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 INLAY USA

The Question: When international small and medium-sized businesses enter the U.S. market, they face numerous critical challenges. These include identifying and attracting the right talent, motivating them, and retaining them over time. In other words, the question is: what are the best ways to manage personnel in a country like the United States?

The Context: The labor market in the United States has always been much more flexible and dynamic than in Europe; people change jobs more quickly and more frequently. This represents a significant challenge for companies. In addition, in recent years, employer-employee relationships have become much more complicated due to new factors that have emerged. These factors include:

·  Changes brought about by the pandemic, such as remote working.

·  The increased use of technology, leading to digital transformation.

·  A greater emphasis on social issues like work-life balance, diversity, equity and inclusion.

To make the context even more complex, there is a widespread shortage of labor in all sectors, leading to fierce competition among firms and significant wage growth.

The Answer: In my experience, both as a Corporate HR professional and as an HR Advisor, I have always considered building an ecosystem that considers, in an integrated way, the following factors:

·  Communication – widespread and transparent

·  Base pay – at least in line with the market

·  Variable pay – simple commission and incentive plans

·  Bonuses and incentives – targeted and effective

·  Benefits – comprehensive and competitive

·  Work environment – healthy, positive, and open

·  Learning – programs dedicated to employee development

In summary, for an effective human resources attraction and retention policy, attention must be paid to both total compensation (base pay, variable pay, incentives, benefits) and the work environment (communication, environment, employee development, and management). This is necessary regardless of company size.

Are you interested to discuss in more details about your specific situation? Call me at +1-954-955-9447 or send an email at stefano.vetralla@inlay.it.

By Stefano Vetralla (INLAY USA – Managing Partner) (*)

(*) Stefano Vetralla, Managing Partner of INLAY USA, is a seasoned global HR Trusted Advisor with extensive experience in start-ups, mergers and acquisitions, HR transformation, and change management, he provides expert guidance to Boards and Executive Leadership Teams.  His work centers on succession strategy, talent recruitment, assessment, and retention, with a particular focus on sourcing global leaders for international companies thriving in North America. In 2014, Stefano relocated to the USA to become EVP and Global Chief People Officer at KEMET Electronics, a global manufacturing leader. Before that, he held a series of progressively responsible international HR positions across EMEA, the Americas, and APAC at industry giants like Hewlett-Packard, 3Com Corporation, and Belgacom.