Article updated in May 2026
The United States remains one of the most important markets for Italian companies looking to expand their international operations. However, entering the U.S. market requires careful management of regulatory aspects, particularly the certifications required by Food and Drug Administration (FDA), the U.S. authority that regulates food safety, medical devices, cosmetics, pharmaceuticals, and other products.
In 2026, FDA regulations and requirements are more complex than ever, but they represent a fundamental gateway to operating successfully in the United States. This article provides a detailed overview of the necessary certifications, regulatory obligations, and strategies for entering and competing effectively in the US market.
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 e 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:
La 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.
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:
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 pre-approval by the FDA, but it is still necessary to ensure that the product meets the standards of security e labeling.Furthermore, in order medical devices e drugs, it is essential to follow thorough registration procedures, which include the submission of detailed technical documentation, safety reports, and GMP compliance.
A fundamental step for exporting to the USA is the Company registration and its manufacturing facilities to the FDA. The company will need to provide detailed information on the products it intends to export and the manufacturing processes, ensuring all requirements are met before shipment.
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 attesting to the product's safety and compliance with U.S. regulations.
Labeling is one of the most important aspects of exporting to the United States. The FDA has specific regulations that require the label to include detailed information such as ingredients, instructions for use, manufacturer's 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 the formats and requirements established by the FDA, particularly regarding the clarity and readability of labels.
Despite the opportunities, the US market also presents challenges that Italian companies must face with a well-defined strategy:
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:
This way, Italian companies will be able to successfully face the challenges and seize the numerous opportunities offered by the US market.
The Food and Drug Administration (FDA) regulates several product categories that many Italian companies wish to export to the United States, and knowing these categories is the first step in correctly setting up an entry strategy. These include, first and foremost, the food and the drinks, which must comply with strict food safety, traceability, and proper labeling standards, in addition to the registration of production facilities that process, package, or store products intended for the US market. Added to these are the cosmetics and personal care products, which, while not requiring prior formal approval before sale, must be safe, bear complete and truthful labeling, and contain only ingredients permitted by U.S. regulations. Another crucial category is that of medical devices, which includes very different products, from simple to more complex devices, all subject to registration and very stringent quality and control requirements. Finally, the Pharmaceutical and related products (as some parapharmaceutical products) undergo an even more rigorous process, which requires extensive technical documentation, safety testing, and compliance with good manufacturing practices, making accurate planning indispensable before entering the US market.
Company and facility registration with the FDA is a fundamental step because it effectively represents the “ID card” of the operator who wants to export to the United States. Without this registration, many products cannot be legally introduced into the U.S. market, and the concrete risk is that My shipment is stuck in customs subject to stricter controls, with significant costs and delays. Registering establishments and activities means providing clear information to the authorities about where and how food, cosmetics, medical devices, or drugs that will arrive in the US territory are produced, processed, or packaged, increasing the transparency and the traceability throughout the entire supply chain. Furthermore, registration is often required by U.S. business partners themselves, such as importers and distributors, who want to be certain they are working with operators who comply with local regulations. From a strategic point of view, therefore, completing these procedures in a timely manner allows Italian companies to present themselves as reliable partners, reduce the risk of border issues, and accelerate the start of sales in the U.S. market.
The Certificate of Free Sale (CFS) is a document that certifies that a specific product is already legally marketed in the country of origin and is therefore not subject to particular prohibitions or restrictions. In the context of exporting to the United States, CLV plays an important role because it represents a guarantee for American authorities and business partners that the product meets the minimum standards required in the country of manufacture. This certificate is frequently required for import practices, especially for sensitive categories such as certain food products, cosmetics, or devices, and is used to support the technical documentation and certifications required by the FDA. For Italian companies, having an updated CLV means being able to demonstrate, in a simple and formal way, that the product is not only compliant with internal regulations but that it is already present on the market without known issues. In practice, the CLV does not replace the authorizations or registrations required by the United States, but rather supplements them, simplifying relationships with importers, customs authorities, and, in general, all actors involved in the distribution chain.
Labeling is one of the most delicate aspects of exporting to the United States because it represents the first point of contact between the product, control authorities, and the final consumer. A correct label is not just a formal requirement, but the tool through which fundamental information is communicated, such as ingredients, Instructions for use, safety warnings, Manufacturer details and in the case of food, Nutritional values e Expiration date. The FDA pays particular attention to the clarity, truthfulness, and readability of labels to prevent US consumers from being misled or from sensitive information, such as allergens or potential risks of use, being omitted. For Italian companies, this means adapting the label to US regulations, correctly translating information into English, and respecting the minimum graphic layouts required, such as the structure of the nutritional panel for food products or the placement of warnings for cosmetic products. An incomplete or non-compliant label can lead not only to disputes and seizures at customs but also to damage to image and loss of trust from business partners and consumers.
Entering the US market means facing a combination of opportunities and challenges that require a well-structured strategy. One of the main difficulties concerns the regulatory barriersThe FDA regulations are complex and vary by product category, which necessitates carefully studying applicable requirements and maintaining a high level of compliance over time. Another challenge is competitionThe United States hosts a large number of deeply rooted local and international companies, which forces Italian businesses to focus on quality, innovation, and the ability to differentiate their offerings to stand out in often saturated sectors. bureaucracy and the Administrative procedures they constitute a significant obstacle, as entering the US market is not limited to simply selling the product. It requires careful management of aspects such as taxation, Incoterms, customs regulations, and intellectual property protection. To face these challenges, it is essential to combine solid regulatory preparation, careful commercial planning, and a network of expert partners and consultants, in order to reduce risks and maximize the potential of "Made in Italy" in the eyes of the US consumer.
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