FDA Compliance Services for Domestic and Foreign Companies
Manufacturing, exporting, importing or distributing an FDA-regulated product in the United States can involve much more than completing a registration form. Depending on the product and activity, a company may need facility or establishment registration, product listing, label review, Nutrition Facts, Supplement Facts or Drug Facts formatting, Prior Notice, Foreign Supplier Verification Program compliance, food-canning filings, a U.S. Agent, adverse-event contact information, or assistance resolving an FDA detention.
U.S. regulatory requirements affect domestic businesses as well as manufacturers and exporters throughout Europe, Asia, Latin America, Africa and other regions that want access to the American market. Determining the correct FDA regulatory category at the beginning of a project can help prevent expensive corrections after goods have already been produced, labeled or shipped.
FDA Compliance Starts With Correct Product Classification
There is no single FDA registration or compliance procedure that applies identically to every product. Conventional food, dietary supplements, acidified and low-acid canned foods, conventional cosmetics, cosmetic-drug combination products, prescription drugs and over-the-counter drugs are regulated under different statutory and regulatory frameworks. Requirements can also change depending on whether the company manufactures, processes, packs, holds, relabels, repackages, imports or distributes the product.
That distinction is especially important for foreign businesses. A European olive-oil producer, an Asian dietary supplement manufacturer, a Latin American canned-food processor or an African cosmetics company cannot safely assume that requirements used for another type of product will apply to its own operations. The first regulatory question should therefore be: What exactly is the product, what claims are being made for it, and what activities are being performed?
A cream marketed only to moisturize and beautify the skin may be a conventional cosmetic. A similar-looking product making therapeutic claims may become subject to drug requirements. A shampoo intended simply to cleanse hair may be a cosmetic, while an antidandruff shampoo may be both a cosmetic and an OTC drug. The regulatory consequences affect establishment registration, product listing, labeling, active ingredients, claims and manufacturing compliance.
FDA registration is not the same as FDA approval.
Registration or listing with FDA should not be represented as an endorsement, certification or approval of a private company or product. The FDA logo also should not be used in a manner that creates the impression that FDA endorses a company, consultant, establishment, product or service.
Experienced U.S. FDA regulatory consultants can assist companies by reviewing the intended product category, identifying applicable registrations and submissions, examining labels and claims, coordinating U.S. Agent requirements, preparing import-related filings, and helping establish a compliance strategy before products reach the U.S. border.
Conventional Food and Dietary Supplement Compliance
Conventional Food
Conventional foods include thousands of familiar products such as coffee, tea, cocoa, olive oil, spices, rice, snacks, confectionery, bakery products, sauces, beverages, cheese, frozen foods and many other products intended primarily for taste, aroma or nutritive value.
A domestic or foreign facility engaged in manufacturing, processing, packing or holding food for consumption in the United States may be required to register with FDA unless a statutory or regulatory exemption applies. Covered food facility registrations must also be renewed during the applicable biennial renewal period.
Dietary Supplements
Dietary supplements can include vitamins, minerals, herbs, botanicals, amino acids, fish oils, probiotics and other dietary ingredients. Although dietary supplements are regulated as a category of food, they have specialized labeling, manufacturing and claim requirements.
A supplement label generally requires a properly formatted Supplement Facts panel instead of the Nutrition Facts panel used for conventional foods. Ingredient identity, serving size, amount per serving, percent Daily Value when applicable, other ingredients, responsible-firm information and claims should all be reviewed carefully.
Companies should also distinguish lawful dietary supplement structure/function claims from claims suggesting that the product is intended to diagnose, treat, cure or prevent disease. Disease-treatment claims can change the regulatory status of a product and may cause FDA to consider it an unapproved drug.
Import compliance extends beyond the package itself. Imported food may also involve Prior Notice, FSVP requirements, supplier verification, entry data, food facility registration and records that must be available if FDA requests them.
Foreign manufacturers commonly focus primarily on manufacturing specifications and product quality. For the U.S. market, however, the regulatory structure surrounding the shipment is equally important. Having a compliant formula and attractive package does not correct a missing registration, an inaccurate label or an incomplete import compliance program.
Canned Food, FCE Registration and SID Process Filing
Canned-food compliance deserves separate attention. Acidified foods and low-acid canned foods can be subject to requirements that go beyond ordinary food facility registration. Commercial processors of covered acidified or low-acid canned foods may need to register the processing establishment as a Food Canning Establishment and file scheduled process information with FDA.
The Food Canning Establishment registration is commonly associated with an FCE number. Process filings are commonly associated with a Submission Identifier, or SID. Different formulations, container dimensions, container types, processing methods or other critical factors can affect the required process filings.
Classify the Food
Determine whether the product is a conventional food, acidified food, low-acid canned food or another category. Product pH, water activity, formulation, packaging and processing method can be important.
Register the Establishment
When the acidified-food or low-acid canned-food regulations apply, the commercial processing establishment may need the applicable FCE registration in addition to other FDA requirements.
File Scheduled Processes
Applicable scheduled processes should be submitted for covered products and container configurations using the appropriate FDA process-filing system.
Importers and distributors should not assume that the foreign processor has completed all required filings simply because the product is already sold in another country. FDA can verify establishment and process-filing information when acidified and low-acid canned foods are offered for import into the United States.
FDA consultants can help coordinate the regulatory side of an FCE/SID project, review the information needed for filings, identify missing records and assist communications among the processor, process authority, importer and other parties involved in bringing the product to the U.S. market.
》Learn more about FCE services .
Conventional Cosmetics and OTC Cosmetic Products
The U.S. cosmetics regulatory environment changed significantly with the Modernization of Cosmetics Regulation Act of 2022, commonly known as MoCRA. Covered cosmetic manufacturing or processing facilities are subject to facility-registration requirements, and responsible persons are subject to cosmetic product-listing requirements, with certain statutory exemptions and limitations.
Conventional cosmetics can include facial and body skincare, cleansers, moisturizers, makeup, lipstick, mascara, shampoos, conditioners, perfumes, deodorizing products and many other products intended to cleanse, beautify, promote attractiveness or alter appearance.
Cosmetics generally do not require FDA premarket approval, except that applicable color additives may require approval for their intended uses. This does not mean cosmetics are unregulated. Manufacturers and responsible persons must evaluate product safety, labeling, ingredient declarations, contact information, adverse-event responsibilities, facility registration and product listing where applicable.
When a cosmetic becomes a drug
Product classification depends heavily on intended use and claims. Products such as antidandruff shampoos, certain sunscreens, antiperspirants and other therapeutic personal-care products may be regulated as drugs as well as cosmetics. Calling a product a “cosmetic” does not remove applicable drug requirements.
A dual-status cosmetic/drug product can therefore require compliance with both sets of rules. The drug portion may trigger drug establishment registration, drug listing, active-ingredient requirements and Drug Facts labeling, while cosmetic requirements may still apply to the same product.
This is why label review should take place before packaging is printed in commercial quantities. A claim that appears to be ordinary marketing language can have significant regulatory consequences if it communicates treatment, prevention or another drug-related intended use.
》Additional information about cosmetic compliance services is available here .
Prescription Drugs and Over-the-Counter Drugs
Drug compliance is fundamentally different from conventional food or cosmetic compliance. A company manufacturing, repacking, relabeling or otherwise conducting covered drug operations must determine the registration, listing, application, monograph, manufacturing and labeling requirements applicable to its specific activity and product.
Prescription Drugs
Prescription drug products can involve approved applications such as New Drug Applications, Abbreviated New Drug Applications and other applicable pathways. Manufacturing facilities and listed products must be evaluated within the appropriate FDA regulatory framework.
Foreign establishments offering covered drug products for import into the United States may have FDA establishment-registration, U.S. Agent and drug-listing obligations in addition to requirements associated with the underlying drug approval or authorization.
OTC Drugs
Nonprescription products can be marketed under an applicable OTC monograph framework or an approved drug application, depending on the product. Examples can include certain sunscreens, antidandruff products, skin protectants, antacids, cough-and-cold products and other nonprescription medicines.
Finished OTC drug labeling generally requires a standardized Drug Facts panel containing information such as active ingredients, purposes, uses, warnings, directions, other information and inactive ingredients.
FDA establishment registration and drug listing are separate concepts. Registration identifies covered establishments, while drug listing provides FDA with information regarding drug products manufactured for U.S. commercial distribution. Electronic drug-registration and drug-listing information is submitted using Structured Product Labeling formats and FDA electronic systems.
Companies should also be cautious about assuming that possession of an NDC number means a product is “FDA approved.” Drug listing and NDC information do not by themselves establish that FDA has approved the product.
Facility or Establishment Registration and Product Listing
The phrases “FDA registration” and “FDA product listing” are sometimes used as though they mean the same thing. They do not. The applicable registration or listing system depends on the type of regulated product.
Food
Covered facilities manufacturing, processing, packing or holding food for U.S. consumption may need food facility registration and biennial renewal.
Dietary Supplements
Dietary supplement facilities can fall within FDA food-facility registration requirements while also being subject to specialized dietary supplement CGMP and labeling rules.
Cosmetics
Under MoCRA, covered cosmetic manufacturing or processing facilities and responsible persons have facility-registration and product-listing responsibilities, subject to applicable exemptions.
Drugs
Covered drug establishments register with FDA and applicable drug products distributed in the United States must be appropriately listed.
Foreign companies may also have requirements involving a U.S. Agent or U.S.-based contact depending on the regulatory program. These roles should be established with a party that understands both the regulatory responsibilities and the practical need to respond promptly to FDA communications.
Registration should never be treated as a certificate of regulatory approval. Its function is primarily administrative and regulatory. Marketing that implies FDA endorsement simply because a facility is registered or a product is listed can be misleading.
FDA Label Review: Nutrition Facts, Supplement Facts and Drug Facts
Label compliance should be treated as an integral part of product development rather than a final proofreading exercise. FDA labeling requirements can affect the principal display panel, information panel, product identity, net quantity, ingredient declaration, allergen statements, business information, nutrition information, directions, warnings and marketing claims.
Nutrition Facts
Conventional packaged foods generally use Nutrition Facts when the applicable labeling regulations require nutrition labeling. Serving size, servings per container, calories, nutrients, Daily Values and formatting must be evaluated for the particular product.
Supplement Facts
Dietary supplements generally use Supplement Facts. Dietary ingredients, amounts, Daily Values where established, proprietary blends when applicable, serving information and the separate declaration of other ingredients require careful organization.
Drug Facts
Finished OTC drugs generally use the standardized Drug Facts format. The panel organizes essential consumer information including active ingredients, purposes, uses, warnings, directions and inactive ingredients.
A professional label review can also examine ingredient nomenclature, statement of identity, net quantity of contents, manufacturer or distributor information, country-of-origin issues that may involve other agencies, required warning statements and claims appearing elsewhere on the package or associated marketing.
Website language and marketplace listings deserve attention too. Claims appearing on Amazon, TikTok Shop, Facebook, YouTube, Shopify, company websites and influencer content may contribute to the intended use FDA associates with a product. A compliant physical package cannot necessarily neutralize problematic therapeutic claims being made elsewhere.
》Request Label Review before committing to a large packaging order.
Prior Notice for Imported Food Shipments
FDA must receive Prior Notice of applicable food shipments before the food is imported or offered for import into the United States. Prior Notice allows FDA to obtain information about incoming food shipments in advance and supports the agency's ability to identify shipments that may require additional review.
Information commonly associated with a Prior Notice filing can include the identity of the article of food, manufacturer, grower when applicable, shipper, country of production, country from which the article is shipped, anticipated arrival information and other shipment-specific data.
Importers should build Prior Notice into their logistics workflow rather than treating it as an afterthought when the cargo is already arriving. Incorrect information can cause complications at the border and may require corrections, coordination with the carrier, customs broker, importer and other parties.
U.S. Toll-Free Number and Domestic Contact Information
Some FDA-regulated product categories require specific domestic contact information for adverse-event reporting or other consumer communications. Depending on the product and applicable regulatory provision, companies may use a domestic address or domestic telephone number where required.
Foreign manufacturers sometimes discover this issue only after their packaging design is otherwise complete. Establishing an appropriate U.S. contact mechanism earlier in the label-development process can avoid expensive printing changes.
A U.S. toll-free telephone solution can also make it easier for American consumers, customers and business partners to communicate with the company, although the precise regulatory need must always be determined according to the specific product category.
》See U.S. Toll-Free Number .
Foreign Supplier Verification Program — FSVP
The Foreign Supplier Verification Program is a central compliance issue for many imported foods. In general, FSVP is designed to provide assurance that foreign suppliers are producing food in a manner that provides the appropriate level of public-health protection and that the food is not adulterated or misbranded with respect to applicable allergen-labeling requirements.
The FSVP importer is a specifically defined regulatory role. It should not automatically be assumed to be identical to the customs Importer of Record, freight forwarder, warehouse, distributor or foreign manufacturer. Determining which entity will serve as the FSVP importer should be addressed before goods are shipped.
Hazard Analysis
The program begins with understanding known or reasonably foreseeable hazards associated with the food and whether those hazards require control.
Supplier Evaluation
Supplier performance, regulatory history, food-safety practices and relevant compliance information can influence supplier approval and verification decisions.
Verification Activities
Verification may involve appropriate activities such as audits, sampling and testing, review of records or other measures selected according to the regulatory requirements and identified hazards.
Dietary supplements can involve modified FSVP requirements in certain circumstances because the FSVP regulation interacts with the separate dietary supplement current good manufacturing practice framework. Companies should therefore avoid applying the same generic FSVP template to every imported product.
FDA consultants can assist companies in developing and maintaining FSVP documentation, evaluating foreign suppliers, organizing records, preparing for FDA review and determining the appropriate U.S. party to perform the FSVP importer function.
》Learn more about FSVP Service .
FDA Detention Assistance and Import Compliance
A shipment arriving at a U.S. port does not automatically enter domestic commerce simply because the goods have cleared commercial arrangements with the buyer or seller. FDA-regulated entries may be reviewed by FDA, and the agency can examine shipment information, registration status, product listing, labeling, prior compliance history and other relevant information.
FDA detention can create significant commercial pressure because cargo may incur storage, demurrage, transportation and professional-service costs while the importer attempts to resolve the regulatory issue. Perishable products face additional risk.
The appropriate response depends on the reason for detention. Potential issues can include registration deficiencies, labeling problems, product listing inconsistencies, missing process filings, Prior Notice problems, admissibility concerns, import-alert issues or questions about the regulatory status of the product.
Respond to the actual detention issue.
A successful compliance response should begin by understanding the notice and the specific concern identified by FDA. Submitting unrelated documents or making unsupported claims can consume valuable time without resolving the issue.
FDA detention assistance may involve reviewing the entry documentation, identifying the apparent compliance deficiency, coordinating with the importer and customs broker, assembling supporting records, communicating with appropriate parties and determining whether corrective action, testimony, relabeling, reconditioning, export or another strategy should be considered.
》Companies facing an import problem can review FDA Detention Assistance Service .
FDA Consulting Services for International Companies
Foreign manufacturers often need a U.S.-based regulatory partner because FDA compliance intersects with commercial, logistics and administrative activities performed across several countries. Time-zone differences, language barriers and unfamiliarity with FDA systems can make even a relatively straightforward filing difficult.
European companies exporting cheese, olive oil, wine, cosmetics, supplements or pharmaceutical products; Asian manufacturers producing food, cosmetics and OTC products; Latin American processors exporting coffee, cocoa, tropical products, canned foods and dietary ingredients; and African businesses exporting spices, botanical ingredients, foods and cosmetics all face the same fundamental question: whether their regulatory preparation will withstand U.S. import scrutiny.
U.S. FDA consultants can help bridge the gap between a foreign manufacturer's existing compliance system and the specific documentation and submissions required for the American market.
Product Review
Identify the product category, intended use, claims, ingredients and manufacturing activity.
Registration Review
Determine applicable facility or establishment registration, product listing and U.S. Agent requirements.
Label & Import Review
Review labeling, claims, nutrition information, Prior Notice, FSVP and other import-related requirements.
Ongoing Compliance
Maintain registrations, listings and records and address FDA communications or import issues when they arise.
FDA Compliance Services Directory
Companies can select the regulatory service that corresponds to their product and stage of U.S. market entry.
Build FDA Compliance Before Products Reach the U.S. Border
FDA compliance is most effective when it begins before manufacturing, packaging and shipping decisions become difficult to change. A product should be correctly classified, its applicable facility or establishment registrations identified, required product listings completed, labels reviewed and import obligations addressed before commercial shipments begin.
For conventional foods, the project may involve food facility registration, Nutrition Facts, Prior Notice and FSVP. Dietary supplements can add Supplement Facts and specialized claim requirements. Acidified and low-acid canned foods can involve FCE registration and scheduled process filings. Cosmetics can involve MoCRA facility registration, cosmetic product listing and safety-related obligations. OTC cosmetic-drug products require additional drug analysis. Prescription and OTC drugs can require establishment registration, drug listing, applicable approval or monograph compliance and highly structured labeling.
These requirements apply not only to American companies. Manufacturers, exporters, importers and distributors throughout Europe, Asia, Latin America and Africa routinely need to integrate U.S. FDA requirements into their supply chains before their products can move efficiently into U.S. commerce.
Registration alone is not a complete compliance strategy. Product classification, labeling, claims, supplier controls, import records and continuing regulatory maintenance are equally important. Addressing these subjects before shipment can reduce avoidable corrections and help companies build a more reliable path into the U.S. market.
Need Help Bringing an FDA-Regulated Product to the United States?
ITB HOLDINGS LLC provides FDA regulatory consulting and compliance services for domestic companies and foreign manufacturers, exporters, importers and distributors throughout Europe, Asia, Latin America, Africa and other international markets.
Services can include facility or establishment registration, U.S. Agent representation, product listing, FDA label review, Nutrition Facts, Supplement Facts, Drug Facts, Prior Notice, FCE/SID assistance, Foreign Supplier Verification Program support, U.S. toll-free contact solutions and FDA detention assistance.
Start the compliance process before producing large quantities of packaging or shipping commercial cargo to the United States. Early regulatory review can identify issues while corrections are still easier to implement.
FDA REGISTRATION SERVICES
Unlike our competitors in the United States and overseas, we offer the following services seven days a week.
FOOD
$180.00
MEDICAL DEVICES
$350.00
DRUGS
$350.00
COSMETICS
$350.00
