By Carlos Bisio – CEO at FastForward (FDA Experts)

For companies aiming to export food, beverages, cosmetics, dietary supplements, or medical devices to the United States, understanding FDA (Food and Drug Administration) regulations is not just recommended—it’s essential.

The FDA is the U.S. federal agency responsible for protecting public health by ensuring the safety and labeling of products that reach American consumers. Its authority covers a wide range of goods, including packaged foods, seafood, snacks, juices, cosmetics, dietary supplements, and over-the-counter medical products.

One of the first steps for foreign manufacturers or distributors is to properly register their facility with the FDA and appoint a U.S. Agent to serve as a liaison with the agency. This process helps ensure traceability and accountability in case of product recalls or inspections. Failure to comply with FDA requirements can result in customs detentions or denial of entry at U.S. ports.

Foreign manufacturers and exporters must adhere to several key requirements before shipping to the U.S., such as:

• Facility registration: All foreign food and cosmetic facilities must register with the FDA and renew the registration every two years (or annually for some products).
  
  
• U.S. Agent designation: A mandatory contact person or entity based in the U.S. to communicate with the FDA on behalf of the foreign company.
  
  
• Labeling compliance: FDA requires specific formats for ingredient lists, nutrition facts (for foods), warnings, and product claims. These differ substantially from European or Latin American labeling rules.
  
  
• Prior Notice: Food shipments must be pre-declared to U.S. authorities before arrival.
  
  
• Adherence to specific laws: Recent updates like the FSMA (Food Safety Modernization Act) and MoCRA (Modernization of Cosmetics Regulation Act) have introduced new standards for safety plans, product listing, and adverse event reporting.
  
  

Failing to meet these standards may result in delays at customs, automatic detention, or import alerts.

At FastForward, we have analyzed recent trade and regulatory data and noted recurring compliance issues among exporters—especially in labeling, prior notice filings, and facility registration lapses. These gaps often delay access to the U.S. market or expose companies to regulatory penalties.

Italian and Latin American companies—particularly in the food and beauty sectors—often face challenges navigating this regulatory landscape, which differs significantly from EU or Latin American standards. Understanding the scope of FDA inspections, labeling rules (such as nutrition facts and ingredient declarations), and import alerts is crucial for market entry and business continuity.

As regulatory updates continue under laws like FSMA (Food Safety Modernization Act) and MoCRA (Modernization of Cosmetics Regulation Act), staying informed and compliant is more important than ever for exporters targeting the U.S.

In 2024, Italy’s exports to the United States reached approximately $70.16 billion, with FDA-regulated sectors playing a significant role in this trade relationship. The top three FDA-regulated Italian export sectors to the U.S. were:

1. Pharmaceutical Products: $10.64 billion
   
   
2. Beverages, Spirits, and Vinegar: $3.19 billion
   
   
3. Essential Oils, Perfumes, Cosmetics, and Toiletries: $1.31

These sectors collectively accounted for over $15 billion in exports, underscoring the importance of FDA compliance for Italian exporters. Looking ahead, projections for 2025 suggest continued growth in these industries, driven by sustained demand and Italy’s strong manufacturing capabilities. However, exporters must remain vigilant regarding regulatory compliance, particularly with FDA requirements, to ensure seamless market access and to capitalize on growth opportunities in the U.S. market.

By Gerson, Preston, Klein, Lips, Eisenberg & Gelber

Cross-border business operations between Italy and the United States create unique opportunities for strategic tax planning. While transfer pricing is often viewed primarily as a compliance matter, forward-thinking companies recognize it as a powerful tool for enhancing profitability and optimizing global tax positions.

The international business landscape has evolved significantly in recent years, with Italian companies expanding their US presence across diverse sectors including manufacturing, luxury goods, yachting, and food & beverage. These expansions create complex intercompany relationships that, when thoughtfully structured, can yield substantial economic benefits.

At a recent business forum, Nicolò Fabbrizio, Partner at Gerson Preston Klein Lips Eisenberg & Gelber, noted how transfer pricing strategy has become a crucial element of financial planning for international businesses. “When properly implemented, strategic transfer pricing aligns business objectives with tax efficiency, creating value beyond mere compliance,” Fabbrizio explained. “Companies that view transfer pricing proactively often discover it can be a competitive advantage.”

The firm’s approach focuses on identifying opportunities within legitimate transfer pricing methodologies that align with business realities while optimizing tax positions. This might include strategic placement of intellectual property, thoughtful structuring of management services, or appropriate allocation of risk and reward across jurisdictions.

Michael Desaulniers, CVA, who leads the firm’s Valuation & Transfer Pricing practice, emphasizes the importance of substance in these arrangements. “The most successful strategies are those built on genuine business operations, not artificial constructs,” he notes. “Our expertise lies in identifying authentic opportunities that reflect operational realities.”

Italian businesses navigating these complexities benefit from advisors with deep understanding of both US and Italian tax systems and cultural nuances. By taking a strategic approach, companies can transform a potential compliance burden into a value-creation opportunity.

For more insights on transfer pricing strategies, Nicolò Fabbrizio (nif@gpkleg.com) and Michael Desaulniers (mjd@gpkleg.com) can be reached at 305-868-3600.

By Jacksonville Port Authority

Amidst rising tariffs and economic uncertainties, U.S. Foreign Trade Zones (FTZs) have become strategic tools for savvy importers and exporters. For members of the Italy America Chamber of Commerce Southeast (IACCSE), an FTZ offers compelling advantages worth exploring.

What Are Foreign Trade Zones?

FTZs are designated areas under U.S. Customs supervision which are considered outside U.S. Customs territory. Within these zones, companies can import, store and process goods while deferring or potentially eliminating customs duties if re-exporting. This arrangement provides significant flexibility for supply chain management and cash flow optimization.

Strategic FTZ Advantages

The Jacksonville Port Authority (JAXPORT) operates Foreign Trade Zone No. 64, Florida’s largest, spanning over 5,000 square miles across 10 counties in Northeast Florida. This extensive coverage provides Italian importers with access to streamlined customs procedures and duty benefits.

“We’ve seen a growing number of companies exploring FTZ benefits as they reevaluate their supply chains,” said Justin Ryan, JAXPORT Manager, FTZ No. 64. “FTZs offer companies supply chain flexibility and a strategy to respond to the dynamic trade environment we see in 2025.”

FTZ participants can deliver their goods directly from the port to their FTZ-approved facilities, simplifying logistics.

Key Benefits for Italian Businesses

For Italian companies importing to the U.S. or American businesses exporting to Italy, FTZs offer multiple advantages:

• Deferred Customs Duties: Improve cash flow by delaying duty payments until goods enter the domestic market

• Duty Elimination: on goods destined for re-export

• Rapid Activation: New storage sites can be operational within 30 days, manufacturing sites within 120 days.

As global trade uncertainties persist, JAXPORT’s FTZ No. 64 – and other U.S. FTZs – represent a valuable resource for IACCSE members seeking to maintain competitive advantage while navigating the complexities of international commerce.

By Fluentis

With new tariffs introduced by President Trump, many Italian manufacturing companies are seriously considering opening production facilities in the US.

It’s a smart move — but it comes with challenges. International expansion isn’t just about opening a branch abroad — it means replicating your entire organizational model in a completely different environment, with new tax rules, different currencies, local teams speaking other languages and the need to keep all branches connected and aligned.

Relying on an advanced ERP system becomes essential to handle operational and regulatory complexity.

Without it, companies can run into key issues like:

• Disconnected operations:
• HQ works in Italian, the US branch in English with different processes. Data isn’t synced, making centralized control tough and leading to delays, errors, and poor visibility.
• Currency headaches:
• Invoices in Euros and USD are managed manually or in Excel, causing reporting errors, margin loss, and planning difficulties.
• Tax compliance risks:
• Local tax rules aren’t supported by the existing ERP, leading to non-compliance, potential penalties, and reliance on third-party software.
• No real-time oversight:
• HQ lacks visibility into inventory, production, and sales abroad, resulting in misaligned strategies and slow decisions.

Fluentis ERP offers a comprehensive solution to support Italian companies in the US, ensuring efficiency, compliance, and seamless integration across all business locations, providing:

✅ Multi-language management, to adapt easily to local teams and markets.

✅ Multi-currency features, with automatic exchange rate updates.

✅ Multi-tax system, to handle different fiscal regulations while keeping full central control.

And thanks to our Cloud-native infrastructure, Italian and US branches can collaborate in real time, share data instantly, and maintain unified governance across borders.

If you’re an Italian SMB already operating in the US – or if you’re just about to take this step – let’s talk.

We’ll show you how Fluentis ERP can support you by simplifying every step of the journey.

For more information: marketing@fluentis.com