FDA Labelling Requirements for Food and Supplement Brands Entering the US

For food, supplement, and cosmetic brands entering the US market, FDA labelling compliance is non-negotiable. It's also one of the most common reasons first-time importers have their shipments detained at the border or products pulled from sale. This guide covers exactly what you need to know.

Who Does the FDA Regulate?

The Food and Drug Administration regulates a broad range of products sold in the US, including:

• Food and beverages (excluding meat, poultry, and egg products, which are USDA)
• Dietary supplements
• Cosmetics and personal care products
• Over-the-counter drugs
• Medical devices

If your product falls into any of these categories, FDA labelling requirements apply from the moment it enters the US — regardless of what country it was manufactured in.

Food and Beverage Labelling Requirements

Nutrition Facts Panel

The US Nutrition Facts panel format is significantly different from the EU format and must follow precise FDA guidelines. Key differences from the EU include:

• Calories must be displayed in a larger, bolder font size
• Added sugars must be declared separately from total sugars
• Vitamin D and potassium must be declared (vitamins A and C are now optional)
• Daily values are expressed as percentages based on a 2,000-calorie diet
• Serving sizes must be based on reference amounts customarily consumed (RACC), not brand discretion

Ingredient List

All ingredients must be listed in descending order by weight, in English. Ingredient names must use the common or usual name recognised in the US — some EU ingredient names differ from their US equivalents and must be translated accordingly.

Allergen Declaration

The US Food Allergen Labeling and Consumer Protection Act (FALCPA) requires declaration of the nine major allergens: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, and sesame (added in 2023). These can be declared in the ingredient list or in a separate "Contains" statement.

Net Quantity of Contents

US labelling requires net quantity declarations in both metric (grams/millilitres) and US customary units (ounces/fluid ounces), in a specific format and minimum font size based on the principal display panel area.

Name and Place of Business

The label must include the name and address of the manufacturer, packer, or distributor. For imported products, this is typically the US importer of record — ImportIQ, in our case — which means our partners' labels include our US address and don't require the brand to have a US entity.

Dietary Supplement Labelling Requirements

Supplements have their own distinct labelling requirements under the Dietary Supplement Health and Education Act (DSHEA):

• Supplement Facts panel (not Nutrition Facts) — with specific formatting requirements
• "Dietary Supplement" statement of identity on the principal display panel
• Serving size and servings per container
• Ingredient declaration for all ingredients, with "other ingredients" listed separately below the Supplement Facts panel
• Disclaimer statement: "These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." — required whenever any structure/function claim is made

Health Claims

The US has strict rules about what you can say on supplement labels. There are three types of permissible claims:

• Nutrient content claims — "High in Vitamin C" (must meet specific criteria)
• Structure/function claims — "Supports immune health" (permitted, but requires the disclaimer above)
• Health claims — claims linking a nutrient to a disease (e.g., "Calcium may reduce the risk of osteoporosis") — must be FDA-authorised or a qualified health claim

Cosmetics Labelling Requirements (Post-MoCRA)

The Modernization of Cosmetics Regulation Act (MoCRA), enacted in December 2022 with implementation through 2024, significantly changed US cosmetics regulation. Key new requirements:

• Facility registration — all cosmetics manufacturing and processing facilities must register with the FDA
• Product listing — cosmetic products must be listed with the FDA
• Safety substantiation — brands must have safety data to support product safety
• Serious Adverse Event Reporting — mandatory reporting of serious adverse events to the FDA

Ingredient Declaration

All cosmetic ingredients must be listed using their INCI (International Nomenclature of Cosmetic Ingredients) names in descending order by weight. INCI names are internationally standardised, but must be in English and follow US conventions where these differ from EU practice.

Warning Statements

Certain cosmetic categories require specific warning statements: sunscreens (Drug labelling applies), products for use near the eye, aerosol products, products containing alcohol. These are mandatory and must appear in specific locations on the label.

Practical Steps for Compliance

1. Conduct a label audit — compare your current label against applicable FDA requirements for your product category
2. Engage a regulatory consultant — for complex products (supplements, cosmetics, specialty foods), professional review is essential
3. Update artwork and obtain revised labels — allow 4–8 weeks for this process, as it typically involves multiple revision rounds
4. Register facilities and products as required (food facilities under FSMA, cosmetics under MoCRA)
5. File Prior Notice for food shipments (required 2–8 hours before arrival at US port)

ImportIQ manages the entire labelling compliance process for all brand partners — from initial audit through revised artwork to final label approval — as part of our standard market entry process.