Exporting to the United States in 2026: FDA Certifications, Regulations, and Strategies for the US Market
TLDR
In 2026, the United States remains the world's largest economy, with a GDP of approximately $32.38 trillion and real growth of 3.9% annually.
The FDA regulates food, cosmetics, medical devices, and pharmaceuticals: each sector has specific requirements to be met before exporting.
Companies and facilities must be registered with the FDA, with exceptions for small agricultural businesses; the HACCP system is also required for food products.
Cosmetics do not require prior FDA approval, but must comply with safety, composition and labeling requirements, with labels translated into English.
Per competere servono conformità normativa con consulenti specializzati, differenziazione del Made in Italy e partner locali per dogane, fisco e proprietà intellettuale.
Index
Article updated in May 2026
Why is the United States a strategic market for Italian businesses
In 2026, the United States continues to be the world's leading economy, with a current price GDP of approximately 32.38 trillion dollars, with annual real GDP growth of 3.91% and a per capita GDP of approximately $7,560. This market represents a strategic destination for Italian companies, thanks to its size, purchasing power and investment-friendly ecosystem. The strength of the US market is reflected not only in its greatness but also in its continuation interest in innovation, the quality and the differentiation, elements that blend well with the Italian excellence in numerous sectors:
Agribusiness: U.S. consumers are very oriented towards high-quality products, particularly in the wine, cheese, pasta, and olive oil sectors. The perception of "Made in Italy" as a symbol of food excellence represents a significant driver for exports.
Cosmetics and beauty: The US beauty market is one of the largest in the world, and consumers are constantly seeking innovative, natural, and sustainable products. Italian companies, with their expertise in high-quality cosmetics, natural ingredients, and cosmetic technology, are in a favorable position.
Technology and innovation: The US technology sector is booming, with growing interest in advanced solutions in automation, artificial intelligence (AI), and industrial robotics. Italian companies can contribute with advanced technologies, leveraging their know-how in sectors such as industrial automation, precision mechanics, and technological design.
Mechanics and machinery: The US industry continues to invest heavily in advanced machinery to improve the productivity and efficiency of its factories. Italian companies, with their reputation for mechanical innovation, find opportunities in sectors such as automation, food processing, and packaging machinery.
FDA Regulations and Requirements for Export to the United States
The Food and Drug Administration (FDA) is the U.S. federal agency that regulates a wide range of products, including food, cosmetics, medical devices, and drugs. Each sector has specific requirements that companies must meet before exporting to United States.
Sectors regulated by the FDA
Food and DrinkTo export food products to the United States, it is essential for companies to obtain the’FDA authorization. Food must comply with food safety, labeling, and traceability regulations. The FDA also requires manufacturing facilities to be registered.
Cosmetics and personal care productscosmetics, while not requiring actual FDA approval before sale, must meet the requirements of security, labeling and composition. In case of products containing unsafe or irregular ingredients, the company must be prepared to respond to requests for evidence or market withdrawals.
Medical devices and pharmaceutical productsIn these sectors, the FDA has very strict regulations. Medical devices must be registered and approved before they can be marketed, and companies must comply with good manufacturing practices (GMPand to the procedures of Quality control.
Necessary certifications and registrations
To operate in the United States, Italian companies must meet specific obligations related to Product registration and all FDA required certifications. Among the main certifications required, we can find:
FDA Registrationit is necessary to register your company and facilities with the FDA, unless you are a small farming business or there are other exceptions provided by law.
Certificate of Free Sale (CLV)For many products, the FDA requires the company to provide a certificate attesting that the product is legally marketed in the country of origin. This certificate is a formality for import and sales authorization.
HACCP System (Hazard Analysis and Critical Control Points): For food products, the HACCP system is fundamental to ensure that products are free of contaminants and to meet the food safety regulations imposed by the FDA.
FDA Good Manufacturing Practices (GMP)GMP compliance is essential to ensure products are manufactured under safe conditions and with appropriate quality standards. These regulations are particularly relevant for medical devices and pharmaceuticals.
How to prepare for export to the USA: practical steps
1. Know the specific industry regulations
Each sector has different requirements, and the company must be well-informed about the regulations applicable to its product. For example, the cosmetics and the personal care products do not require prior FDA approval, but it is still necessary to ensure that the product meets the standards of security and labeling.In addition, for medical devices and drugs, ; it is essential to follow thorough registration procedures, which include the submission of detailed technical documentation, safety reports, and GMP compliance.
2. Register the company and products
A fundamental step for exporting to the USA is Company registration and its production facilities to the FDA. The company will need to provide detailed information about the products it intends to export and its production processes, ensuring that all requirements are met before shipment.
3. Certify product safety
In the case of food, cosmetics, medical devices, or pharmaceuticals, each exported product must comply with U.S. safety regulations. This involves conducting laboratory tests, implementing a traceability system, and preparing quality control reports. The FDA often requires the manufacturer to provide documents certifying the product's safety and compliance with U.S. regulations.
4. Adapt labeling
Labeling is one of the most important aspects of exporting to the United States. The FDA has specific regulations that require the label to provide detailed information such as ingredients, usage instructions, manufacturer data, safety warnings, and, in the case of food, also the Expiration date.The information must be translated correctly into English and must comply with formats and requirements established by the FDA, particularly regarding the clarity and readability of labels.
Entering the US Market: Challenges and Strategies
Despite the opportunities, the US market also presents some challenges that Italian companies must face with a well-defined strategy:
Regulatory barrierslFDA regulations, particularly for food, cosmetics, and medical devices, are strict and complex. Italian companies must ensure their products comply with U.S. safety and labeling requirements. FDA certification is often necessary to market certain products, and thorough management of documentation and certifications is crucial to avoid customs delays or blockages.
Local competition: The United States hosts numerous large companies and well-established international brands operating in various sectors. Competition is therefore intense, especially in more mature sectors such as food, fashion, and cosmetics. To successfully enter the market, Italian companies must focus on differentiation, innovation, and added value.
Bureaucratic and procedural barriersl’Entry into the United States is not limited to product sales, but requires a solid administrative structure, adequate tax compliance, and careful management of import and distribution rules. The adoption of correct Incoterms, oversight of customs regulations, and management of intellectual property are all crucial factors in avoiding legal issues.
How to Face Challenges: A Strategic Approach
To deal with the risks associated with the United States market, Italian companies must adopt a multidimensional strategic approach, which unfolds in three fundamental steps:
Investing in regulatory compliance: Rely on specialized legal consultants to thoroughly analyze local regulations, particularly those related to the FDA and other regulators. It is essential to ensure that documentation is complete and up-to-date, thereby preventing the risk of delays or penalties.
Differentiate to compete focus on innovation, high quality, and a strong brand, adapting products to U.S. consumer preferences while maintaining the authenticity of Made in Italy, to stand out from local competition.
Build a network of reliable local partners: Identify partners with experience in customs management, tax compliance, and intellectual property protection to effectively overcome bureaucratic and procedural barriers.
This way, Italian companies will be able to successfully face the challenges and seize the numerous opportunities offered by the US market.
Frequently Asked Questions
Quali prodotti italiani sono regolati dalla FDA per l’export negli Stati Uniti?
The FDA regulates food and beverages, cosmetics and personal care products, medical devices and pharmaceuticals. Food requires registration of facilities, safety, labeling and traceability. Cosmetics do not require prior approval but must be safe. Medical devices and pharmaceuticals have the strictest regulations, with registration, approval and compliance with GMPs.
Perché un’azienda italiana deve registrare impianti e stabilimenti presso la FDA prima di esportare negli USA?
La registrazione presso la FDA è necessaria perché permette di introdurre legalmente i prodotti sul mercato statunitense ed evita blocchi doganali, ritardi e controlli più severi. Fornisce all’autorità informazioni su dove e come si produce, aumentando la tracciabilità. Sono previste eccezioni, come le piccole imprese agricole. Gli importatori e i distributori americani la richiedono spesso ai partner.
What is the Certificate of Free Sale (CLV) for exporting to the United States?
Il Certificato di Libera Vendita attesta che il prodotto è legalmente commercializzato nel Paese di origine, quindi senza divieti o restrizioni. Per molti prodotti la FDA lo richiede come formalità per l’importazione e per la vendita. Non sostituisce registrazioni e autorizzazioni americane, ma le integra e semplifica i rapporti con importatori e autorità doganali.
What FDA labeling rules must an Italian product that is exported to the United States comply with?
L’etichetta deve riportare ingredienti, istruzioni d’uso, dati del produttore, indicazioni di sicurezza e, per gli alimenti, la data di scadenza. Le informazioni vanno tradotte correttamente in inglese e rispettare formati, chiarezza e leggibilità stabiliti dalla FDA. Un’etichetta incompleta o non conforme può causare contestazioni, sequestri in dogana e danni d’immagine con i partner commerciali.
Do FDA approvals are needed to export Italian cosmetics to the United States?
No, i cosmetici non richiedono una vera approvazione FDA prima della vendita, ma devono rispettare requisiti di sicurezza, etichettatura e composizione. Se il prodotto contiene ingredienti non sicuri o irregolari, l’azienda deve essere pronta a rispondere a richieste di prove o a ritiri dal mercato. Conoscere la normativa di settore resta quindi indispensabile.
Quali sono le principali sfide per un’impresa italiana che vuole entrare nel mercato USA e come affrontarle?
The main challenges are the FDA regulatory barriers, strong local competition and the bureaucratic complexity, which includes tax, Incoterms, customs and intellectual property. To overcome them, three actions are needed: investing in compliance with specialized legal advisors, differentiating ourselves through innovation and the quality of Made in Italy products, and building a network of reliable local partners.
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