Entering the U.S. market requires not only a high-quality product but also strict compliance with the requirements of the Food and Drug Administration (FDA) — the federal agency that regulates the safety of food, supplements, cosmetics, and medical devices. Therefore, FDA registration is a mandatory condition for exporters planning to sell or import goods into the United States.
Without the proper authorization, a product may be detained at customs or removed from the market, even if it meets all national standards. FDA registration is not a formality — it confirms that the product is safe, the manufacturing process is transparent, and the supplier is a reliable partner for American consumers.
G8toUS helps businesses complete this process without risks or delays — from document review to full registration support and production status verification.
Which products must be registered with the FDA
The Food and Drug Administration oversees nearly all product categories that can affect human health. Thus, FDA certification is required not only for food or pharmaceutical manufacturers, as often assumed, but for a much wider range of businesses.
Mandatory registration includes:
- Food and beverages. Everything consumed by humans — from ready meals to ingredients, spices, drinks, alcohol, and dietary supplements.
- Dietary and biologically active supplements. The FDA checks their composition and safety.
- Cosmetics and personal care products. Creams, shampoos, decorative cosmetics, perfumes.
- Medical devices. From thermometers to laboratory or clinical equipment, as well as pharmaceuticals.
- Contact lenses, dental materials, veterinary drugs — anything related to human or animal health.
- Packaging and auxiliary materials — if they come into contact with food or affect its quality.
FDA registration for export is mandatory even if the product meets EU standards or holds other international certificates. U.S. law requires separate confirmation, and without it, the product will not be approved for import into the United States.
For manufacturers, this may seem like an additional step, but in practice, FDA registration provides open access to one of the world’s largest markets and demonstrates compliance with global safety standards.
How FDA certification works — key steps
The FDA registration procedure may seem complex, but it simply requires a clear sequence of actions and attention to detail. Companies planning to export products to the U.S. must go through several stages to obtain approval for sales.
- Document preparation. First, it is necessary to determine whether the product requires registration. Then, documents are prepared — manufacturer details, product composition, production processes, and labeling.
- FDA facility registration. The FDA must know exactly where the product is manufactured. Each facility goes through registration to confirm compliance with U.S. safety and hygiene requirements.
- Obtaining a unique registration number. After verification, the company receives a registration number required for customs clearance, transportation, and quality control during import.
- Data renewal. Registration is not a one-time procedure — it must be renewed every two years or whenever production, storage, or company address changes.
The G8toUS team helps clients go through all stages smoothly — from document preparation and translations to communication with FDA and customs representatives. This saves time and prevents unnecessary expenses.
Documents required for FDA approval
Preparing the correct documentation package is a key step, without which FDA certification is impossible. Many companies face difficulties at this stage because U.S. regulatory requirements are detailed and specific.
Typically, to complete FDA documentation, you need:
- Product description — detailed information about composition, production technology, packaging, and labeling.
- Manufacturer details — company name, address, contact information, and legal status confirmation.
- Quality and safety certificates proving compliance with FDA standards.
- Supply chain information — how cargo delivery to the USA is carried out (by sea, air, or road). For certain product categories, the FDA may require additional technical or laboratory confirmations.
Many clients come to us after unsuccessful attempts to complete the procedure independently. G8toUS specialists help ensure everything is done right the first time — from document review to submission of the final package for approval.
How we simplify your path to FDA certification
The FDA approval process may seem complex, especially for first-timers. We take a systematic approach — from product analysis to the final certificate that opens access to the U.S. market.
What we do:
- check whether your product falls under FDA regulation and determine the exact registration category;
- help collect and review documents to avoid application rejections;
- coordinate the submission process and support you through final approval;
- ensure correct product labeling and documentation consistency during shipment;
- advise on import and logistics, including delivery to marketplace warehouses or domestic cargo transportation across North America after certification.
Our approach combines precision, expertise, and understanding of the U.S. market’s nuances. You get not just registration, but a ready-to-use solution that works for your business long-term.
FDA certification with G8toUS: confidence in every step
After FDA registration, we continue to support our clients. G8toUS ensures safe delivery of products to the U.S. — from transport cost planning to final documentation and storage in our U.S. warehouses. For large or regular shipments, sea freight is often the optimal choice, while for urgent deliveries, we offer air freight services.
We make sure every step — from documentation to delivery — meets FDA requirements and avoids delays. With us, entering the U.S. market is not bureaucracy but a well-structured process where every step delivers results.
