FDA labeling requirements are the most common reason a promising international brand stalls at the U.S. border. A product that sells beautifully in London, Sydney, or Seoul can be refused entry, rejected by a retailer's compliance desk, or pulled from shelves because of a panel that is technically non-compliant in ways the founder never thought to check.
Brand Refinery is a CPG consulting firm that helps international and emerging brands enter the U.S. market, including navigating FDA registration, labeling compliance, and retailer-specific requirements. This guide covers what changed heading into 2026 and gives you a category-by-category checklist you can act on.
Who the FDA Regulates
The FDA has jurisdiction over most consumer packaged goods sold in the United States, including conventional food and beverage, dietary supplements, cosmetics and personal care, and over-the-counter drugs. The USDA regulates meat, poultry, and certain egg products. The TTB regulates most alcoholic beverages. The FTC separately polices advertising claims, including "Made in USA."
Critically, the FDA does not pre-approve labels for food or cosmetics. There is no submission process that returns a stamp of approval. The burden sits entirely with the brand, and enforcement happens after the fact through import alerts, warning letters, and recalls. That asymmetry is why compliance has to be engineered in at the design stage, not checked at the end.
What Changed for 2026
Three regulatory shifts matter most to brands launching or relabeling this year.
FSMA Section 204 food traceability
The FDA's Food Traceability Rule requires enhanced recordkeeping for companies that manufacture, process, pack, or hold foods on the Food Traceability List. The list covers high-risk categories including leafy greens, fresh-cut fruits and vegetables, certain cheeses, shell eggs, nut butters, and ready-to-eat deli salads.
The rule requires you to capture Key Data Elements at each Critical Tracking Event and produce a sortable electronic record within 24 hours of an FDA request. The compliance date has been the subject of proposed extension, so confirm the operative date for your category before you build your system. Either way, brands touching FTL foods should be building traceability capability now rather than waiting.
MoCRA for cosmetics and personal care
The Modernization of Cosmetics Regulation Act is now fully in force and represents the largest expansion of FDA cosmetics authority in more than 80 years. Obligations include facility registration and product listing, a named Responsible Person on the label, substantiation of safety for each product, adverse event reporting and recordkeeping, and mandatory fragrance allergen disclosure as the FDA phases in its rule.
For international beauty brands this is the single biggest change. Products that shipped freely into the U.S. under the old regime now require a registered U.S. facility relationship, a designated Responsible Person with a U.S. address, and a safety substantiation file that can be produced on request.
Front-of-package nutrition labeling
The FDA has proposed a mandatory interpretive front-of-package system that would signal levels of saturated fat, sodium, and added sugars on the principal display panel. If finalized, expect a multi-year phase-in scaled by company size. Brands designing new packaging in 2026 should reserve principal-display-panel real estate now so a future redesign does not force a full artwork rebuild.
Food and Beverage Labeling Checklist
Every packaged food label sold in the U.S. must carry the following, correctly formatted and correctly placed.
Statement of identity. The common or usual name of the food, on the principal display panel, in bold type reasonably related in size to the most prominent printing on the panel.
Net quantity of contents. Expressed in both U.S. customary and metric units, placed in the bottom 30 percent of the principal display panel, with minimum type sizes tied to panel area.
Nutrition Facts panel. Current format with calories in large type, added sugars declared, updated Daily Values, and updated serving sizes reflecting the amounts people actually eat. This is a frequent failure point for imported products still carrying an EU or UK nutrition table.
Ingredient list. All ingredients in descending order of predominance by weight, using common or usual names. Sub-ingredients of compound ingredients must be disclosed.
Allergen declaration. The nine major allergens must be identified: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame. Sesame joined the list under the FASTER Act and continues to trip up imported products.
Name and place of business. The manufacturer, packer, or distributor, with a full street address unless the firm is listed in a current city or telephone directory.
Country of origin where required by customs rules.
Beyond the federal baseline, state law adds a second layer. California Proposition 65 requires warning language for listed chemicals, and a growing set of states have enacted their own food additive restrictions and disclosure requirements. Your label needs to be compliant in every state where you distribute, not just at the federal level.
Cosmetics and Personal Care Checklist
INCI ingredient naming. Ingredients must be declared using International Nomenclature of Cosmetic Ingredients names, in descending order of predominance down to one percent, after which order does not matter. Colorants are listed last regardless of concentration.
Identity and net contents on the principal display panel, with the same placement and type-size rules as food.
Responsible Person name and U.S. address under MoCRA, along with facility registration and product listing with the FDA.
Warnings where required, including flammability, "keep out of reach of children," and specific warnings for products such as aerosols and certain hair treatments.
Claim discipline. This is where most beauty brands create legal exposure. A claim that a product affects the structure or function of the body converts a cosmetic into a drug in the FDA's eyes. Phrases like "reduces wrinkles by stimulating collagen production," "treats acne," or "regrows hair" can push you into a drug classification requiring an entirely different approval pathway. Appearance-based language keeps you in cosmetic territory.
Fragrance allergen disclosure as the MoCRA rule phases in.
Dietary Supplements Checklist
Supplements sit in their own regulatory lane. Required elements include a Supplement Facts panel rather than Nutrition Facts, the statement of identity including the word "supplement," the FDA disclaimer for any structure/function claim, and full facility compliance with dietary supplement cGMP under 21 CFR Part 111.
Novel ingredients may require a New Dietary Ingredient notification submitted to the FDA at least 75 days before marketing. Disease claims are prohibited outright. The line between an acceptable structure/function claim and an unlawful disease claim is narrow and actively enforced.
The Compliance Sequence We Recommend
- Classify the product correctly. Food, supplement, cosmetic, OTC drug, or a hybrid. Everything downstream depends on this, and misclassification is the most expensive mistake to unwind.
- Register facilities. FDA food facility registration, or MoCRA facility registration and product listing for cosmetics. International facilities also need a U.S. Agent.
- Build the label from regulation to artwork, not artwork to regulation. Give your designer the required panel elements and minimum type sizes as constraints up front.
- Substantiate every claim with documentation you could hand to a regulator or a plaintiff's attorney tomorrow.
- Run a formal compliance review before you commit to a production run. Rework at the plate stage is inexpensive. Rework after 100,000 units are printed is not.
- Layer on retailer requirements. Walmart, Target, Whole Foods, and Costco each impose supplier standards that exceed FDA minimums, covering banned ingredient lists, packaging specifications, and third-party certifications.
- Set a monitoring cadence. Regulations move. Review your portfolio against current requirements at least annually.
Get Your Labels Reviewed Before You Print
Brand Refinery handles FDA and regulatory compliance, labeling and packaging review, and retailer-specific compliance as part of our logistics and operations service line. We have guided 23+ brands through U.S. market entry, and label compliance is where we most often prevent expensive mistakes. Learn more about our approach.
Have artwork you need reviewed before a production run? Schedule a consultation or call (424) 397-3047.
This article is general information, not legal advice. Regulatory dates and rule status change frequently — verify current requirements with the FDA or qualified counsel before acting.
Frequently Asked Questions
Does the FDA approve product labels before I can sell in the U.S.?
No. The FDA does not pre-approve labels for food, beverage, dietary supplement, or cosmetic products. The brand is fully responsible for ensuring compliance, and the FDA enforces after the fact through import alerts, warning letters, seizures, and recalls. Because there is no approval safety net, a pre-production compliance review is essential.
What is MoCRA and does it apply to international beauty brands?
MoCRA is the Modernization of Cosmetics Regulation Act, which gave the FDA expanded authority over cosmetics including facility registration, product listing, safety substantiation, adverse event reporting, and mandatory recalls. It applies to any cosmetic product marketed in the United States regardless of where it is manufactured, so international beauty brands must comply and must designate a Responsible Person with a U.S. address on the label.
Do I need to change my label if I already sell in the EU or UK?
Almost certainly yes. U.S. requirements differ from EU and UK rules in nutrition panel format, serving size basis, unit declarations, allergen list, and required address information. The U.S. requires sesame as a declared allergen and uses a Nutrition Facts format that has no EU equivalent. Assume a full relabel rather than a translation.
What happens if my product label is non-compliant?
Consequences escalate from FDA refusal of entry at the port and detention without physical examination under an import alert, through warning letters, to seizure, injunction, and mandatory recall. Retailers separately delist non-compliant items, and non-compliant claims invite class action litigation, which has been rising sharply in food and beauty.
How long does FDA labeling compliance take for a new product?
For a straightforward food or cosmetic product with no novel ingredients, plan four to eight weeks for classification, panel construction, claim substantiation, and legal review. Products requiring a New Dietary Ingredient notification need at least 75 days of FDA review on top of preparation time, and novel food ingredients requiring a GRAS pathway can take considerably longer.