FDA Entry Point Label Review: What We Check Before You Ship

How the label review works

FDA Entry Point compares print-ready label artwork, the product formula, and every marketing claim against the labeling rules for the product’s FDA category. The review starts before printing or a label change so required corrections can be connected to the registration, product listing, SPL, or GUDID record already handled by the same compliance team.

Inputs, review actions, and returned findings
Stage	Customer provides	FDA Entry Point handles
Artwork intake	Print-ready artwork or PDF for each container, carton, insert, or package configuration	Maps the principal display panel, information panel, ingredient statement, required warnings, directions, and business information.
Product data	Full formulation or ingredient list, including compound ingredients and sub-ingredients	Checks naming, order of predominance, active and inactive ingredient treatment, allergen disclosure, and formula-to-label consistency.
Claims analysis	On-label claims, website copy, advertising language, and intended uses	Identifies disease, treatment, structure/function, sunscreen, acne, and other claims that can change the FDA category or require a different labeling framework.
Market context	Intended U.S. market, product category, distribution model, and country of manufacture	Applies the appropriate food, cosmetic, drug, or device rules and checks imported-product marking requirements.
Review return	Clarifications requested during review	Returns artwork-specific findings, required corrections, governing rule citations, claim flags, and a list of registration or listing records affected by the proposed label.

Label review and regulatory filing remain separate scopes. When a finding requires a cosmetic product-listing amendment, drug SPL update, device GUDID change, or another filing, the review identifies that connection before shipment or print approval.

Cross-vertical label control map

Each review follows the rule set attached to the product category rather than applying a generic packaging checklist. Cosmetics rely heavily on 21 CFR Part 701 and the Fair Packaging and Labeling Act, foods on 21 CFR Part 101, drugs on 21 CFR Part 201, and devices on 21 CFR Part 801.

Mandatory elements checked by FDA Entry Point and their governing rules
Vertical	Elements checked	Primary rule	Connected compliance record
Cosmetics	Product identity and net quantity on the principal display panel; manufacturer, packer, or distributor name and place of business; required warnings; English-language presentation	21 CFR 701.2 and 701.10 to 701.13	Cosmetic product listing and Responsible Person information
Cosmetics	U.S.-accepted ingredient names, commonly handled through INCI nomenclature; descending order of predominance; fragrance and flavor treatment; color additives; compound-ingredient and sub-ingredient disclosure	21 CFR 701.3 under the Fair Packaging and Labeling Act	Formula and ingredient data used for the cosmetic product listing
Cosmetics	Responsible Person name as shown on the label, business information, and a domestic address, domestic phone number, or electronic contact for adverse-event reports	21 CFR 701.12 and FD&C Act Section 609(a), codified at 21 U.S.C. 364e(a)	Responsible Person and Cosmetics Direct records
Professional cosmetics	Clear and prominent statement that the product shall be administered or used only by licensed professionals	FD&C Act Section 609(c), codified at 21 U.S.C. 364e(c); effective December 29, 2023	Professional-use designation and product listing
Food and beverages	Statement of identity, net quantity, name and place of business, ingredient statement, sub-ingredients, and the appropriate Nutrition Facts or Supplement Facts framework	21 CFR 101.3, 101.4, 101.5, 101.9, 101.36, and 101.105	Product identity used in import and Prior Notice records
Food and beverages	Major allergen sources, including sesame, either within the ingredient statement or in a compliant Contains statement	FD&C Act Sections 201(qq) and 403(w); sesame requirements effective January 1, 2023	Formula, supplier documentation, and import product description
Food and beverages	Nutrient content, health, structure/function, organic, natural, and other marketing claims	21 CFR 101.13, 101.14, and applicable claim-specific provisions	Label artwork and marketing copy
Drugs	OTC Drug Facts headings and order, active ingredient and purpose, uses, warnings, directions, other information, and inactive ingredients	21 CFR 201.66	NDC product listing and SPL labeling content
Drugs	Prescription drug Highlights, full Prescribing Information, boxed warnings, and required patient labeling	21 CFR 201.56 and 201.57	SPL submission and current drug listing
Medical devices	Name and place of business, intended use, adequate directions, required warnings, prominence, prescription-use language, and false or misleading statements	21 CFR 801.1, 801.4, 801.5, 801.6, 801.15, and 801.109	Device listing and intended-use records
Medical devices	UDI presentation and consistency with the device identifier and GUDID record for devices subject to UDI requirements	21 CFR 801.20 and Part 830	GUDID and device listing records
Imported products	English country-of-origin marking in a conspicuous location	19 U.S.C. 1304 and 19 CFR Part 134, administered by U.S. Customs and Border Protection	Artwork and customs-entry product description
Regulatory sources: FDA cosmetic labeling requirements, 21 U.S.C. 364e, FDA Food Labeling Guide, FDA OTC Drug Facts requirements, FDA device labeling requirements, and 19 CFR Part 134.

Claims that can change a cosmetic into a drug

FDA classification follows intended use, which can be established by package claims, website copy, advertising, directions, and other promotional statements. A product presented as a cosmetic can become a drug, or a cosmetic and drug combination, when its claims promise disease treatment or an effect on the body’s structure or function.

Recurring cosmetic claim triggers checked during review
Claim pattern	Regulatory effect	Review treatment
SPF, sunscreen, sunburn prevention, or UV-protection claims	Sunscreens are regulated as OTC drugs in the United States, including moisturizers and cosmetics labeled with SPF values.	The review checks the OTC Drug Facts framework, permitted active ingredients, SPF presentation, warnings, and directions rather than treating the product as cosmetic-only.
Treats, prevents, controls, or clears acne	Acne treatment is a disease-treatment purpose and creates a drug intended use.	The claim is flagged for drug classification, applicable OTC monograph analysis, and drug labeling requirements.
Stimulates collagen, rebuilds tissue, removes wrinkles, or changes skin structure	Claims to affect the structure or function of skin can make the product a drug or, in some cases, a medical device.	The review separates appearance-focused cosmetic language from physiological or structural claims that require another regulatory pathway.
Moisturizes skin or temporarily reduces the appearance of fine lines	Appearance and moisturizing claims can remain cosmetic when they do not promise structural change or treatment.	The wording is checked in its full context, including supporting website and advertising copy.
Heals, repairs, regenerates, reduces inflammation, or restores a body function	These terms can communicate treatment or structure/function intent even when the package calls the product a serum, cream, or cosmetic.	The review flags the exact wording and identifies the registration, listing, or labeling framework implicated by the claim.
Sources: FDA cosmetic labeling claims, FDA anti-aging claim guidance, and FDA Entry Point cosmetic label review.

What the completed review returns

Deliverable	Contents
Artwork findings	Issues tied to the affected panel, statement, ingredient line, warning, direction, or claim.
Correction schedule	Required text changes, placement changes, missing elements, nomenclature corrections, and formula-to-label discrepancies.
Rule references	The FDA regulation, statutory provision, or customs-marking rule behind each material correction.
Claims disposition	Cosmetic, food, drug, or device claim flags, including language that creates a disease-treatment or structure/function issue.
Record impact list	Existing product listings, SPL records, GUDID data, or import descriptions that need to remain consistent with the corrected label.

Work outside label review

Label review does not perform safety substantiation testing, toxicology studies, stability testing, package artwork design, or print production. Claims analysis identifies FDA classification triggers and their filing consequences, but it is not a legal opinion on a disputed product classification.

Registration, product listing, Responsible Person support, SPL submission, GUDID submission, and filing amendments can remain under the same FDA Entry Point relationship. Each is a separate service unless an issued quote expressly bundles it with the label review.

Published label review pricing

Published starting prices checked on October 24, 2026 are charged per label, product, or change. Label review is priced independently from annual U.S. Agent coverage, which prevents the agent fee from being presented as though it includes technical label work.

FDA Entry Point published pricing
Service	Billing unit	Starting price
Food Label Review: Basic formatting	Per label or change	$349
Food Label Review: Standard	Per label or change	$600
Cosmetic Label Review	Per product or change	$449
Drug Label Review	Per product or change	$449
Medical Device Label Review	Per product or change	$449
Food or cosmetic U.S. Agent service	Annual, separate from label review	$295 per year
Drug or medical device U.S. Agent service	Annual, separate from label review	$395 per year
Pricing source: FDA Entry Point pricing. Annual subscriptions renew automatically and can be canceled with 30 days’ notice; payment is due before work begins.

Illustrative scenario: one foreign skincare label

In October 2026, a French skincare brand submits one 50 mL serum label before approving its first U.S. print run. The submission includes bottle and carton PDFs, the complete formula, website claims, and confirmation that the product is intended to remain a cosmetic.

The ingredient review replaces a non-standard marketing name with the appropriate U.S. ingredient name and checks the formula’s order of predominance.
The principal display panel is corrected from “50 mL” alone to a net quantity statement that includes U.S. customary measure alongside the metric declaration.
The information panel is updated with the responsible business name and place of business, the MoCRA adverse-event contact channel, and the English country-of-origin marking.
The phrase “stimulates collagen production” is flagged because it claims an effect on skin structure. The revised cosmetic claim addresses visible appearance without promising physiological change.
The final findings identify the corresponding cosmetic product-listing information that must remain consistent with the corrected label.

The cosmetic label review starts at $449. If the same foreign facility also purchases annual cosmetic U.S. Agent coverage at $295, those two published line items total $744. Cosmetic facility registration, product listing, Responsible Person support, and later filing amendments remain separately priced unless the quote expressly bundles them.

Frequently asked questions

Can I get cosmetic label review and U.S. Agent support from FDA Entry Point in one place?

Yes. FDA Entry Point can hold the U.S. Agent designation, handle cosmetic registration and listing work, and review the label through the same compliance team. The services remain separately priced, so the $295 annual cosmetic U.S. Agent fee does not silently absorb or conceal the $449 per-product label review charge. Buyers comparing service models can also review the dedicated FDA Entry Point and FDAImports comparison and FDA Entry Point and FDABasics comparison.

What should a foreign cosmetics brand check on its INCI label before selling in the United States?

The label should use U.S.-accepted ingredient names, place ingredients in the correct order of predominance, address fragrance, flavor, color additives, and sub-ingredients correctly, and display the ingredient declaration prominently. The artwork also needs the product identity, net quantity, responsible business information, applicable MoCRA contact information, required warnings, and country-of-origin marking. Marketing claims must be reviewed with the artwork because acne, sunscreen, disease-treatment, and skin-structure claims can move the product into drug regulation.

Can a labeling problem cause a product to be detained or refused at the U.S. border?

Yes. FDA may detain or refuse an imported product that appears misbranded, including a product with missing required information, false or misleading claims, or the wrong regulatory labeling framework. FDA’s entry review can include a label examination, and a refused shipment must be exported or destroyed under FDA and U.S. Customs and Border Protection supervision within 90 days. Label review reduces preventable errors but does not guarantee FDA admission. FDA import requirements explain the admissibility standard.

Does cosmetic label review include MoCRA registration, product listing, or Responsible Person support?

FDA Entry Point can perform those services under the same relationship, but the label review itself remains a separate scope. The review checks whether the Responsible Person information, adverse-event contact, ingredients, product identity, and claims align with the proposed cosmetic product listing. Registration, listing, Responsible Person work, and amendments are then handled as their own filing services rather than being hidden inside the label-review charge.

Does FDA Entry Point provide artwork design or safety substantiation testing?

No. FDA Entry Point reviews regulatory content and identifies the changes the artwork requires; it does not create the package design or operate as a printing service. The review also does not perform toxicology, stability, microbiological, clinical, or other safety-substantiation testing. The manufacturer or Responsible Person remains responsible for maintaining adequate cosmetic safety substantiation under FD&C Act Section 608.

Does claims analysis provide a legal opinion on whether a product is a cosmetic, drug, or device?

The review provides a regulatory classification screen, not a legal opinion in a contested classification matter. FDA Entry Point identifies claims that communicate disease treatment, prevention, or effects on body structure or function, then maps those claims to the drug, device, registration, listing, or labeling consequences they create. A disputed classification requiring formal legal interpretation remains outside routine label review.