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 its 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.