosure, and additive function labeling
- Allergen compliance: correct identification of all nine major allergens under FALCPA and the FASTER Act
- Nutrition Facts panel: format, serving size, mandatory nutrients, percent Daily Values, and any applicable exemptions or modified formats
- Claims review: evaluation of any nutrient content claims, health claims, or structure/function claims for compliance with applicable regulations
- Name and place of business: correct format and required qualifying statements
You receive a written report of recommended revisions and an annotated label file ready for production.
Dietary Supplement Labeling
Dietary supplements are regulated separately from conventional foods under the Dietary Supplement Health and Education Act (DSHEA). Supplement labels use a Supplement Facts panel rather than a Nutrition Facts panel, and the rules for structure/function claims, ingredient disclosure, and disclaimer language differ from conventional food requirements.
FDABasics reviews dietary supplement labels as well. If you are unsure whether your product is classified as a food or a dietary supplement under FDA's rules, we can help you work that out before reviewing the label.
Who Needs a Label Review?
FDA food labeling rules apply to both domestic and foreign manufacturers. If your product is sold in the United States, the label must comply with 21 CFR Part 101 regardless of where it was produced. Foreign companies exporting food to the U.S. are subject to the same requirements as domestic producers.
FDABasics works with food companies in more than 50 countries. We are familiar with the specific labeling challenges that come with adapting labels from other markets for U.S. distribution, including translation issues, format differences, and ingredient naming conventions that do not align with FDA's requirements.
Pricing
Food label review: Starts at $299 per product. If you have multiple products, contact us and we will put together a discounted rate.
Turnaround is 5 to 10 business days. Need it faster? Tell us when you reach out and we will do our best to accommodate.
Does FDA approve food labels before a product goes to market?
No. FDA does not pre-approve food labels. The responsibility for compliance rests with the manufacturer, packer, or importer. FDA reviews labels reactively, through inspections, import screening, and enforcement actions.
What regulations govern food labeling in the U.S.?
The primary regulation is 21 CFR Part 101. Additional requirements come from the FD&C Act, the Fair Packaging and Labeling Act (FPLA), FALCPA, the FASTER Act (for sesame), and DSHEA (for dietary supplements).
What is the principal display panel?
The principal display panel (PDP) is the part of the label most likely to be seen by a consumer at the point of purchase. Certain required elements, including the statement of identity and net quantity, must appear on the PDP.
What are the nine major food allergens?
Milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame. Sesame was added as a major allergen under the FASTER Act, effective January 1, 2023.
Can I make health claims on my food label?
Only FDA-authorized health claims are permitted. Health claims describe a relationship between a food component and a disease or health-related condition. Using an unauthorized health claim, or wording a claim in a way that implies a product treats or cures a disease, can cause FDA to regulate the product as an unapproved drug.
My label was printed for another market. Can you adapt it for the U.S.?
Yes. We work with companies adapting labels from the EU, Canada, Australia, and other markets for U.S. distribution regularly. This is one of the more common and genuinely complex requests we handle.
What happens if I send my product to the U.S. with a non-compliant label?
FDA can refuse entry at the port. Labeling violations are consistently among the most common reasons for import refusals. Getting the label right before the shipment leaves is significantly easier and less expensive than dealing with a detention or refusal after the fact. That is what the review is for.
Why Choose FDABasics?
FDABasics has been helping foreign manufacturers navigate US FDA requirements since 1995, with over 30 years of regulatory experience serving clients across the food, drug, medical device, and cosmetics industries. We are headquartered in New York, USA and combine deep expertise with the most competitive fees in the industry.
30+ Years of Experience
Originally founded in 1995 as Tobias Systems, we have guided thousands of foreign companies through FDA registration, US Agent services, and full compliance across all four regulated industries.
5-Star Rated on Trustpilot and Google
Our clients consistently rate us 5 stars on both Trustpilot and Google for fast turnaround times, clear communication, and expert handling of their FDA compliance needs.
Strict Client Confidentiality
We believe in ethical business practices and maintain strict confidentiality for all clients. We do not share your information and we do not offer advice simply to sell services.
Lowest Fees, No Hidden Charges
Our fees are straightforward with no hidden charges. We guarantee a cost-effective solution for your business, whether you are a startup or an established manufacturer.
Fast Turnaround and Responsive Service
We know that FDA registration issues can hold up your shipments and delay your market entry. We work quickly and respond promptly so that your compliance is never a bottleneck for your business.
Global Clients, US-Based Team
We serve manufacturers from over 100+ countries and are physically located in the United States, which is a legal requirement for any company serving as your official US FDA Agent.
Not Sure Where To Start?
FDA compliance requirements can be complex, and the right path depends on your specific product, your role in the supply chain, and whether you are a foreign or domestic company. The FDABasics team is happy to point you in the right direction. Contact us for a free consultation and we will help you identify exactly what your business needs to stay compliant and keep products moving into the US market.
