FDA Food Ingredient &
Label Review

A food label review is a professional evaluation of a conventional food label and the product information supporting it. The review can cover the statement of identity, net quantity, ingredient declaration, major allergens, Nutrition Facts, serving size, manufacturer/packer/distributor information, claims, warnings, and other product-specific requirements.

FDA generally does not pre-approve conventional food labels before marketing. The responsible company must ensure that the food and its labeling comply with applicable law. A professional review is a compliance service, not FDA approval or certification.

For a meaningful review, we normally need the current label artwork, complete formulation/ingredient information, sub-ingredient information when applicable, package/net quantity, nutrition data or source data, serving-size information, product specifications, claims, and any special product-category details relevant to the label.

The standard professional fee is $250 per label. Nutrition analysis, laboratory testing, translation, substantial reformulation, multiple distinct package formats, or specialized category work may require a separate or expanded quote.

A typical standard review is targeted for approximately 2–3 business days after complete artwork and product information are received. Complex formulations, missing specifications, nutrition-data questions, or extensive claims can extend the timeline.

Common required elements include the statement of identity, net quantity of contents, ingredient list, major food allergen disclosure when applicable, Nutrition Facts unless an exemption or special provision applies, and the name and place of business of the manufacturer, packer, or distributor. Additional requirements can apply by product category.

The statement of identity is the name of the food. Depending on the product, it may be a name required by law/regulation, a common or usual name, or an appropriately descriptive name. A brand name alone does not necessarily satisfy the statement-of-identity requirement.

For most packaged foods subject to FDA's rule, the net quantity of contents statement appears on the principal display panel and is subject to placement, prominence, unit, and type-size requirements tied to the package/PDP size.

Ingredients are generally listed by their common or usual names in descending order of predominance by weight, subject to exceptions and special rules. Compound ingredients can also require declaration of their sub-ingredients.

Federal law recognizes nine major food allergens: milk, egg, fish, Crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame.

Sesame became the ninth major food allergen effective January 1, 2023. FDA-regulated packaged foods using sesame as an ingredient must meet the applicable allergen-labeling requirements.

Depending on the ingredient naming, allergen sources can be identified in the ingredient list or through a properly formatted Contains statement immediately after or adjacent to the ingredient list. If a Contains statement is used, it must identify all applicable major food allergens used as ingredients.

Advisory statements such as 'may contain' are voluntary. They should not be used as a substitute for good manufacturing practices or for proper declaration of major allergens that are intentionally used as ingredients.

Most packaged foods subject to FDA nutrition-labeling requirements need Nutrition Facts, but exemptions and special provisions exist. A product should not omit Nutrition Facts unless it actually qualifies under the applicable exemption or rule.

One low-volume exemption can apply when the person claiming it meets the employee and unit-sales thresholds and files the required notice annually. Other sales-based exemptions also exist. These exemptions address nutrition labeling only and do not remove other mandatory label information. Nutrition/health claims can also make certain exemptions unavailable.

Generally not for the low-volume/small-business nutrition-labeling exemptions that are conditioned on the absence of nutrient content claims, health claims, or other nutrition information. The specific exemption and product facts should be checked before relying on it.

We can review a Nutrition Facts panel and the supporting serving-size/nutrition information included in the service scope. If nutrient values must be generated from formulation databases, laboratory analysis, or other source data, that work should be identified separately from a basic artwork review.

Serving sizes for many foods are based on FDA Reference Amounts Customarily Consumed (RACCs), together with package size and product-specific rules. Serving size should not simply be chosen for marketing preference.

Nutrient content claims characterize the level of a nutrient in a food, such as 'low sodium,' 'sugar free,' or 'high fiber.' The claim must meet the applicable FDA criteria and related labeling conditions.

A health claim describes a relationship between a food or food substance and reduced risk of a disease or health-related condition. FDA has specific pathways and requirements for authorized or qualified health claims.

The term 'healthy' is a regulated implied nutrient content claim when used in the relevant labeling context. FDA updated its criteria in a final rule; qualifying foods must meet food-group and nutrient-limit criteria, including limits for saturated fat, sodium, and added sugars.

As of August 2026, FDA's Nutrition Info box remains a proposed rule, not a final mandatory front-of-package nutrition-labeling requirement. FDA's current regulatory agenda lists a final rule as a future action, so labels should not be treated as if the proposal is already law.

A voluntary 'gluten-free' claim must meet FDA's applicable gluten-free definition and requirements. The claim should be reviewed against the product ingredients, manufacturing conditions, and any relevant testing or supplier information.

Claims such as 'natural' require careful review because they can be misleading depending on the product and context. FDA has historically maintained a policy rather than a comprehensive formal definition for 'natural' in conventional foods, so the full claim context matters.

Organic certification and the USDA Organic seal are primarily governed by USDA's National Organic Program, while FDA food-labeling requirements still apply to the food. Organic status does not replace FDA labeling requirements.

Yes. FDA-regulated foods offered for import into the United States must comply with applicable U.S. food-labeling requirements. Foreign-market artwork should be reviewed rather than assumed to be acceptable for U.S. sale.

FDA requires mandatory food-label information to appear in English unless an applicable exception applies. When a label contains a foreign-language representation, the regulations can require mandatory information to appear in that language as well.

A sticker or supplemental label can sometimes be used when it produces labeling that is complete, accurate, legible, conspicuous, and compliant before the product is introduced or delivered for introduction into U.S. commerce. The exact correction and timing should be reviewed for the specific product and import situation.

The label must identify the name and place of business of the manufacturer, packer, or distributor as required by FDA's food-labeling rules. Whether a U.S. importer is the appropriate named party depends on the business relationship and how the food is labeled.

Country-of-origin marking is principally a U.S. Customs and Border Protection requirement rather than an FDA Part 101 requirement. A comprehensive import-label review can flag the issue, but FDA and CBP requirements should not be confused.

No. A competitor's formulation, nutrient profile, serving size, process, package dimensions, claims, exemptions, and supplier ingredients may differ from yours. The label should be built from your own product data.

Only when the labels and underlying formulations are sufficiently identical for the agreed scope. Different flavors can change ingredients, allergens, nutrient values, claims, statements of identity, colors, or other mandatory information, so each distinct label may require its own review.

No. Food labeling and FSVP are separate compliance programs. FSVP applies to the FDA-defined FSVP importer of covered imported food, subject to exemptions and modified requirements.

No. A label review does not register the manufacturing facility, and Food Facility Registration does not approve the label. Each requirement should be handled separately when applicable.

No. Prior Notice is a separate FDA import requirement for covered imported food shipments, subject to exemptions and timing rules.

FDA does not issue a general conventional-food label approval certificate. A private consultant may provide a review report or service documentation, but it should not be represented as FDA approval or certification.

Depending on the issue and circumstances, a food can be considered misbranded and may face regulatory or import consequences. The appropriate correction can range from artwork revision to relabeling, claim removal, ingredient/allergen correction, or other product-specific action.

Yes. A change in ingredients, supplier composition, allergen status, nutrient values, serving size, package size, product name, claims, or other material information can affect the label and should trigger a review of the affected sections.