Key import and export compliance considerations for successful US market entry.

The US market holds vast potential, but for international businesses, stepping onto American soil is more than a new chapter—it’s a leap into a highly regulated and strong lawsuit environment. In a country where complex rules shape the game, overlooking the finer legal details can mean the difference between rapid growth and costly setbacks. Yet, with the right strategy, companies can thrive here, navigating both the challenges and the unparalleled growth opportunities.  

At Amesto Global, we have seen this firsthand with our clients as they enter this unique domain. To provide expert guidance on the import and export compliance landscape in the US, our Founding Partner, Armin Kirchner, recently sat down with Deanna Clark, Esq., Founder and Managing Partner of Clark-Esposito Law Firm, whose team is dedicated to helping businesses streamline global operations while managing regulatory risks. With extensive experience in US Customs, national security issues and risk management, Clark-Esposito Law empowers international companies to minimize risk and capitalize on growth—all while maintaining a keen focus on customized, practical solutions.  

Dive in to discover the critical legal considerations that international companies should be aware of before scaling up in the US.

Answered by Deanna Clark, Esq. – Managing Attorney at Clark-Esposito Law Firm, P.C.

As a starting point, it is crucial to consider how your product itself is regulated within the United States. As with any product, if it does not meet these basic domestic regulations, you are going to have compliance issues, whether at the border or with regulators in the US marketplace.  This can include a variety of both mandatory and prohibited consumer product label content, which depending on the product, may be regulated by more than one agency, such as the U.S. Food and Drug Administration and the U.S. Federal Trade Commission, who regulate some aspects of product labeling for virtually all consumer products in the US. This may also include prohibited ingredients in foods, packaging regulations, domestic permitting and licensing, and so on. Always begin with asking the question, “how is my product regulated in the destination market?”

Second, there may be (and often are) some specific requirements that apply only to imports in a particular product category. For example, for foods, the first thing that comes to mind is the Foreign Supplier Verification Program, or FSVP, which is a robust FDA compliance mechanism to ensure that foods imported into the US are manufactured abroad under acceptable health and safety standards. Consider also the importer permit required for most alcohol and tobacco importers by the U.S. Alcohol and Tobacco Tax and Trade Bureau, and the requirement that the company maintain a legal entity and a physical facility within the US. These are examples of special regulations which apply only to the imported versions of consumer products. 

Finally, a business seeking to expand into the US marketplace will need to understand their import compliance obligations. Make no mistake, if importing into the US is a frequent or core component of your business, establishing a robust internal import/export compliance program is essential. Importing is complex, and compliance is often monitored by multiple agencies with the authority to turn your goods around at the border and send them back to their country of origin. For example, consumer goods regulated by the FDA face dual scrutiny; while Customs inspects the shipments, FDA agents stationed at ports of entry also examine FDA-regulated products for compliance. These agents have the authority to reject any non-compliant goods, potentially disrupting your supply chain and market entry plans. 

Advance preparation is crucial. All imported goods must comply with US laws at the time of importation, so exporters must identify and implement all applicable US regulatory requirements before shipping. This includes ensuring the product and its packaging meet standards, such as permanently marking the product or packaging with its country of origin, well in advance of departure.

With respect to goods, these must be in a compliant state and accurately reported at the time of export, as US Customs requires an importer to submit advance reporting before an exported shipment ever leaves the foreign port. Recognizing that your goods are of no use to you if they are detained in a Customs warehouse upon arrival, or worse, rejected outright, this is where your product-specific advance compliance work pays off.

At the time of export, you should have confidence that the products themselves are US market-ready, that your product labels are compliant and that all other US-side considerations are in order.

FDA regulations are a key consideration for businesses entering the US. Companies must address multiple layers of compliance, from ingredient restrictions and labeling accuracy to health claims on packaging. For example, both domestic and foreign food facilities must register with the FDA as “food facilities” to be eligible to supply the US market. 

The FDA, in collaboration with US Customs, enforces strict import protocols. “Import Alerts”, for instance, can block certain goods—such as specific foods or ingredients—from being imported unless sourced from approved manufacturers. These can be as obscure as “mustard seeds” from anywhere but a South Pacific destination, and where the FDA has issued an Import Alert, any goods imported in the classification of goods will automatically be detained.  Therefore, you want to ensure that your product is not subject to an Import Alert.

To navigate these complexities, businesses should undertake an early assessment through the development of an import/export plan (which is largely exploratory), followed by the development of an internal import/export compliance manual. This document acts as a “dry run,” simulating the compliance process on paper, anticipating issues, understanding your compliance obligations at all levels and working out unknowns before you have real goods in transit. By planning ahead, companies can avoid delays, ensure regulatory alignment and achieve faster market entry.

Companies can face various types of trouble for non-compliance. Financial penalties are the most common, but more severe administrative actions, such as debarment—which can prohibit your company from importing into the US—are also possible. In extreme cases, criminal penalties may apply, particularly for violations involving sensitive dual-use items (those with both civilian and military applications, such as night vision goggles) or strictly military-use goods.

Businesses also must keep in mind the risk of loss for non-compliance. This is not so much a formal penalty, but it can certainly feel like a penalty when FDA orders fifty thousand dollars of your imported food goods destroyed.

It’s crucial to note that many financial penalties don’t require willful wrongdoing, which is why we strongly advocate for creating and consistently using an import/export compliance manual. Importing is not a “put goods in transit and see what happens” kind of game; penalties can be substantial, not to mention the risk of debarment.

US Customs maintains several penalty frameworks for various types of trade violations. While these are highly scenario and value-dependent, I would just note two important considerations: 1) financial penalties can be severe, and 2) companies who maintain internal import/export compliance manuals will know that for innocent mistakes, they can substantially reduce or even eliminate financial penalties where they voluntarily disclose errors (this is called “prior disclosure”).

US Customs penalties can include significant financial consequences depending on the nature of the violation. A claim of fraud may result in a civil penalty up to the value of the merchandise in question. For grossly negligent violations, penalties can range from up to the value of the merchandise to 4x the lawful duties, taxes and fees owed to the US, or 40% of the dutiable value of the merchandise. Similarly, negligent violations may also result in steep penalties, including up to the value of the merchandise, 2x times the duties, taxes, and fees owed, or 20% of the dutiable value.

That said, it is not all doom and gloom. Mistakes happen, and US Customs recognizes this. For this reason, there are mechanisms for businesses to go to US Customs and ask forgiveness (and mitigate penalties), as well as mechanisms for challenging US Customs when businesses disagree with the agency.

A strong compliance strategy begins with a detailed import/export compliance manual. A well-researched import/export compliance manual is a roadmap to advance compliance in international trade. It is an investment in your business and its future in a foreign market.

Developing this manual requires collaboration with experienced counsel who can anticipate challenges, address gaps and tailor the strategy to the company’s specific needs before the first shipment embarks. By investing in this proactive approach, businesses can confidently navigate the complexities of US regulations and focus on scaling their operation.

The value in counsel really boils down to experience – experience on all fronts. An attorney specializing in international trade will have experience in front-end compliance, logistics and all the steps involved in getting goods from their point of origin past US Customs and into the destination marketplace. This includes anticipating and effectively addressing the common challenges that can arise during trade operations.

Legal skill in this particular area of law is crucial. For example, I have dealt with just about every possible type of violation involving household goods and clothing, to FDA-regulated products such as medications, food and tobacco, to bulk titanium and highly complex dual-use nuclear technologies.

It is particularly important to have counsel familiar with communicating effectively with US Customs. US Customs is a massive agency with its own culture and language, and having counsel who can speak that language, knows how US Customs operates and how US Customs is likely to respond to certain things, is invaluable.

Lastly, in most Customs matters, time is critical. When a potential violation arises, having experienced counsel ready to act immediately, engage with Customs and stay ahead of deadlines can make all the difference.